LaNova Medicines Ltd.

I-Mab Biopharma announced a slew of changes after the US market closed on Thursday, including acquiring a retinal disease drug, naming a new CFO, and planning a dual listing in Hong Kong. The Rockville, MD-based biotech also said it plans to change its name to NovaBridge Biosciences later this month. I-Mab is preparing to trade on the Hong Kong Stock Exchange by the end of the year, executive chair Wei Fu told Endpoints News . Fu is CEO of CBC Group, one of the leading healthcare asset management firms in Asia and a key backer of I-Mab. He was named I-Mab executive chair last month. The HKEX has become the go-to IPO market for biotech companies, with more than 40 Chinese biotechs submitting their pitches so far this year. To help with the listing, I-Mab brought on a CFO with HKEX expertise. Kyler Lei was previously head of capital markets at Sino Biopharmaceutical. Sino, which is listed on the HKEX, acquired LaNova Medicines earlier this year. I-Mab’s decision to pursue an HKEX listing comes about a year and a half after the company split its US and China businesses, citing R&D and operating expenses , among other reasons. Multiple executives departed shortly thereafter. With China’s biotech ecosystem attracting global attention, Fu believes that I-Mab can benefit from that interest, describing the drug development environment there as a “sustainable opportunity.” “Therefore, we try to repurpose I-Mab to service this need to bring the innovation out of that market, China, to serve the global patients,” he said. The biotech is also adopting a hub-and-spoke model, in which assets are housed in individual units to facilitate simpler dealmaking with pharma companies. The model has become more common following successful experiments at companies like Roivant Sciences and BridgeBio. The company said the spokes allow it to “maintain operational focus and agility.” In an interview, I-Mab CEO Sean Fu said the company will continue working on its internal pipeline, which includes three clinical-stage cancer drugs: “What we are providing is a commitment to continue to deliver on giva and the rest of the innovative assets in the I-O space,” he said. As part of the model, I-Mab created a subsidiary called Visara, and it pumped $37 million into the unit, which will serve as the basis for its foray into ophthalmology. The company plans to look for additional ophthalmology assets in China, Korea, the US and elsewhere, Wei Fu said. Visara acquired an experimental retinal disease drug from AffaMed Therapeutics and its partner AskGene Pharma for undisclosed terms. Known as VIS-101 (formerly AM712), the bifunctional biologic targets VEGF-A and ANG2. The experimental medicine has been through Phase 1 in patients with diabetic macular edema and neovascular age-related macular degeneration . It’s currently in a Phase 2 in China, I-Mab said. Another Western biotech recently licensed a VEGF and ANG2 candidate from a Chinese drug developer. Ollin Biosciences launched last month with $100 million to develop a bispecific from Innovent Biologics and another ophthalmology asset from VelaVigo. I-Mab and Ollin are both trying to develop therapies that can compete with Roche’s Vabysmo. Heading up the board at Visara is Emmett Cunningham, who is also on the boards of other ophthalmology companies like Aviceda Therapeutics and Eyconis, the Ascendis Pharma spinout.

As Wall Street continues to digest this week’s disappointing results for Summit Therapeutics’ PD-1xVEGF bispecific cancer drug, one competitor is primed to take advantage. Summit’s stock $SMMT closed 20% lower on Monday after the company shared full data showing its drug ivonescimab might be less efficacious in Western patients than those in China. It’s the first time that executives there have had to play defense , and some observers — including the most bearish sell-side Summit analyst — are questioning whether bispecifics work if not combined with other therapies. “We have increased conviction that the bispecifics are best placed as backbones for novel/novel combinations and/or in settings where they can replace [Avastin] standard of care,” Leerink’s Daina Graybosch wrote in a Tuesday note to investors. Enter Pfizer. As recently as this spring, the drugmaker wasn’t the obvious choice. It only entered the VEGF bispecific race in May, when it signed a licensing deal with Shenyang, China-based 3SBio for the rights to SSGJ-707. The drug still hadn’t entered a Phase 3 study in China when the companies signed the deal, though Pfizer now describes a global Phase 3 as a “ priority .” But Pfizer isn’t planning to conduct any trials pitting SSGJ-707 directly against standard of care or placebo at this time. Instead, it will run studies that combine the drug with the antibody-drug conjugates it acquired from Seagen, Pfizer’s head of thoracic oncology Arati Rao told Endpoints News in a recent interview. “For us to do a study like the Summit study, as a global study, would be tough,” Rao said last month. “We have this great advantage at Pfizer of having this wealth of multiple ADCs that we can combine with, or work with, that we don’t want to muddy those waters.” Rao said Pfizer could change course and still run a monotherapy trial for SSGJ-707, on which she has oversight. Rao and Jeff Legos, Pfizer’s chief oncology officer, have said SSGJ-707 has the potential to be more efficacious than PD-1 checkpoint inhibitors alone on a call with investors in July. They describe it as “structurally distinct” from other PD-1xVEGF programs. In lung cancer, however, Rao said the space is “pretty crowded right now,” including Pfizer’s other ADC trials. She pointed to a Phase 3 study in lung cancer for sigvotatug vedotin as a reason against launching a similar trial for SSGJ-707. Sigvotatug vedotin comes from Pfizer’s roughly $43 billion acquisition of Seagen in 2023. If Pfizer wanted to do a monotherapy trial in lung cancer, it would have to enroll only patients with at least 50% expression of PD-1 or PD-L1 on their tumor cells to beat the standard of care, Rao added. “The bottom line is we don’t need to have a monotherapy study,” Rao said. “Our time is better spent treating patients who truly need this drug in combination with chemo or with something else.” It’s possible other companies will soon start combining their PD-1xVEGF bispecifics as well. Pumitamig, which is at the heart of a licensing deal between Bristol Myers Squibb and BioNTech, is a program ripe for combination, according to Graybosch. She also expects Merck to take a similar approach with the bispecific program it licensed from LaNova Medicines, though that drug is in an earlier stage of development compared to pumitamig. At the end of the day, it’s Merck that every company is chasing: The PD-1xVEGF bispecific class is the biggest threat to its immunotherapy Keytruda, the world’s top-selling drug.

