Join our Start-up Pitches

2 July, 14:30 - 16:00, during Networking Break on Stage 2

2 July, 17:15 - 17:30 BayOConnect Start-up Award sponsored by aws (aws credits worth 5.000 USD)

Start-ups promote their ideas and get in touch with experts, experienced founders, investors and scientists to get constructive feedback.

1. Modiblast

1. Modiblast

Modiblast is developing immunomodulatory therapies aimed at reprogramming leukemic cells in vivo to establish a profound and lasting immune response against the tumor. In acute myeloid leukemia and high-risk myelodysplastic syndrome, our goal is to prolong phases of remission and delay or prevent relapses. Ultimately, we aim to provide safe, easy-to-use, and self-administrable therapies that support patients at several stages of disease. Our lead program, MB101, advances towards the clinic and is backed by a growing body of preclinical and patient data created under off-label use.

Direct cell reprogramming is an emerging field in human medicine with therapeutic potential that equals cell and gene therapy yet avoids the cost-intensive and time-consuming logistical challenges associated with the latter.

Modiblast is a privately held biopharmaceutical company developing proprietary cell reprogramming regimens aimed at turning cancer cells into antigen-presenting cells following the “Trojan horse” motif. Its lead program, MB101, combines cytokine and prostaglandin pathway modulation, to elicit a comprehensive and sustained anti-tumor immune response.

Modiblast’s scientific framework was developed by its CEO/CSO Prof. Dr. Helga Schmetzer and her group at the LMU University Clinic. Since its foundation in 2020, Modiblast has generated robust preclinical data, strengthened IP and regulatory aspects, and more recently formed alliances with renowned clinical centers to generate patient data from off-label use applications. In three heavily pretreated patients, MB101 was well-tolerated, activated leukemia-specific adaptive and innate immune cells, showed early signs of efficacy, and contributed to hematological recovery.

Other key aspects of Modiblast’s therapeutic strategy include:

Personalized therapy, yet non-disruptive workflow
By reprogramming the patient’s own leukemic cells into antigen-presenting cells in vivo, Modiblast addresses the full individual repertoire of leukemic antigens. As a result, the therapeutic strategy is universally applicable across all subtypes. At the same time, no laborious ex vivo manipulation, patient conditioning such as lymphodepletion, neoantigen prediction, or shipments of patient specimens are needed.

Quality of live-focused product profile

Patients in remission are reluctant to commit to frequent hospital visits and prolonged stays. Given the patients’ fragile status, maintenance therapies should not cause additional burdens. Modiblast exploits a novel combination of endogenous substances that have been shown to be safe and well-tolerated individually. Novel subcutaneous formulations of our drug regimens will unlock the possibility of self-administration at home.

Synergistic effects through hematological recovery

Patient data hint at MB101’s ability to restore neutrophil and thrombocyte counts in heavily pre-treated patients potentially avoiding neutropenia, thrombocytopenia, and the associated need for transfusions. A positive effect on hematological recovery could enable progressing into earlier lines of treatment or an expanded treatment label.

www.modiblast.com

2. Reactive Oxygen Therapeutics (ROT)

2. Reactive Oxygen Therapeutics (ROT)

“How selective amplification of inflammation can have a curative effect”.

We all know that inflammation is “bad”. It causes aging, harms tissue, and helps cancer. We try to prevent and avoid it. Right now, all autoimmune conditions are treated with immunosuppressants and antioxidants. The problem is that functioning immune system also gets affected and causes infections and adverse side effects. We offer selective and careful induction of oxidative stress in affected cells which can cure them without compromising the immune system.

ROT is an early-stage pre-seed start-up. We are dedicated to the treatment of health conditions triggered or accompanied by oxidative stress (OS), such as autoimmune diseases and cancer. Our innovative approach will utilize a novel small molecule prodrug strategy, which is built upon OS-inducing molecular catalysts. These prodrugs are meticulously designed to activate exclusively within cells already experiencing oxidative stress, thereby addressing the patient's condition without causing harm to healthy tissues. The modular design of the prodrugs lets us attach any drug and significantly boost its selectivity toward cancerous tissue and activated myeloid cells (responsible for inflammatory boost). 

We already have one drug candidate able to resolve inflammation in autoimmune conditions by selectively generating OS in already activated but compromised neutrophils. Healthy cells stay unaffected. This drug can potentially be used against rheumatoid arthritis, chronic granulomatous disease, and gout.  

The company is a spin-off from Friedrich-Alexander-Universität Erlangen-Nürnberg. The main work and discovery were done in the NeutroCure project (www.neutrocure.eu). The new drugs were developed in Erlangen and tested by all colleagues from Germany, Spain, UK, Sweden, and Ukraine. We are preparing to apply for EXIST-Forschungstransfer to do preliminary toxicology study and scout for optimized structures of our drug, as well as to prepare for VC funding. 

3. IRUBIS

3. IRUBIS

IRUBIS brings life-saving medications faster to patients by real-time monitoring in process development and drug manufacturing
Until now, monitoring of critical process parameters in the manufacturing of biopharmaceuticals are still performed manually. IRUBIS enables automated monitoring and control of bioprocesses with the innovative measuring system Monipa.


IRUBIS GmbH is a biotech start-up based in Munich, Germany. The company was founded in 2017 with the aim to make inline monitoring of bioprocessing by mid-infrared (MIR) spectroscopy to become the standard in manufacturing of biopharmaceutical drugs. During the past seven years the company has developed Monipa, in- a mid-infrared spectroscopy system for bioprocessing.
Biopharmaceuticals (such as vaccines) are produced with the help of mammalian cells in socalled bioreactors. A major challenge is to ensure optimal conditions for the cultivation of the cells (upstream) as well as quality control during the subsequent purification of the active
ingredients (downstream). Therefore, samples have to be taken and analyzed manually every day so far. “The faster the production batch is released, the faster it can be sold, the faster patients can obtain their life-saving medications, and the lower the value of inventory that needs to be held by the manufacturer.” [1] On average it takes more than 10 yrs and costs more than 1 bn $ to bring a new drug to market [2]. In Biopharma there is still a huge lack of automation! IRUBIS enables the continuous monitoring and control of important parameters (e.g. metabolites/nutrient/protein/excipients) with a novel spectroscopy system, Monipa combined with IRUBIS own evaluation software. Monipa's hardware consists of an infrared spectrometer and a disposable sensor element. The software uses smart algorithms for analytics and process control to enable the first time a spectroscopy plug-and-play solution.
The most important unique selling points are the automated and continuous monitoring, the easy ready-to-use solution, the sterile disposable component, and the low acquisition costs compared to other spectroscopic systems.
[1] https://bit.ly/3AQY0Q9
[2] https://bit.ly/3BYT0dK

www.irubis.com

4. Mallia Therapeutics

4. Mallia Therapeutics

The soluble CD83 molecule as a new therapeutic product for topical treatment of hair loss.

