Along with Enhertu, Astrazeneca plc now has another breast cancer treatment in its portfolio. Truqap (capivasertib), combined with Faslodex (fulvestrant), is now U.S. FDA-approved for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. The label restricts the treatment to adults with one or more of the biomarker alterations PIK3CA, AKT1 or PTEN. The patients must have progressed on at least one endocrine-based regimen in the metastatic setting or experienced a recurrence on or within 12 months of completing their adjuvant therapy. Breast cancer is the most common cancer and afflicts about 240,000 women in the U.S. each year.

Merck’s chronic-cough therapy comes under adcom scrutiny

The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee is taking up the matter of whether Merck & Co. Inc.’s P2X3 receptor antagonist gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough. Nothing is approved for the condition, and regulators find themselves in new territory, with a number of firms trying to help by way of varied strategies.

US FDA letting FTC decide if Orange Book listings ‘improper’

The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.” As BioWorld recently reported, the FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process. At the time, FTC Chair Lina Khan said the commission had identified more than “100 patents that we believe are improperly listed, affecting products ranging from inhalers to Epipens.”

Newco news: T-Therapeutics raises $59M in series A for T-cell receptors

Newco T-Therapeutics Ltd has raised £48 million (US$59 million) in a series A to advance development of T-cell receptors (TCRs) generated by its transgenic mouse platform for the treatment of solid tumors, autoimmune diseases and infections. The co-founder and CEO of the Cambridge, U.K.-based company is Allan Bradley, the scientist behind two of the leading in vivo platforms for producing fully human antibodies, Kymouse and Humab mouse. Next in line comes Optimus, a mouse engineered to make TCRs that do not exist in the human repertoire. Optimus will be the source of what T-Therapeutics says will be “an almost unlimited supply of TCRs, which have unique properties in terms of activity, affinity, half-life and diversity.” The Cambridge University spin-out will apply machine learning to enable the selection of TCRs that target patient-specific cancer antigens identified through single cell sequencing of cancer cells.

Biocom, KoreaBIO bridge California, Korea bioeconomies

In efforts to strengthen cooperation between the U.S. and South Korea’s life sciences sector, industry organizations like Biocom California and KoreaBIO are helping foster cross-border collaboration as Korea looks to ramp up the so-called Bio Economy 2.0. KoreaBIO, which stands for the Korea Biotechnology Industry Organization, in its latest feat welcomed a trade delegation run by the San Diego Regional Economic Development Corp. and the World Trade Center San Diego in November 2023, helping bolster cooperation between companies in Korea and in the San Diego and Tijuana, Mexico, regions. “The San Diego delegation’s visit to Korea was a follow-up measure to strengthen bioeconomy cooperation between Korea and the U.S. Biotechnology Innovation Organization as well as R&D cooperation between the two countries,” Jurie Hwang, KoreaBIO’s director of public and international affairs, told BioWorld.

Apollomics gets China NMPA nod for lung cancer drug vebreltinib

The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription (c-MET) inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd. The Chinese regulatory body approved Apollomics’ vebreltinib as an orally bioavailable, highly selective, small-molecule c-MET inhibitor for non-small-cell lung cancer with Exon 14 skipping mutations, which inhibits the abnormal activation of the HGF/c-Met axis – a key pathway involved in tumor growth, proliferation and development of resistance to certain targeted therapies.

Also in the news

ABVC, Alentis, Alkermes, Altamira, Alterity, Apollomics, Ardelyx, Arecor, Argenx, Biocardia, Bone, Bristol Myers Squibb, Certa, Chemomab, Crispr, Dermata, Eli Lilly, Emergex, Ensysce, Epic, Gradalis, Halia, Halozyme, Kane, Khiron, Lighthouse, Minoryx, Momentum, Mural Oncology, Oxurion, Palvella, Point, Praxis, Springworks, TB Alliance, Tenax, Umecrine, Versameb, Vertex, Virpax, Visen