Although it wasn’t a shutout, Spectrum Pharmaceuticals Inc. didn’t get the support it needed today from a U.S. FDA advisory committee for its non-small-cell lung cancer (NSCLC) candidate, poziotinib. Only four members of the Oncologic Drugs Advisory Committee (ODAC) voted that the drug showed a favorable benefit-risk profile as a second-line treatment for locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations. Even though the other nine members acknowledged that the toxicities could be managed, they voted that the drug’s benefits don’t outweigh the risks. Before the vote, Richard Pazdur, acting director of the FDA’s Office of Oncologic Diseases, reminded the panel that it was only voting on the benefit-risk profile, not on whether poziotinib should be granted accelerated approval. But given the FDA’s comments throughout the meeting, such approval seems unlikely at this point.

ODAC deliberates on Oncopeptide’s myeloma drug, Pepaxto

The U.S. FDA’s Oncologic Drugs Advisory Committee is mulling the fate of Oncopeptides AB’s held-up multiple myeloma drug, Pepaxto (melphalan flufenamide), which trails a checkered past. In February 2021, the FDA made Pepaxto the first cancer peptide-drug conjugate to win accelerated approval. Less than eight months after the green light, safety issues that arose in the confirmatory Ocean study caused Stockholm-based Oncopeptides to pull the drug from the U.S. market, though data analysis since has painted what the company characterized as a more encouraging picture.

Spero signs $600M license deal for UTI antibiotic with GSK – three months after FDA rejected it

Spero Therapeutics Inc. has come out swinging after a U.S. FDA rejection for its oral antibiotic tebipenem Hbr, picking up a potential $600 million licensing deal with U.K. pharma giant GSK plc after agreeing a plan with the regulator to revive the drug. Cambridge, Mass.-based Spero received a complete response letter for tebipenem Hbr in June 2022, when officials deemed there were deficiencies in the application late in a review as a treatment for complicated urinary tract infection (cUTI). GSK is beginning a new chapter after spinning off its consumer drugs business in July 2022 and promoting Tony Wood from its senior ranks to replace Hal Barron as chief scientific officer on Aug. 1, making this the first major deal signed off by the new research head.

FDA tells DBV to patch up Viaskin Peanut phase III study protocol before recruiting patients

DBV Technologies SA blindsided investors by disclosing that the U.S. FDA had placed a partial clinical hold on its phase III Vitesse trial of its Viaskin patch immunotherapy for peanut allergy, calling for several changes to the study protocol. Its demands came just two weeks after the company claimed to have finalized the protocol in consultation with the agency. DBV released this latest disclosure after the markets closed on Sept. 21. On Sept. 7, it had stated that it “finalized the Vitesse protocol after productive exchanges with the U.S. Food and Drug Administration (FDA) concerning key study design elements.”

Innocare raises ¥2.92B in Shanghai IPO, but shares fall on debut

Innocare Pharma Ltd. raised ¥2.92 billion (US$412 million) in a second listing on the Shanghai STAR Market. Its shares opened at ¥10.86 apiece, sliding 15.4% to close at ¥9.33 on the first trading day, Sept. 21.The company will use the proceeds to support cancer and autoimmune drug R&D, improve its drug development platform, build its sales network, and upgrade its information technology, said Chief Commercial Officer Jin Xiaodong.

Chinese US-listed pharma, med-tech companies gear up for PCAOB inspections

Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards. The PCAOB inspections follow an announcement in late August 2022 that biopharma and med-tech companies based in China and Hong Kong will for the first time need to comply with the same accountability standards that companies in the U.S. and other countries follow as a condition of trading on U.S. markets. The Aug. 26 agreement with the PCAOB, the China Securities Regulatory Commission and the Ministry of Finance of the People’s Republic of China includes detailed and specific commitments from China to allow PCAOB audit inspections and investigations.

Polaris’ lead candidate, pegargiminase, meets primary, secondary endpoints in phase II/III pivotal Atomic trial

Polaris Pharmaceuticals Inc.’s pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of significant improvement in progression-free survival in patients enrolled in the pivotal phase II/III Atomic study in malignant pleural mesothelioma. Polaris said it would proceed with regulatory submissions in the U.S in 2023. The FDA awarded fast track designation to ADI-PEG 20 in 2022; it also has orphan drug status. A submission to the EMA is also planned.

Research identifies proteins that let sleeping bears lie

Investigators at Washington State University have identified a set of eight proteins that were expressed in the serum of Ursus arctos horribilis, better known as the grizzly bear, specifically during their hibernation period. In addition to reporting new basic insights into hibernation, the study, which was published in the Sept. 21, 2022, issue of iScience, could also give clues to insulin resistance and its relationship to body fat.

The BioWorld Insider Podcast – Psychedelic evolution: Mindset Pharma looks to change mental health treatment

An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Lanthier discussed challenges facing companies developing psychedelic treatments and how to overcome the one-size-fits-all, trial-and-error approach to mental health treatment that often seems stuck in the past.

Also in the news

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