The German biotech ecosystem has evolved significantly over the years, marked by a complex interplay of scientific excellence and challenges in translating research into marketable products. Historically, the sector has seen limited access to capital, which has been a major obstacle in the commercialization of scientific breakthroughs. Despite these challenges, the German biotech landscape has seen biotech companies grow and become well-established entities and young promising companies make their entrance.
This article delves into 13 biotech companies based in Germany that represent innovation and technological advancement in the field. From groundbreaking cancer treatments and pioneering mRNA technologies to novel approaches to treating neurological disorders, these companies are worth knowing in the industry.
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Affimed, a clinical-stage immuno-oncology company based in Mannheim in Germany, is a biotech primarily focused on harnessing the potential of the innate immune system to fight cancer. The company’s proprietary ROCK platform generates customized innate cell engager (ICE) molecules. These molecules are designed to engage patients’ immune cells in attacking tumor cells, a method that sets Affimed apart in the field of cancer treatment.
One of the key developments at Affimed is the progress in their AFM24-102 phase 1/2a study. This study focuses on EGFR-wildtype (epidermal growth factor receptor) non-small cell lung cancer (NSCLC). As of early 2024, there have been positive updates regarding this study, including confirmed complete and partial responses in heavily pre-treated patients. The study will be expanded to include a total of 40 EGFR wildtype NSCLC patients, with ongoing enrollment in the EGFR-mutant NSCLC cohort. The results from both cohorts are expected in the first half of 2024.
Moreover, Affimed has reported encouraging early safety and efficacy results with the combination of AFM24 and atezolizumab, particularly for patients with advanced NSCLC who require additional treatment after first-line therapy. This combination is seen as a potential method to reactivate both the innate and adaptive immune systems for the recognition and destruction of EGFR-positive NSCLC tumors.
Atai Life Sciences
Founded in 2018 and headquartered in Berlin in Germany, biotech company Atai focuses on developing innovative therapies for mental health disorders such as depression, anxiety, addiction, and substance use disorders.
One of the notable compounds in Atai’s pipeline is PCN-101 (R-Ketamine), which is being developed for treatment-resistant depression. This compound, a single isomer of ketamine, is notable for its potential as a rapid-acting antidepressant with anti-suicidal effects. Atai has been working on a bridging study from intravenous to subcutaneous administration of PCN-101.
Another significant project is COMP360, a proprietary formulation of synthetic psilocybin, which is being investigated for its efficacy in treating treatment-resistant depression. This therapy, which involves administering psilocybin in conjunction with psychological support, has shown promising results in a phase 2b study and is progressing into a phase 3 program, with top-line data expected in summer 2024.
Atai is also developing RL-007, a pro-cognitive neuromodulator for cognitive impairment associated with schizophrenia (CIAS). The phase 2b study for RL-007, a compound that modulates cholinergic, glutamatergic, and GABA-B receptors, is ongoing with initial results anticipated in the second half of 2024.
Additionally, GRX-917, a deuterated version of etifoxine, is being developed for anxiety disorders. Following positive results from its phase 1 study, Atai plans to proceed with a phase 2 study to further assess the drug’s efficacy and safety profile.
Additionally, Atai Life Sciences announced a strategic investment in Beckley Psytech Limited, a company specializing in psychedelic medicine. Collaborations and investments in other companies within the same field can provide Atai with access to new research, expanded expertise, and potential synergies in drug development, especially in the burgeoning field of psychedelic medicine for mental health disorders.
BioNTech is a leading biopharmaceutical company and has gained global recognition for the part it played during the COVID-19 pandemic. In partnership with the American giant Pfizer, BioNTech developed the BNT162b2 vaccine, more commonly known as the Pfizer-BioNTech COVID-19 vaccine. This vaccine was one of the first to receive emergency use authorization (EUA) from various regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
One of their main projects is BNT316/ONC-392 (Gotistobart), a next-generation anti-CTLA-4 (Cytotoxic T-lymphocyte-associated protein 4) monoclonal antibody candidate. This is being developed in collaboration with OncoC4, Inc., and is currently in a pivotal phase 3 trial for patients with non-small cell lung cancer (NSCLC) who have previously undergone immunotherapy.
