With the FDA approval of Scemblix (asciminib), a STAMP inhibitor for treating chronic myeloid leukemia (CML) in adults, Novartis AG has a companion to its longstanding therapy Gleevec (imatinib) as a treatment for the indication.
Optimism for the potential of a bifunctional fusion protein complex in development at HCW Biologics Inc. for the potential treatment of pancreatic cancer jolted company shares (NASDAQ:HCWB) skyward to $4.73 on Oct. 28, up 62%, though still far short of the company's $8 per share summer market debut. The company, founded and led by former Altor Bioscience Corp. CEO Hing Wong, gained FDA clearance to start a first-in-human phase Ib trial of the candidate, HCW-9218.
A phase III trial of Rafael Pharmaceuticals Inc.’s devimistat in pancreatic cancer has failed, sending shares in its publicly listed holding company through the floor. Shares in Rafael Holdings (NYSE:RFL) closed Oct. 28 down 73% to $8.09, for a loss of $22.08 after an independent data monitoring committee also recommended a separate phase III trial of devimistat in acute myeloid leukemia should be stopped due to lack of efficacy.
Antengene Corp. Ltd. has formed a partnership with Legochem Biosciences Inc. to jointly develop new antibody-drug conjugates (ADCs) primarily for cancer. The partners will integrate antibodies from Antengene with Legochem’s ADC technology.
Quanta Therapeutics Inc., a company developing therapies for RAS-driven cancers, closed $60 million in series C financing led by Surveyor Capital and Vida Ventures. The South San Francisco-based company said it would use proceeds from the financing to advance oncology-focused programs targeting RAF1 and KRAS through clinical candidate selection, IND filing and on to initial proof of concept.
When James Peyer, Cambrian Biopharma Inc.’s CEO, watched his grandfather fail every cancer treatment and eventually pass away, he came to a realization that now forms the backbone of his company. “The more I learned about cancer, the more convinced I became that we were approaching cancer as a disease in the wrong way,” Peyer told BioWorld. “We were waiting until people were sick and only then doing something about it.” Cambrian just closed on an oversubscribed series C that brought in $100 million to develop a pipeline of therapies designed to treat and prevent age-related diseases.
Cedilla Therapeutics Inc., an oncology company targeting upstream aspects of native protein degradation pathways, extended its year-ago series B with a $25 million investment bringing the round's total to $82.6 million. Proceeds from the financing will support advancement of its two lead programs, an inhibitor of the transcriptional enhanced associate domain (TEAD) transcription factor in the Hippo signaling pathway for the treatment of solid tumors and a selective inhibitor of CDK2/cyclin E for the treatment of multiple tumor types.
CEO Gil Beyen of Erytech Pharma AS said the firm is mulling next steps in the aftermath of phase III data with eryaspase in second-line pancreatic cancer, where the compound – which consists of L-asparaginase encapsulated in a donor-derived red blood cell – missed its primary endpoint of overall survival. “We will have to regroup and see how we can further continue on the different programs that are ongoing,” he said during a conference call with investors.
Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone.
Novartis AG has had another setback in its attempt to get canakinumab to work in oncology, after the interleukin-1beta (IL-1β) inhibitor flunked a phase III trial in first-line advanced lung cancer.