Latest news with #PDAC
Toronto Sun
5 days ago
- Politics
- Toronto Sun
Ontario First Nation asks for halt to Ring of Fire mining development
Published Aug 07, 2025 • 1 minute read Ontario Premier Doug Ford speaks at the PDAC mining conference at Toronto's Metro Toronto Convention Centre, Monday March 3, 2025. Photo by Peter J. Thompson / Postmedia An Ontario First Nation that has worked toward road access to the mineral-rich Ring of Fire on its traditional territory is now asking the courts to prevent the provincial and federal governments from mineral development in the region. This advertisement has not loaded yet, but your article continues below. THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLY Subscribe now to read the latest news in your city and across Canada. Unlimited online access to articles from across Canada with one account. Get exclusive access to the Toronto Sun ePaper, an electronic replica of the print edition that you can share, download and comment on. Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. SUBSCRIBE TO UNLOCK MORE ARTICLES Subscribe now to read the latest news in your city and across Canada. Unlimited online access to articles from across Canada with one account. Get exclusive access to the Toronto Sun ePaper, an electronic replica of the print edition that you can share, download and comment on. Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. REGISTER / SIGN IN TO UNLOCK MORE ARTICLES Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account. Share your thoughts and join the conversation in the comments. Enjoy additional articles per month. Get email updates from your favourite authors. THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK. Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account Share your thoughts and join the conversation in the comments Enjoy additional articles per month Get email updates from your favourite authors Don't have an account? Create Account Marten Falls First Nation, located about 400 kilometres northeast of Thunder Bay, has filed a statement of claim asking for interim and permanent injunctions preventing Ontario and Canada from funding or participating in mining-related activities in the Ring of Fire. The claim centres on a series of massive projects between the 1930s and 1950s that the First Nation says diverted river systems on their territory using dams and artificial channels to benefit residents and industry in the southern part of the province and harmed their way of life. The First Nation now worries that a pair of contentious federal and provincial laws known as Bill C-5 and Bill 5 could be used to push through Ring of Fire development, including hydroelectric projects to serve as a power supply, over environmental concerns. Chief Bruce Achneepineskum says his people have seen the ill-effects of development on their territory without their consent, with the water diversion destroying fish populations and drying up canoe routes, and they do not want it to happen again. Marten Falls First Nation has been working on environmental assessments for roads that would both connect its community to the provincial highway system and lead to the Ring of Fire, and an Ontario government spokesperson says in a statement that Marten Falls has shown 'steadfast support' for the Ring of Fire since 2018. Columnists Toronto & GTA Celebrity Basketball Editorial Cartoons
Yahoo
7 days ago
- Business
- Yahoo
Elicio Therapeutics Announces Positive Recommendation by IDMC to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis
The AMPLIFY-7P study of ELI-002 7P successfully passes event-driven interim analysis for efficacy, futility, and safety by the IDMC The Company views the IDMC's positive recommendation as an indication that ELI-002 7P has shown preliminary signals of efficacy Final disease-free survival analysis is anticipated to occur in Q4 2025 Elicio previously reached alignment with the FDA on key elements of the planned pivotal Phase 3 study design The Company's current cash runway extends into Q1 2026, past the anticipated final DFS analysis BOSTON, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, 'Elicio' or the 'Company'), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced that following the Independent Data Monitoring Committee's ('IDMC') pre-specified interim review of the unblinded safety and efficacy data in the Company's Phase 2 AMPLIFY-7P study in mutant KRAS ('mKRAS')-driven pancreatic ductal adenocarcinoma ('PDAC'), the IDMC recommended that the trial continue to the final analysis without modifications. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date. 'We are encouraged by the IDMC's recommendation to support the continuation of the AMPLIFY-7P trial as planned, as we believe it indicates that ELI-002 7P has shown preliminary signals of efficacy. We look forward to the final disease-free survival ('DFS') analysis anticipated to occur in the fourth quarter of 2025 and continue to believe that ELI-002 7P has the potential, based on the compelling data generated to date, to offer a new solution to patients facing PDAC in the adjuvant setting,' said Robert Connelly, Chief Executive Officer of Elicio. 