Astellas received positive CHMP opinion for zolbetuximab plus chemo in gastric cancer

CLINICAL AND REGULATORY 

Astellas received positive CHMP opinion for zolbetuximab plus chemo in gastric cancer 

Zolbetuximab, a first-in-class CLDN18.2-targeted monoclonal antibody, is recommended in combo with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive. If approved, zolbetuximab would become the first and only CLDN18.2-targeted therapy available for patients in the EU. 

FDA recommends against accelerated approval for botensilimab plus balstilimab combination 

Agenus announced the results of its end-of-Phase 2 meeting with FDA for the advancement of its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for the treatment of adult patients with relapsed or refractory microsatellite stable colorectal cancer with no active liver metastases. Following the report of an impressive 23% response rate in a challenging microsatellite-stable CRC population earlier this year, Agenus said FDA is advising against pursuit of an accelerated approval for BOT/BAL combination regimen. The concern, according to Agenus, is that the ORR data may not translate to a survival advantage. The agency is recommending inclusion of a BOT monotherapy arm in Phase 3 trial design. 

Biontech announced positive topline Phase 2 results for mRNA immunotherapy candidate 

Biontech announced positive topline data from the ongoing Phase 2 trial in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-L1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo (cemiplimab), an anti-PD-1 monoclonal antibody being developed by Regeneron, and assesses the two single agents alone. The trial met its primary efficacy outcome measure, demonstrating a statistically significant improvement in ORR in patients treated with BNT111 in combination with cemiplimab as compared to historical control in this indication and treatment setting. Both randomized monotherapy arms showed clinical activity. The ORR in the cemiplimab monotherapy arm was in line with the historical control of anti-PD-L1 or anti-CTLA-4 treatments in this patient group. The treatment was well tolerated and the safety profile of BNT111 in combination with cemiplimab in this trial was consistent with previous clinical trials assessing BNT111 in combination with anti-PD-L1-containing treatments. The Phase 2 trial will continue as planned to further assess the secondary endpoints, which were not mature at the time of the primary analysis. 

Latest TIGIT failure announced by Genentech in NSCLC patients 

Genentech announced that the Phase 2/3 SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq and chemotherapy versus pembrolizumab and chemotherapy as first-line treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous NSCLC did not meet its primary endpoints of PFS. The combination showed reduced efficacy compared to the comparator arm. 

DEALS AND FINANCING 

Pentixapharm acquired target discovery business Glycotope 

Pentixapharm, a clinical-stage biotech discovering and developing novel targeted radiopharmaceuticals against a range of malignancies, has announced the execution of an agreement, effective July 1st, to acquire the target discovery business of Berlin-based Glycotope. The deal encompasses a portfolio of preclinical antibodies against multiple oncology targets that can be developed into radiopharmaceuticals. It also includes Glycotope’s laboratories, cell banks, tumor target data base, and the equipment needed to exploit the discovery platform, along with a range of patents, licenses, and other tangible assets. In total, Pentixapharm will be able to add an integrated team of 40 seasoned executives, R&D specialists, and administrators to its staff. 

Third Arc launched with oversubscribed $165 million Series A financing 

Third Arc Bio, a biotech company developing multifunctional antibodies that are optimized for best-in-class T cell engagement across solid tumors and inflammatory & immunology disease, today announced a $165 million oversubscribed Series A financing that will advance the company through clinical studies to address significant unmet needs in oncology and autoimmunity. The company was launched in 2022 with seed financing from Omega Funds and has since advanced multiple programs that will enter the clinic starting in early 2025.