Sierra Oncology, Inc.

IDRX-42 is currently being evaluated in a phase 1/1b trial dubbed StrateGIST 1 for patients who have received second-line therapy or beyond. \n In a deal worth up to $1.15 billion, GSK is acquiring precision medicine biotech IDRx and its phase 3-ready gastrointestinal cancer asset.“We really became impressed with what IDRx had achieved,” GSK Chief Commercial Officer Luke Miels told Fierce Biotech in an interview ahead of the J.P. Morgan Healthcare Conference. “I think we have an opportunity to develop a best-in-class product here for patients and move the standard of care ahead after 20 years.”GSK is doling out $1 billion cash for the Boston-based biotech, tacking on the potential for an additional $150 million regulatory approval milestone payment, according to a Jan. 13 release.The Big Pharma will also assume responsibility for milestone payments and potential royalties for the cancer candidate—dubbed IDRX-42—that are owed to Merck KGaA, from which IDRx licensed in 2022.The tyrosine kinase inhibitor (TKI) is designed to be a first- and second-line therapy for gastrointestinal stromal tumors (GIST) by hitting all key KIT mutations, something that gives the asset best-in-class potential.   Given IDRx’s status as a private company that holds almost all its value in the singular asset, it made sense to acquire the whole portfolio versus striking a licensing deal, according to GSK’s Miels.The Big Pharma will bring over “key members” from IDRx to help run the clinical program, with Miels saying the intent is to try and retain as many people from the biotech as possible.The Boston company emerged in 2022 with $122 million and secured a similar $120 million in August 2024, with investors including Andreessen Horowitz (a16z), Blackstone, RA Capital and Merck KGaA, among others.The biotech’s IDRX-42 is currently being evaluated in a phase 1/1b trial among GIST patients who have received second-line or more treatment. Data from the study, dubbed StrateGIST 1, demonstrate a manageable safety profile and favorable durability, according to GSK.Across 87 evaluable patients of all KIT mutation subsets, the objective response rate (ORR) was 29%, including one complete response (CR) and 24 partial responses (PRs). For 15 patients who only had one prior line of treatment, the ORR was 53%, including one CR and seven PRs.About 80% of GIST cases are driven by KIT gene mutations that prompt tumor cell growth and survival. What’s more, most patients who receive first-line therapy develop new KIT mutations that often lead to relapse and limit treatment options. At this time, there aren’t any approved TKIs that stop the full range of relevant KIT mutations, according to the release.The current standard of care for GIST includes Novartis’ TKI Gleevec (imatinib). But Miels said the toxicity levels associated with the drug, which leads to around 43% of patients experiencing grade 3 or greater toxicity, are a driving part of GSK’s interest in IDRx.The pharma was looking for a candidate that doesn’t have the “off target effects which were driving the toxicity of the other TKIs in the class, and we found that with IDRx\'s molecules,” Miels explained.IDRX-42 has snagged FDA fast-track designation for treating patients with GIST after disease progression on or intolerance to imatinib, plus an orphan drug tag for GIST.“It’s a phase 3-ready asset,” Miels said. “Our intent is to move it into second-line as quickly as we can, and then subsequently follow up with the first-line.”“There\'s a pathway to a best-in-class drug here that can improve upon the results that are achieved with Gleevec, and certainly a lot stronger than what you see with the second-, third- and fourth-line drugs,” the CCO said.The deal is a continuation of GSK’s M&A strategy: acquiring assets designed to treat validated targets with unmet need, according to Miels, who cited the pharma’s $2 billion Bellus Health buyout and $1.9 billion takeover of Sierra Oncology.“Hopefully we can identify more opportunities like IDRx and subsequently execute those deals in the future,” Miels concluded.