'Importantly, we previously reached alignment with the U.S. Food and Drug Administration ('FDA') on the key elements of the planned pivotal Phase 3 study design, and, upon final DFS analysis, plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study.' The AMPLIFY-7P trial is a 2:1 randomized, open-label, multicenter clinical trial that enrolled 144 patients at 24 U.S. sites to evaluate the effectiveness and safety of ELI-002 7P monotherapy compared to standard of care ('SOC') (observation) to improve DFS in patients with PDAC in the adjuvant setting post local therapy, following surgery, chemotherapy, with or without radiation. Currently, the SOC in this setting is to conduct serial imaging scans to monitor closely for cancer progression. ELI-002 7P treatment consists of six doses, followed by an observation period of eight weeks, and followed with four additional booster doses. PDAC is an aggressive cancer with a five-year survival rate of 13% and is projected to become the second leading cause of cancer death in the U.S. by 2030. ELI-002 7P is an investigational, off-the-shelf, immunotherapy vaccine administered by subcutaneous injection targeting seven KRAS mutations in 88% of PDAC patients and 25% of all solid tumors. The Company remains blinded to the trial clinical efficacy outcomes. Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical successes in the personalized cancer vaccine space to develop effective, off-the-shelf vaccines. Elicio's Amphiphile ('AMP') technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio's ELI-002 lead program is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf vaccine approaches have the potential benefits of low cost, rapid commercial scale manufacturing, and rapid availability of drug to patients especially in neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized vaccines approaches. ELI-002 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer ('CRC') in Phase 1 studies. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, Elicio plans to expand ELI-002 to other indications including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio's pipeline includes additional off-the-shelf therapeutic cancer vaccines candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit About ELI-002 Elicio's lead product candidate, ELI-002, is a structurally novel investigational AMP cancer vaccine that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio's AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration. ELI-002 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002. About the Amphiphile Platform Elicio's proprietary AMP platform delivers investigational immunotherapeutics directly to the 'brain center' of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies. Elicio's AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships. The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. Cautionary Note on Forward-Looking Statements Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding the sufficiency of Elicio's existing cash and cash equivalents to support operations into the first quarter of 2026, beyond the anticipated AMPLIFY-7P Phase 2 final DFS analysis expected in the fourth quarter of 2025; Elicio's planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected final DFS analysis of the Phase 2 AMPLIFY-7P clinical trial anticipated in the fourth quarter of 2025; the potential efficacy of Elicio's product candidates, including ELI-002 7P; the potential of Elicio's product candidates, including ELI-002, to offer a new solution to patients facing PDAC in the adjuvant setting; Elicio's plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study and the potential outcome of such meeting, if granted; the potential for future expansion of ELI-002 to other indications, including in combination regimens for PDAC and colorectal cancer; the potential benefits and effectiveness of off-the-shelf vaccine approaches; and other statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as 'anticipates,' 'believes,' 'plans,' 'expects,' 'projects,' 'future,' 'intends,' 'may,' 'will,' 'should,' 'could,' 'estimates,' 'predicts,' 'potential,' 'continue,' 'guidance,' and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio's financial condition, including its anticipated cash runway, and ability to obtain the funding necessary to advance the development of ELI-002 and any other future product candidates, and Elicio's ability to continue as a going concern; Elicio's plans to develop and commercialize its product candidates, including ELI-002; the timing of initiation of Elicio's planned clinical trials; the timing of the availability of data from Elicio's clinical trials, including the final DFS analysis from the Phase 2 AMPLIFY-7P trial expected in the fourth quarter of 2025; the timing of any planned investigational new drug application or new drug application; Elicio's plans to research, develop and commercialize its current and future product candidates; and Elicio's estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed under the heading 'Risk Factors' in Elicio's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC filed with the SEC on May 13, 2025, as updated by subsequent reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law. Investor Relations ContactBrian RitchieLifeSci Advisors(212) 915-2578britchie@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Mercury
31-07-2025
- Business
- Mercury
Quarterlies: Canadian activity continuing
