BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors), MEK inhibitors(Dual specificity mitogen-activated protein kinase kinase inhibitors)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases+ [9]

Active Indication

Ovarian Serous TumorMesonephromaEndometrial Carcinoma+ [26]

Inactive Indication-

Originator Organization

F. Hoffmann-La Roche Ltd.

Active Organization

Verastem, Inc.

Chugai Pharmaceutical Co., Ltd.

Eli Lilly & Co.

+ [1]

Inactive Organization

Hoffmann-La Roche, Inc.

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US)

Structure

Molecular FormulaC21H18FN5O5S

InChIKeyLMMJFBMMJUMSJS-UHFFFAOYSA-N

CAS Registry946128-88-7

Clinical Trials associated with Avutometinib

NCT06369259 / Not yet recruitingPhase 2IIT

Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer

To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.

Start Date31 Oct 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT06394804 / RecruitingPhase 2IIT

Combination Targeted and Hormonal treAtMEnt of Low-gradE Serous Ovarian Cancer in the upfroNt Setting

The researchers are doing this study to find out whether the combination of avutometinib, defactinib, and letrozole is an effective treatment for people with low-grade serous ovarian cancer (LGSOC). The researchers will also look at the safety of this combination.

Start Date29 Apr 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT06072781 / RecruitingPhase 3

A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

Start Date18 Mar 2024

Sponsor / Collaborator

Verastem, Inc.

[+2]

100 Clinical Results associated with Avutometinib

100 Translational Medicine associated with Avutometinib

100 Patents (Medical) associated with Avutometinib

Literatures (Medical) associated with Avutometinib

01 Aug 2022·Pharmacology & therapeutics

“RB-reactivator screening” as a novel cell-based assay for discoveries of molecular targeting agents including the first-in-class MEK inhibitor trametinib (trade name: Mekinist)

Review

Author: Sakai, Toshiyuki

The retinoblastoma gene (RB) was discovered as the first tumor-suppressor gene. It was subsequently shown to be inactivated in most malignant tumors, particularly at the protein level. Therefore, many activated oncogenes as well as inactivated tumor-suppressor genes inactivate the function of the RB protein. I hypothesized that most of the molecular-targeting agents against activated oncogenes may reactivate the function of RB, and proposed screening systems for agents up-regulating the expression of cyclin-dependent kinase inhibitors, such as p15, p27, and p21, which convert the phosphorylated inactive form of the RB protein to the unphosphorylated active form. I termed this screening as "RB-reactivator screening". Using the screening systems for agents that up-regulate the expression of p15, p27, and p21, we discovered the novel MEK inhibitor trametinib, the novel RAF/MEK inhibitor CH5126766/RO5126766/VS-6766, and the histone deacetylase inhibitor YM753/OBP-801, respectively. Trametinib exerted remarkable effects in patients with advanced BRAF mutant melanoma, and was approved in the USA as the first-in-class MEK inhibitor (trade name: Mekinist) in 2013. The British Pharmacological Society selected trametinib as the Drug Discovery of the Year in 2013. The combination of trametinib and the BRAF inhibitor dabrafenib was approved for advanced BRAF mutant melanoma in the USA, EU, Japan, and many other countries. Additionally, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the combination of trametinib and dabrafenib in the treatment of patients with advanced BRAF mutant non-small cell lung cancer in 2015, and this combination was subsequently approved in the EU, USA, and Japan. In 2018, this combination was also approved for locally advanced or metastatic BRAF V600-mutant anaplastic thyroid cancer in the USA after it had been granted Breakthrough Therapy Designation by the FDA. I describe here the characterization of our original screening system, RB-reactivator screening, by which these three molecular-targeting agents that advanced into clinical trials were identified.

