Anticancer

The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.

Acepodia’s dual-payload antibody-drug conjugates can link multiple tumor-killing agents without antibody modification. Apart from a GPC3-targeting candidate, the Taiwan-US biotech is also working on a bispecific antibody ADC with two different payloads, its CEO tells Scrip in an interview.

Scrip spoke with Lilly chief medical officer David Hyman at J.P. Morgan about the company’s oncology dealmaking strategy and plans for Scorpion’s selective PI3Kα-targeting asset.

After setbacks and a withdrawn filing, Dato-DXd is back on track for a potential second-line approval later this year in EGFR-mutant lung cancer. The partners are still counting on success in first line lung cancer and breast cancer treatment

The drug maker announced positive topline Phase III results for its subcutaneous PD-1 inhibitor sasanlimab in first-line, BCG-naïve non-muscle invasive bladder cancer combined with BCG.

The French biotech plans to file for EMA approval in graft-versus-host disease in mid-2025 while starting a US Phase III trial, which the CEO said in an interview is contingent on financing.

Acquired in August 2021 by Bayer, the San Diego-based biotech has used its autonomous operating model to make a purchase of its own, taking control of its functional genomics partner Tavros.

Five months after taking over the dual-masked T-cell engagers from Sanofi amid a restructuring, the company posted promising initial Phase I data from its PSMA- and HER2-targeting IO candidates.

Galapagos and Gilead are calling time on their ill-fated licensing deal and the Belgian biotech is looking to unlock value by creating a business development-focused spin-out armed with a €2.45bn cash pile. Major job cuts are also on the cards.

Topline Phase III results in EGFR exon 19 deletion/L858R substitution mutation NSCLC indicate more than a year in overall survival improvement over Tagrisso, the current standard of care.

Following promising Phase II data presented at ASH on the company's allogenic leukemia-derived dendritic cell vaccine, Mendus has secured support from the FDA and the EMA for pivotal studies starting later this year.

The new year is only a couple of days old but the Anglo-Irish biotech has agreed a sale to Hookipa that will create a US-listed entity around HB-700, which targets multiple KRAS mutations in lung, colorectal and pancreatic cancers, and Poolbeg's Phase II-ready drug which is designed to prevent cancer immunotherapy-induced cytokine release syndrome.

Data presented at the ASH conference showed high overall response and complete response rates in heavily pretreated CLL patients with Epkinly.

Faced with going out of business after repeated Phase II fails in a variety of tumor types for its investigational universal cancer vaccine, Norway’s Ultimovacs has been saved by compatriot Zelluna.

With two products on the market, a third on the way and a fourth under development too, the question becomes how they will fit in relative to each other and also CAR-T cell therapies.

After investing heavily in both mechanisms for IO-IO combinations, Merck is cutting its losses with vibostolimab and favezelimab, and switching its anticancer bets to other modalities.

BMS presented Phase I/II data for its next-generation small molecule drugs mezigdomide and iberdomide at ASH.

Expert panelists discuss regulatory challenges, flexible approaches to assay selection, and applying scientific reasoning with guidelines to address immunogenicity and safety assessment challenges in oncology biologics and biosimilars.

The drug maker presented Phase I data for PF-08046040 at ASH, having designed it to avoid some of the toxicities associated with antibody-drug conjugates.

The biotech’s lead candidate now looks approvable as the first new localized prostate cancer treatment in 20 years – allowing Candel to raise much-needed funds – but a filing must wait