Another promising candidate is BNT327/PM8002, an anti-VEGF-A antibody fused with a humanized anti-PD-L1 (programmed cell death protein 1) VHH. Developed in partnership with Biotheus Inc., it is currently being assessed in multiple phase 2/3 studies in China, with further studies planned in the U.S.
BNT311/GEN1046 (Acasunlimab) and BNT312/GEN1042 are two first-in-class bispecific antibody candidates. BNT311/GEN1046 combines PD-L1 checkpoint inhibition with 4-1BB costimulatory activation and is being developed with Genmab S/A. BNT312/GEN1042, also a collaboration with Genmab, is designed to induce immune activation by crosslinking CD40 and 4-1BB positive cells.
Moreover, BNT122 (Autogene Cevumeran), an mRNA cancer vaccine candidate based on individualized neoantigen-specific immunotherapy (iNeST), is being developed in collaboration with Genentech, Inc. This vaccine is currently undergoing phase 2 trials for multiple cancer indications, including pancreatic ductal adenocarcinoma, melanoma, and colorectal cancer.
BioNTech has also been expanding its oncology pipeline through strategic acquisitions and collaborations. The company acquired bispecific antibodies for advanced solid tumors from Biotheus and engaged in a licensing deal with MediLink Therapeutics for antibody-drug conjugates targeting the HER3 protein. Additionally, BioNTech has a collaboration with Duality Biologics for two solid tumor ADCs and has a deal with OncoC4 for the development of the anti-CTLA-4 antibody ONC-392 for solid tumors. Even more recently BioNTech signed a research service agreement with WuXi Biologics to obtain exclusive rights over two undisclosed investigational monoclonal antibodies.
Overall, BioNTech is well-positioned to have ten or more potentially registrational trials by the end of 2024, leading up to its first oncology product launches from 2026 onwards. The Germany-based biotech company’s focus remains on expanding and developing its innovative pipeline, particularly in the area of cancer treatments.
CureVac was not as successful as its peers during the COVID-19 pandemic but is rebounding with some interesting science and candidates in the field of mRNA vaccines.
One of the key highlights in CureVac’s recent activities is their phase 2 study of COVID-19 vaccine candidates developed in collaboration with GSK. This study has yielded positive interim data, showcasing the potential of their second-generation mRNA backbone. The trial included both monovalent and bivalent modified vaccine candidates, with the results indicating competitive immune responses at lower doses and a favorable tolerability profile compared to licensed mRNA-based COVID-19 vaccines.
In the field of oncology, CureVac has presented encouraging preclinical studies. One of their significant contributions is a multiepitope mRNA cancer vaccine construct targeting tumors in a murine melanoma model. This research supports the ongoing evaluation of their multiepitope cancer vaccine candidate, CVGBM, which is currently in a phase 1 study for patients with resected glioblastoma. The preclinical data, presented at the 11th International mRNA Health Conference, showed strong induction of both CD8+ (cytotoxic T lymphocytes) and CD4+ T cell responses, suggesting the vaccine’s potential to inhibit tumor growth and extend survival.
Overall, the Germany-based biotech company remains an interesting player in the field of RNA technologies with a strong focus in the areas of infectious diseases and oncology.
Ethris has been making notable advancements in developing next-generation RNA therapeutics and vaccines.
An important development is the approval and initiation of a phase I clinical study for ETH47, a first-in-class inhaled mRNA solution targeting respiratory viral infections. This innovative product candidate, developed using Ethris’ Stabilized Non-Immunogenic mRNA (SNIM RNA) platform, is designed to be administered directly to the lung via inhalation or nasal spray. ETH47 aims to induce a mucosal innate immune defense response at virus entry sites and inhibit viral replication. It holds promise for addressing a range of respiratory virus infections, including those that exacerbate chronic respiratory diseases like asthma and COPD. The program’s initiation in the UK marks a significant advancement for Ethris in its quest to offer innovative solutions for respiratory viral infections. The company announced in December the first-in-human dosing for ETH47.
