The FDA’s Oncologic Drugs Advisory Committee voted 6-2 April 29 to recommend withdrawing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a third-line treatment for a subgroup of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer. However, the vote was based on FDA assurances that, if it withdrew the approval, it would work with Merck to delay the withdrawal or set up an access program to ensure the estimated 1,000 patients who are beyond first-line treatment could still get Keytruda.

Gene therapy startup Capsida banks $140M in series A round plus Abbvie deal

Capsida Biotherapeutics Inc., a gene therapy startup focused on advanced capsid engineering to generate tissue-selective vectors, emerged from stealth with $50 million in series A funding and another $90 million in cash from a strategic collaboration and option agreement in neurodegenerative disease with Abbvie Inc. Thousand Oaks, Calif.-based Capsida is building on the work of Viviana Gradinaru at Caltech in Pasadena, who has developed a platform for generating and screening massively diverse libraries of adeno-associated virus vectors, in order to fish out capsids with enhanced properties.

Cara’s oral Korsuva falls short in phase II; PDUFA for injectable this summer

Shares of Cara Therapeutics Inc. (NASDAQ:CARA) were trading midday at $15.20, down $10.59, or 41%, as Wall Street reacted to data from the phase II dose-ranging study with the oral version of Korsuva (difelikefalin) for moderate to severe pruritis in patients with moderate to severe atopic dermatitis. The 401-patient experiment missed its primary endpoint of worst-itch change from baseline at week 12 as well as the secondary endpoint of four-point responder analysis in the intent-to-treat population, measured by way of the pruritis Numerical Rating Scale. The injectable version of Korsuva, which targets peripheral kappa opioid receptors, is under review by the FDA for pruritis in patients undergoing hemodialysis, with a PDUFA date of Aug. 23.

ADC specialist Adcentrx debuts with $50M series A

Cross-border startup Adcentrx Therapeutics Inc., with operations in San Diego and soon in Shanghai, secured $50 million in a series A financing round led by CBC Group to establish its presence in the antibody-drug conjugate (ADC) space. Adcentrx CEO Hui Li told BioWorld in an exclusive interview that the startup is looking at novel targets to create a “truly differentiated portfolio” and intends to file its first IND in 2022.

SPAC surplus helps private health care companies side-step IPO process

Just four months after Blue Water Acquisition Corp. raised $50 million in an IPO, it set out on April 27 to merge with Clarus Therapeutics Inc., the developer of testosterone replacement therapy Jatenzo, valuing the Northbrook, Ill.-based firm at $379 million. Earlier in April, BCTG Acquisition Corp. announced plans to buy Cambridge, Mass.-based targeted precision cancer company Tango Therapeutics Inc. for $353 million, about seven months after completing its $167 million IPO. Both Clarus and Tango are seeking the public markets by merging with a special purpose acquisition company, or SPAC, a method that is becoming increasingly popular and an alternative to the traditional IPO. More and more SPACs are targeting companies within the health care sector, including biotech and med-tech firms. A BioWorld analysis found at least 90 IPO examples of these industry-focused shell companies since the start of 2020.

New COVID-19 therapy trials ramp up as weekly cases surpass previous peaks

Urgency to meet the world's worsening load of COVID-19 cases appeared unflagging Thursday, with four new trials kicking off to keep people from progressing to worsened disease and two new variant-focused efforts yielding signs of preclinical promise. Amid the progress, an early effort to evaluate Abbvie Inc.'s cenicriviroc in critically ill COVID-19 patients was dropped due to futility, the trial's sponsor said.

Shionogi bags agreement for Inveniai’s AI drug discovery platform Alphameld

HONG KONG – Shionogi & Co. Ltd. has inked a multitarget drug discovery collaboration for Inveniai LLC’s artificial intelligence and machine learning platform Alphameld. Inveniai is eligible to receive up to $200 million per program through a combination of up-front payments, development and commercial milestones, and royalties.

Fat no proxy for quality in transplant livers

Researchers have gained new insights into what makes for transplantable livers – and what doesn’t. In a clinical trial of 12 livers, a team from Massachusetts General Hospital showed that both livers with high fat content and those without could be viable for transplantation. They presented their work, the goal of which it is to increase both the quantity and the quality of transplantable livers, at the 2021 Experimental Biology meeting, held virtually this week.

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