Did Summit Therapeutics set expectations too high? Excitement has been building over its cancer drug ivonescimab over the last two years as the company, investors and clinicians all wondered if it could pose a major challenge to Merck’s best-selling immunotherapy Keytruda. But after yet another mixed readout Sunday from its closely-watched Phase 3 trial , Summit was busy defending itself on Monday, as Wall Street analysts peppered executives with unusually pointed and direct questions. Many of those questions dealt with Summit’s plans, which seemed yet to be determined. The stock $SMMT lost almost a quarter of its nearly $20 billion market value. Sunday’s data included a new post-hoc analysis showing that, after several months of additional data from Western patients, the trial finally hit statistical significance on overall survival after failing that test earlier this year. But detailed breakdowns of subgroups in the trial — from China and Western patients — showed that the drug might be less effective in Western patients than those in China. Those variations between geographic groups were a major focus on Monday’s call with Summit executives, who acknowledged the lack of a clean outcome but said there was still interest from physicians. “None of us is claiming that this is statistically significant. It will not be. That is the way it went,” said Jack West, Summit’s VP of clinical development, arguing that there were enough good data to be meaningful for oncologists. “As I said, we are always, as clinicians, looking for truth within the reality that the trials don’t always provide clear answers.” Part of the company’s challenge is the way the trial was built. When Summit first licensed the drug, it was only being studied in Chinese patients. Summit then got permission from the FDA to enroll North American and European patients, forcing the company to read out the final OS analysis before Western patient data were mature. That “sequential nature” of the trial caused a large divergence in follow-up times between patients in and outside China, West said. On Monday, Summit co-CEO Bob Duggan largely let others take the lead on the questions. He only chimed in at the very end, noting that the FDA’s allowance of sequential enrollment was unexpected in the first place. But he also said North American physicians were more cautious in treating patients than anticipated, contributing to the different follow-up periods. “That’s why the estimated time for completion of the trial then came in a bit shorter than, had we been able to evaluate that properly, it would have,” Duggan said. “That’s the only reason why we have extended it, and allowed the maturity of the data to be equalized.” Ivonescimab is a PD-1xVEGF bispecific drug, which combines immunotherapy’s PD-1 approach with another successful cancer-fighting mechanism in a single drug. After Summit licensed ivonescimab in 2022 from China’s Akeso, the company stayed largely silent about it as it began to design trials outside China. That all changed in May 2024, when the company put out an announcement during the annual ASCO conference saying ivonescimab topped Keytruda in a head-to-head Phase 3 study of NSCLC patients in China. The prospect of a drug that could beat Keytruda suddenly had the industry buzzing about whether there was a competitor, and potential successor, to one of the biggest-selling drugs of all time. But over the following months, additional results have begun to temper the hype. This year, Summit followed up 2024’s ASCO news by saying it had a positive trend in overall survival data, but had missed statistical significance in the global trial. In the ramp-up to Sunday’s reveal, many were hopeful that the full Phase 3 data would give better, clearer answers. Instead, they may have just added to the confusion. “Are there any additional analyses you plan to provide to us? Especially overall survival data from the Western populations that are later data cuts down the road? Or will it depend on your regulatory interactions?” Jefferies analyst Clara Dong asked on Monday’s call. Leerink analyst Daina Graybosch, who has been perhaps the most bearish sell-side commenter on Summit, wrote in a note to investors Sunday evening that she thought FDA approval of ivonescimab was unlikely based on the new results. “Based on FDA comments in recent oncology drug advisory committee (ODAC) meetings, and given potential for OS harm in NA & EU patients, we think US approval would have been challenging with this study even if it had met statistical significance on the OS HR endpoint,” Graybosch wrote. Summit’s data also got the engines going on dealmaking for other drugs in the same class. BioNTech made the biggest move, acquiring its Chinese partner Biotheus and licensing its bispecific to Bristol Myers Squibb. Pfizer is also tied up with a program from 3SBio, and Merck licensed its own PD-1xVEGF from LaNova Medicines. And in July, Bloomberg News reported that Summit and AstraZeneca are talking about a potentially huge deal for ivonescimab. On Monday, BioNTech and Bristol Myers released their own data from a Phase 2 study for pumitamig (formerly BNT327) plus chemotherapy. In 38 patients with extensive-stage small cell lung cancer who hadn’t received any prior treatment, and whose cancers spread beyond one side of the chest, pumitamig and chemo had a median progression-free survival of 6.8 months. Wall Street is continuing to digest the data, and questions will likely linger as Summit moves to meet with the FDA for next steps.