 

Introduction
Mallia Therapeutics develops novel therapies for people suffering from hair loss.
Unique investment opportunity with low risk of failure, but high rewarding potential of expected 50x return on investment in less than 3 years
This unique and novel treatment option has a tremendous sales potential in androgenetic alopecia and alopeciaareata as well as cosmeceutical
Topical application and nonsystemic availability results in a superior safety profile. Based on 20 years of research, sCD83 mediates hair regrowth | prevents the onset of hair loss reactivates hair follicles | induces new hair follicles

Around 147 million people affected globally with alopecia areata
More than 3000 million people affected globally with androgenetic alopecia
Expected global market expansion by the end of 2033 to  US$ 24.0 Billion  9.1% CAGR

 

The CD83 protein
Our product is the soluble CD83 protein - Mode of Action is known
IP is secured in the field of hair loss and wound healing
Clinical development plan has been discussed with the BfArM
Shelf-life stability: over 10 month at RT and for years at -80°C
Long term experiments – no morbidity, mortality, increased risk of Clinical candidate
->Proof of principle - murine and humaninfections or tumor cell growth

 

sCD83 induces new hair growth in a pre-clinical Androgenetic hair loss model

Translation into the human ex-vivo system

Topical sCD83 (twice a week) boosts hair regrowth after 4 months

Development Plan after BfArM Meeting
Based on the financial requirements to reach POC, Mallia Therapeutics is raising €10 million in a series A financing round
n order to bridge the time to finalize series A, Mallia-Therapeutics closed a seed funding round through convertible loan with a financing
volume of up to EUR 500,000 Rate of interest on the loan shall be six per cent per annum (6 % p.a.) Loan period is 18 months at maximum
Next Equity Round regarding the equity investment under application of a discount of fifteen percent (15%) on the applicable (fully diluted) pre-money valuation of the company

Exit scenario: Short term exit strategy in 2026 based on a trade sale at an expected price tag of €1 billion, resulting in a potential multiple of about 50x

www.mallia-therapeutics.com

5. mbiomics

5. mbiomics

Mbiomics- Unlocking the full Immunological Pand Metabolic Power of the Gut to redefine therapeutics
There is strong clinical evidence that the microbiome has a game-changing impact across a variety of indications – ranging from cancer to autoimmune disease, and neurological disoders: enabled by the tailwinds of technology conversion and consolidating all clinical evidence in the field, mbiomics is building a techbio platform that redefines microbiome-based therapeutics – Let’s jointly explore our innovative platform approach and how we combine cutting-edge assets to design, develop, and manufacture synthetic complex consortia products that reinstate healthy microbial ecosystemswith indication-specific features. Our modular product concept can rapidly expand into pipeline indications, with a first lead program entering the clinic in 2026.

mbiomics was founded in 2020 with the vision to overcome the current limitations and improve the clinical efficacy of fecal transplants by designing complex microbial consortia with superior safety and disease-tailored activity.
Although we have yet to understand the human microbiome and its role in disease fully, the scientific evidence on the efficacy of complex live biotherapeutic products (LBPs) in modulating the microbiome is striking, as evidenced by the FDA approval of the first two commercial donorderived products in 2022 and 2023, respectively.
Bacterial LBPs have demonstrated the potential to modulate the human microbiome and positively alter this highly complex and interactive community.1 Today’s advances in precision analytics and computational biology allow us to rationally design and manufacture novel and improved LBPs.
Based on the growing evidence of positive outcomes seen with full ecosystem products, mbiomics has developed a proprietary techbio platform that aims to combine the disease-modifying potential of large consortia with the safety and scalable manufacturability of GMP-manufactured nonengineered microbial strains isolated from healthy individuals.
Enabled by our proprietary analytics technology, in combination with patient insights and cuttingedge data science, our products will recapitulate the functional diversity and activity of healthy microbiomes and are enriched for indication-specific mechanisms of action. With this approach, we aim to access the gut microbiome’s full immunological and metabolic potential to restore healthy
microbial ecosystems and thereby overcome disease in a range of severe and chronic indications.
We now have the tools to consolidate the last 20 years of experience in the field and build a scalable platform for developing LBP-based microbiome therapeutics. This will help address a variety of indications with high unmet medical needs, such as autoimmune diseases, cancer, and neurological disorders.
In spring 2023, we closed a series A round of total 18M EUR to recruit an expert microbiome drug discovery team, expand to Boston, and deliver a translationally de-risked lead candidate consortia by H2 2025 - as a first demonstration of our integrated platform.
We are currently seeking bold and experienced (tech)bio investors to join our current investor syndicate in a series A-2. We plan a US-focused clinical trial strategy with a first-in-human trial in 2026, and fast-track expansion of our product pipeline.

www.mbiomics.com

6. CMD Health

6. CMD Health

Revolutionizing CMD Treatment: Our Holistic Digital Approach (DiGA)
Discover our groundbreaking DiGA, the first comprehensive digital solution for managing craniomandibular disorder (CMD). Our talk will explore how integrating multiple therapeutic approaches digitally can transform patient outcomes in oral health.


