CT-388

Eli Lilly showed a drug that goes after two metabolic targets to treat obesity can successfully shed weight and become a revenue-generating heavyweight. Other companies aspire to improve on the Lilly drug’s approach and Kailera Therapeutics is the newest of them, backed by $400 million to support a pipeline of obesity drug candidates. Kailera, which splits its operations between San Diego and Waltham, Massachusetts, is joining a growing field of companies developing drugs that mimic peptides in the body, binding to and activating receptors to spark metabolic effects. The company’s lead program goes after GLP-1 and GIP, targets addressed by Lilly’s blockbuster drug Zepbound, which won FDA approval for chronic weight management last November. Kailera’s portfolio of four metabolic disorder dugs comes from China-based Jiangsu Hengrui Pharmaceuticals. In May, Kailera licensed exclusive rights to develop those molecules globally, except for greater China where Hengrui retails rights. The most advanced program is KAI-9531, a once-weekly injectable dual agonist of the GLP-1 and GIP receptors. Under Hengrui, Kailera said this drug showed “compelling results” in obesity and type 2 diabetes from Phase 2 tests conducted in China. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB The Phase 2 test in obesity enrolled 249 participants randomly assigned one of four doses of the once-weekly injectable study drug or a placebo. The double-blind treatment period was 24 weeks. Hengrui presented Phase 2 results in obesity in June, during the American Diabetes Association Scientific Sessions meeting. These results showed a dose-dependent increase in weight loss during the treatment period. At the 6 mg dose — the highest one tested — 53.1% of patients lost 15% or more of their body weight compared to baseline. Adverse events reported from the study included nausea, diarrhea, decreased appetite, and vomiting. Gastrointestinal problems are consistent with other weight management drugs and Hengrui classified the side effects in its study as mild to moderate in severity. It’s difficult to make cross-trial comparisons, but the results for the drug that is now Kailera’s lead program suggest it’s competitive with others targeting both GLP-1 and GIP. In Zepbound’s pivotal study, patients lost an average 18% of their body weight compared to those who received a placebo. In February, San Diego-based Viking Therapeutics reported Phase 2 data for its once-weekly injectable GLP-1 and GIP agonist, VK2735, showing an average 13.1% placebo-adjusted weight loss after 13 weeks of treatment. A larger and longer Phase 3 study is planned for this molecule. An oral version of the Viking drug is expected to begin a Phase 2 test in obesity by the end of this year. Roche is going after GLP-1 and GIP with CT-388, an injectable peptide from its $2.7 billion acquisition of Carmot Therapeutics last year. In a Phase 1 test, Roche reported the average placebo-adjusted weight loss at 24 weeks was 18.8%. An oral drug included in that M&A deal posted encouraging Phase 1 data over the summer. Kailera’s pipeline also includes oral therapies. The Hengrui deal brought two small molecule programs, KAI7535 and KAI-9531. Kailera’s fourth program is an injectable drug that goes after three targets: GLP-1, GIP, and glucagon receptor. New York-based Metsera has a program that also goes after those three targets. Its most advanced program hits only GLP-1, but with a dosing edge of an injection once a month. Last week, Metsera announced Phase 1 results showing 7.5% reduction in body weight measured at day 36. The company, which launched in April backed by $290 million, expects to begin a Phase 2b test of its lead program by the end of this year; preliminary data are expected in the first half of 2025. presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health Kailera’s Series A financing announced Tuesday was co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments. Lyra Capital also participated in the round. The company is led by CEO Ron Renaud, who was most recently the chief executive of Cerevel Therapeutics, a neurological diseases drug developer recently acquired by AbbVie. “In this period of rapid innovation in the metabolic space, I believe that Kailera is poised to make an impact beyond the current market leaders,” Renaud said in a prepared statement. “We have an incredible opportunity to develop next-generation treatments for chronic weight management, helping people reclaim their health and live their lives to the fullest.”

iStock, HJBC The acquisition was featured in Roche’s Pharma Day presentation, which also included projections of more than $3 billion in annual sales from three early-stage obesity and diabetes drugs. A portfolio of CDK inhibitors developed by Regor Pharmaceuticals has found a home at Roche, which announced Monday it would buy the investigational cancer drugs for $850 million upfront. Cambridge, Mass.– and China-based Regor will see two ongoing Phase I trials of CDK4 inhibitor RGT-419B through to their completion, at which time Roche’s Genentech subsidiary will take over global clinical development, manufacturing and commercialization of this asset. The deal also includes additional CDK4 inhibitors for cancer. Last December, Regor announced results from a Phase Ia trial of RGT-419B, showing that the drug was safe and well tolerated in patients with HR+/HER2- advanced breast cancer who have progressed on CDK4/6 inhibitors and endocrine therapy. “Monotherapy clinical efficacy” was also observed, Regor reported. The deal, which is expected to close in the fourth quarter of this year, includes the potential for Regor to claim additional cash payments based on the achievement of predetermined development, regulatory and commercial milestones. “Genentech is well-positioned to bring these novel therapeutics to their full potential to benefit patients with breast cancer around the world,” Xiayang Qiu, founder and CEO of Regor, said in a statement. Indeed, Roche currently markets three treatments for breast cancer: Perjeta, Kadcyla and Phesgo, which generated a combined $4.38 billion during the first half of this year. Perjeta was Roche’s third-top-selling drug in the first half. The company has a Nov. 27 PDUFA date for a fourth drug, inavolisib, for which it is seeking approval in first-line PIK3CA-mutated hormone receptor positive breast cancer. During Roche’s Pharma Day presentation in London Monday morning, CEO Teresa Graham called the Regor additions a “perfect fit” with the company’s breast cancer franchise, Endpoints News reported. In a second deal, Roche picked up Wnt signaling biotech AntlerA, gaining possession of a library of anti-FZD/LRP drug candidates. Roche is envisioning AntlerA’s lead preclinical asset as a “potential best-in-class treatment” for neovascular age-related macular degeneration and diabetic macular edema, according to Fierce Biotech . Financials were not disclosed. Another recent acquisition was in the spotlight at Roche’s Pharma Day as the company said three early-stage obesity and diabetes drug candidates stemming from its $2.7 billion buyout of Carmot Therapeutics could bring in more than $3.6 billion in annual sales. The revenue projection specifically pertains to investigational weight-loss treatment CT-388, oral GLP-1 analog CT-996 and diabetes drug CT-868, according to Reuters . In May, Roche unveiled Phase Ib data showing that CT-388 could significantly lower body weight in healthy adults with obesity. Then, in July, it announced topline data from an ongoing Phase I study showing that CT-996 could elicit “clinically meaningful” weight loss in patients with obesity but without type 2 diabetes.