01 May 2022·Future oncology (London, England)Q4 · MEDICINE

Single agent VS-6766 or VS-6766 plus defactinib inKRAS-mutant non-small-cell lung cancer: the RAMP-202 phase II trial

Q4 · MEDICINE

Article

Author: Novello, Silvia ; Koustenis, Andrew ; Bungaro, Maristella ; Denis, Louis ; Bironzo, Paolo ; Capelletto, Enrica

KRAS mutations occur in approximately 30% of lung adenocarcinomas, mainly in codon 12 (83% of cases), p.G12C being the prevalent one (40%), followed by p.G12V and p.G12D (22 and 16%, respectively). Treatment options for advanced KRAS mutant non-small-cell lung cancer ( KRAS-MT NSCLC) are limited to chemotherapy and immune checkpoint inhibitors (CPIs). However, clinical trials exploring specific targeted agents are expected to change the treatment landscape of this disease. Here, we describe the design and scientific rationale of the randomized, phase II, open label, RAMP-202 study, which will evaluate the efficacy and safety of VS-6766 versus VS-6766 in combination with defactinib in advanced KRAS-MT NSCLC patients after failure of prior platinum-based chemotherapy and CPI.

01 Oct 2021·Cancer science

Novel RAF/MEK inhibitor CH5126766/VS‐6766 has efficacy in combination with eribulin for the treatment of triple‐negative breast cancer

Article

Author: Horinaka, Mano ; Nishimoto, Emi ; Yasuda, Shusuke ; Konishi, Eiichi ; Sukeno, Mamiko ; Morita, Mie ; Sakai, Toshiyuki ; Ono, Hisako

Abstract:

Various molecular‐targeting drugs have markedly improved the treatment of patients with breast cancer. As yet, therapies for triple‐negative breast cancer are mainly cytotoxic agents. To investigate the novel therapy for triple‐negative breast cancer, we herein examined the effects of a new combination therapy comprising a RAF/MEK inhibitor CH5126766, also known as VS‐6766, which we originally discovered, and eribulin. The combination of CH5126766 and eribulin potently inhibited cell growth in the triple‐negative breast cancer cell lines tested. The underlying mechanism in the efficacy of this combination treatment in vitro and in vivo was due to enhanced apoptosis through the suppression of survivin and Bcl‐2 family proteins. We also showed the suppressed expression of programmed cell death ligand 1 (PD‐L1) in combination therapy in vivo. We found that combination therapy with eribulin and CH5126766 for triple‐negative breast cancer inhibited cell growth by apoptosis and raised a possibility that immune responses through suppression of PD‐L1 might partially contribute to inhibition of tumor growth, indicating the potential of this combination as a novel strategy for triple‐negative breast cancer.

News (Medical) associated with Avutometinib

01 Jul 2024

·www.biospace.com

Verastem Oncology Announces Addition to Russell 3000® and Russell Microcap® Indexes

