Innovent Biologics’ Phase 3 Orient-31 trial for sintilimab in EGFR-mutated nonsquamous NSCLC met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar) and chemotherapy, the treatment improved PFS vs. chemotherapy alone. The Orient-31 study looked into sintilimab plus Byvasda and chemotherapy as a treatment for disease that has progressed after treatment with an EGFR tyrosine kinase inhibitor. Patients were randomized in a 1-to-1-to-1 ratio to receive the sintilimab/Byvasda/chemo combo therapy, sintilimab plus combined with chemotherapy (pemetrexed and cisplatin), or placebo combined with pemetrexed and cisplatin. The study continues until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Target accrual is 480 patients. The study showed no additional safety signals. Sintilimab in combination with chemotherapy demonstrated a trend of PFS benefit compared to chemotherapy alone.
Innovent’s PD-1 inhibitor meets primary endpoint in Phase 3 NSCLC study
CLINICAL
Agenus withdraws BLA at FDA’s recommendation following full approvalof Keytruda
Agenus announced a strategic decision to withdraw its BLA for balstilimab, its PD-1 inhibitor. The decision to withdraw the BLA does not change the development plans for balstilimab combinations. Following the full approval of Keytruda, announced four months earlier than the FDA goal date, FDA no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw. The BLA submission for balstilimab received Fast Track and Priority Review designation from the FDA, with a target action date of December 16, 2021. As part of the BLA review process, Agenus successfully completed 3 FDA inspections with no cited issues, concerns, or Form-483s. As previously reported, in the largest single-arm trial to date in this population (140 evaluable patients), balstilimab demonstrated objective responses in both PD-L1 positive and negative patients, with an ORR of 20% and 8% respectively. Keytruda has demonstrated an ORR of 14% and 0% in PD-L1 positive and negative patients respectively, which led to its accelerated approval in 2018. Balstilimab has shown superior killing of PD-L1 negative tumors compared to other anti PD-1 therapies, including Keytruda, suggesting a broader mechanism consistent with balstilimab’s clinical activity in both PD-L1 positive and negative cervical cancer. Concurrent with the withdrawal, Agenus will discontinue its ongoing confirmatory trial BRAVA in this population, which is expected to reduce R&D expenses by over $100 million. However, given the clinical benefit demonstrated by balstilimab, Agenus plans to launch expanded access programs to give patients and doctors access to balstilimab in several countries, including the US, pending regulatory processes.
DEALS AND FINANCING
Eucure Biopharma and Tracon Pharma partnered to develop clinical stage CTLA-4 antibody
Eucure Biopharma, a subsidiary of Chinese Biocytogen, has entered into a collaborative partnership agreement with Tracon Pharmafor the development of YH001, a CTLA-4 antibody with enhanced ADCC and CDC effector functions, for development in multiple oncology indications, including soft tissue sarcoma, in North America. Tracon will be responsible for the clinical development and commercialization of YH001 in multiple oncology indications in North America, with the majority of the development activities expected to occur in US. Tracon will bear the costs of clinical trials and Eucure Biopharma will supplyYH001. Tracon will be responsible for commercializing YH001 in multiple oncology indications in North America and will owe Eucure escalating double digit royalties on net sales.
German iOmx headed for clinic with €65 million Series B
iOmx Therapeutics, a company developing cancer therapeutics based on next generation immune checkpoint targets, announced the closing of a Series B round totaling €65 million. The financing was co-led by Athos Service, the Strüngmann family office, and MIG Capital, with participation from existing investors Wellington Partners, Sofinnova Partners and M Ventures. The new funds will be invested to advance the company’s lead program IMT-07, a SIK3 kinase inhibitor to treat solid tumors, through the first-in-man clinical trial, and to further develop IMT-18, a first-in-class IGSF11-targeting antibody to treat PD-1/PD-L1-resistant tumors. In addition, iOmx will continue to leverage its target discovery platform, iOTarg, to advance additional novel immune checkpoint programs to lead candidate stage.
