Semaglutide (Novo Nordisk)

Hansoh Pharma is currently running both a phase 2b study of its GLP-1/GIP receptor agonist in diabetes and a phase 3 trial in obesity in its home territory of China.\n Regeneron is paying Hansoh Pharma $80 million upfront for a phase 3-stage GLP-1/GIP receptor agonist the companies believe can hold its own against Eli Lilly’s Zepbound.As well as the upfront fee, Regeneron has agreed to pay up to $1.93 billion in development, regulatory and sales milestones to secure the ex-China rights to the asset, dubbed HS-20094. Hansoh has already studied the drug in more than 1,000 patients, according to Regeneron, which claimed that HS-20094 has a “potentially similar profile” to Lilly’s approved GLP-1/GIP agonist.Hansoh is currently running both a phase 2b study of the drug in diabetes and a phase 3 trial in obesity in its home territory of China.“Despite the transformative impact of recent weight loss therapies, significant unmet needs remain, including the ability to sustain weight loss and maintain muscle mass over time,” Regeneron Chief Scientific Officer George Yancopoulos, M.D., Ph.D., said in a June 2 release.“Securing access to a GLP-1/GIP receptor agonist will increase the versatility of our clinical programs for obesity and accelerate our mission to support quality, sustained weight loss and the associated long-term health benefits,” Yancopoulos added.Regeneron already has an obesity pipeline in the works in the form of the GDF8 antibody trevogrumab. In a separate update this morning, the company unveiled interim results from an ongoing phase 2 study that it claimed showed combining trevogrumab with semaglutide—the ingredient in Novo Nordisk’s obesity drug Wegovy—“helped preserve lean mass while increasing loss of fat mass.”A number of other biopharmas are chasing the same holy grail of treating obesity without losing muscle. They include Roche, which is hoping that combining an injectable dual GLP-1/GIP receptor agonist acquired from Carmot Therapeutics alongside its own anti-myostatin antibody could also help patients reduce the muscle loss typically associated with losing weight. Regeneron’s own trial is also assessing allying its anti-activin antibody garetosmab to see what impact that could have on weight loss.“In-licensing a late-stage GLP1/GIP agonist will allow us to study combinations with Regeneron’s proprietary drugs and drug candidates in order to holistically address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes and liver conditions,” Boaz Hirshberg, M.D., senior vice president for clinical development, internal medicine, at Regeneron, explained in the Hansoh deal release.“This is an exciting development in our obesity work at Regeneron, which also includes the muscle-sparing phase 2 COURAGE study investigating the addition of trevogrumab.”Regeneron isn’t the only Big Pharma to spot potential in Hansoh’s obesity pipeline. Merck & Co. ended last year paying $112 million upfront for a preclinical GLP-1 drug the company hopes will have a wide range of cardiometabolic benefits.

CHICAGO The American Society of Clinical Oncologys annual meeting is a forum for data. On Monday, it was also the backdrop to oncologys latest deal, when Bristol Myers Squibb and BioNTech announced a multibillion-dollar alliance around a newly in-vogue drug.BioNTechs drug is a bispecific antibody that simultaneously targets the proteins PD-L1 and VEGF. Pharmaceutical companies like Bristol Myers are increasingly enthusiastic about drugs of this type, following startling data in lung cancer from partners Akeso and Summit Therapeutics last year.Bristol Myers will now co-develop BioNTechs version, which BioNTech gained in a 2024 acquisition of Biotheus. On Tuesday, researchers will present data at ASCO from a mid-stage study of the drug in endometrial cancer. While its on the conferences last day, the cancer doctors and other attendees who remain will now have even more reason to listen in. Ned PagliaruloAnother PD-L1/VEGF contenderBioNTech has a lot of company in developing bispecific antibodies that target VEGF and either PD-1 or PD-L1. Pfizer recently licensed rights to one developed by Chinas 3SBio, while Merck & Co. is partnered with LaNova Medicines on another.Would-be pharma buyers still have a few drug candidates they could choose from, however. One such antibody that remains unpartnered is HB00025, developed by Huabo Biopharm. Results from a Phase 2 study presented in a poster at ASCO show promise for its use treating endometrial cancer.Researchers tested HB00025 alongside chemotherapy in 54 women, as of an April 25 data cutoff. In 45, their cancer had spread to the lungs, liver or bones. Treatment shrank tumors in 