After spending decades developing targeted chemotherapy and bringing a dozen or so compounds into the clinic, Fusion Pharmaceuticals Inc. Chief Scientific Officer Christopher Leamon switched careers to focus on radio-oncology because he saw the need for “a really strong bomb to target cancer to get it to respond.” That was radiotherapy, said Leamon, who was one of the scientific founders of Endocyte Inc., which Novartis AG acquired.
Radioactive revolution: Scientifically, radioligands may head from bedside back to bench
If its challenges can be overcome, radioligand therapy is poised to change the way many cancers are treated. It is also likely to become an example of how scientific advances, once they are translated successfully, can enable further insights in a bench-to-bedside-to-bench loop. David Piwnica-Worms, professor and chair of cancer systems imaging at The University of Texas MD Anderson Cancer Center, predicted that as radioligand therapy expands, many questions will be answered about both radiation biology and the interaction of radiation with the immune system more specifically.
Advamed, BIO urge US Supreme Court to find for defendants in False Claims Act litigation
The Advanced Medical Technology Association (Advamed) and the Biotechnology Innovation Organization (BIO) have teamed up on a friend-of-the-court brief for the U.S. Supreme Court’s upcoming hearing on twin cases that examine the question of a defendant’s state of mind when filing claims with federal health programs. Advamed and BIO argue that the existing judicial approach is critical to ensuring that companies in the life sciences are not subject to treble damages when acting reasonably in connection with products reimbursed by federal health programs, adding that an overturn of existing judicial practice would stifle innovation at the cost of patient access to life-saving medical therapies.
FDA approves first anti-PD-1/ADC combo therapy
As Seagen Inc. preps for a merger, the U.S. FDA awarded accelerated approval to the company’s big-selling Padcev (enfortumab vedotin). The approval is for a combination therapy with Merck & Co. Inc.’s Keytruda (pembrolizumab) in treating adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy. This is the first approved regimen combining an anti-PD-1 and an antibody-drug conjugate in the U.S. Padcev brought $451 million to Seagen in 2022. That number was 33% higher than the $340 million it earned in 2021. Astellas Pharma Inc. also collaborated on the study. Pfizer Inc. is acquiring Seagen for a whopping $43 billion in a move that will double the size of its early-stage oncology pipeline.
Scorpion strikes precision oncology deal worth up to $618M with Pierre Fabre
Scorpion Therapeutics Inc. has out-licensed two of its small-molecule EGFR inhibitors to Pierre Fabre SA in exchange for a $65 million up-front fee and could also earn up to $553 million in potential milestone payments, plus royalties on net sales. The up-front payment includes the achievement of near-term milestones, with Boston-based Scorpion leading clinical development of one of the two candidates, STX-721, under the co-development deal, and French firm Pierre Fabre taking the reins on the second, STX-241. Both are in preclinical development for EGFR mutant non-small-cell lung cancer.
CMS trims list of Part B drugs subject to inflation rebate
Offering no explanation, the U.S. Centers for Medicare & Medicaid Services (CMS) has scaled back the list of Medicare Part B drugs that will be subject to an inflation rebate this quarter under the Inflation Reduction Act. A few weeks ago, with much fanfare, CMS announced that 27 Part B drugs would be subject to the first round of the rebate because their price increase exceeded the rate of inflation. Late last week, the agency quietly updated its March 15 news release and list of drugs to show that only 20 drugs would face the rebate. Four of the drugs removed from the list are cancer therapies, including Kite Pharma Inc.’s cell therapy, Yescarta (axicabtagene ciloleucel).
Deaths, partial hold bring end to Gossamer’s BTK inhibitor for CNS lymphoma
A few weeks after Gossamer Bio Inc. said it was pausing enrollment in a phase Ib/II study of CNS-penetrant BTK inhibitor GB-5121 in relapsed/refractory CNS lymphoma, citing the drug’s risk/benefit profile observed to date and a prioritization of resources, the company disclosed the U.S. FDA placed the trial on a partial clinical hold. In an 8-K filing with the U.S. SEC, Gossamer said serious adverse events in the STAR-CNS study included atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage. With the latest update, development of GB-5121 will be discontinued.
Innate out-licenses antibodies for celiac disease to Takeda in deal worth $400M
Innate Pharma SA inked a licensing deal that grants Takeda Pharmaceutical Co. Ltd. exclusive worldwide rights to research and develop antibody-drug conjugates using a panel of selected Innate antibodies against an undisclosed target, with a primary focus in celiac disease. Under the terms of the deal, Innate, of Marseille France, will receive a $5 million up-front payment and is eligible to receive up to $410 million in future development, regulatory and commercial milestones, plus sales-based royalties.
Adcendo raises $34M in series A extension to advance lead ADC
Adcendo ApS has added a further €31 million (US$33.6 million) to its series A round, providing the means to take its lead antibody-drug conjugate (ADC) through to clinical proof of concept in the treatment of sarcoma. The ADC is aimed at a proprietary target, uPARAP, a collagen scavenger that is overexpressed on the cell surface of several cancers and is implicated in invasive tumor growth. This is seen as an attractive target for ADCs because it plays a role in transporting cargo both into and out of cells.
More oversight issues facing the US NIH
In the latest round of questions about the U.S. NIH’s oversight of certain research, the Government Accountability Office called on the agency to do more to ensure that foreign facilities conducting NIH-funded animal research are compliant with U.S. standards and policy regarding animal care and use, as well as international standards. In a separate inquiry, House Energy and Commerce Committee leaders are seeking answers about a research project involving mpox virus enhancement that was planned or conducted at the NIH’s National Institute of Allergy and Infectious Diseases.
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