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. Canada is rich in critical minerals, sought after for essential high-tech applications Government has made moves to boost investment in resources Australian companies have been progressing resource projects in the country Canada is well known for its mineral riches including sought-after rare earths, uranium, lithium and other critical minerals essential for running the modern economy. While the Trump administration continues to slap trade tariffs on friend and foe alike, Canada's proximity makes it infinitely valuable as a potential source of critical minerals with which to build supply chains that are independent of Chinese influence. This potential has been clearly recognised by the Canadian federal and provincial/territorial governments as evidenced by the Canadian Northern Economic Development Agency (CanNor) introducing a C$420,000 investment at the PDAC conference earlier this year to facilitate promotional efforts by the territorial governments of Yukon, Northwest Territories and Nunavut. Other steps include the removal of interprovincial trade barriers, streamlined project approvals through a new 'One Project, One Review' framework, the creation of a 'First Mile Fund' to boost early-stage investment, improved labour mobility across provinces and increased participation by indigenous communities. Here are some ASX juniors progressing their resource projects in Canada… During the June 2025 quarter, a power study completed by global engineering consultancy firm Hatch identified and quantified technical solutions for the supply of 100% renewable energy for the Iron Bear mining and concentrator complex and the adjacent city of Schefferville. This evaluated three staged power supply scenarios including with the first phase providing 120 megawatts for a concentrator complex with an operating capacity of 10Mtpa, Phase 2 providing 250MW for a 25Mtpa concentrator, and Phase 3 providing 500MW for a 50Mtpa concentrator. Phase 1 could be powered by a new 60MW hydropower plant at Menihek and a new 280MW windfarm. This will be supplemented by a 10MWh battery energy storage system and two 315 kilovolt power lines connected to the Churchill Falls hydroplant in Phase 2. A third power line from Churchill Falls will help meet energy requirements for Phase 3. Cyclone has also progressed the engineering workstreams for the scoping study and rail study, both of which are currently under review. Additionally, the company has completed Phase 4 of the metallurgical testwork, which confirmed the ability to produce a direct reduction concentrate grading 71% iron, a blast furnace concentrate at 69.1% iron and direct reduction pellets grading 68.4% iron. Critical flotation optimisation testwork also delivered recoveries of up to 89% mass yield, substantially higher than the previous 80% mass yield, while the first stage of terrestrial and hydrology field surveys in and around the Iron Bear project area have been completed. Meanwhile, assays from maiden drilling at the Danvers prospect within White Cliff's Rae project in Nunavut, have confirmed and validated the strategy to explore previously untested high-grade zones and vertical depth extension of mineralisation. All drillholes intersected significant mineralisation with notable results including 90m at 4% copper and 7.5g/t silver from surface and 58m at 3.08% copper and 13.3g/t silver from 52m. This led to the definition of Danvers as a 150m-long, thick and vertical, rectangular shaped structure with mineralisation from surface that is open both to the north and south. The company will start updating the historical non-JORC resource at Danvers to 2012 standards while further drilling will now focus on testing for mineralisation along a total of ±10km of prospective structure in both directions. White Cliff has also raised $12.4m using 'flow-through' provisions under Canadian tax law while its shares have commenced trading on the OTCQB Venture Market. During the quarter, Loyal Metals changed its name from Loyal Lithium to reflect its 'Ground to Grid' strategy to broaden its critical minerals and technology portfolio beyond hard rock lithium. It is also progressed evaluation of advancement strategies for each of its three North American lithium assets to maximise return and minimise shareholder dilution. These include the Hidden Lake lithium project in the North West Territories and the Trieste lithium project in Quebec. Trieste covers ~250km2 and hosts eight lithium mineralised pegmatite dykes that are notable for spodumene mega crystals, that predominantly occur within metasediments. A 3D model developed with the aid of mobile magnetotellurics highlighted three distinct high-resistivity metasediment-hosted trends extending over 300m below the surface. Geologists from the Quebec government are planning a structural geology study at the Trieste site to assess regional mineralization controls and potential lithium-bearing pegmatites. Hidden Lake is 65km from the mining city of Yellowknife and has a regional resource of 50.4Mt at 1% Li2O. It hosts seven mineralised spodumene dykes that span 3,250m, four of which have been drill tested to depths of 30-50m with all holes intersecting high-grade spodumene pegmatite intervals. During the June 2025 quarter, a Plan of Survey was started in preparation for conversion to mineral leases. During the June 2025 quarter, GT1 completed a $3.46m capital raising to support ongoing project development and submitted an application for Round 2 CMIF funding of C$5.5m to support indigenous consultation, further studies and early engineering works at its Seymour and Root lithium projects. Adding interest, EcoPro Innovation completed at its South Korean facility pilot lithium conversion testing of spodumene concentrate sourced from its Seymour project in Ontario, Canada. GT1 is carrying out a strategic review of its broader exploration portfolio after discovering a substantial rubidium resource at Seymour. It also submitted two additional mining lease applications during the quarter that complement the existing lease covering the core development area at Seymour. At Stockhead, we tell it like it is. While Cyclone Metals, White Cliff Minerals, Loyal Metals and Green Technology Metals are Stockhead advertisers, they did not sponsor this article. Originally published as ASX Resources Quarterly Wrap: These ASX plays are thriving in Canada
