Upbeat phase III findings outweighed less encouraging late-stage trial news, as big pharma provided a mixed bag of cancer findings – with one data batch to form the basis of global approval bids, as Astrazeneca plc with Daiichi Sankyo Co. Ltd. unveiled interim results from a study called Tropion-Breast01. Targeting trophoblast cell surface antigen 2, datopotamab deruxtecan (dato) hit the mark in progression-free survival for patients with hormone receptor-positive, HER2-low or negative breast cancer in the study called Tropion-Breast01.
Wuhan YZY Biopharma Co. Ltd. made its debut on the Hong Kong Stock Exchange, raising HK$121 million (US$15.48 million) in its IPO on Sept. 22, with shares (HKEX:02496) opening at the lower end of its range at HK$16 per share and ending the day at HK$16.60, a rise of 3.75%.
Although preclinical studies of genetically engineered interleukin-18 (IL-18) historically indicated its potential in cancer treatment, interest in the cytokine languished after GSK plc shelved its IL-18 therapeutic on lack of responses in a phase II melanoma trial. But in 2020, Yale University-based professor of immunobiology Aaron Ring set about reviving IL-18 as a cancer therapeutic. He went on to engineer a decoy-resistant form of IL-18 and then founded Simcha Therapeutics Inc. to develop the drug – named ST-067.
Merck KGaA has entered deals that could bring U.K. artificial intelligence companies Benevolentai Ltd. and Exscientia plc more than $1.2 billion. Oxford, U.K.-based Exscientia and Merck will collaborate to find three small-molecule candidates in oncology, neuroinflammation and immunology. Exscientia is getting $20 million up front and could bring in $674 million in milestones payments.
Peptidream Inc. and Genentech Inc., a Roche Holding company, signed a deal worth up to $1 billion to discover and develop macrocyclic peptide-radioisotope (peptide-RI) drug conjugates. Peptidream, of Kawasaki, Japan, will use its peptide discovery platform system technology to discover, optimize and develop macrocyclic peptide candidates for use as peptide-RI drug conjugates against targets of interest to Genentech. Genentech will pay Peptidream an up-front payment of $40 million and up to $1 billion in potential development, regulatory, and commercial-based milestones. In addition, Peptidream is eligible to receive tiered royalties on net sales (ex-Japan) of any products arising from the collaboration.
Magnet Biomedicine Inc. emerged from stealth mode and pulled down a $50 million series A round co-led by founding investor Newpath Partners alongside Arch Venture Partners. The firm is advancing molecular glue discovery by way of rational selection and design, looking past known protein-protein interactions and what Magnet calls “tangential” degradation approaches to analyze the broader protein landscape and ultimately pair targets with rationally chosen presenters in the tissue where the disease manifests.
Starpharma Holdings Ltd.'s nanoscale drug delivery technology shows enhanced safety and durable responses in phase II trials compared to standard of care therapies in patients with advanced colorectal and ovarian cancer.
Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.).
In the daunting shadow of previous years’ numbers, two companies jumped into this year’s relatively tepid IPO market. Rayzebio Inc. priced its upsized $311 million IPO of 17.2 million shares at $18 each. Gross proceeds of about $290.1 million are expected by the radiopharmaceutical cancer therapy developer. On Sept. 15, shares (NASDAQ:RYZB) closed up 33.3% at $24 each. Also, Neumora Therapeutics Inc. priced its IPO of 14.7 million shares at $17 each, looking for gross proceeds of about $250 million. The company, which is developing seven products targeting brain diseases, saw shares (NASDAQ:NMRA) close 4.4% downward at $16.25 on Sept. 15.
Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA dug in its heels about withdrawing the drug from the U.S. market.