Jounce Therapeutics, Inc.

Today, a brief rundown of news involving Regeneron Pharmaceuticals, IGM Biosciences and Catalio Capital, as well as updates from Roche, Hikma Pharmaceuticals and several others that you may have missed.The Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals bispecific antibody linvoseltamab for relapsed or refractory multiple myeloma. The clearance was based on tumor response rates in clinical testing and is conditional on Regeneron obtaining confirmatory evidence of the drugs benefit in further study. Regeneron previously tried to secure an FDA OK of the drug last year, but had its application rejecteddue to issues with a third-party manufacturer. Linvoseltamab, which Regeneron will sell as Lynozyfic, is one of two bispecific antibodies the company hopes will boost its oncology business. The other, odronextamab, is under regulatory review for lymphoma, with a decision expected by July 30.Ned PagliaruloConcentra Biosciences is buying another struggling biotechnology company, this time agreeing to pay roughly $1.25 per share to acquire IGM Biosciences. The entity controlled by Tang Capital Partners announced Tuesday that IGMs shareholders would also receive a contingent value right equal to 80% of the proceeds of a deal involving IGMs intellectual property and experimental drugs, as well as all net cash in excess of $82 million at closing. IGM's board unanimously approved the merger agreement, and the deal is expected to close in August. Last month, Concentra brokered a similar agreement with Elevation Oncology, and previously acquired companies Jounce Therapeutics and Kronos Bio.Gwendolyn WuVenture capital firm Catalio Capital Management has brought in more than $400 million for its latest healthcare investment fund, according to a Tuesday announcement. The fund is its fourth since launching in 2020. Recently, Catalioinvested in the AI drug discovery company Superluminal Medicines and antibody-drug conjugate developer Alentis Therapeutics. Catalio will continue investing in “deals with prospects for near-term liquidity,“ as well as “prospects for long-term growth,“ said Diamantis Xylas, Catalio's head of research. Gwendolyn WuWith biotech markets still unsettled, several drugmakers this week turned to royalty and debt deals to obtain new funding. BridgeBio Pharma secured $300 million to support launching its new drug Attruby with an agreement that sells some of the companys royalties on sales of the medicine in Europe, where its marketed by Bayer. Meanwhile, Dyne Therapeutics will receive up to $275 million in debt financing via a deal with Hercules Capital, and Apellis will trade Sobi up to 90% of ex-U.S. royalties on sales of its drug Aspavelifor as much as $300 million. Ned PagliaruloRoche said two of its top executives will be retiring from the company, leaving vacancies on its corporate executive committee. Johannes Clevers, head of Roche pharma research and early development since 2022, will step down in August from his current role but remain as leader of the companys Institute of Human Biology until a successor can be found. Barbara Schdler, head of group communications whos been employed by Roche since 2019, will retire at the end of the year. Roche said it will announce successors in due course. Jonathan GardnerGeneric drugmaker Hikma plans on spending $1 billion to boost its U.S. manufacturing and research and development capacity by 2030, the company said Saturday. Hikma said the expansion will increase the company's US-based capacity to produce large volumes of high-quality and affordable medicines, which currently stands at 12 billion doses a year. The U.K.-based company joins Johnson & Johnson, Eli Lilly, Merck & Co., Novartis, Roche and Gilead Sciencesin pledging to build up U.S.-based manufacturing as President Donald Trump has threatened tariffs on drugs produced overseas. Hikma has facilities in Ohio and New Jersey. Jonathan Gardner '

