Headlines favorable and not so great emerged from big pharma companies in late-stage efforts across various cancer indications. Of particular note was the phase III win by Merck & Co. Inc. in the Keynote-A39 trial (also known as EV-302), which was conducted in collaboration with Seagen Inc. and Astellas Pharma Inc., testing Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Astellas’ Nectin-4 directed antibody-drug conjugate Padcev (enfortumab vedotin-ejfv) for previously untreated locally advanced or metastatic urothelial carcinoma. The closely watched study – deemed a “must-win” by Evercore ISI analyst Umer Raffat – is important to the $43 billion buyout by Pfizer Inc. of Seagen. Merck, with Eisai Co. Ltd., had less pleasing news, too, disclosing a pair of phase III failures testing Keytruda with Eisai’s Lenvima (lenvatinib) in non-small-cell lung cancer (NSCLC). Others reporting phase III data were Bristol Myers Squibb Co. on its PD-1-blocking Opdivo (nivolumab) in NSCLC, and Astrazeneca plc and Daiichi Sankyo Co. Ltd. on datopotamab deruxtecan for breast cancer.
Abpro gives it another go, this time with a SPAC
Abpro Corp. is making another attempt to go public, this time by merging with Atlantic Coastal Acquisition Corp. II. The merger would put Abpro’s company value at $725 million. Atlantic Coastal is a special purpose acquisition corporation (SPAC) that went public in January 2022. Its stock (NASDAQ:ACAB) was down a little less than a percentage point at midday as shares were going for about $10.53 each. Abpro originally filed for an IPO in April 2018 only to withdraw the $60 million offering a month later. In 2022, Abpro entered a global partnership valued at up to $1.75 billion with Celltrion Healthcare Inc. to develop ABP-102, a bispecific antibody targeting HER2-positive cancer.
UK tribunal upholds ruling for ‘unfair’ hiked hydrocortisone prices
The U.K.’s Competition Appeal Tribunal has rejected appeals by drugmakers, including Actavis plc and Allergan Inc., against a ruling by regulators that they hiked the price of a life-saving adrenal insufficiency drug excessively for almost a decade, saddling the companies with fines amounting to nearly £130 million (US$159 million). According to the Competition and Markets Authority (CMA), Dublin-based Actavis and generics manufacturer Auden Mckenzie Holdings Ltd., of Hillingdon, U.K., (which is now part of Actavis), raised the fees the U.K.’s National Health System had to pay for hydrocortisone tablets by over 10,000% – from 70 pence (US$0.86) for a pack of 10-mg tablets in April 2008 to £72 (US$88) by March 2016 – costs the CMA described in July 2021 following an investigation as “unfair” and an “abuse of dominance infringement.”
Wuhan YZY raises $15 million in Hong Kong IPO to advance BsAbs
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%. Founded in 2010, YZY, of Wuhan, China, is developing bispecific antibody (BsAb)-based therapies to treat cancer and cancer-associated complications as well as age-related ophthalmologic diseases. The company’s pipeline includes seven clinical-stage candidates.
US FDA approvals up 16% over last year
Approvals from the U.S. FDA are up more than 16% from last year, with 113 drugs approved in the first eight months of this year, including 13 in August. New approvals include two different treatments for relapsed or refractory multiple myeloma, two treatments for ultra-rare diseases, and a biosimilar to Biogen Inc.’s Tysabri.