BioNTech and Regeneron launch new melanoma collab; Harbour BioMed finds incubation partner
BioNTech and Regeneron have announced they are collaborating on a Phase II trial to study how the combination of the former’s BNT111 candidate with the latter’s Libtayo can treat melanoma.
The trial will enroll patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma. More details about the trial will be revealed at a later date, with the companies hoping to launch sometime in the fourth quarter.
Regeneron is a latecomer in the PD-(L)1 market and has been developing Libtayo together with Sanofi over the last several years. Though Libtayo has seen setbacks, including last October when a pair of clinical trials failed in combination with Sanofi’s CD38, the drug recently returned positive data in a single-arm study for basal cell carcinoma in patients whose disease had advanced beyond the reach of a Hedgehog pathway inhibitor.
BNT111, an mRNA cancer immunotherapy, is the most advanced of BioNTech’s candidates coming out of its FixVac platform. The company says it targets four antigens frequently expressed in the tumors of patients with melanoma: NY-ESO-1, MAGE-A3, tyrosinase, and TPTE. — Max Gelman
Harbour BioMed finds partner for startup incubation
Harbour BioMed, the Chinese-Dutch-Cambridge antibody company from former Sanofi exec Jingsong Wang, has signed an agreement with Shanghai-based Viva Biotech to help incubate new startups.
The agreement comes several weeks after Harbour announced they had raised $102 million to fund a slate of clinical and preclinical programs, mostly in cancer. The company has now raised nearly since $300 million since its founding in 2016, and Wang has established over 160 employees in China, Cambridge and Rotterdam.
The new collaboration will make Harbour’s transgenic mice and Viva’s structure-based drug discovery platform available to emerging biotechs. “Some of these innovative startups may become the next big biotech in the industry,” Wang said. — Jason Mast
Axovant and Oxford Biomedica expand Parkinson’s partnership
Axovant has expanded their partnership with Oxford Biomedica to advance their Parkinson’s gene therapy deep into the clinic.
The Vivek Ramaswamy neuroscience and gene therapy outfit has signed a three year clinical supply agreement with Biomedica, the UK-based gene therapy CDMO. Axovant originally licensed the gene therapy from Biomedica two years ago, after a major trial failure in Alzheimer’s forced the biotech to rethink its pipeline.
Although originally founded as a gene therapy developer, Biomedica has long since organized much of its business around manufacturing gene therapy and viral vector technology for other companies. Most notably, they make the lentiviral vectors for Novartis’s CAR-T therapy Kymriah. They were also contacted in the spring to help produce AstraZeneca’s viral vector vaccine.
Axovant is now in Phase II for its Parkinson’s gene therapy, with 6-month safety and efficacy data expected in Q4 of this year. — Jason Mast
Takeda forecasts higher profits with continued R&D refocusing
The revision was announced Friday as Takeda reported quarterly earnings, including about $871 million in profits this quarter. Previously, the pharma expected $3.36 billion in revenue. The changes reflect a net gain from one-time items recognized in the first quarter.
Takeda has been selling off assets left and right since the Shire purchase and refocused its pipeline around prescription drugs in order to reduce leverage. The company expects to file seven Wave 1 NME applications over the next 12 months as it continues this R&D push. — Max Gelman
Cincinnati/Atlanta-based Expression Therapeutics announces new construction plans
Expression Therapeutics is planning to construct a 43,000 square foot manufacturing facility in Cincinnati, OH to fulfill the company’s ex vivo cell processing and recombinant protein production needs. The new digs will manufacture lentiviral, retroviral and adeno associated viral GMP vectors, with the capability to manufacture up to 100 GMP vector products per year.
Expression also announced Thursday that it has appointed Bill Swaney as vice president of manufacturing. Swaney previously worked at the Cincinnati Children’s Hospital Medical Center. — Max Gelman