“We have a pipeline that can deliver at this point, but we will absolutely further optimize it,” Gilead Sciences\' Dietmar Berger, M.D., Ph.D., told Fierce.\n Dietmar Berger, M.D., Ph.D., joined Gilead Sciences as chief medical officer at the start of this year after the company’s oncology department suffered some prominent setbacks. The run of bad luck included two back-to-back phase 3 flops of Trodelvy in non-small cell lung cancer and bladder cancer as well as the demise of the anti-CD47 drug magrolimab from a $4.9 billion acquisition.But Berger, who boasts a deep background in cancer drug development, still believes the virology giant made the right move to branch out into oncology and immunology.“I am a strong believer that diversification for Gilead is the right decision,” Berger told Fierce in an interview on the sidelines of the 2025 American Society of Clinical Oncology (ASCO) annual meeting.“I also think that oncology and immunology are the right areas for Gilead, because of the emerging science … and because we can apply a lot of the strength that Gilead has—for example in chemistry, in protein design and deep understanding of biology—very strongly to oncology and immunology.”As a new head of development joining a biopharma company, it’s natural to think about ways to improve the portfolio, he said. “We have a pipeline that can deliver at this point, but we will absolutely further optimize it,” Berger added.The CMO said he’s trying to build a “balanced” and “partially derisked portfolio” by combining direct cytotoxic mechanisms with immuno-oncology. Again, diversification is key here. At ASCO, Gilead’s cell therapy unit Kite Pharma reported some early positive data for its anti-CD19/CD20 bicistronic CAR-T therapy in advanced B-cell lymphoma. Another bivalent CAR-T candidate partnered with the University of Pennsylvania targeting EGFR and interleukin-13 receptor alpha 2 recorded notable tumor shrinkage in eight (62%) of 13 patients with recurrent glioblastoma, a notoriously aggressive and hard-to-treat brain cancer.Trodelvy also had a positive story to tell at this year’s ASCO, courtesy of two positive phase 3 readouts in first-line triple-negative breast cancer (TNBC). In a potentially practice-changing data set, Trodelvy and Merck & Co.’s Keytruda significantly reduced the risk of progression or death by 35% versus Keytruda and chemotherapy in first-line PD-L1-positive TNBC.In immuno-oncology, Berger highlighted GS-1811, an anti-CCR8 antibody Gilead obtained from Jounce Therapeutics. The drug, designed to remove immunosuppressive tumor-infiltrating T regulatory cells, is still in early-stage development.All told, Gilead has 58 projects across virology, oncology and immunology in its portfolio, the largest and most diverse pipeline in the biopharma\'s history. Challenges in ADC and immuno-oncologyFor Trodelvy, new TROP2 competition has arrived in the form of AstraZeneca and Daiichi Sankyo’s Datroway and Merck and Kelun-Biotech’s sac-TMT.In Trodelvy’s home base of second-line TNBC, the Gilead drug is the only one that has demonstrated an overall survival benefit. Parallel data that could help experts compare these drugs side by side in a cross-trial fashion have not yet read out, Berger explained.Besides first-line TNBC, Trodelvy is also being tested in earlier-line HR-positive, HER2-negative breast cancer, which could represent a bigger patient population than TNBC. Following the Evoke-01 flop, the Evoke-03 study for Trodelvy and Keytruda in first-line PD-L1-high NSCLC remains ongoing.Since Gilead’s $21 billion acquisition of Immunomedics in 2020, the company still has only one antibody-drug conjugate asset, whereas other players in the space such as AstraZeneca and Pfizer have developed multiple products.The Immunomedics deal was a strategic acquisition designed to give Gilead an anchor in its diversification into solid tumors, and the company then built R&D capabilities around that, Berger noted.“That bit of a time lag is largely based on: How do you build an oncology organization?” Berger said.New oncology molecules are now coming out of Gilead’s internal research capabilities, and the company will also “focus strongly” on external opportunities, he said. Berger wouldn’t name specific ADC projects outside of Gilead that he’s interested in. Toward the end of 2024, before Berger officially moved across from Sanofi, Gilead penned a deal with Tubulis to develop a topoisomerase I inhibitor-based ADC.