Week of August 10
This weekly post looks to identify important advancements in the areas of oncology, CNS disorders and neurodegeneration, technologies, and industry and corporate developments. More in-depth reading and analysis can be found in the attached links.
Oncology
Roche announced negative Phase 3 results for Tecentriq in combination with paclitaxel to treat PD-L1+ mTNBC. The combination failed to be statistically significant compared to placebo plus paclitaxel on its primary endpoint of progression-free survival (PFS). Link
FDA approved MorphoSys’ and Incyte’s Monjuvi in combination with Revlimid as a second-line therapy to treat relapsed or refractory diffuse large B-cell lymphoma. This is the first FDA approval of a second-line treatment for relapsed or refractory DLBCL. Link
FDA approved GSK’s Blenrep to treat relapsed or refractory multiple myeloma. Blenrep, a first-in-class anti-BCMA therapy, will be a monotherapy given to multiple myeloma patients who have received at least four prior lines of therapy. Link
Novartis’ announced positive interim Phase 2 results for Kymriah to treat relapsed or refractory follicular lymphoma. Kymriah met its primary endpoint of complete response rate with the data being available at an upcoming medical meeting and included in US and EU regulatory submissions. Link
Researchers at Sanford Burnham Prebys Medical Discovery Institute identified a protein, PPP1R1B, which significantly reduced the ability of pancreatic cancer to metastasize in mice. PPP1R1B is inversely correlated with hypoxia-inducible factor 1A (HIF1A), a target that has recently received attention, with three scientists having received the 2019 Nobel Prize for their work on HIF’s mechanisms. Link
Pfizer announced positive Phase 3 results for Lorbrena in people with untreated ALK+ NSCLC. Lorbrena met its primary endpoint of PFS compared to patients treated with Xalkori. Link
Bristol Myers Squibb announced positive Phase 3 results for Opdivo plus Yervoy to treat previously untreated, unresectable malignant pleural mesothelioma. The combination demonstrated a significant increase in OS compared to platinum-based standard of care chemotherapy. Link
CNS Disorders and Neurodegeneration
Voyager Therapeutics announced the termination of their partnership with AbbVie in developing tau and alpha-synuclein AAV-based gene therapies to treat severe neurological diseases. With this termination, Voyager is free to pursue vectorized antibody programs alone or in collaboration with another partner. Link
Denali Therapeutics, a company developing drugs for Alzheimer’s and Parkinson’s disease, signed an agreement with Biogen to co-develop and co-commercialize Denali’s LRRK2 small molecule inhibitors to treat Parkinson’s disease. Link
FDA approved Roche’s Evrysdi to treat spinal muscular atrophy (SMA) in adults and children. For SMA patients, Evrysdi is the only treatment that can be taken at home. Link
Industry and Corporate Developments
T-knife GmbH closed $66M Series A Financing from Versant Ventures and RA Capital Management. T-knife is using a humanized T cell receptor mouse platform for treatment of solid tumors. Link
GentiBio closed $20M seed funding from OrbiMed, Novartis Venture Fund and RA Capital Management. GentiBio is developing engineered regulatory T-cells to treat autoimmune, alloimmune, autoinflammatory, and allergic diseases. Link
Versant Ventures launched Matterhorn Biosciences with a $30M investment, the latest company to come out of Versant’s Ridgeline Discovery Engine. Matterhorn is developing MR1-restricted T cell receptor therapies. Link
GI Partners, a private investment firm, announced the acquisition of Clinical Ink to accelerate the development of their clinical trial workflow solutions. Clinical Ink develops technologies to capture and integrate electronic data from clinical sites, physicians, and patients. Link
Moderna disclosed in their Q2 report that they received approximately $400 million in deposits for their COVID-19 vaccine. In addition, Moderna’s Phase 3 study is on track to complete enrollment in September 2020 with results announced in October. Link
Novavax and Takeda announced a collaboration to develop, manufacture, and commercialize Novavax’ COVID‑19 vaccine candidate in Japan. Novavax will license the vaccine to Takeda for local production and commercialization which Takeda expects to manufacture around 250 million doses per year. Link
Teva Pharmaceutical and Alvotech announced an exclusive strategic partnership to commercialize five biosimilar product candidates in the US. Alvotech will focus on the manufacturing while Teva will focus on the commercialization of biosimilar products. Link
Pfizer announced a multi-year manufacturing agreement with Gilead Sciences to help manufacture and supply remdesivir. This agreement is part of Pfizer’s five-point plan, launched in March, asking pharmaceutical companies, biotech companies, government agencies, and academic institutions to work together in addressing this crisis. Link
Johnson & Johnson announced an agreement with the US government for 100 million doses of their COVID-19 vaccine. The Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense have committed over $1 billion towards this agreement with the possibility of receiving an additional 200 million doses. Link