Ethris has also been actively participating in collaborative efforts to enhance the field of mRNA therapeutics. The company joined as a founding member of the Alliance for mRNA Medicines (AMM). Additionally, Ethris has been working with DIOSynVax on a broadly protective mRNA vaccine against Betacoronaviruses, leveraging its mRNA modification and design technologies, as well as its lipidoid nanoparticle (LNP) and stabilization platforms.
Financially, Ethris has attracted significant investment, including a $16 million investment from Cipla, initiating a strategic collaboration. The German biotech company also raised $26.3 million in a Series B funding round in 2022, further supporting its ongoing research and development efforts.
Evotec is an interesting player in the biotech industry as its business model allows it to be on many fronts. On the one hand, Evotec is a contract research organization (CRO) providing clinical trial and research services to other actors. On the other hand, the company develops its own pipeline of drugs.
The company is known for its expertise in discovering and developing small molecule drugs across various conditions such as oncology, neurological and nephrological conditions, cardiovascular diseases, inflammation, pain, metabolic, and respiratory diseases.
In recent developments, Evotec announced a strategic R&D collaboration with Dewpoint Therapeutics to advance oncology pipeline programs. This partnership is focused on condensate modifying therapeutics (“c-mods”) and utilizes Evotec’s fully integrated data-driven platform (“INDiGO”).
Evotec has also entered into a partnership with Amplitude Ventures, a venture capital firm. This collaboration aims to nurture early research from academic institutions into novel therapeutics, with a focus on precision medicine. Another collaboration includes a partnership with Lightstone Ventures, ClavystBio, Leaps by Bayer, Polaris Partners, and the Polaris Innovation Fund to advance drug discovery in Singapore.
The company’s activity heavily relies on partnerships and collaborations as Evotec leverages its proprietary platforms to co-develop new solutions. This strategy is perfectly represented by the company’s BRIDGE (Biomedical Research, Innovation & Development Generation Efficiency) program, an integrated fund and framework to accelerate drug discovery from academic research to clinical proof of concept. This initiative has generated exciting collaborations with entities such as Bristol Myer Squibb or in 2022 with CDP Venture Capital Sgr and Angelini Ventures.
Evotec is a unique company in the German biotech ecosystem but also in the industry as a whole.
Heidelberg Pharma AG specializes in oncology and is known for its pioneering work in developing the toxin Amanitin into cancer therapies using its proprietary Antibody Drug Conjugates (ADC) technology, ATAC. This technology uniquely combines the high affinity and specificity of antibodies with the efficacy of small toxic molecules, such as Amanitin, to target cancer cells.
One of the significant developments at Heidelberg Pharma is their lead candidate HDP-101, which is a BCMA-ATAC in clinical development for multiple myeloma, a type of bone marrow cancer. Preliminary findings from the ongoing phase 1/2a trial of HDP-101 were presented at the ASH Annual Meeting 2023. The trial, which has completed the first four patient cohorts, indicated that HDP-101 was safe and well-tolerated.
Besides HDP-101, Heidelberg Pharma is also developing other ATAC candidates targeting different indications, such as non-Hodgkin’s lymphoma, metastatic castration-resistant prostate cancer, and gastrointestinal tumors like colorectal cancer.
Financially, Heidelberg Pharma has been active in securing funds to support its research and development efforts. In 2022, the company raised approximately $87 million (€80 million) from a capital increase. Additionally, in 2023, the Germany-based biotech company sold its stakes in its spin-off Emergence Therapeutics to Eli Lilly and Company for an undisclosed amount.
Immatics is a clinical-stage biopharmaceutical company actively engaged in the discovery and development of T cell-redirecting cancer immunotherapies. Based Tuebingen, Germany, the company has recently made significant strides in its financial and developmental efforts.
In January 2024, Immatics announced the pricing of a substantial public offering, aiming to raise $175 million. The successful closure of this offering is expected to significantly bolster Immatics’ financial position, supporting its ongoing research and development activities in cancer immunotherapy.
The company’s research focuses on leveraging the power of T cells in cancer treatment. Its pipeline includes innovative Adoptive Cell Therapies and TCR Bispecifics, along with strategic partnerships with global leaders in the pharmaceutical industry. Immatics aims to enable robust and specific T cell responses against cancer targets, underlining its commitment to advancing cancer treatment modalities.