Time of India
24-07-2025
- Health
- Time of India
US Scientists discover new early warning sign for deadly pancreatic cancer
With 508,533 new cases and 505,752 deaths worldwide in 2021, pancreatic cancer remains a significant global health challenge with increasing incidence and mortality rates. Pancreatic cancer is often considered deadly due to its tendency to be diagnosed at a late stage, its aggressive nature, and the lack of effective treatments for advanced cases. However, may soon gain a powerful new ally in the battle against this cancer: a biological 'early warning' system that can signal the presence of precancerous pancreatic cells. Researchers at the University of California, San Diego, have uncovered a crucial link between inflammation, cellular stress, and the development of pancreatic ductal adenocarcinoma (PDAC), the most common and aggressive type of pancreatic cancer. What is pancreatic cancer? Pancreatic cancer is a disease in which malignant (cancerous) cells form in the tissues of the pancreas. The pancreas is a gland located behind the stomach that plays a crucial role in digestion and blood sugar regulation by producing enzymes and hormones. While the exact causes are not always clear, risk factors include smoking, family history of pancreatic cancer, long-standing type 2 diabetes, and chronic pancreatitis. Pancreatic cancer is often difficult to diagnose early because symptoms may be subtle or absent in the early stages. The deadliness of PDAC Pancreatic ductal adenocarcinoma (PDAC) originates in the small ducts of the pancreas and carries an incredibly grim prognosis. The average five-year survival rate is less than 10%. According to 2023 estimates, over 62,000 new cases of pancreatic cancer were diagnosed in the US alone. Because it usually shows no symptoms in early stages, PDAC is typically detected only after it has spread, making it hard to treat and nearly impossible to cure. Scientists have long known that inflammation and cellular stress are involved in the growth and spread of pancreatic cancer. But the exact mechanism remained unclear until now. The silver lining In a new study, the UC San Diego team focused on a protein called STAT3 (signal transducer and activator of transcription 3), which is activated under stressful or inflammatory conditions in the body. Once turned on, STAT3 triggers a chain of biological reactions that help tumors grow, adapt, resist treatment, and spread. David Cheresh, a pathologist and co-author of the study, told Newsweek, 'Given the fact that STAT3 plays such an important role in many cancers and the fact that it controls so many genes prompted us to drill down on which genes in particular are associated with cancer development, progression, and drug resistance.' The team also discovered that under low oxygen conditions and inflammation, both common in cancer, STAT3 activates a gene called Integrin β3 (ITGB3) in pancreas cells. This gene speeds up tumor growth and helps cancer spread faster. Even more concerning, they found that common treatments like chemotherapy can also trigger STAT3, which may explain why some tumors become resistant over time. However, the good news is, when researchers blocked STAT3's pathway, they were able to delay the development of tumors, offering a potential new direction for future therapies. The STRESS UP gene signature Through this work, the scientists identified 10 genes, including ITGB3, that STAT3 turns on during stress. Together, they form what the team calls the "STRESS UP" signature, a genetic fingerprint of precancerous activity. As per Cheresh, 'A significant number of patients are what we refer to as 'inducible' for these STRESS UP genes, including ITGB3.' But why is that important? Because it could help doctors predict which patients are likely to develop pancreatic cancer and how aggressive that cancer might become. It could also help determine who is more likely to respond to current treatments. Cheresh added, 'Having knowledge of this gene signature in patients could be valuable since there are known drugs on the market for other diseases that block STAT3 activation and thereby inhibit the expression of the STRESS UP genes in cancer cells.' The importance of early detection (and personalized treatment) The research suggests that STRESS UP could play a role at every stage of pancreatic cancer, from the earliest precancerous lesions to fully drug-resistant tumors and even those that have spread to other organs. According to Cheresh, 'We observed that the STRESS UP gene signature is linked to various critical stages of cancer development including: tumor initiation as precancerous lesions develop into actual tumors, as tumors develop drug resistance, and as tumors develop an invasive or metastatic behavior [when cancer spreads].' The researchers are now examining each of the 10 genes in the STRESS UP signature more closely to develop targeted therapies. One such therapy is already in early clinical trials for patients with drug-resistant cancers. Cheresh explained, 'We are now examining each of these STRESS UP genes for their specific role in the development and progression of cancer with the hope that new specific therapies can be developed. We already have one such therapeutic just now entering clinical trials for patients with drug-resistant cancers.' World Lung Cancer Day 2024: Combating The Deadly Disease With Advanced Treatments
