Shares of Prometheus Biosciences Inc. (NASDAQ:RXDX) were trading at $100.16, up $64.10, or 177.8% after the company disclosed phase II results in ulcerative colitis (UC) and Crohn’s disease (CD) with tumor necrosis factor-like cytokine 1A-targeting PRA-023. The Artemis-UC phase II study and the Apollo-CD phase IIa experiment turned up strong efficacy and favorable safety data. Prometheus plans to advance the compound into phase III next year.

Replimune finds consistent efficacy in its skin cancer study

Replimune Group Inc. has found consistent treatment efficacy in its pivotal phase II Ignyte study. New data showed the first 75 patients in the study’s anti-PD1 failed cutaneous melanoma cohort benefited from treatment with the company’s RP1 (vusolimogene oderparepvec) combined with Opdivo (nivolumab). Results showed a 36% overall response rate (ORR), a little lower than the 37.5% ORR found in the study’s prior cohort. Also, participants showed a 20% complete response rate, compared to the 12.5% rate in the prior cohort. Clinically meaningful activity was seen across all the subgroups, Replimune added, including the most advanced stage IVM1b/c patients. The company’s stock (NASDAQ:REPL) was up 20% at midday, with shares trading at about $23 each.

FDA yanks Oncopeptides’ Pepaxto authorization for multiple myeloma

Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. While unsurprising, given the FDA’s negative advisory committee vote in September 2022 and the agency’s increasing scrutiny on the accelerated approval pathway, Oncopeptides continues commercialization of the drug in Europe and is expected to present data for Pepaxto at the upcoming American Society of Hematology meeting.

Apogee reaches for the top with $169M financing for antibody portfolio

Apogee Therapeutics Inc. emerged from stealth with $169 million in financing and a pipeline of four preclinical antibody development programs that take aim at major immunological and inflammatory disorders. It has just closed an over-subscribed series B round, which took in $149 million, having received $20 million earlier this year from its founding investors Fairmount and Venrock Healthcare Capital Partners.

Nanomaterial allows location-specific fat targeting

The positively charged nanoparticle polyamidoamine generation 3 (P-G3) can be specifically targeted to either visceral or subcutaneous fat, and affects both types of fat in different ways, researchers from Columbia University reported in two papers recently published.

The BioWorld Insider Podcast: Looking ahead to 2023, CEOs contemplate the new normal

We wrapped up 2022 and are preparing for 2023 on this BioWorld Insider podcast. Staff writer Lee Landenberger talked to four CEOs, visionaries of companies producing new science and drug development. The CEOs offered their insights into what happened this year and looked at the challenges and opportunities for next year.

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