CMD Health is spearheading a transformative approach in the digital health sector with its innovative
Digital Health Application (DiGA) for the management of temporomandibular disorders (TMD), more
commonly known as jaw joint disorders or CMD. Our application is the first to offer a holistic,
multidisciplinary digital treatment platform that integrates physiotherapeutic exercises,
psychoeducation, and extensive disease-specific information, enabling patients to manage their
condition from the comfort of their homes.
Our business model revolves around the DiGA framework, which allows digital health applications to
be prescribed by doctors and reimbursed by statutory health insurance in Germany. This framework
not only facilitates rapid market penetration and adoption but also ensures that patients receive
access to innovative, safe, and effective treatment solutions.
Since our inception, CMD Health has reached several significant milestones. We have developed a
prototype that has been tested in a pilot study, demonstrating its effectiveness. The positive
outcomes from our initial research have propelled us into further development stages, aiming for
official certification as a medical device and subsequent listing as a DiGA by the German Federal
Institute for Drugs and Medical Devices (BfArM).
In addition to our technological advancements, our commitment to research and development is
evidenced by ongoing clinical studies designed to validate the efficacy of our digital therapeutic
approach. These studies are crucial for our application's certification process and help in refining the
product to meet the specific needs of our target audience.
Our solution not only addresses a significant gap in the treatment of CMD but also sets a precedent
for digital therapies in the dental sector, potentially expanding to other areas of medical need. As we
continue to innovate and push the boundaries of what is possible in digital health, CMD Health
remains at the forefront of offering cutting-edge solutions that significantly improve patient
outcomes and enhance the quality of life for those suffering from chronic conditions.

7. 4NEURON

7. 4NEURON

REDEFINING EPILEPSY MANAGEMENT THROUGH NEXT-GENERATION
THERAPEUTICS
Embark on a journey to revolutionize rare disorder seizures treatment.
Discover the power of scientific ingenuity as we unveil a groundbreaking class of small molecule compounds. Join us on our preclinical into clinical development journey to transform children's lives. Promising data package with in-vitro, in-vivo and ex-vivo shows that seizure-free future can go hand in hand with clear cognition and vigilance of our young patients.

Imagine a world where those suffering from some rare disorders starting in
early ages and accompanied by daily seizures, find hope in a groundbreaking new
class of compounds. Today, we embark on a journey together to revolutionize
treatment for these patients, offering the possibility of a life unburdened by the
relentless grip of seizures.
Currently, individuals with these rare disorders face an uphill battle. Conventional
treatments fall short, leaving patients and their families grappling with the harsh
realities of frequent seizures and limited options for relief, facing trying different
medications and treatment schemes which are only partly helpful. The need for a
transformative solution for them has never been more pressing.
Enter our game-changing approach - a novel class of compounds designed to target the intricate mechanisms underlying rare disorders characterized by seizures. These compounds represent a beacon of hope, offering the potential to disrupt the status quo and usher in a new era of treatment.
Our lead candidate, crafted and tested through in-vitro, in-vivo, and ex-vivo studies on rodents and human brain tissue of a multi-drug resistant patient, has surpassed expectations. Compared to standard-of-care treatments, it showcases superior efficacy by significantly reducing the amplitude and frequency of bursts. But that's not all! Our lead candidate doesn't just stop seizures - it preserves the remarkable plasticity and cognition of the brain. This is a game-changer, especially for pediatric patients, ensuring not only seizure control but also the preservation of crucial cognitive functions. Witness the undeniable evidence of success as hippocampal rat slices remain seizure-free during in-vitro testing, even after washout.
The market potential for our groundbreaking compounds class is vast, from thousands of individuals worldwide grappling with specific rare disorders characterized by seizures up to further potential on CNS indications. By addressing this unmet need, we not only tap into a lucrative market opportunity but, more importantly, fulfill a moral imperative to improve the lives of those in desperate need of effective treatment.
Join us on this journey as we forge ahead, driven by a shared vision of a seizure-free world.

www.4neuron.com

8. Repairon Immuno

8. Repairon Immuno

Enabling First-In-Class Complimentary Therapies at Scale
Repairon Immuno uses exclusively licensed induced Pluripotent Stem Cell (iPSC) line (the only iPSC line being currently validated in European clinical trial) in combination with proprietary differentiation platform and gene editing designs to generate never-done-before types of cell drug products. These products broaden the applications of iPSCs and the first lead product candidate is a complimentary therapy to stregthen the in vivo function of CAR T cells.


Repairon Immuno GmbH is a startup with a mission to develop novel cell therapies to treat most challenging diseases. Our vision is to improve efficiency of already existing cell therapies as well as address unmet patient needs with new cellular medicines.​ To achieve this goal, we will take advantage of exclusively licensed induced Pluripotent Stem Cell (iPSC) line, which is the only iPSC line being currently validated in European clinical trial. This cell line in combination with our proprietary, scalable, GMP-compliant differentiation platform as well as proprietary gene editing designs will enable us to generate never-done-before types of cell drug products. Moreover, using iPSCs as an initial cell source will allow to dramatically simplify manufacturing and significantly reduce therapy costs. Our proprietary gene editing designs will broaden application of derived cellular medicines to first-in-class complimentary “boosting” therapy and anti-autoimmune treatments. Hence, we believe that with our products we will address unmet medical needs of patients. 

www.repairon.de
 

9. Leopard Biosciences

9. Leopard Biosciences

The best of both worlds: Molecular Diagnostics at the Point-of-Care
Leopard Biosciences is democratizing diagnostics by bringing the power of molecular testing in the hands of doctors and patients. We are developing a proprietary new CRISPR platform for multiplex detection of DNA and RNA biomarkers with the ease-of-use of lateral flow assays and the accuracy and sensitivity of molecular biology.