43 of 51 patients who had a follow-up appointment. Trial investigators didnt yet have enough data to measure its effects on tumor progression or overall survival. Among participants whod been in the trial six months, 98% hadnt had their disease progress.The drug is also being tested in lungand kidney cancer. Jonathan GardnerParsing the promise of oral SERDsNew oral SERDs are displaying an impact on advanced breast cancer, but mainly against tumors with a certain mutation. Questions also persist about treatment sequence and patient quality of life.This year at ASCO, therapies from Arvinas and Eli Lilly were in the spotlight for how they might help people with breast cancer thats hormone receptor positive, but negative for the protein HER2. Study data for Arvinas and partner Pfizers PROTAC drug vepdegestrant and Lillys SERD imlunestrant show the drugs can reduce disease progression or death in patients with ESR1 gene mutations.Still, some doctors wonder how beneficial these medications will prove to actually be.Almost every one of these drugs is being developed with other therapies. And there are a number of unknowns that comes from the data we have, at least today, said William Gradishar, a professor of breast oncology at the Northwestern Feinberg School of Medicine, during an ASCO presentation Saturday.Gradishar noted that, while holding tumors in check is a notable benefit, the data must be looked at critically, as quality of life decreases each time disease progresses. Clinicians must also weigh that impact against the side effects associated with the new oral SERDs. In Arvinas and Pfizers trial, for example, about one-fifth of participants experienced side effects that were rated severe or worse, although few discontinued treatment.We have to make every effort to mitigate these side effects, Gradishar said. Delilah AlvaradoCervical cancer preventionCervical cancer deaths have declined significantly in young women in the U.S., likely due to HPV vaccination, which is effective at preventing infection and related tumors. A study from the Medical Unviersity of South Carolina Hollings Cancer Center published last year indicated that HPV shots can significantly impact cervical cancer mortality as well as its incidence, and do so more quickly than previously thought.Emerging data suggest a more convenient single-dose approach could be used in teens and children, which might help address hurdles in uptake.Data from a study called KEN SHE, presented at ASCO on Sunday, support the idea that a one-time dose of an HPV vaccine is just as efficacious as two or three doses. The U.S. currently recommends two doses for children aged between 9 and 14 years, while three doses are recommended for persons aged 14 through 45.“This is the only time we've seen this in public health, which is intervention actually has gotten better over time,“ said Philip Castle, director of the Division of Cancer Prevention at the National Cancer Institute, during the presentation.In 2022, the World Health Organization changed its global recommendations to either a one- or two-dose regimen. The recommendation came a couple years after the launch of a global strategy to eradicate cervical cancer by 2023, but the U.S. as well as lower-income countries are well behind. Delilah AlvaradoA bold GLP-1 forecastGLP-1 drugs for weight loss can help people with diabetes, obesity, heart and kidney disease as well as sleep apnea. A wide range of other uses are also being studied.So its fitting researchers would look at whether the medicines can help prevent cancer, too. The hypothesis makes some sense. Excess weight is a known risk factor for 13 types of cancer, including more challenging tumors like those of the pancreas, colon, breast, ovaries and kidney, Darren Brenner, an associate professor at the University of Calgary, told ASCO attendees at a session on Sunday.A growing share of the population in the U.S. and elsewhere is overweight or obese. The impact of GLP-1 drugs like Wegovy or Zepbound on new cancer cases could therefore be large, Brenner said.Using a simulation that modeled 10% weight loss in people with obesity, he estimated more than 1 million new cases of cancer could be averted between now and 2050. Brenner noted that preliminary data from small real-world analyses of GLP-1 users hints at a benefit along these lines, reducing the risk of esophageal cancer, as well in many of the other forms of cancer where excess weight is a risk factor.Long-term follow up data from the Select trial of Wegovy, which enrolled 17,000 people with obesity to assess its effect on heart disease, could shed further light on whether GLP-1s can also help prevent cancer, he added. Jonathan Gardner '