Is the frenzy of JPM dealmaking finally underway? GSK announced Monday morning that it will acquire the privately-held biotech IDRx for $1 billion upfront, bringing a rare cancer treatment into the British drugmaker’s fold. If all milestones are met, GSK will pay up to another $150 million. It’s the first big deal to be announced at the annual JP Morgan Healthcare Conference, which begins Monday. The buyout gives GSK a bolt-on oncology program called IDRX-42. It also shares similarities to the company’s 2022 acquisition of Sierra Oncology, according to Luke Miels, GSK’s chief commercial officer. Through that deal, GSK gained Ojjaara, a JAK inhibitor also known as momelotinib that was approved in 2023. “The way I would look at it is it’s further building our portfolio,” Miels said in an interview. GSK CSO Tony Wood previously told Endpoints News that it’s aiming to build “careful” momentum for its oncology pipeline. Both the IDRx buyout and a recent licensing agreement with Rgenta to develop splice modulators for different cancers appear to fall into that strategy. Miels said that the deal started coming together last month, when the IDRx team gave a presentation to GSK executives. “The IDRx molecule, when the team presented it, certainly got Tony’s and my attention,” Miels said. IDRx chair Ben Auspitz said the startup had run a dual-track process looking at both an IPO and an M&A deal. It was “highly competitive” with “multiple suitors” in the mix, he told Endpoints on the sidelines of JPM on Monday. If approved, the market for IDRX-42 also has parallels to Miels’ past work at AstraZeneca, where he helped shepherd the lung cancer drug Tagrisso across the finish line, he said. There were already approved drugs on the market, but Tagrisso helped fill in some treatment gaps because it targeted specific tumor mutations — in that case, EGFR. In the case of IDRX-42, the program is designed to treat GIST, a type of cancer that grows in the digestive tract lining, and goes after tumors with a mutation called KIT that’s found in over 80% of GIST tumors. This is where GSK believes it can improve on already-approved treatment options like Novartis’ Gleevec, which was first approved in 2008 for GIST, according to Miels. There are about 6,000 GIST patients in the US and 5,000 in the EU, Miels added, though global estimates range between 80,000 and 120,000 because of how individuals are diagnosed. Durability will be a key question for IDRX-42 since GIST patients typically survive for at least five years. GSK intends to start a study in second-line patients this year. A study in first-line patients is expected to follow relatively quickly, though there’s no timeline yet. “We won’t wait for the second-line study to conclude,” Miels said. IDRx had been targeting a pivotal study sometime in the middle of 2025. At the annual ASCO meeting in June, the company shared Phase 1 data that showed IDRX-42 shrank tumors in 23% of patients regardless of how many prior regimens they had tried and in 43% of second-line patients. IDRx last raised money in August, putting together a $120 million Series B from a syndicate that included RA Capital, Commodore Capital and Blackstone. The company licensed IDRX-42 from Merck KGaA prior to its de-stealthing in 2022. The Financial Times first reported last week that a deal was close. (Endpoints is part of FT Specialist, a unit of the Financial Times.) Editor’s note: This story was updated to include information from an interview with IDRx chair Ben Auspitz.

Frazier Life Sciences has added more than $630 million to its evergreen public fund, the firm said Wednesday. The long-only fund, which is based in Palo Alto, CA, has been marketed to investors as a “hybrid structure to navigate volatility and liquidity in SMID-cap biotech,” according to materials posted by the New Mexico State Investment Council, which is committing up to $50 million to the public fund. “We are seeking to strategically take advantage of market volatility,” the firm said in June in its investor presentation. It now has $1.7 billion in total commitments after debuting with $830 million in 2021 and raising $243 million a year later. The biotech landscape is far different than when Frazier unwrapped its public fund in the fall of 2021. In September of that year, the number of life sciences companies with a negative enterprise value was 21. As of Sept. 20 of this year, that tally stood at 133, according to a recent Stifel report . “The number of early-stage companies going public has just exploded over the course of the last five-plus years,” general partner Jamie Brush told Endpoints News in 2021. “So the opportunity set for early-stage companies where Frazier wants to be investing has really increased on the public side.” The biotech IPO market cratered soon after that unveiling. Since then, initial public offerings have been few and far between, though there’s been a string of debuts this fall and more interest-rate cuts could be a positive signal for the market going forward. Follow-on offerings, meanwhile, have had a “ very strong year ,” according to Stifel. Frazier’s strategy Frazier has five main strategies for the fund. The first is “fallen angels,” which Frazier has described as companies that have “fallen out of favor but have promising assets,” like BridgeBio and Immunovant. Bain Capital Life Sciences, which just raised a $3 billion fourth fund, employs a similar strategy . Another bucket is “proprietary information,” in which Frazier gets data that are not publicly available, as it has done in the case of Rocket Pharmaceuticals and Mirum Pharmaceuticals. The third is “structured terms” or “creative” deals. The firm also invests in companies that are newly public like CG Oncology, which had the largest biotech IPO of the year at $380 million in January . And the final strategy is “off-the-beaten path,” or companies that are “lesser known” such as Egetis Therapeutics and Chinook Therapeutics. Novartis bought Chinook in a deal worth up to $3.5 billion last year. Frazier has said its public fund portfolio companies have secured a dozen FDA approvals, including Acadia’s Daybue, bluebird’s three gene therapies, Iovance’s Amtagvi and Phathom’s Voquezna. Some companies have been acquired, including Iveric Bio, which sold to Astellas for $5.9 billion ; Reata’s $7.3 billion exit to Biogen; Alpine Immune Sciences’ $4.9 billion sale to Vertex; and Sierra Oncology’s $1.9 billion exit to GSK. On the venture side, Frazier last disclosed a $987 million life sciences fund in March 2022.