At Leopard Biosciences, we are democratizing diagnostics by putting the power of molecular testing in the hands of doctors and patients at the point-of-care. Molecular diagnostics is central to patient health, yet it has been confined to centralized testing facilities because of a requirement for advanced instrumentation and highly trained personnel. This separation from where samples are collected, and where testing results are used, creates unnecessary delays and costs, impacting the quality and effectiveness of patient care and treatment decisions. To address this challenge and reshape the paradigm of molecular diagnostics, we are commercializing LEOPARD, a first-in-class molecular diagnostics platform based on a unique spin on CRISPR technology. The LEOPARD technology not only provides freedom-to-operate in the crowded CRISPR IP space but also allows us to offer simple-to-use, multiplex tests combining accuracy and sensitivity equivalent to PCR with the ease and accessibility of antigen “rapid” tests. We are developing frontline tests addressing unmet clinical needs representing large market opportunities in infectious disease, pharmacogenomics and oncology. As a lead example, we are developing a respiratory viral panel for multiplex detection of the four most common viruses (RSV, Influenza A, Influenza B, and SARS-CoV-2) for use in pediatrician’s offices, with a global market of over 2 billion USD. We are currently raising a seed investment round to build company infrastructure, add key hires, and develop the first manufacturable product.

www.leopard.bio

10. Telexos

10. Telexos

For the first time, circulating tumor cells (CTCs) are detected and isolated quantitatively out of blood for comprehensive analysis using Telexos’ patented technology. This is finally the base to use CTCs for diagnostics. First clinical results look quite promising.

Telexos is a German Cancer Diagnostics Startup providing products for the cancer research and cancer diagnostics market and offers services.  It has developed a new highly sensitive technology to quantitatively detect, isolate and fully characterize rare cells such as circulating tumor cells (CTCs) from blood samples (Liquid Biopsy). The patented technology can be used for a variety of applications like e.g., patient stratification and therapy monitoring. Telexos is looking for additional cooperations.

11. BioMagnetix

11. BioMagnetix

Bacterial magnetic nanoparticles as innovative materials for biomedicine

Cancer continues to be a leading cause of death worldwide, driving the growing demand for efficient and sensitive diagnostic and therapeutic solutions. Our startup project BioMagnetix now for the first time makes biogenic high-quality magnetic nanoparticles, so-called magnetosomes, available for applications in diagnostics and therapy, thereby outperforming chemically synthesized nanoparticle formulations.

The diagnostics and therapy of cancer remains one of today’s most challenging issues, and great efforts are being made to develop technologies that enable both an early detection and efficient treatment of cancer. Magnetic nanoparticles represent the most promising ‘tool’ to combine diagnostics and therapy, however, the material properties required for such applications can only inadequately be realized by means of chemical synthesis. In contrast, magnetic nanoparticles that are naturally produced by bacteria, so-called magnetosomes, remarkably fulfil the rigorous requirements – but have not been available so far.

BioMagnetix is a pioneering biotech startup aiming to commercialize magnetosomes as a novel class of biogenic high-quality magnetic nanoparticles for applications in biotechnology and (bio)medicine. Emerging from years of research at the Department of Microbiology at the University of Bayreuth, our team has gained unique expertise in the field of bacterial nanoparticles. Our genetic platform technology enables the environment-friendly ‘green’ production of high-quality nanoparticles without applying harsh reaction conditions and toxic chemical compounds. As the bacteria can be genetically optimized, magnetosomes can be tailored and produced according to customers’ needs. This includes the synthesis of magnetosomes of different size classes with adjustable magnetic properties as well as the display of further functionalities on the particle surface in a controllable and highly selective manner.   

Because of their inherent material characteristics, magnetosomes are best suited as diagnostic tools, particularly in the fields of in vitro diagnostics or as contrast agents in magnetic imaging techniques. In cancer therapy, magnetosomes can be used as effective carrier for a variety of drugs and as agents for magnetic hyperthermia. Remarkably, magnetosomes enable the efficient combination of diagnostics and therapy as a theranostic tool. Thus, engineered, e.g. antibody-presenting magnetosomes can not only be used for the targeted detection of cancer cells but can also treat the tumor directly on site.

As a provider for high-quality magnetic nanoparticles, BioMagnetix will not only offer a standard assortment of size-adjusted and surface-modified magnetosomes, but also develop and produce optimized magnetosomes according to customers’ needs, thereby uncovering the great potential of bacterial magnetosomes. 

12. immuneAdvice

12. immuneAdvice

We visualize immune cells to guide immunotherapy.

Hot or Cold? Decoding the tumor microenvironment with ICE-Ts
Hot or cold: Forget about the weather or your morning coffee. We're diving into the world of
hot and cold tumors, where the tumor's microenvironment dictates the success of
immunotherapy in cancer treatment. Discover how immuneAdvice pioneers the development
of so-called immune cell tracers (ICE-Ts) to visually distinguish between these tumor types
completely non-invasively and learn how pharma companies can benefit from our ICE-Ts.


Immunotherapies have revolutionized cancer treatment, yet their response rates vary widely, ranging from 12% to 40%. This unpredictable individual response to immunotherapy results in many patients undergoing months of treatment without significant benefit. Currently, there is no established diagnostic procedure to assess the response to immunotherapy at an early stage.
The tremendous success of immunotherapies has also led to intense competition to develop novel immunotherapeutics. So-called non-responders limit the efficacy of new therapeutics in clinical trials. Pharmaceutical companies are therefore faced with the challenge of selecting the "right" patient population in order to outperform competing therapies.
Innovation: immuneAdvice is pioneering the development of immune cell tracers (ICE-Ts) for non-invasive clinical imaging, aimed at detecting and monitoring specific immune cell populations. This technology will facilitate early assessment of individual responses to immunotherapy and the identification of primary and secondary therapy resistance. With a growing proprietary ICE-T pipeline and two filed patent applications (PCT), immuneAdvice has already secured its own
competitive position.
Our CD4 ICE-T, targeting T cells, and SIRPα ICE-T, targeting myeloid cells, have
demonstrated proof-of-concept in distinguishing "hot" or "cold" tumors non-invasively. This capability allows to unravel the underlying mechanisms of therapy response or resistance for the first time.
By 2025, immuneAdvice plans to advance the CD4 ICE-T into Phase I clinical trials for patients with solid tumors, marking a significant step forward in the translation of the ICE-T technology into clinical practice.
Team & Organization:
immuneAdvice is a startup in the field of molecular imaging and immunotherapy-associated diagnostics from Tübingen, Germany (expected founding Q2, 2024). The seven-member founding team unites outstanding scientists and clinicians from the NMI Natural and Medical Sciences Institute at the University of Tübingen, Werner Siemens Imaging Center Tübingen and the Eberhard Karls University Tübingen and fully covers the expertise from scientific development to clinical translation.
Business model & market:
Following the successful completion of clinical phase I of the first ICE-T in 2027, immuneAdvice will offer ICE-Ts along with licenses to pharmaceutical and biotech companies (B2B), targeting a total market volume of € 26 billion. Looking ahead, immuneAdvice aims to secure marketing authorization for ICE-Ts (B2C) in the long term.
Funding:
immuneAdvice is currently supported with € 2 million via EXIST Forschungstransfer Phase I of the BMWK (duration 24 months). For clinical translation and clinical phase I, we require a seed investment of € 7.5 million from Q1 2025.

