CLINICAL AND REGULATORY

GSK’s PD-1 gets priority review in first-line endometrial cancer

Jemperli is approved as monotherapy for previously-treated dMMR endometrial cancer, and has shown early efficacy signals in rectal cancer patients with the same biomarkers.

Roche wins an approval for its bispecific antibody Columvi

Roche intends to launch newly approved bispecific antibody Columvi glofitamab in the coming weeks after FDA granted the bispecific antibody accelerated approval to treat third-line diffuse large B cell lymphoma. The approval was based on response rates in a Phase 1/2 trials in which 30% of patients had previously received CAR T therapy.

Columvi will compete with fellow CD3 x CD20 bispecific Epkinly epcoritamab from AbbVie, which received accelerated approval in the setting last month. Epkinly’s response rates were slightly higher than Columvi’s in clinical testing, but Columvi has the advantage of being developed as a fixed-dose course of treatment. Both bispecifics offer an off-the-shelf alternative to CAR Ts.

BioNTech, OncoC4 build case for CTLA-4 product with lung cancer readout

Months after BioNTech paid OncoC4 $200 million up front for rights to ONC-392/BNT316, interim data from a Phase 1/2 trial showed that the CTLA-4 inhibitor led to an overall response rate of 29.6%, including one complete response and seven partial responses, as monotherapy among 27 evaluable patients with PD-1/PD-L1-resistant non-small cell lung cancer.

The companies said an immune-related adverse event rate of 30% was “lower than what was reported for similar drugs,” and they believe its reduced effect on regulatory T cells outside the tumor microenvironment is a differentiator for the program.

Replimune gains on oncolytic virus data in melanoma

Shares of Replimune rose 20% following the company's ASCO presentation of updated data from its registration-directed Phase 1/2 IGNYTE trial combining vusolimogene oderparepvec (RP1), an engineered herpesvirus expressing the fusogenic protein GALV-GP R- and the cytokine GM-CSF, with anti-PD1 mAb Opdivo in 91 melanoma patients who had previously progressed on anti-PD1 therapy. The combination had an ORR of 37.4% with a median follow-up of 75.9 weeks, and there was no progression in responding patients since Replimmune’s readout in Dec. 2022, after which the company raised a $225 million follow-on.

Replimmune also reported Phase I data for RP2, which adds an encoded anti-CTLA-4 antibody-like molecule to the RP1 construct, showing responses in four of 14 uveal melanoma patients including those with metastatic tumors in the liver and bone.

Astellas submits first-in-class Claudin program in Japan

Astellas has submitted an NDA for first-in-class CLDN18.2 inhibitor zolbetuximab to Japan’s Ministry of Health, Labour and Welfare to treat locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive. The pharma is preparing submissions in the US, Europe, China and other territories during the company’s current fiscal year, which ends March 31, 2024.

Full approval for Amgen’s Blincyto

Blincyto blinatumomab from Amgen now has two full FDA approvals after the agency converted the bispecific T-cell engager’s 2018 accelerated approval to a full approval to treat CD19-positive B cell precursor ALL in first or second complete remission. Blincyto’s 2014 accelerated approval to treat relapsed or refractory CD19-positive B cell precursor ALL was converted to a full approval in 2017.

DEALS AND FINANCING

Hookipa adds 6 months cash runway after positive combo cancer data

Arenavirus company Hookipa Pharma raised $50 million in a follow-on after the biotech disclosed Phase 2 data for HB-200 plus Keytruda in first-line HPV-positive head and neck cancer patients that showed the combination doubled the ORR to 43% vs. 19% for Keytruda monotherapy patients. The offering sold 22.9 million shares at $1.31 per share. At March 31, Hookipa had $110 million in cash and a three-month operating loss of $25.8 million.