Zovegalisib

Roche and BioNTech stole the show at this year’s San Antonio Breast Cancer Symposium. The Swiss drugmaker unveiled Phase 3 data for its oral SERD giredestrant, showing the drug slashed the risk of disease recurrence in certain early-stage breast cancers. Meanwhile, BioNTech shared triple-negative breast cancer (TNBC) data for its PD-L1xVEGF-A bispecific contender. But other drugmakers, such as Celcuity, Relay Therapeutics, and Anixa Biosciences, also had a notable presence at the confab. Celcuity’s Phase 3 subgroup analysis for multi-target drug: The biotech’s gedatolisib plus standard of care palbociclib and AstraZeneca’s selective estrogen receptor degrader (SERD) Faslodex achieved 12.4 months of progression-free survival in a group of breast cancer patients whose time to progression on prior therapy was over 18 months. The result is numerically higher than the 1.9-month PFS seen with Faslodex alone in the same type of patients. Celcuity has projected that gedatolisib could hit up to $3 billion in annual peak sales. The drug acts on a trio of targets: PI3K, AKT and mTOR. The SABCS data came from a cohort of patients without a PIK3CA mutation enrolled in the VIKTORIA-1 trial, which is testing gedatolisib in previously treated HR-positive, HER2-negative advanced breast cancer. Celcuity first announced positive results from the PIK3CA wild-type cohort back in October, but the company waited until Thursday to unwrap details. The company said patients who had reported lower-grade stomatitis as a side effect largely saw it resolve within two weeks. TD Cowen analysts said the new data help alleviate safety concerns that had cropped up during the trial’s initial readout. Relay’s breast cancer drug works consistently across subgroups : The biotech on Friday presented updated data from the first human trial of zovegalisib. The drug, also called RLY-2608, is a PI3Kα inhibitor and is Relay’s lead candidate. The data concern patients in an arm of Relay’s Phase 1/2 ReDiscover study that tested zovegalisib plus Faslodex. In 64 patients who received 600 mg of zovegalisib twice daily, 44% had received two or more prior lines of therapy, 52% had taken a SERD (either Faslodex or an oral SERD), and 29% had detectable ESR1 mutations at baseline. The results come from a cutoff date of Oct. 15. Among the total efficacy population of 52 patients without a PTEN or AKT co-mutation, zovegalisib plus Faslodex yielded a median PFS of 10.3 months, Relay said . Based on a Nov. 29 note by Jefferies analysts, these results appear inferior to Celcuity’s Phase 1b data on gedatolisib in a similar population. Relay also said Friday that among the 31 patients with measurable disease, the ORR was 39%. In second-line patients, median PFS was 11.4 months and ORR was 47%. The PFS here is unchanged from a data cut released a year ago , but the response rate has improved. Meanwhile, in patients who had had prior SERD treatment, median PFS was 11.4 months and the ORR was 44%, Relay said. Among those with a mutated ESR1 gene, which encodes the estrogen receptor, median PFS was 8.8 months and ORR was 60%. SERDs tend to work best in patients who have ESR1 mutations. ReDiscover will go on to test higher doses of zovegalisib and will also investigate triplet cohorts in which a CDK4/6 inhibitor is added to the combo. Relay said this will identify a regimen for use in a future frontline trial in metastatic disease. A Phase 3 study, called ReDiscover-2, is currently testing zovegalisib and Faslodex in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer. Anixa’s early data for cancer vaccine: The company said its unnamed vaccine triggered “protocol-defined” α-lactalbumin (aLA)-specific T cell responses in more than 70% of 35 participants in a Phase 1 trial. The idea is that patients given Anixa’s vaccine will develop a pre-emptive immune response if breast cancer cells that express aLA protein emerge. The vaccine targets aLA, which is usually only found in breast tissue during lactation, but is also expressed by many types of breast cancer. The Phase 1 trial enrolled TNBC patients who were being treated with Keytruda after surgery, as well as certain women at risk of developing TNBC again or for the first time. Those receiving Keytruda also reported promising T cell responses with no major new side effects, Anixa said. The biotech is now planning for a Phase 2 study, including a potential combination trial with Keytruda in the newly-diagnosed, neoadjuvant setting.