13. AATec Medical

13. AATec Medical

Novel Therapeutics for Globally Increasing Respiratory Diseases

AATec Medical is a growing biotech company dedicated to major respiratory diseases. We develop a novel drug platform for inflammatory diseases of the airways, such as COPD, bronchieactasis, asthma and airway infections. These conditions affect a growing number of hundreds of millions of patients worldwide. Current treatment options are limited, and the disease cannot be adequately controlled in many patients. The commercial potential for new therapeutics for chronic airway diseases is highly attractive due to the significant medical need.

Our product platform is based on a recombinant version of human alpha-1 antitrypsin (AAT) for inhalation. AAT is a protease inhibitor and immunomodulator with broadband anti-inflammatory properties. It restores the protease-antiprotease balance which is severely disrupted in chronic lung diseases, leading to tissue damage, sustained inflammation and recurrent airway infection. AAT inhibits excessive tissue-damaging neutrophil proteases, modulates inflammatory cytokines, and has anti-infective effects. The clinical safety profile of AAT is proven. We apply our products by inhalation for optimal effects directly in the airways. The first indication for clinical development will be non-CF
bronchiectasis, the third leading chronic lung disease worldwide.

We have demonstrated preclinical proof-of-principle in several respiratory diseases and established an industrial manufacturing process for recombinant AAT. A nebulization device and protocol were developed in cooperation with a global inhaler device manufacturer. A proof-of-concept clinical study in non-CF bronchiectasis is planned to start in the first half of 2025. Our technology is covered by a strong IP portfolio owned by AATec. A broad network of academic and industrial partners has been established and is collaborating with our company.
AATec is supported by SPRIND, the German Agency for Disruptive Technologies.

A seed financing round of EUR 2.7M was concluded in 2023. We are currently fundraising in a Series A round for the preparation and conduct of the first clinical study.

AATec is based in in Munich, Germany and was founded in 2021 by physician scientists from the University Clinic Munich based on decades of biomedical research. AATec is operated by a team of senior experts from biopharmaceutical product development, clinical medicine, and product
industrialization, supported by a high-level Science Advisory Board.

www.aatec-medical.com

14. YuvenLife

14. YuvenLife

At YuvenLife GmbH iG, we are driving the next level of personal healthcare to support healthy ageing. It all starts with consumer health education to help people understand how nutrition and fitness affect cellular aging, and what is necessary to delay these processes effectively. We develop solutions for innovative nutritional products based on deep expertise in bio-formulation for improved bioavailability and rational design. Learn more about our key insights in our pitch!

The evolving field of healthy ageing is at the crossroads of wellness, lifestyle and healthcare, and since 'style' has more of an aesthetic connotation, we distinguish between personal and medical healthcare. While medical healthcare is taken care of by Healthcare Practitioners (HCPs), we ourselves need to take care of our personal healthcare. YuvenLife´s mission is to become the trusted source of information and solutions for delaying ageing, thus healthy ageing.  

Customer needs can be categorized into

    Health education

    Personalized healthcare products, services and solutions

    Tools and guidance for personal healthcare decision-making

    Delivery, which requires daily routines, and monitoring of effectiveness.

The founders and partners of YuvenLife are all former scientists from the Technical University of Munich. Deep expertise in the life sciences, bio-formulation and new venture development brought them together to add innovation and science to the field of healthy ageing and longevity medicine, which is currently emerging as a serious specialty in medical and personal healthcare by people demanding answers to their questions.

The review of more than 3000 scientific papers and publications on phytonutrients and their associated health benefits or risks, as well as the science of formulation and bioavailability, form the basis of the product concepts developed by YuvenLife. The rational design of the product composition is driven by which phytonutrients need to be included and how to present them to the body so that they reach where they are needed, in the blood, organs and cells of the relevant biological function. The first YuvenLive products are nearing maturity and will be launched soon.

15. Vision Health

15. Vision Health

VisionHealth designs and implements innovative digital health solutions of the highest quality that enable real progress and improvements in therapy standards for patients and their caregivers in a connected world. 

 

We believe in a world where all people with chronic respiratory disease have access to optimal therapy support regardless of income, background or education level. 

 

VisionHealth has a mission, to build a world where patients with chronic respiratory diseases can live healthier and breathe easier. By properly using today's digital capabilities, Kata® improves healthcare for all stakeholders (patients, caregivers, clinicians).

www.visionhealth.gmbh


Visit our Scientific Posters

2 - 3 July, poster all day and discussions during the breaks at Work Lab

Scientists from research institutes or industry like to take the opportunity to discuss their scientific work and share their expertise with the conference attendees.

1. Single Molecule Analytics enable measurement of target occupancy in cells and patient biopsies

1. Single Molecule Analytics enable measurement of target occupancy in cells and patient biopsies

Authors: Jacob, Uwe; Hannus, Stefan; Becker, Frank; Intana Bioscience GmbH, Lochhamer Str. 29a, 82152 Planegg

Lack of target engagement is one of the major reasons for failures in clinical studies. We developed an assay platform to detect and quantify target occupancy values in patient and animal biopsies to guide dosing and PK/PD-Modelling during the drug development process.

FCCS (fluorescence cross correlation spectroscopy) is a powerful tool to characterize drug target interaction in physiological environments on single molecule resolution. Over the last decade this technology was used to understand the binding and kinetics of small molecules and antibodies to challenging target proteins in great detail and accuracy.

Intana Bioscience expanded the application of FCCS from affinity measurements to comprehensive interaction studies including kinetics, multi component complex formation, assessing stoichiometry and quantification of aggregation, PK studies and target engagement. This presentation will highlight results obtained with FCCS in projects ranging from early stages in drug discovery up to the support of clinical trials to quantify target occupancies in patient liquid biopsies.

