LAVA Therapeutics, a biotech company pioneering the development of bispecific antibodies to engage gamma-delta T cells for cancer therapies, today announced the closing of an oversubscribed $83 million (€71 million) Series C financing to fund the advancement of its pipeline and platform. The financing was co-led by new investors Novo Ventures, the venture arm of Novo Holdings, and Sanofi Ventures, and included additional new investors Redmile Group, LLC, Ysios Capital and BB Pureos Bioventures. In addition, current investors Versant, Gilde Healthcare and MRL Ventures Fund, LLC participated significantly in the round.

As part of the transaction, Nanna Lüneborg, partner at Novo Ventures, Laia Crespo, EU head of investments at Sanofi Ventures, and Joël Jean-Mairet, managing partner and co-founder of Ysios, joined LAVA as members of the board of directors.

“We are grateful to have attracted a high-quality syndicate of new investors complementing strong continued support of our existing investors. This financing provides meaningful capital to advance our bispecific gamma-delta T cell engager portfolio into multiple proof-of-concept clinical trials expected to start in 2021 for the treatment of solid tumors and hematologic malignancies,” said Stephen Hurly, chief executive officer of LAVA Therapeutics. “We believe our targeted approach, leveraging the unique features of gamma9-delta2 T cells with innovative bispecific antibodies, will deliver novel T cell-based therapies offering advantages over today’s oncology treatments. In addition to the funding raised, the appointments of Nanna, Laia and Joël to our board further strengthen our team, and we look forward to benefiting from their insights and industry expertise.”

Gamma-delta T cells are the natural surveillance cells of the immune system, continuously patrolling the human body for the identification and targeting of tumor cells. These cells bridge the innate with the adaptive immune system and are a largely untapped opportunity in cancer treatment. LAVA’s bispecific gamma-delta T cell engager platform is harnessing the unique properties of these T cells creating a revolutionary truly tumor-targeted immunotherapy to improve outcomes for cancer patients.

“LAVA’s bispecific antibody approach to targeting and engaging gamma-delta T cells has the potential to transform the treatment of a wide range of cancers,” said Dr. Lüneborg. “We are impressed by the preclinical data generated by LAVA to date, which validate the company’s platform and support their transition into a clinical-stage organization. The team is highly experienced in drug development, and I look forward to working with them.”

“Gamma-delta T cells are an emerging field and an incredibly exciting area in oncology. Bispecific antibodies able to directly engage this type of cells offer the potential to significantly impact patients across the globe in these diseases with high morbidity and mortality,” said Dr. Crespo

Source: Lava Therapeutics (Press release)

Neogene Therapeutics, Inc., a pre-clinical stage biotechnology company pioneering a new class of fully personalized neo-antigen T cell therapies to treat cancer, today announced that is has raised $110 million in a Series A financing. The financing was co-led by EcoR1 Capital, Jeito Capital and Syncona, with participation from Polaris Partners and Pontifax. Seed investors Vida Ventures, TPG and Two River also participated in the round.

Neogene, a Two River company, was founded in 2018 by a team of world-class cell therapy experts to advance the development of neo-antigen T cell therapies. Carsten Linnemann, Ph.D., Chief Executive Officer of Neogene, and Ton Schumacher, Ph.D., Principal Investigator at the Netherlands Cancer Institute, Oncode Institute and 2020 recipient of the Dutch Research Council’s Stevin Award co-founded the company with individual investments by cell therapy industry veterans Arie Belldegrun, M.D. FACS, founder of Kite Pharma, Inc. and Co-Founder and Executive Chairman of Allogene Therapeutics, Inc. and David Chang, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of Allogene. Dr. Linnemann and Dr. Schumacher previously co-founded T-Cell Factory B.V., a company acquired by Kite Pharma in 2015.

Dr. Schumacher, an internationally leading immunologist in the areas of neo-antigen biology and T cell engineering, developed the seminal concepts of Neogene’s proprietary technology. Neogene’s platform allows for the isolation of neo-antigen specific TCR genes from tumor biopsies that are routinely obtained from cancer patients during treatment. The tumor-infiltrating lymphocytes (TIL) obtained by these tumor biopsies frequently express TCRs specific for mutated proteins found in cancer cells (neo-antigens). The Company’s proprietary technology uses state-of-the-art DNA sequencing, DNA synthesis and genetic screening tools to identify such neo-antigen specific T cell receptor genes within tumor biopsies with high sensitivity, specificity and at scale. The isolated TCR genes are subsequently engineered into T cells of cancer patients to provide large numbers of potent T cells for therapy.

“Neogene is committed to forging a path for new fully personalized engineered T cell therapies in solid cancer that are redirected towards neo-antigens found on cancer cells,” said Dr. Linnemann. “While engineered T cell therapies have transformed the treatment paradigm for patients with hematologic malignancies, the industry has struggled to translate this success to the enormous unmet need in patients with advanced solid tumors. We believe that through a fully individualized approach using patient-specific TCRs to target neo-antigens, engineered T cell therapy can become broadly accessible to these patients. We are excited that our vision is shared by an outstanding syndicate of marquee investors, who have a deep understanding of and commitment towards the development of novel cell therapies in oncology.”