Immatics’ clinical development strategy revolves around making its cell therapies targeting preferentially expressed antigens of melanoma (PRAME) accessible to a wide range of solid cancer patients. One of their leading strategies includes focusing on IMA203 GEN1 in cutaneous melanoma, with a plan to enter a registration-enabling Phase 2 clinical trial in 2024. The company also aims to expand its treatment modalities to include ovarian and uterine cancer, leveraging the potential of IMA203CD8 GEN2.
Additionally, the German biotech company has announced a strategic collaboration with Moderna, combining its target and TCR platforms with Moderna’s mRNA technology. This collaboration, which includes bispecifics, cell therapy, and cancer vaccines, involves a significant upfront payment to Immatics and the potential for future milestone payments and royalties. This partnership is expected to enhance the development of novel cancer treatment approaches, utilizing the strengths of both companies.
InflaRx is focused on the development of anti-inflammatory therapeutics.
One of the key developments at InflaRx is the positive topline results from the Multiple Ascending Dose (MAD) Phase 1 study with their C5aR inhibitor, INF904. This study demonstrated that INF904 was well tolerated in participants over various dosing levels without any significant safety concerns. The drug showed potential in blocking C5a-induced neutrophil activation by more than 90% over a 14-day dosing period, indicating its efficacy. InflaRx plans to introduce INF904 into Phase 2 development towards the end of 2024.
In April 2023, InflaRx achieved a significant milestone by receiving an Emergency Use Authorization (EUA) from the FDA for their product Gohibic (vilobelimab). This authorization allows for the treatment of critically ill COVID-19 patients. Following this, Gohibic became commercially available to hospitals in the United States.
In April 2023, InflaRx successfully closed a $40 million public offering of ordinary shares, marking a significant financial milestone for the company. This closing represented a pivotal step in securing funding for its ongoing and future projects, particularly in the area of anti-inflammatory therapeutics. The offering’s completion solidified InflaRx’s financial foundation, enabling the company to continue its clinical-stage biopharmaceutical developments aimed at targeting the complement system in various inflammatory diseases.
Medigene AG, an immuno-oncology platform company, has been focusing on the development of T cell immunotherapies for solid tumors. Throughout the past 18 months leading up to 2024, the company has concentrated on prioritizing projects and optimizing resource allocation. This strategic approach has ensured the progress of their lead program, MDG1015, which targets solid tumors. The program is on track for Investigational New Drug (IND)/Clinical Trial Application (CTA) filing in the second half of 2024, with plans to commence clinical trials as soon as possible.
The Germany-based biotech company’s portfolio also includes two KRAS-targeted programs, MDG2011 and MDG2021. By optimizing the development of these programs, Medigene anticipates accelerated future development for KRAS programs and other cancer targets. However, the lead selection for their third KRAS-targeted program, MDG2012, has been moved to 2025.
Medigene has also been advancing a broad, proprietary “end-to-end” platform. This platform incorporates a range of technologies, from target screening through TCR generation and optimization to clinical development, aiming to create best-in-class TCR-T therapies for solid tumor treatment. These technologies are designed to enhance TCR-T drug products’ safety, durability, and efficacy and optimize development processes at multiple sequential stages.
Medigene’s strategic focus on developing TCR-T therapies, which engage both surface and intracellular antigens on target cells, positions the company at the forefront of cellular immunotherapy. These therapies have shown promise in clinical trials for solid tumors, with improvements in efficacy and lower risks of adverse effects.
Seamless Therapeutics, a Germany-based biotech startup, has made a notable entrance into the gene editing sector with its innovative approach to treating severe conditions. The company raised $12.5 million in seed funding. This investment, led by Wellington Partners and Forbion, aims to accelerate the development of Seamless Therapeutics’ novel gene editing platform based on designer recombinases.
Seamless Therapeutics’ technology centers around reprogramming site-specific recombinases, a class of enzymes that have been used in scientific research for decades. These recombinases can precisely modify the genome of model organisms but were previously limited in their ability to act on new target sites. The breakthrough at Seamless Therapeutics has enabled these enzymes to target any sequence within the genome, providing a range of gene editing capabilities such as inversion, excision, exchange, and insertion of DNA fragments.