2. Prolevi Bio - Drug delivery through Chronotherapy: Hypothyroidism

2. Prolevi Bio - Drug delivery through Chronotherapy: Hypothyroidism

Authors: Prolevi Bio, Scheelevägen 2, Medicon Village, Lund, Sweden

Controlled release formulation for Chronotherapy – Drug delivery synced with Circadian rhythm

INNOVATION & MARKET
• First indication: Hypothyroidism
• Prevalence: 750M patients
• First target market: 150M non responders to T4 therapy
• Solution: ProT3 tablet, mimics healthy T3 cycles synced to
circadian rhythm (Chronotherapy)
• Fast Market access: Medical regulatory agency recommended
• IP: 2 Controlled release Patent families


INVESTMENT
• Financing: Seeking 5-6M EUR + 10-16M EUR
• Use of Proceeds: Pilot (PoC) & Pivotal (Market access) Trials
Controlled release formulation for Chronotherapy – Drug delivery synced with Circadian rhythm


DEVELOPMENT & NEXT STEPS
• Traction: Leading Meetings/ CDAs with 7 pharma corporates
• Clinical Data: Pilot first In Human Clinical trial shows
effective release profiles
• Manufacturing: Production site identified, GMP analytical
methods validated.
• Phase I: Identified trial site, Regulatory prep completed,
Clinical trial planned for 2025

3. IMITEX: Protecting Honey bees effectively against Varroa Mites with Lithium

3. IMITEX: Protecting Honey bees effectively against Varroa Mites with Lithium

Authors: Stefan Hannus, Varolis Apimed GmbH

Lack of target engagement is one of the major reasons for failures in clinical studies. We developed an assay platform to detect and quantify target occupancy values in patient and animal biopsies to guide dosing and PK/PD-Modelling during the drug development process.

FCCS (fluorescence cross correlation spectroscopy) is a powerful tool to characterize drug target interaction in physiological environments on single molecule resolution. Over the last decade this technology was used to understand the binding and kinetics of small molecules and antibodies to challenging target proteins in great detail and accuracy.

Intana Bioscience expanded the application of FCCS from affinity measurements to comprehensive interaction studies including kinetics, multi component complex formation, assessing stoichiometry and quantification of aggregation, PK studies and target engagement. This presentation will highlight results obtained with FCCS in projects ranging from early stages in drug discovery up to the support of clinical trials to quantify target occupancies in patient liquid biopsies.

4. The NAKO Health Study

4. The NAKO Health Study

Authors:
1) Peters A; German National Cohort (NAKO) Consortium; Peters A, Greiser KH, Göttlicher S, Ahrens W, Albrecht M, Bamberg F, Bärnighausen T, Becher H, Berger K, Beule A, Boeing H, Bohn B, Bohnert K, Braun B, Brenner H, Bülow R, Castell S, Damms-Machado A, Dörr M, Ebert N, Ecker M, Emmel C, Fischer B, Franzke CW, Gastell S, Giani G, Günther M, Günther K, Günther KP, Haerting J, Haug U, Heid IM, Heier M, Heinemeyer D, Hendel T, Herbolsheimer F, Hirsch J, Hoffmann W, Holleczek B, Hölling H, Hörlein A, Jöckel KH, Kaaks R, Karch A, Karrasch S, Kartschmit N, Kauczor HU, Keil T, Kemmling Y, Klee B, Klüppelholz B, Kluttig A, Kofink L, Köttgen A, Kraft D, Krause G, Kretz L, Krist L, Kühnisch J, Kuß O, Legath N, Lehnich AT, Leitzmann M, Lieb W, Linseisen J, Loeffler M, Macdonald A, Maier-Hein KH, Mangold N, Meinke-Franze C, Meisinger C, Melzer J, Mergarten B, Michels KB, Mikolajczyk R, Moebus S, Mueller U, Nauck M, Niendorf T, Nikolaou K, Obi N, Ostrzinski S, Panreck L, Pigeot I, Pischon T, Pschibul-Thamm I, Rathmann W, Reineke A, Roloff S, Rujescu D, Rupf S, Sander O, Schikowski T, Schipf S, Schirmacher P, Schlett CL, Schmidt B, Schmidt G, Schmidt M, Schöne G, Schulz H, Schulze MB, Schweig A, Sedlmeier AM, Selder S, Six-Merker J, Sowade R, Stang A, Stegle O, Steindorf K, Stübs G, Swart E, Teismann H, Thiele I, Thierry S, Ueffing M, Völzke H, Waniek S, Weber A, Werner N, Wichmann HE, Willich SN, Wirkner K, Wolf K, Wolff R, Zeeb H, Zinkhan M, Zschocke J. Framework and baseline examination of the German National Cohort (NAKO). Eur J Epidemiol. 2022 Oct;37(10):1107-1124. doi: 10.1007/s10654-022-00890-5. Epub 2022 Oct 19. PMID: 36260190; PMCID: PMC9581448.

2) Wichmann HE, Hörlein A, Ahrens W, Nauck M. [The biobank of the German National Cohort as a resource for epidemiologic research]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2016 Mar;59(3):351-60. doi: 10.1007/s00103-015-2305-4. German.

3) German National Cohort (GNC) Consortium. The German National Cohort: aims, study design and organization. Eur J Epidemiol. 2014 May;29(5):371-82. doi: 10.1007/s10654-014-9890-7. Epub 2014 May 20.

 

The NAKO Health Study is the largest population health study ever implemented in Germany by a national network of 27 research institutions (1, 2, 3) and is now open for data access applications for research purposes: Its overall aim is to provide data and biosamples for the investigation of major chronic diseases, including cardiovascular diseases, cancer, diabetes, neurodegenerative/-psychiatric diseases, respiratory and infectious diseases, and their pre-clinical stages or functional health impairments but as well rare diseases.  

