FDA dings Regeneron for seeking accelerated approval before launching trials to confirm benefit

CLINICAL AND REGULATORY

FDA dings Regeneron for seeking accelerated approval before launching trials to confirm benefit

The only approvability issue is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing. Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronextamab as part of the OLYMPIA program – one of the largest clinical programs in lymphoma. As the OLYMPIA program is intended to change the treatment paradigm of several B-cell non-Hodgkin lymphoma subtypes – including in earlier lines of therapy – in agreeing to the program, the FDA required that the trials include both dose-finding and confirmatory portions. Enrollment in the dose-finding portion has begun, but the CRLs indicate that the confirmatory portions of these trials should be underway and that the timelines to completion be agreed prior to resubmission. Regeneron is committed to working closely with the FDA and investigators to bring odronextamab to patients with R/R FL and R/R DLBCL as quickly as possible. Regeneron plans on sharing updates on enrollment and regulatory timelines later this year. Regulatory review of odronextamab remains ongoing by the EMA for the treatment of R/R DLBCL and R/R FL. In the European Union, odronextamab was granted Orphan Drug Designation in DLBCL and FL.

DEALS AND FINANCING

Novartis acquires IFM Due to develop STING antagonist targeting innate immune system

IFM Therapeutics announced that Novartis has exercised its option to acquire all of the outstanding capital stock of IFM Due, a subsidiary company of IFM. Launched in February 2019, with a focus on developing small molecules that inhibit the cGAS-STING pathway, the company entered into an option and collaboration agreement with Novartis in September, 2019 whereby Novartis made fixed payments sufficient to fully finance IFM Due’s research and development costs for the cGAS-STING program in exchange for the option to acquire the IFM Due subsidiary. IFM received $90 million in upfront payment and will be eligible for up to $745 million in milestone payments, adding up to $835 million in total consideration. The acquisition provides Novartis with full rights to IFM Due’s portfolio of STING antagonists, which have the potential to treat an array of serious inflammation-driven diseases characterized by excessive interferon and other pro-inflammatory cytokine signaling. The cGAS-STING (cyclic GMP-AMP Synthase, Stimulator of Interferon Genes) pathway functions within the innate immune system to sense cytosolic DNA, which is a signal of cellular danger, and then triggers a STING-dependent inflammatory response. Inappropriate pathway activation, which leads to excessive interferon/cytokine signaling, can result from mutations that activate the pathway or other drivers of aberrant pathway activation, such as mitochondrial dysfunction.

Clasp Therapeutics launches with $150 million to develop next-generation T cell engagers

Clasp Therapeutics, a biotechnology company bringing unparalleled precision to immuno-oncology using next-generation T cell engagers, launched with $150 million in financing. The round was led by Catalio Capital Management, Third Rock Ventures and Novo Holdings, with participation from Vivo Capital, Cure Ventures, Blackbird BioVentures, Pictet Alternative Advisors, American Cancer Society’s Bright Edge and Alexandria Venture Investments. Clasp is developing modular TCEs tailored to each patient’s immune system that are directed to common oncogenic driver mutations, resulting in off-the-shelf, antibody-like medicines that can specifically target a wide variety of hard-to-treat tumor types. Clasp is leveraging advances made by its scientific founders at Johns Hopkins University. The researchers’ structure-driven understanding of human leukocyte antigen (HLA)-antibody interactions enables the engineering of advanced TCEs that can precisely target common oncogenic mutations with exquisite specificity.