“There’s usually the question, do you combine different mechanisms, or do you double down on a specific pathway,” Berger said of target selection for ADCs.Choosing the linker is dependent on whether a bystander effect—in which the cytotoxic payload from the ADC kills cells surrounding the target cell—is desired, and the toxin needs to be carefully evaluated because these payloads hit different tumor types differently, Berger noted.Meanwhile, things don’t look too promising for Gilead’s late-stage immuno-oncology program, the Arcus Biosciences-partnered domvanalimab. The drug is one of the few remaining anti-TIGIT antibodies still in development after companies such as Merck, Bristol Myers Squibb, GSK and BeOne (formerly BeiGene) walked away from the field. Roche’s Genentech, where Berger used to lead oncology clinical development, has all but abandoned tiragolumab after several disappointing studies, and the pharma is now only waiting for two fully enrolled phase 3 trials to read out.Berger argued that domvanalimab may still stand a chance. The TIGIT molecules that have failed so far are mostly Fc-competent antibodies, whereas domvanalimab is Fc-silent.Fc-enabled anti-TIGIT antibodies theoretically have enhanced tumor-killing effects because they can bind to FcγRs and activate immune cells. But they could possibly also eliminate certain regulatory T cells and therefore lead to unwanted immune responses. Before nixing its TIGIT candidate vibostolimab, Merck had noted a higher rate of immune-related adverse events in at least two failed phase 3 trials. Only data will tell whether Fc-competence is the key. Gilead and Arcus are running two phase 3 trials that combine domvanalimab with Arcus’ PD-1 drug zimberelimab and chemotherapy in first-line NSCLC and gastric, gastroesophageal junction and esophageal adenocarcinoma.Gilead has a stated goal to have 30% of its revenue from oncology products by 2030. Berger acknowledged that the huge clinical success—and potential imminent approval—of twice-yearly lenacapavir for HIV prevention could make achieving that goal harder but said the company remains committed to a target of 30% of revenue from outside virology.“It does place a stronger focus on oncology,” Berger said. “But don’t get me wrong, I think we are in a good spot now.”

Elevation Oncology has agreed to be acquired by an investment firm focused on buying struggling biotechs and shutting them down.The cancer drug developer on Monday accepted a bid from Concentra Biosciences, a vehicle controlled by hedge fund Tang Capital Partners. Through the deal, Concentra will pay $0.36 in cash for each Elevation share. The biotechs stockholders could also receive a so-called contingent value right equal to 80% of the proceeds of a deal involving the companys sole drug prospect, EO-1022, subject to certain time constraints, as well as all net cash at closing over $26.4 million.The offer has the full support of Elevations board and is expected to close in July, pending shareholder approval.Elevations deal is the latest example of a shift in the investment climate for public biotech companies, many of which have suffered setbacks that have rendered them worth less than their cash reserves. Historically, these types of companies tend to change course or merge with a privately held counterpart. However, investors have begun to more closely scrutinize these biotech zombies and press their boards, arguing their cash should be returned to shareholders instead.In recent months, companies like Third Harmonic Bio and iTeos Therapeutics have announced plans to dissolve. Others, such as Acelyrin, Essa Pharma, Pliant Therapeutics and Keros Therapeutics have faced pressure from investors. And multiple investment funds are looking specifically to acquire floundering biotechs and liquidate them. Through Concentra, for instance, Tang Capital has already bought several struggling companies, including Allakos, Jounce Therapeutics and more recently, Kronos Bio.Elevation is its latest target. The company went public in 2021 during a boom in initial public offerings. But its lead drug disappointed in clinical testing, ultimately leading the company to shelve the program, lay off a majority of its staff and begin a strategic review. Its shares have traded at less than $1 apiece for nearly a year. Investment firm and shareholder BML Capital Management in April called for the firm to liquidate and return all of its cash to stockholders, given the state of the equity markets and abysmal performance of many recent reverse mergers.Elevations one remaining drug, dubbed EO-1022, is an antibody-drug conjugate in preclinical development for solid tumors. Prior to accepting Concentras bid, the company said it planned to ask regulators in 2026 to begin human testing. '