Eli Lilly and Co. just built on its radiopharmaceutical prowess with a deal that could bring Aktis Oncology Inc. $1.1 billion. The two plan to develop radiopharmaceuticals targeting cancer. Privately held Aktis also is getting $60 million in cash up front along with an equity investment. The big money would come from preclinical, clinical, regulatory, commercial milestones and tiered royalties. Lilly is getting global rights to any radiopharmaceutical therapeutics and diagnostics that Aktis comes up with. Lilly will select the targets. Lilly bought Point Biopharma Global Inc. for about $1.4 billion in late December 2023 to acquire a pipeline of preclinical and clinical radioligand therapies for cancer.

Touting ‘first-in-class’ ADC, Pheon nabs $120M in series B round

Pheon Therapeutics Ltd. is poised to start the first of three clinical trials of its lead antibody-drug conjugate (ADC), after closing a $120 million series B. The company is taking a “three-pronged approach” in order to stake out as much of the ground as it can for its next-generation ADC, which delivers an in-house-designed topoisomerase inhibitor to a novel undisclosed transmembrane protein target.

Biocon, Samsung win FDA nods for interchangeable Eylea biosimilars

The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. An interchangeable biosimilar allows for substitution of the original without additional medical consultation. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15) for four of Eylea indications, including: wet age-related macular degeneration; macular edema following retinal vein occlusion; diabetic macular edema; and diabetic retinopathy.

Usual players show up again in US trade report of bad actors

The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property (IP). And once again, industry asked the USTR to go further by placing new players on the list. While the USTR report acknowledged the concerns expressed by the IP-intensive U.S. drug and medical device industries regarding the policies of several trading partners – Australia, Brazil, Canada, China, Colombia, Japan, Korea, Mexico, New Zealand, Russia, Saudi Arabia and Turkey – the agency declined to go so far as identifying some of them as bad actors.

Théa returns rights to Curacle’s oral diabetic macular edema drug

Théa Open Innovation, a subsidiary of France’s Laboratoires Théa SAS, returned rights to South Korea’s Curacle Co. Ltd.’s CU-06, an oral diabetic macular edema drug candidate. Curacle posted positive top-line phase IIa data of CU-06 just three months prior. Announced after market closing on May 21, Curacle disclosed Théa’s decision to return the technology transfer rights of CU-06 in a public filing on the Korea Exchange (KRX). Curacle initially handed off ex-Asia, global rights to CU-06 to ophthalmology-focused Théa in a potential $2 billion deal in October 2021, which included $6 million up front and up to $157.5 million in development, regulatory and sales milestone payments, along with royalties on sales.

Cleveland Clinic clipped for $7.6M for research oversight lapses

The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards. CCF will pay $7.6 million to settle the allegations, which includes an accusation that the foundation had “repeatedly failed to disclose” that the principal investigator for three grants was already receiving support from a foreign government in a manner that had “obligated that employee’s research time.”

BioWorld Insider Podcast: Fibrobiologics walks the unconventional financing path

A non-traditional route for financing has been the path to success for Fibrobiologics Inc. In the newest BioWorld Insider podcast, CEO Pete O’Heeron offers insight into the company’s unusual path to a Nasdaq listing in January. SPACs, reverse mergers and traditional IPOs weren’t attractive enough for Fibrobiologics’ management or board, so they decided to go public through a direct listing with no banks as underwriters. It took about seven months to get the company ready for its listing, an around-the-clock effort that O’Heeron said was worth the effort. “We couldn’t be more happy with the outcome,” he said.

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