With two respiratory syncytial virus (RSV) vaccines approved by the U.S. FDA in 2023 and a third nearing its May PDUFA date, decades of research has finally provided infants and older adults protection from the disruptive and sometimes deadly virus. But what about people in the middle, particularly those with certain chronic medical conditions? New York-based Pfizer Inc. rolled out phase III data April 9 showing that its approved RSV vaccine, Abrysvo (RSVpreF), met primary endpoints in adults ages 18 to 59 who were at high risk of RSV. The vaccine was well-tolerated and noninferior to immune response results seen with those 60 and older, a group for whom the company gained FDA approval last May. That approval was extended in August to protect the unborn infants of pregnant women through 6 months of age.

Vincerx hammered on early phase I tumor data with VIP-236

Shares of Vincerx Pharma Inc. (NASDAQ:VINC) tumbled by $3.55, or 74%, to trade at $1.23 on the disclosure of preliminary phase I data with small-molecule drug conjugate VIP-236 in metastatic solid tumors during the American Association for Cancer Research annual meeting in San Diego. Designed to target alpha-v beta-3 integrins in tumor tissue and to release the payload 7-ethyl camptothecin 1, VIP-236 offered encouraging early signs, said Vincerx, of Palo Alto, Calif., including tumor reduction and an improved safety profile in heavily pretreated patients. The pharmacokinetic data show very little free payload in circulation, consistent with previous findings.

More biosimilars from China, US encroach on Amgen’s denosumab 

Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases. Mabwell first gained NMPA approval for the biosimilar as Mailishu in March 2023 to treat osteoporosis in postmenopausal women at high risk of fracture. Chinese approval of Maiweijian comes one month after the U.S. FDA first approved Sandoz Group AG’s Jubbonti (denosumab) as a biosimilar to Prolia and Wyost (denosumab-bbdz) as a biosimilar to Xgeva on March 5.

Essential gaining neuroblastoma candidate in Renaissance buy

Essential Pharma Ltd. is paying up to £70 million (US$88.7 million) to acquire Renaissance Pharma Ltd., taking ownership of Hu14.18, a treatment for high-risk neuroblastoma. The antibody has completed a 64-patient phase II trial conducted by St Jude’s Children’s Research Hospital, in which it showed an improvement in overall survival of around 50% compared to currently available therapies. Following a licensing agreement with St Jude’s in August 2023, Renaissance has had discussions with the FDA and EMA on the design of a registration trial. Essential Pharma now holds the baton and aims to stage a single international study that satisfies the needs of both regulators.

Medicxi, Starpharma create Petalion with $25M round

A day after investing $40 million in China’s D3 Bio Inc., London-based venture capital firm Medicxi is investing $25 million to co-found a new U.K.-based company called Petalion Therapeutics Ltd. that will focus on an early stage oncology asset from Australia’s Starpharma Holdings Ltd. to develop novel dendrimer-based treatments. “We were looking for a specific target over the last year or so for a specific asset,” said Medicxi Venture Partner Mehdi Shahidi, who will become the new CEO of Petalion.

Galderma’s IPO marks biopharma’s highest as March financings total $13.8B 

The biopharma sector secured $13.84 billion in financings in March, marking a 38% decline February’s $22.3 billion yet a 27% increase from January’s $10.9 billion. In 2023, biopharma financings averaged $5.91 billion per month.

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