CCR4

Investors have bought into Rapt’s plan, funnelling $150 million into the biotech. \n Rapt Therapeutics has charted a new course following the implosion of its lead program, agreeing to pay $35 million for a long-acting challenger to Novartis and Roche’s Xolair.The California-based biotech went into 2024 focused on zelnecirnon, a CCR4 agonist that was in phase 2 atopic dermatitis and asthma trials. However, the FDA put the trials on hold in February in response to a case of liver failure. Rapt stopped the studies early in May and axed the program in November, putting a hole in the biotech’s clinical-phase pipeline.A deal with Shanghai Jemincare Pharmaceutical has filled the hole. Rapt is paying $35 million upfront, plus up to $672.5 million in milestones, for ex-China rights to a half-life extended anti-immunoglobulin E (IgE) antibody that is in clinical development at Jemincare.The Chinese biotech is studying the antibody, which Rapt calls RPT904, in phase 2 trials in asthma and chronic spontaneous urticaria. But Rapt is prioritizing development in food allergy and planning to start a phase 2b trial in the indication next year. Rapt’s interest in food allergy is underpinned by the success Xolair is enjoying in the indication. The FDA approved Novartis and Roche’s anti-IgE antibody for use in people with certain food allergies in February. Rapt has been following Roche’s updates on the launch, telling investors 30,000 food allergy patients were on the drug after its first two quarters on the market.While Xolair has burst out of the blocks, Rapt has market research showing payers and prescribers would welcome a longer-acting alternative. Xolair is given every two to four weeks. If RPT904 can match Xolair’s safety and efficacy while extending dosing to every eight weeks, Rapt said the antibody could be used in 16% of moderate-to-severe food allergy patients.Rapt estimates peak U.S. food allergy sales could hit $4.5 billion. The biotech predicts that the development of the antibody in chronic spontaneous urticaria, another indication in which Xolair is approved, could add another $1 billion in revenue.The forecasts reflect Rapt’s belief RPT904 is a best-in-class molecule. RPT904 will need to be better than Xolair to make a mark. While Roche no longer expects a Xolair biosimilar to launch in the U.S. in 2025, off-patent challengers are coming. Rapt said RPT904 could command at least 30% premium over Xolair biosimilars because its long-acting design may increase compliance and convenience. RPT904 targets the same epitope as Xolair but features tweaks intended to extend half life, boost affinity and reduce the potential for immunogenicity. Jemincare’s phase 1 trial showed RPT904 had a half life of 63 days, compared to 27 days for Xolair, and achieved superior IgE reduction than Novartis and Roche’s product.Investors have bought into Rapt’s plan, funnelling $150 million into the biotech. The investment extends the biotech’s cash runway beyond the anticipated delivery of phase 2b food allergy data in the first half of 2027. 

Rapt Therapeutics is officially shelving its mid-stage immunology candidate after a case of liver failure triggered clinical holds earlier this year. Back in February, the FDA placed holds on two Phase 2 studies of zelnecirnon in atopic dermatitis and asthma after an atopic dermatitis patient experienced liver failure that required a transplant. Rapt closed and unblinded both studies a few months later in the hopes that it had collected enough data to determine the next steps for the treatment. But after speaking with regulators, CEO Brian Wong said Monday that “we do not see a viable path forward for zelnecirnon.” Rapt’s stock $RAPT was down about 42% on Monday afternoon, pricing at $1.66 per share. The company specified that no other trial participants experienced liver toxicity or treatment-related serious adverse events. “We plan to continue advancing our next-generation CCR4 compounds with improved safety margins for inflammatory disease and expect to identify a new candidate in the first half of 2025,” Wong said in the news release. The company also plans to “continue to actively pursue in-licensing opportunities for clinical-stage assets,” according to Wong. Rapt’s only other clinical candidate, tivumecirnon, is currently in mid-stage oncology trials as both a monotherapy and in combination with Merck’s Keytruda, according to the company’s pipeline . In July, Rapt said it was laying off 47 employees, or 40% of its staff, to preserve cash.

Continues to advance preclinical pipeline, including next generation CCR4 compounds, and pursue licensing opportunitiesSOUTH SAN FRANCISCO, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced it is terminating its zelnecirnon (RPT193) program. Zelnecirnon was being evaluated in two randomized, placebo-controlled Phase 2 clinical trials in asthma and atopic dermatitis (AD), and both trials were placed on clinical hold by the U.S. Food and Drug Administration (FDA) in February 2024 due to a serious adverse event (SAE) of liver injury requiring transplant in one patient in the AD trial. No liver toxicity nor other treatment-related SAEs were reported in any other trial participant. The company subsequently closed both studies before completing the planned enrollment. Following feedback recently received from the FDA, the company has stopped its zelnecirnon program. “In light of the agency’s feedback, we do not see a viable path forward for zelnecirnon, although we continue to believe that CCR4 remains an exciting target with the potential to provide a safe, oral therapeutic option across a number of inflammatory diseases,” commented Brian Wong, M.D., Ph.D., President and CEO of RAPT. “We plan to continue advancing our next generation CCR4 compounds with improved safety margins for inflammatory disease and expect to identify a new candidate in the first half of 2025. Additionally, we continue to actively pursue in-licensing opportunities for clinical-stage assets.” About RAPT Therapeutics, Inc.RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. Forward-Looking StatementsThis press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the termination of the zelnecirnon program; the company’s business and clinical development plans, including future CCR4 molecules and pursuit of licensing opportunities for clinical-stage assets; and other statements that are not historical fact. Factors that may cause actual results to differ materially from the plans, intentions and expectations disclosed in these forward-looking statements include uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of RAPT’s product candidates; the risk that clinical trials may have unsatisfactory outcomes; risks associated with preclinical development of product candidates; risks that efforts to secure licensing and other business development opportunities may not be successful; and other important factors, detailed in RAPT’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements. Investor Contact:Sylvia Wheelerswheeler@wheelhouselsa.com Media Contact:Aljanae Reynoldsareynolds@wheelhouselsa.com