This week's Lab Notes has items on a Big Pharma company's planned acquisition of a vaccine developer, a key FDA clearance for a Philadelphia early-stage cell therapy developer, a Penn Medicine milestone and more.
Here's the roundup:
AstraZeneca
The England-based Big Pharma company, which has its North American commercial business headquarters in Wilmington, has entered into a definitive agreement to acquire Icosavax Inc. (NASDAQ: ICVX), a vaccine developer based in Seattle. The deal is valued at up to $1.1 billion.
Icosavax specializes in virus-like particle vaccine technology that AstraZeneca Executive Vice President for Vaccines and Immune Therapies Iskra Reic said "has the potential to transform prevention against severe infectious diseases."
Under the terms of the deal, AstraZeneca (NYSE: AZN), through a subsidiary, will initiate a tender offer to acquire all of Icosavax’s outstanding shares for $15 each in cash at closing. In addition, it will have a non-tradable contingent value right for up to $5 per share in cash payable upon achievement of a specified regulatory milestone and a sales milestone.
The upfront cash portion of the proposed transaction, valued at $800 million, represents a 43% premium to Icosavax’s closing market price on Dec. 11, when shares were trading at $10.49.
Vittoria Biotherapeutics
The Philadelphia CAR T-cell therapy company received clearance from the Food and Drug Administration to begin human testing of its lead therapy candidate, VIPER-101.
VIPER-101 is a gene-edited, autologous, CAR T-cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma — a rare type of cancer that begins in white blood cells.
Nicholas Siciliano, CEO of Vittoria, called the FDA clearance a "pivotal milestone" for the company.
“With limited advancements in T-cell lymphoma treatment over the last decade, this signifies a crucial step toward bringing an innovative treatment option to T-cell lymphoma patients with the potential to transform patient outcomes," Siciliano said.
Vittoria, whose technology was licensed exclusively from the University of Pennsylvania, expects to initiate a phase 1 clinical trial for VIPER-101 in early 2024. Initial study results are expected in early 2025.
Penn Medicine
The University of Pennsylvania Health System last week set a world record with 100 kidney paired donation transplants in a 12-month period.
Coordinated through the National Kidney Registry, paired exchanges are an approach to living donor kidney transplantation where patients with incompatible donors swap kidneys to receive a compatible kidney.
Penn Medicine’s 100th paired kidney exchange surgery was completed on Dec. 6.
“This milestone wouldn’t be possible without the countless number of people who make the choice to donate a kidney to a loved one, neighbor, or sometimes even complete stranger," said Dr. Amanda Leonberg-Yoo, medical director for Penn's Kidney Living Donor Program. "Their selfless act of generosity often inspires others to do the same.”
Last December, Penn launched its Center for Living Donation, which is based at the Hospital of the University of Pennsylvania.
More than 90,000 people in the United States are waiting to receive a kidney transplant. Those on the list must receive regular dialysis to stand in for their failed kidneys, and 4,000 people in the U.S. die each year waiting to receive a transplant.
Quick Hits
Carisma Therapeutics (NASDAQ: CARM) of Philadelphia announced the nomination of its first lead candidate under a collaboration with Moderna, Inc. (NASDAQ: MRNA). This first lead candidate will target an antigen present on a solid tumor with "significant unmet medical need," the company said. Michael Klichinsky, co-founder and chief scientific officer at Carisma, said based on preclinical studies Carisma believes the therapy has the potential to benefit patients with a "broad variety" of cancers. … Malvern-based Ocugen (NASDAQ: OCGN) said it dosed its first patient for its phase 1/2 study evaluating the safety and effectiveness of its experimental gene therapy OCU410 as a treatment for dry age-related macular degeneration. …The FDA has extended by three months the review period for Yardley-based OptiNose's (NASDAQ: OPTN) supplemental new drug application requesting approval of Xhance as a treatment for chronic rhinosinusitis. Xhance is already approved to treat nasal polyps. The FDA's goal date for ruling on the application is March 16, 2024. … Nexgel (NASDAQ: NXGL), a Langhorne wound care products company, has entered into a partnership with Stada AG of Germany to distribute and commercialize Stada's consumer health over-the-counter products in North America beginning in mid-2024.
