The Cellular, Tissue and Gene Therapies Advisory Committee scrutinized Bluebird Bio Inc.’s gene therapy elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy (CALD) in patients without a matched sibling donor.
The “showdown” at the American Society of Clinical Oncology (ASCO) meeting foreseen by one analyst between breast cancer drugs from Gilead Sciences Inc. and Astrazeneca plc with partner Daiichi Sankyo Co. Ltd. didn’t quite materialize.
Wall Street took in stride mixed FDA briefing documents with regard to the upcoming adcom review of Bluebird Bio Inc.’s two gene therapy prospects, and shares of the company (NASDAQ:BLUE) closed at $3.61, up 63 cents, or 21%.
I-Mab Biopharma Co. Ltd. chief medical officer John Hayslip said the firm is “moving forward at our best speed” in tandem with partner Shanghai Junshi Biosciences Co. Ltd. to produce a diagnostic test that could be used in further clinical work with anti-CD73 antibody uliledlimab, for which results from an ongoing phase II trial were disclosed May 26.
After weeks of mounting speculation by backers of Gilead Sciences Inc., data from the phase III Tropics-02 study testing Trodelvy (sacituzumab govitecan) vs. physicians’ choice of chemotherapy rolled out June 4 at the American Society of Clinical Oncology (ASCO) meeting in Chicago. Wall Street had hoped for better.
The “showdown” at the American Society of Clinical Oncology (ASCO) meeting foreseen by one analyst between breast cancer drugs from Gilead Sciences Inc. and Astrazeneca plc with partner Daiichi Sankyo Co. Ltd. didn’t quite materialize. Or the showdown happened, but turned out more nuanced than a one-to-one, high-noon gunfight on Main Street. Gilead ended considerable suspense June 4 by offering at ASCO phase III data from the Tropics-02 study with Trodelvy (sacituzumab govitecan), expectations for which already had grown lukewarm. Astrazeneca and Daiichi dazzled the next-day meeting with phase III data from the Destiny-Breast04 (DB04) study with Enhertu (fam-trastuzumab deruxtecan).
As the American Society of Clinical Oncology (ASCO) meeting began, researchers discussed abstracts related to findings due to roll out during the course of the weekend event. On the table June 3 were primary results from the double‐blind, placebo‐controlled, phase III Shine study of Imbruvica (ibrutinib) from Abbvie Inc. and Johnson & Johnson (J&J) in combination with bendamustine‐rituximab and rituximab maintenance therapy as a first‐line treatment for patients ages 65 and over with mantle cell lymphoma.
I-Mab Biopharma Co. Ltd. chief medical officer John Hayslip said the firm is “moving forward at our best speed” in tandem with partner Shanghai Junshi Biosciences Co. Ltd. to produce a diagnostic test that could be used in further clinical work with anti-CD73 antibody uliledlimab, for which results from an ongoing phase II trial were disclosed May 26.
Glaxosmithkline plc (GSK) pledged $2.1 billion up front and as much as $1.2 billion in development milestone payments to take over privately held Affinivax Inc. and bring aboard the phase II-stage, next-generation, 24-valent pneumococcal vaccine candidate, AFX-3772. London-based GSK is buying all outstanding shares of Affinivax, of Cambridge, Mass., for $2.1 billion upon closing the deal in the third quarter of this year, and two potential milestone payments of $600 million to be paid if certain pediatric development goals are reached.
Phase II melanoma data characterized by Iovance Biotherapeutics Inc. as positive failed to excite Wall Street, which took away 53.6% of the company’s share value (NASDAQ:IOVA), or $8.10, and pushed the closing price to $7.02 on May 27. The San Carlos, Calif.-based firm offered results from registrational cohort 4 (n=87) of the C-144-01 study testing lifileucel (LN-144, autologous tumor infiltrating lymphocytes) in advanced melanoma.