In the baseline examination, from 2014-2019, the GNC has recruited more than 205,000 participants aged 20-69 years, drawn randomly from population registries in 18 study regions across Germany. All of them have been reinvited to the study centers for follow-up visits. A third examination is being in the coming weeks. The assessments include a face-to-face interview and touchscreen-based self-completion questionnaires, a range of medical examinations and the collection of biological material (blood, urine, saliva, nasal swabs and stool). In addition, in five of the 18 study centres, a total of 30,000 study participants were examined by magnetic resonance imaging (MRI) (4). Additional information is collected through a combination of active follow-up, including questionnaires every 2-3 years, and record linkage with secondary data sources, including participants health insurance records and a thorough mortality follow up. Preparations for the genetic characterization of the cohort are ongoing. Subgroups are being molecularly characterized by a multi-omics panel incl. metabolomics, serolomics and epigenetic characterization.  

Helmholtz Munich is running one of NAKOs largest study centers with dedicated MRI unit and a total of 20.000 participants enrolled. Helmholtz Munich is also running the NAKOs central biorepository, where the majority of biosamples collected in the 18 study centers are stored. The highly innovative Biorepository provides very large storage capacities (> 20 mio samples) for various sample volumes to be stored at -80 or -180° C. Farmost automated sample handling for storage, selection and release allow for high throughput and high accessibility. The NAKO is planned for an overall duration of 30 years. It has just opened for data & sample access applications and will provide a major resource for medical research on mechanisms, detection, prediction and primary prevention of major diseases for academic as well as commercial research purposes. 

5. Novel Therapeutics for Globally Increasing Respiratory Diseases

5. Novel Therapeutics for Globally Increasing Respiratory Diseases

Authors: Dr. Manfred Stangl, Dr. Michael Strassmair,, Dr. Pavan Beleyur, Dr. Rüdiger Jankowsky, AATec Medical GmbH

AATec Medical is a growing biotech company dedicated to major respiratory diseases. We develop a novel drug platform for inflammatory diseases of the airways, such as COPD, bronchieactasis, asthma and airway infections. These conditions affect a growing number of hundreds of millions of patients worldwide. Current treatment options are limited, and the disease cannot be adequately controlled in many patients. The commercial potential for new therapeutics for chronic airway diseases is highly attractive due to the significant medical need.
Our product platform is based on a recombinant version of human alpha-1 antitrypsin (AAT) for inhalation. AAT is a protease inhibitor and immunomodulator with broadband anti-inflammatory properties. It restores the protease-antiprotease balance which is severely disrupted in chronic lung diseases, leading to tissue damage, sustained inflammation and recurrent airway infection. AAT inhibits excessive tissue-damaging neutrophil proteases, modulates inflammatory cytokines, and has anti-infective effects. The clinical safety profile of AAT is proven. We apply our products by inhalation for optimal effects directly in the airways. The first indication for clinical development will be non-CF bronchiectasis, the third leading chronic lung disease worldwide. 
We have demonstrated preclinical proof-of-principle in several respiratory diseases and established an industrial manufacturing process for recombinant AAT. A nebulization device and protocol were developed in cooperation with a global inhaler device manufacturer. A proof-of-concept clinical study in non-CF bronchiectasis is planned to start in the first half of 2025. Our technology is covered by a strong IP portfolio owned by AATec. A broad network of academic and industrial partners has been established and is collaborating with our company. AATec is supported by SPRIND, the German Agency for Disruptive Technologies.
A seed financing round of EUR 2.7M was concluded in 2023. We are currently fundraising in a Series A round for the preparation and conduct of the first clinical study.
AATec is based in in Munich, Germany and was founded in 2021 by physician scientists from the University Clinic Munich based on decades of biomedical research. AATec is operated by a team of senior experts from biopharmaceutical product development, clinical medicine, and product industrialization, supported by a high-level Science Advisory Board.

6. Nucleate Germany

6. Nucleate Germany

Authors: Nucleate Germany 

 

Nucleate is a student-led organization that represents the largest global community of bio-innovators. Now forming an international community, with ‘chapters’ throughout the USA, Germany, UK, Denmark, Switzerland and more nucleate aims to identify future biotech entrepreneurs, build bridges between academia and the biotech ecosystem and educate scientists and business students. In Germany, we have just completed the inaugural activator program where nine teams underwent a six-month accelerator program consisting of expert workshops and personalized mentor matching. We can show the results of this six-month accelerator and advertise next year’s activator program to a new batch of teams.

7. Towards a virtual patient foundation model to predict clinical efficacy of drug assets in complex diseases

7. Towards a virtual patient foundation model to predict clinical efficacy of drug assets in complex diseases

Authors: Gurdeep Singh1, Lilija Wehling1, Ahmad Wisnu1, Douglas McCloskey1
1 BioMed X GmbH Im Neuenheimer Feld 515 69120 Heidelberg, Germany

 

It takes approximately 1.3 Bi USD and a median 8.3 years to bring new drugs to market because approximately 97% of all drug candidates will fail during drug discovery and development [1]. Importantly, approximately 90% of the time, cost, and failures occur during clinical trials for which approximately 60% fail due to lack of efficacy [2]. Supplementing or replacing clinical trials with virtual patients (i.e., digital representations of human disease biology, e.g., digital twins in medical devices) is a viable solution that is gaining market and regulatory support for example in rare diseases where few patients exist or in patient populations with ethical concerns such as young children or pregnant mothers. Current virtual patient solutions can replace clinical trials in diseases with known pathways and mechanisms but are not suitable for complex diseases with unknown pathways and mechanisms including oncology, neurology, nor autoimmunity. We analyse the shortcomings of current virtual patient technologies for efficacy prediction of first-in-class and best-in-class drug assets in complex disease, and survey the landscape of emerging next generation technologies. We conclude the analysis and survey with a discussion of promising AI research directions and unresolved problems left to tackle to supplement or replace clinical trials with virtual patients.