Business Wire
24-07-2025
- Business
- Business Wire
Verastem Oncology Granted Fast Track Designation for VS-7375 for the Treatment of KRAS G12D-mutated Locally Advanced or Metastatic Pancreatic Cancer
BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy. Fast Track is a process designed to facilitate the development and expedite the review of new drugs intended to treat or prevent serious conditions and address unmet medical needs. 'The Fast Track Designation for VS-7375 underscores the importance of our potential best-in-class KRAS G12D (ON/OFF) inhibitor. As we continue enrollment in our U.S. Phase 1/2a clinical trial, our goal is to accelerate the program's development given the lack of FDA-approved, KRAS G12D-targeted treatments for people living with KRAS G12D cancers,' said Dan Paterson, president and chief executive officer of Verastem Oncology. 'Given the encouraging initial safety and efficacy results in China reported by our partner, GenFleet Therapeutics, at ASCO this year, we are excited to be advancing VS-7375 in the U.S. to evaluate it in advanced pancreatic cancer and non-small cell lung cancer and in combination with cetuximab in advanced solid tumors, including colorectal cancer.' VS-7375-101 is a Phase 1/2a study being conducted in the U.S., with plans to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors, including PDAC. The monotherapy dose escalation phase of the study started at a 400mg QD dose based on an efficacious dose identified in the Phase 1/2 study conducted in China by the Company's partner, GenFleet Therapeutics. GenFleet announced encouraging initial safety and efficacy results from its Phase 1 dose-escalation phase of its study of VS-7375 (known as GFH375 in China) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Verastem plans to dose-escalate across dose levels where encouraging initial safety and efficacy were observed in patients with advanced KRAS G12D mutant solid tumor cancers in GenFleet's study. Upon successful completion of the dose-escalation phase, the Company will select a recommended Phase 2 dose and assess the efficacy and safety of monotherapy VS-7375 in expansion cohorts of patients with advanced pancreatic cancer and non-small cell lung cancer. In parallel with the monotherapy dose escalation, Verastem will evaluate VS-7375 in combination with cetuximab in advanced solid tumors. Subject to the results of the Phase 1 dose escalation combination of VS-7375 and cetuximab, Verastem plans to initiate a combination expansion cohort in colorectal cancer. About KRAS G12D KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer. About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and initiated a Phase 1/2a clinical trial in June 2025. GenFleet's IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024. About the GenFleet Therapeutics Collaboration The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. Verastem selected VS-7375 (also known as GFH375), an oral KRAS G12D (ON/OFF) inhibitor, as its lead program in December 2023 and the license for VS-7375 that was exercised in January 2025 is the first one from this collaboration. These licenses give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI™ FAKZYNJA™ CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit and follow us on LinkedIn. Forward-Looking Statements Notice This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as 'anticipate,' 'expect,' 'plan,' 'could,' 'may,' 'believe,' 'estimate,' 'forecast,' 'goal,' 'project,' and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology's programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the expected outcome and benefits of the Company's collaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of commencing and completing trials and compiling data, the expected timing of the presentation of data by the Company and the potential clinical value of various of the Company's clinical trials. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the uncertainties inherent in research and development, such as the possibility of negative or unexpected results of clinical trials; that we may not see a return on investment on the payments we have and may continue to make pursuant to the collaboration and option agreement with GenFleet, or that GenFleet may fail to fully perform under the agreement; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that data may not be available when expected; the risk that our preliminary and interim data may not be representative of more mature data; uncertainties related to the recent change in the U.S. presidential administration, including regulatory and policy changes that may adversely affect our business; that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients; and the risks identified under the heading "Risk Factors" as detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (SEC) on March 20, 2025, as well as the other information we file with the SEC, are possibly realized. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
