Unveiled by Oxfordshire, U.K.-based Immunocore Ltd. at the November meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Md., were encouraging new findings from the phase I/II study with tebentafusp (also known as IMC-gp100), a bispecific protein in the pivotal works for metastatic uveal melanoma (MUM). The results showed a correlation between treatment-induced immune response and improvement in overall survival (OS) and tumor shrinkage in advanced uveal as well as cutaneous melanoma.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency. Daiichi's Enhertu (trastuzumab deruxtecan), the subject of a $6.9 billion deal with Astrazeneca, won accelerated approval for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eisai's Dayvigo (lemborexant) was approved to treat insomnia. Intra-Cellular's Caplyta (lumateperone) was approved to treat schizophrenia. Allergan’s Ubrelvy (ubrogepant) became the first of a relatively new class of drugs to be approved for the acute treatment of migraine.
BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
Though they made known their reservations about the patient sample size and queried front-line vs. second-line use of tazemetostat, members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-0 to recommend approval of the oral, first-in-class EZH2 inhibitor from Cambridge, Mass.-based Epizyme Inc.
BEIJING – Jinan, China-based Qilu Pharmaceutical Co. Ltd. has won the first approval for a China-developed biosimilar to Avastin (bevacizumab, Roche Holding AG). Its biosimilar QL-1101, to be sold under the trade name Ankada, has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer.
Transgene SA is quitting development of one of its lead therapeutic vaccines after a combination of the candidate, TG-4010, with chemotherapy and Opdivo missed its primary endpoint in a phase II trial evaluating the combination as a first-line treatment for certain advanced non-squamous non-small-cell lung cancers.
HONG KONG – Israel-based Biolinerx Ltd. has unveiled the latest data from its ongoing phase IIa COMBAT/KEYNOTE-202 study at the European Society of Medical Oncology Immuno-Oncology Congress 2019 which evaluates Biolinerx’s BL-8040, an inhibitor of the chemokine receptor CXCR4.
HONG KONG – Singapore and U.S.-based Hummingbird Bioscience Pte Ltd. has raised $19 million in a series B financing round. Proceeds will be used to support the discovery of new disease targets and to fuel the work of co-discovery projects that are part of a multitarget collaboration agreement valued at more than $1 billion signed with Amgen Inc. in September.
BEIJING – Suzhou-based Alphamab Oncology Co. Ltd. (HK:9966), which aims to bring the first PD-L1/CTLA4 bispecific antibody to China, saw its share prices jump almost 30% on its debut on the Hong Kong Stock Exchange (HKEX) on Dec. 12, 2019, ending the year on a positive note for the pre-revenue biotech.
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