References

[1] https://doi.org/10.1038/d41573-021-00190-9

[2] https://doi.org/10.1016/j.apsb.2022.02.002

8. Spotlight your immune response – CD4+ T cell and SIRPα+ macrophage PET tracers to guide immunotherapy

8. Spotlight your immune response – CD4+ T cell and SIRPα+ macrophage PET tracers to guide immunotherapy

Authors:
Teresa R. Wagner, NMI Natural and Medical Sciences Institute at the University of Tübingen,
immuneAdvice
Bjoern Traenkle, NMI Natural and Medical Sciences Institute at the University of Tübingen,
immuneAdvice
Simone Blaeß, NMI Natural and Medical Sciences Institute at the University of Tübingen,
immuneAdvice
Philipp D. Kaiser, NMI Natural and Medical Sciences Institute at the University of Tübingen,
immuneAdvice
Dominik Sonanini, NMI Natural and Medical Sciences Institute at the University of Tübingen,
immuneAdvice
Ulrich Rothbauer, Eberhard Karls University Tübingen, Pharmaceutical Biotechnology
Manfred Kneilling, University of Tübingen, Werner Siemens Imaging Center, Department of
Preclinical Imaging and Radiopharmacy
Bernd J. Pichler, University of Tübingen, Werner Siemens Imaging Center, Department of
Preclinical Imaging and Radiopharmacy

 

With current clinically established methods, response to cancer immunotherapy can only be diagnosed after several months of treatment. As responses vary greatly from patient to patient, and are low overall, the narrow window of opportunity to effectively adjust the treatment is often missed. Therefore, new diagnostic approaches that enable early assessment of the individual response are urgently needed.
Increasing evidence suggests that the (re-)distribution of specific cellular immune regulators in the tumor microenvironment is decisive for treatment success. As this process occurs within days upon initiation of effective immunotherapies, it emerged as a promising biomarker for early therapy control. However, as immune cell distribution is a dynamic process at microscopic scales that can vary from lesion to lesion even within the same individual, a viable diagnostic procedure in this arena is required to comprehensively capture the spatio-temporal nature of this process throughout the entire body.
Positron Emission Tomography (PET) is a non-invasive whole-body clinical imaging technique, capable to repeatably visualize markers at sufficient resolution, but requires specific radiotracers to track targets of interest. Therefore, we develop single-domain antibody (sdAb)-based Immune CEll Tracers, short ICE-Ts. As CD4+ T cells and signal-regulatory protein α+(SIRPα+) myeloid cells have proven of particular importance for therapeutic response and resistance, we selected and optimized highly specific and sensitive ICE-Ts against human CD4 and human SIRPα to track the corresponding immune cell populations.
Both ICE-Ts have been extensively validated by in vivo imaging of humanized mouse models. Using various tumor models and immunotherapies, we could demonstrate the applicability of both ICE-Ts to visualize tumor infiltration of the respective cell type. The high-resolution PET image data allowed to visualize the precise spatial distribution of intratumoral immune cells and to distinguish between immune cell-infiltrated (hot), immune cell-excluded and immune cell-free (cold) tumors in vivo, which could be directly correlated with response to therapy. To translate these high potential diagnostic tools into the clinic, we have initiated GMP manufacturing and validation of toxicological safety.
Immunotherapies have established themselves as outstanding treatment alternatives for patients with advanced tumor diseases. However, due to the current limitations in therapyaccompanying diagnostics, most of these patients are subjected to futile treatment with toxic side effects. Our ICE-Ts are promising diagnostic tools that could enable clinicians to assess the response to immunotherapies early on and adapt individual treatment regimens more effectively.

9. New non-invasive, label-free monitoring approach for 2D and 3D cell culture

9. New non-invasive, label-free monitoring approach for 2D and 3D cell culture

Authors:
Anna Jötten, Ludwig-Maximilians-University Munich, PHIO scientific GmbH
Philipp Paulitschke, Ludwig-Maximilians-University Munich, PHIO scientific GmbH

Two major issues of cell-based toxicological and drug response assays are the lack of the temporal component of endpoint assays, and the strong dependency of reproducibility and significance on the quality and condition of the cells used. Thus there is a tremendous need to provide insight into the usually inaccessible processes inside the incubator. We developed a novel lensfree imaging method exploiting the optical properties of the cell itself for imaging inside the incubator, which allows non-invasive, super compact, label-free, live-cell monitoring. By applying AI to determine key cell culture parameters such as confluence, proliferation, and cell motility [1], high-quality, automated, objective, and real-time data can be collected.  Applying our lensfree microscopy (LM) method, we find that memory effects from heterogeneous cell culture conditions lead to an increase of variance during subsequent assays like e.g. omics-readouts [2] or other cell based assays, like wound healing assays, motility and proliferation assays significantly. Furthermore, our LM is also suitable for 3D applications and will enable quantification of organoid growth dynamics and interactions. Our approach dramatically increases control and processing speed. In the context of the reproducibility crisis, we hope to make a contribution in the direction of standardization of cell-based research in the future.

References
[1]           M. Rempfler et al., “Tracing cell lineages in videos of lens-free microscopy,” Med. Image Anal., vol. 48, pp. 147–161, 2018.

10. Secarna Pharmaceuticals: Leading independent European antisense drug discovery & development company

10. Secarna Pharmaceuticals: Leading independent European antisense drug discovery & development company

Authors:
Secarna Pharmaceuticals

Secarna Pharmaceuticals is a biopharmaceutical company focusing on the discovery and development of next-generation antisense oligonucleotide (ASO) therapies – both targeted and unconjugated –  to address challenging or previously undruggable targets in indications of high unmet medical need.

The Company employs its proprietary, AI-powered ASOarchitect platform for the discovery, testing and selection of best-in-class ASOs. The platform covers all aspects of drug discovery and preclinical development. It has proven to be fast, reliable, scalable and efficient, including targeted delivery for an optimized therapeutic window. Secarna’s technology integrates the powerful proprietary Oligofyer™ bioinformatics system, a streamlined AI-guided screening process, the Company’s proprietary LNA-Vit(r)ox™ in vitro safety test system and target-specific functional assays or animal models. This approach has been validated through numerous inhouse and external collaboration projects across multiple indications including oncology, immunology, neurodegenerative and cardiometabolic diseases. Secarna’s proprietary lead program SECN-15 is an ASO targeting Neuropilin-1 for the treatment of a range of solid tumors.

www.secarna.com 


Contact:

Dr. Max Pöhlmann
Dr. Max Pöhlmann

Cluster Development Lead

+49 (0) 89 / 89 96 79-19

 

  

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