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 20, 2025 /PRNewswire/ -- USA News Group News Commentary – The costs of cancer drugs is skyrocketing, according to a recent report from Bloomberg. Analysts at Nova One Advisor estimate that the global oncology drugs market will grow at a 7.4% CAGR through to US$366.24 billion by 2034. Help doesn't appear to be coming from the public sector, as reports state that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For investors to note, plenty of oncology innovators have provided recent developments, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Immuneering Corporation (NASDAQ: IMRX), GRAIL, Inc. (NASDAQ: GRAL), Intensity Therapeutics, Inc. (NASDAQ: INTS), and Relay Therapeutics, Inc. (NASDAQ: RLAY). Continue Reading With Public Funding Under Pressure, Biotech Innovators Are Picking Up the Slack in Oncology Pelareorep Factsheet The global oncology market is expected to see strong growth over the next decade, with ResearchAndMarkets forecasting it to reach US$866.1 billion by 2034 at a 10.8% CAGR. A separate estimate from Vision Research Reports projects the market will surpass US$903.81 billion by the same year, growing at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new phase of leadership with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. Kelly brings a background in high-stakes biotech transactions and strategic immuno-oncology development, positioning him to guide the company through its next stage of clinical and business evolution. Before joining Oncolytics, Kelly served as General Counsel at Ambrx Biopharma, where he played a key role in its $2 billion acquisition by Johnson & Johnson. His earlier work includes advising life sciences firms on licensing, partnerships, and M&A while at Kirkland & Ellis LLP and Lowenstein Sandler LLP. Now leading Oncolytics, he steps into a company advancing pelareorep, a virus-based immunotherapeutic designed to work synergistically with checkpoint inhibitors and other agents across a range of solid and blood cancers. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear strategic focus: advancing pelareorep toward key late-stage milestones through a capital-conscious approach that remains open to strategic collaboration. Pelareorep currently holds FDA Fast Track designation for both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC)—a rare dual recognition that underscores its regulatory momentum. Across multiple studies, the virus-based therapy has demonstrated consistent immune activation, broad combinability with checkpoint inhibitors and chemotherapies, and encouraging response rates in challenging cancer types. In mPDAC, pelareorep has achieved over 60% objective response rates in tumor-evaluable patients across Phase 1 and 2 trials—more than double what's typically seen in historical benchmarks. Separate analyses also reported two-year survival rates four to six times higher than control arms or prior studies. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed survival benefits supportive of further investigation. Meanwhile, a Phase 2 cohort in anal cancer pairing pelareorep with a checkpoint inhibitor reported partial or complete responses in nearly half of evaluable patients—substantially higher than historical norms for monotherapy in this setting. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." Kelly's compensation package includes equity grants and milestone-linked incentives tied to future financings and potential strategic transactions—aligning leadership priorities with long-term shareholder interests. The structure signals a commitment to advancing both clinical and corporate goals while preserving balance sheet discipline and maintaining appeal for potential partners. With multiple cohorts progressing in the GOBLET study—including those in pancreatic and anal cancer supported by external funding and regulatory engagement— Oncolytics is positioned to move forward with a combination of scientific momentum, financial agility, and renewed strategic focus. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Immuneering Corporation (NASDAQ: IMRX) reported positive Phase 2a data for atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. At six months, the study showed 94% overall survival and 72% progression-free survival in 34 patients, with no median OS or PFS reached yet. "These exceptional data demonstrate the potential of atebimetinib plus mGnP to dramatically extend the lives of patients with advanced pancreatic cancer," said Ben Zeskind, Ph.D., Co-founder and CEO of Immuneering. "Our ultimate goal is to help cancer patients outlive their disease, and today's announcement represents an important milestone on that journey." The combination also demonstrated a 39% overall response rate, an 81% disease control rate, and a notably favorable tolerability profile. Many patients experienced deep, durable tumor regressions, including lesions rendered undetectable. The regimen was well tolerated, with an adverse event profile suggesting potential best-in-class positioning among MEK inhibitors. GRAIL, Inc. (NASDAQ: GRAL), recently announced strong top-line results from the PATHFINDER 2 registrational study evaluating its Galleri® multi-cancer early detection test in over 25,000 adults. "We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial's prevalent screening round," said Josh Ofman, MD, MSHS, President at GRAIL. "We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward." The study showed a substantially higher positive predictive value (PPV) compared to the original PATHFINDER trial, with consistent specificity and cancer signal origin accuracy, and no serious safety concerns reported. GRAIL plans to submit these results to the FDA as part of its ongoing premarket approval process under Breakthrough Device Designation. Intensity Therapeutics, Inc. (NASDAQ: INTS) announced that the first patients in its ongoing Phase 2 INVINCIBLE-4 trial achieved high levels of tumor necrosis within eight days of receiving two doses of INT230-6, before starting standard-of-care immunochemotherapy for triple-negative breast cancer (TNBC). "We are excited to see that INT230-6 is achieving meaningful levels of necrosis in patients with evidence of immune activation," said Lewis H. Bender, President and CEO of Intensity. "TNBC patients risk their lives to achieve a pCR, and about forty percent fail to achieve the desired result." MRI scans showed substantial tumor destruction and inflammation, suggesting immune activation following direct intratumoral injection. The randomized study compares INT230-6 followed by standard treatment versus standard treatment alone, with pathological complete response (pCR) as the primary endpoint. Relay Therapeutics, Inc. (NASDAQ: RLAY) reported updated interim data from its Phase 1/2 study of RLY-2608 plus fulvestrant, showing a median progression-free survival (PFS) of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. "We are encouraged by the consistency of these updated RLY-2608 + fulvestrant data, which continue to show the potential benefit of a mutant-selective PI3Kα inhibitor for improving both the tolerability profile and progression free survival compared to standard of care," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "We look forward to starting the first mutant-selective PI3Kα Phase 3 trial, ReDiscover-2, in the middle of this year." Among patients at the recommended Phase 3 dose, the clinical benefit rate reached 67%, and 39% had confirmed partial responses, with notably higher response rates in those with kinase mutations. The combination maintained a favorable tolerability profile, with low rates of high-grade adverse events and minimal treatment discontinuations. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. 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