Injecting a combination of cisplatin and vinblastine – engineered by way of the company’s Dfuserx platform – turned out to be just the ticket for early stage breast cancer in the phase II study called Invincible conducted by Intensity Therapeutics Inc. Shares of the Shelton, Conn.-based firm (NASDAQ:INTS) closed Dec. 8 at $6.88, up $2.68, or 63%, having traded as high as $11.44, thanks to Wall Street’s satisfaction with the data testing INT230-6, which emerged during the San Antonio Breast Cancer Symposium.
Three giants have produced new phase III study data for their already approved, big name therapies. Two were positive and the third was stopped for futility.
While early stage and involving a relatively small patient population, the interim phase Ib readout from the combination cohort testing estrogen receptor (ER)-targeting candidate vepdegestrant in combination with CDK4/6 inhibitor Ibrance (palbociclib) in heavily pretreated patients with ER-positive/HER2-negative breast cancer was impressive enough to prompt partners Arvinas Inc. and Pfizer Inc. to expand development work on the program. The results also struck a chord on the Street, with shares of Arvinas (NASDAQ:ARVN) gaining 31% on the day.
South Korean pharmaceuticals Celltrion Inc. and Cyron Therapeutics Co. Ltd. are teaming up to discover and develop bispecific and trispecific antibodies, collectively called polyspecific antibodies, under the ₩1.158 trillion (US$882.38 million) joint research agreement inked on Dec. 6. Under the terms, privately held Daegu-based Cyron will discover and develop at least three polyspecific antibodies for blood and solid cancers pre-selected by Incheon-based Celltrion via Cryon’s CD-3 targeting T-cell engager platform that helps engage T cells to attack cancer cells.
The oral drug inavolisib, when added to two other therapies, significantly improved progression-free survival in the first-line phase III treatment of advanced hormone receptor-positive, HER2-negative breast cancer in which patients have a PIK3CA mutation.
Replimune Group Inc.’s lead candidate, RP-1 (vusolimogene oderparepvec), took a solid hit as it missed both primary endpoints in the Cerpass phase II study of skin cancer. Despite some better results from the study and good news from other studies along with a plan to drop some programs, the company’s stock still suffered.
Samsung Bioepis Co. Ltd. will partner with South Korean biotech Intocell Inc. to develop antibody-drug conjugate (ADC) drugs, continuing the Samsung Group and the wider industry’s hunt for novel ADCs. Under the joint research agreement inked on Dec. 5, the Daejon-based ADC platform technology firm Intocell will supply the Songdo, Incheon-based Samsung Bioepis its linker technology, coined OHPAS, or ortho-hydroxy protected aryl sulfate, upon which Samsung Bioepis will develop ADC drugs for up to five cancer targets.
Abbisko Therapeutics Co. Ltd. has out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck KGaA in a deal worth up to $605.5 million. Pimicotinib is in phase III trials in patients with tenosynovial giant cell tumors in China, the U.S., Canada and Europe.
Eli Lilly and Co., through its Loxo@Lilly oncology unit, secured its second accelerated approval for non-covalent Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib), this time to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The U.S. FDA approval of 100-mg and 50-mg tablets is for patients who have received two prior lines of therapy, including another BTK inhibitor and a BCL-2 inhibitor. It is based on phase I/II data from a subset of 108 patients participating in the open-label, single-arm, multi-cohort Bruin trial.
Cellcentric's inobrodib, a novel drug with a distinct mechanism of action, shows promise in treating various hematological malignancies, as revealed in a recent publication in Cancer Cell.
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