“Neo-antigens represent ideal targets for cancer therapy, as they inevitably arise from DNA mutations that enable tumor development in the first place. Further supporting this concept is clear, correlative evidence linking T cell reactivity against neo-antigens with tumor regression in several patients.” said Dr. Schumacher. “The Neogene platform makes it possible to exploit the neo-antigen reactive TCRs that are present in TIL without a requirement for viable tumor material. In addition, its syn-bio based approach offers major advantages with respect to standardization and scalability and will be critical to achieve our goal of bringing personalized engineered T cell therapies to patients.”

In this Series A financing, Neogene expands its distinguished investor base with leading health-care investors from both the US and Europe. For the seed-investors Vida Ventures, TPG and Two River, Neogene marks the second major collaboration in the cell therapy space after the launch of Allogene Therapeutics in 2018. Neogene’s seed-financing in 2019 enabled the Company to achieve proof-of-concept for its neo-antigen technology platform and built on the respective expertise of Vida Ventures, Two River and TPG in the gene and cell therapy space.  

“We believe that Neogene’s technology and therapeutic approach has the potential to become a game changer for the treatment of cancer,” said Oleg Nodelman, Founder and Managing Director of EcoR1 Capital. “We are impressed by the bold vision of the management team and are thrilled to support Neogene as it advances its mission of developing novel therapies for cancer patients in need.”

“Neogene’s approach perfectly aligns with Jeito’s mission. Jeito was launched recently to support new and established entrepreneurs aspiring to help patients in need by pioneering novel, ground-breaking medicines underlined by highest quality innovation,” said Rafaèle Tordjman, Founder and Chief Executive Officer at Jeito Capital. “We are delighted to welcome Neogene as the first investment into our new portfolio.”

“We are excited to partner with the outstanding Neogene team,” said Martin Murphy, Chief Executive Officer of Syncona. “Neogene’s technology offers a radically innovative approach to utilize the therapeutic potential of TIL cells by employing state-of-the-art TCR engineering and synthetic biology technologies.” Facilitated by the Series A, Neogene intends to further develop its technology with growing offices in Amsterdam and the US with the goal to initiate Phase I clinical studies in 2022.

Source: Neogene Therapeutics (Press release)

CATO SMS unveiled its new brand, revealing an updated look and logo capturing the company’s powerful offering following the merger of CATO Research, LLC and Specialized Medical Services-oncology BV (SMS-oncology). Now, as a fully integrated company, CATO SMS leverages 30 years of global experience to provide comprehensive regulatory support and full-service clinical trial solutions to small and emerging biopharmaceutical companies with a commitment to making trials digital.

CATO and SMS-oncology joined forces in 2019 to expand their global footprint, deepen their oncology and regulatory expertise, and broaden their suite of services. As one company, CATO SMS offers a unique blend of capabilities specializing in supporting biopharmaceutical companies with advancing drug development. CATO SMS has conducted 500+ trials in more than 25 countries, focusing on some of the most complex development areas including oncology, rare and orphan indications, and cell and gene therapy. The company has contributed to the successful development of over 50 marketed products and includes a prolific regulatory group that completes approximately 750 submissions of various types annually.

“Our new brand reflects the value and insight CATO SMS brings to our clients as one organization,” said Mark A. Goldberg, M.D., executive chairman, CATO SMS. “We’ve formed a high-performance team across a variety of therapeutic areas, from our global regulatory experts to our center of excellence in oncology. We are excited to provide our clients with a broader set of solutions supported by the same high level of operational excellence and personalized customer service they have come to expect from us over the past three decades.”

CATO SMS’ new website is now live at CATO-SMS.com.

About CATO SMS
CATO SMS is a provider of specialized clinical research solutions. The company was formed when CATO Research, LLC and Specialized Medical Services-oncology BV (SMS-oncology) merged in 2019. With more than 30 years of experience focusing on the needs of small and emerging biopharmaceutical companies, CATO SMS effectively designs and executes studies ⁠— from strategy to approval ⁠— in complex indications and modalities across a variety of therapeutic areas, with a proven center of excellence in oncology. CATO SMS’ regulatory, therapeutic, and operational expertise supports clients with achieving their goals and exceeding their expectations. Visit CATO-SMS.com for more information.

Source: CATO SMS (Press release)

Het FD schreef afgelopen week over het beurssucces van het Deens-Nederlandse Genmab. In de opbouw van de koersstijging ontwaart de krant een driedeling. Naast de miljoenenomzet als gevolg van medicijn Darzalex, wordt ook de aankondiging van de samenwerking met AbbVie en de onverwachte meevallers van twee recent geïntroduceerde geneesmiddelen genoemd als succesfactoren. Dit laat goed zien hoe volatiel en onvoorspelbaar de biotechnologiesector kan zijn.

Het hele verhaal lees je in het FD: https://fd.nl/ondernemen/1355089/de-hink-stap-sprong-van-biotechbedrijf-genmab