AnHeart Therapeutics (Hangzhou) Co., Ltd.

Nuvation Bio outlined pooled data from its two Phase 2 studies at the annual European Society for Medical Oncology confab in Barcelona this weekend as it prepares to approach the FDA soon. The company said that across the two trials — one conducted in China, the other in Western countries — 89% of patients saw their tumors shrink after taking its once-daily oral drug taletrectinib. Separate datasets from both Phase 2 studies, as well as the pooled ESMO analysis, are expected to form the backbone of Nuvation’s FDA submission, CEO David Hung told Endpoints News . With the data, Nuvation is aiming to capitalize on its all-stock deal for AnHeart Therapeutics from March. Nuvation enrolled 337 patients who had ROS1-positive non-small cell lung cancer in both studies, and individuals took 600 mg of the drug in 21-day cycles. The median follow-up was 21 months, and the cut-off date was June 7. Researchers also took a closer look at 160 patients who hadn’t yet received TKI inhibitors in the studies. Nuvation said tumors shrank in 89% of these individuals, and measurable brain metastases shrank in 13 of 17 people. The median duration of response was 44 months and median progression-free survival was 46 months, Nuvation said. Additionally, 56% of 113 patients who had previously received a TKI inhibitor also saw their tumors shrink. The brain metastases shrank in 21 of 32 patients as well. Hung said that these groups of patients are important to the FDA because ROS1-positive NSCLC is much rarer and more aggressive than ROS1-negative NSCLC. TKI inhibitors are approved to treat the ROS1-positive form, but many patients end up developing resistance mutations to them. “This is a relatively rare type of lung cancer. It’s about 2% of non-small cell lung cancer, but it tends to be quite aggressive,” Hung said. “If you look at the standard of care for non-small lung cancer in immuno-oncology agents and chemotherapy, the median progression-free survival is generally about six to eight months.” Analysts also viewed the data positively after the Western study data were published at the World Conference on Lung Cancer annual meeting earlier this week. TD Cowen analyst Yaron Werber wrote that the WCLC data “continue to support taletrectinib’s promise” in ROS1-positive NSCLC. If everything goes according to plan, Werber expects Nuvation could launch taletrectinib by the end of 2025. Hung is also experienced in running biotechs attractive to large pharma M&A teams — in 2016, Pfizer acquired Hung’s last biotech, Medivation, for $14 billion.

Nuvation’s pipeline priority right now is taking its ROS1 inhibitor taletrectinib to the FDA. After taking a look at phase 1 data, Nuvation Bio has decided to halt work on its one-time lead BD2-selective BET inhibitor while considering the program’s future.The company has come to the decision after a “careful review” of data from phase 1 studies of the candidate, dubbed NUV-868, to treat solid tumors as both a monotherapy and in combination with AstraZeneca-Merck's Lynparza and Pfizer-Astellas' Xtandi.Specifically, the Lynparza combo had been assessed in a phase 1b trial in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors. The Xtandi portion of that trial only assessed individuals with mCRPC.Nuvation’s number one priority right now is taking its ROS1 inhibitor taletrectinib to the FDA with the ambition of a rollout to U.S. patients next year.“As we focus on our late-stage pipeline and prepare to potentially bring taletrectinib to patients in the U.S. in 2025, we have decided not to initiate a phase 2 study of NUV-868 in the solid tumor indications studied to date,” CEO David Hung, M.D., explained in the biotech’s second-quarter earnings release this morning. Nuvation is “evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.”NUV-868 rose to the top of Nuvation’s pipeline two years ago after the FDA placed a partial hold on the company’s CDK2/4/6 inhibitor NUV-422 over unexplained cases of eye inflammation. The biotech decided to end the NUV-422 program, lay off over a third of its staff and channel its remaining resources into NUV-868 as well as identifying a lead clinical candidate from its novel small-molecule drug-drug conjugate platform.Since then, taletrectinib has crept up the priority list, with the company now eyeing the opportunity to bring the ROS1 inhibitor to patients as soon as next year. The latest pooled date from the phase 2 TRUST-I and TRUST-II studies in non-small cell lung cancer are set to be presented at the European Society for Medical Oncology Congress in September, with Nuvation using this data to support a planned approval application to the FDA.Nuvation ended the second quarter with $577.2 million in cash and equivalents, having completed its acquisition of fellow cancer-focused biotech AnHeart Therapeutics in April.

Pictured: Photo illustration of hundred dollar bill and graph/iStock, Darren415 Life sciences investment firm Decheng Capital on Monday unveiled plans for its fifth fund with a target raise of $700 million, according to an SEC filing. Decheng has not yet disclosed the investment priorities for its fifth fund, including therapeutic areas, platform technologies or target companies, nor has it provided a specific timeline for when it expects to close its fundraising. The investment firm—which is based in Shanghai, New York and Silicon Valley—is focused on supporting “early-stage life science companies” working on “revolutionary technologies,” according to its website. Decheng also backs “growth stage healthcare companies with strong market presence.” Since its founding in 2012, the firm has raised over $2 billion in capital and has helped fund some of the promising start-ups across the industry. Decheng’s portfolio includes Acelyrin, Arcus Biosciences and CG Oncology, which all have successfully gone public in recent years. The firm has also backed ARMO Biosciences which was acquired by Eli Lilly, Checkmate Pharmaceuticals which was bought by Regeneron, and GeneWeave which was purchased by Roche. Many of Decheng’s other portfolio companies are also in the process of being absorbed by or partnering with large pharma players. In April 2024, Mammoth Biosciences inked a research, development and commercialization contract with Regeneron, leveraging its in vivo CRISPR-based gene editing platform. That same month, Bristol Myers Squibb signed a $380 million deal with Cellares to use the biotech’s Cell Shuttle technology, an end-to-end and fully automated platform for manufacturing CAR-T cell therapies. A few weeks earlier, Decheng-backed Alpine Immune Sciences agreed to be bought by Vertex Pharmaceuticals for $65 per share or approximately $4.9 billion in cash. The deal, which has been approved by both companies’ boards of directors, is expected to close later this year. Another Decheng company, Anheart Therapeutics, was bought by Nuvation Bio in March 2024 in an all-stock transaction. Decheng’s announcement on Monday comes after two other life science investment firms closed major funds last week. With $900 million in capital commitments, Foresite Capital on Wednesday announced its goal of supporting innovative projects at the intersection of biotechnology and technology. Foresite is looking to back growth-oriented biotechs working in precision therapeutics, life science infrastructure and healthcare delivery. Also last week, J.P. Morgan Private Capital unveiled its $500 million fund. Secured from various backers, the fund will largely be agnostic in terms of stage, modality, geography and therapeutic area, though J.P. Morgan will focus primarily on private biotechs specializing in cardiometabolic diseases, immunology, oncology and genetic medicines. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.