The Germany-based biotech company’s platform stands out for its potential to surpass existing gene editing tools like CRISPR in terms of precision and safety. The recombinases can modify DNA seamlessly, without the DNA repair mechanisms that often cause errors in other editing approaches, making them potentially safer. Seamless Therapeutics is currently working on a pipeline of treatments targeting a broad spectrum of indications, with one target already in the preclinical stages and others in the discovery stage.
The German biotech company is known for generating uniquely matched protein-drug conjugates, using novel proprietary technologies combined with disease-specific biological insight. Their focus is on expanding the therapeutic potential of antibody-drug conjugates (ADCs), a field showing promising growth in cancer therapy.
One of Tubulis’ major advancements is its strategic partnership with Bristol Myers Squibb (BMS), announced in April 2023. This collaboration involves the development of next-generation ADCs for cancer treatment, leveraging Tubulis’ proprietary P5 conjugation and Tubutecan platforms. The agreement terms include an upfront payment of $22.75 million to Tubulis, with potential milestone payments exceeding $1 billion, plus royalties on net product sales. BMS will gain exclusive rights to access Tubulis’ technology for developing highly differentiated ADCs aimed at treating solid tumors. This alliance highlights the potential of Tubulis’ approach in developing ADC-based therapeutics and positions them as a significant player in oncology treatment.
In addition to the partnership with BMS, Tubulis successfully closed a $65 million (€60 million) series B financing round. This funding will help accelerate the development of their ADC pipeline and expand the range of their platform technologies.
Tubulis aims to build new conjugates to fill its growing pipeline and continue collaborating with industry partners to usher in a new era of ADCs and deliver better outcomes for cancer patients. The company’s innovative approach in the field of ADCs, combined with strategic partnerships and successful funding rounds, positions Tubulis as an emerging key player in the development of advanced cancer treatments.
Headquartered in Germany, Vivoryon Therapeutics is a clinical-stage biotech company focused on developing small molecule-based medicines for severe diseases. The company has been particularly focused on Alzheimer’s disease (AD) with its lead program, varoglutamstat. This investigational small-molecule medicine aims to treat the early stages of Alzheimer’s disease and is currently being evaluated in two major phase 2 studies, VIVIAD in Europe and VIVA-MIND in the U.S. These studies are designed to evaluate the safety, tolerability, and efficacy of varoglutamstat, with final top-line data from VIVIAD expected by the end of the first quarter of 2024.
Varoglutamstat is unique due to its potential to modulate the activity and stability of proteins altered in disease settings, specifically targeting N3pE-amyloid, a variant implicated in the toxicity and pathology of Alzheimer’s disease. The preclinical evidence suggests that inhibiting the enzyme QPCT, which is involved in N3pE-amyloid formation, could alter the course of AD progression. The drug’s oral administration offers an advantage in terms of ease of use for patients, and preliminary safety data indicate it may not have the risks of brain swelling and bleeding seen with some other amyloid-lowering treatments.
Beyond Alzheimer’s disease, Vivoryon has a pipeline of small molecule inhibitors for various indications, including cancer, inflammatory diseases, and fibrosis. The German biotech company’s innovative approach to leverage post-translational modifications to develop new therapies positions it as a notable player in the sector.
Germany’s biotech brilliance: A fusion of legacy companies and startup pioneers
Germany’s standing in medical biotechnology is bolstered by a combination of both long-established companies and startups. This diverse industrial base is supported by cohesive efforts from the industry, government, and research sectors, which have worked together to solidify the country’s position as a major international hub for medical biotechnology.
Innovation is a cornerstone of the German biotech sector, supported by 30 BioRegions, regional initiatives that have been instrumental in advancing modern biotechnology within the country.
The industry’s infrastructure in Germany is well-developed, encompassing legal and operational frameworks that support biotech companies. Education and workforce development are other key focus areas, given the technical nature of the biotech field. Germany’s emphasis on science and technology education is crucial for maintaining the industry’s growth, as the sector demands a highly skilled workforce. The country’s education system, renowned for its quality in science and technology, supports the industry’s ongoing need for skilled professionals, making Germany one of the most accomplished biotech ecosystems in the world.