BOSTON--(BUSINESS WIRE)-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that in connection with the 2024 Russell U.S. Indexes annual reconstitution, the company will be added to the Russell 3000® and Russell Microcap® Indexes, effective at the open of U.S. equity markets today, Monday, July 1, 2024. “The recognition and increased exposure of being added to the Russell Indexes underscore the recent progress we’ve made across our pipeline, which includes bringing avutometinib in combination with defactinib one step closer to being a potential new treatment option for patients with recurrent low-grade serous ovarian cancer in the U.S.,” said Dan Paterson, president and chief executive officer of Verastem Oncology. “We remain on track to announce mature data from RAMP 201 and complete our rolling NDA submission in the second half of 2024 while advancing our other clinical programs in metastatic pancreatic cancer and non-small cell lung cancer. Now that GenFleet has initiated the Phase 1/2 clinical trial in China for GFH375/VS-7375, a potent and selective oral KRAS G12D (ON/OFF) inhibitor, we look forward to leveraging this data to accelerate a path forward in the U.S. and rest of world.” The annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of Thursday, April 30, 2024, ranking them by total market capitalization. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. According to the data as of the end of December 2023, about $10.5 trillion assets are benchmarked against the Russell U.S. indexes, which belong to FTSE Russell, a prominent global index provider. For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section of the FTSE Russell website. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. Our pipeline is focused on RAS/MAPK-driven cancers, specifically novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition and FAK inhibition. For more information, please visit and follow us on LinkedIn. About FTSE Russell FTSE Russell is a leading global provider of benchmarking, analytics, and data solutions for investors, giving them a precise view of the market relevant to their investment process. A comprehensive range of reliable and accurate indexes provides investors worldwide with the tools they require to measure and benchmark markets across asset classes, styles, or strategies. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products, and index-based derivatives. FTSE Russell is focused on applying the highest industry standards in index design and governance, employing transparent rules-based methodology informed by independent committees of leading market participants. FTSE Russell fully embraces the IOSCO Principles, and its Statement of Compliance has received independent assurance. Index innovation is driven by client needs and customer partnerships, allowing FTSE Russell to continually enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit . Forward Looking Statements This press release includes forward-looking statements about, among other things, Verastem Oncology’s programs and product candidates, strategy, future plans and prospects, including statements related to the impact of the company’s addition to the Russell 3000® and Russell Microcap® Indexes, the expected outcome and benefits of collaborations, including with GenFleet Therapeutics (Shanghai), Inc. (“GenFleet”), the timing of commencing and completing trials, including topline data reports, interactions with regulators, the potential for the commercialization of product candidates and potential for additional development programs involving Verastem Oncology’s lead compound. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "can, " "promising" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks and uncertainties, among other things, regarding: the success in the development and potential commercialization of our product candidates, including avutometinib in combination with other compounds, including defactinib, LUMAKRAS and others; the uncertainties inherent in research and development, such as negative or unexpected results of clinical trials, the occurrence or timing of applications for our product candidates that may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed for our product candidates, and, if approved, whether our product candidates will be commercially successful in such jurisdictions; our ability to obtain, maintain and enforce patent and other intellectual property protection for our product candidates; the scope, timing, and outcome of any legal proceedings; decisions by regulatory authorities regarding trial design, labeling and other matters that could affect the timing, availability or commercial potential of our product candidates; whether preclinical testing of our product candidates and preliminary or interim data from clinical trials will be predictive of the results or success of ongoing or later clinical trials; that the timing, scope and rate of reimbursement for our product candidates is uncertain; the market opportunities of our drug candidates are based on internal and third-party estimates which may prove to be incorrect; that third-party payors (including government agencies) may not reimburse; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected, which may delay our development programs, including delays in submission or review by the FDA of our NDA submission in recurrent KRAS mutant LGSOC if enrollment in our confirmatory trial is not well underway at the time of submission; that our product candidates will cause adverse safety events and/or unexpected concerns may arise from additional data or analysis, or result in unmanageable safety profiles as compared to their levels of efficacy; that we maybe unable to successfully validate, develop and obtain regulatory approval for companion diagnostic tests for our product candidates that require or would commercially benefit from such tests, or experience significant delays in doing so; that the mature RAMP 201 data and associated discussions with the FDA may not support the scope of our rolling NDA submission for the avutometinib and defactinib combination in LGSOC, including with respect to KRAS wild type LGSOC; that our product candidates may experience manufacturing or supply interruptions or failures; that any of our third-party contract research organizations, contract manufacturing organizations, clinical sites, or contractors, among others, who we rely on fail to fully perform; that we face substantial competition, which may result in others developing or commercializing products before or more successfully than we do which could result in reduced market share or market potential for our product candidates; that we will be unable to successfully initiate or complete the clinical development and eventual commercialization of our product candidates; that the development and commercialization of our product candidates will take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that we may not have sufficient cash to fund our contemplated operations , including certain of our product development programs; that we may not attract and retain high quality personnel; that we or Chugai Pharmaceutical Co., Ltd. will fail to fully perform under the avutometinib license agreement; that our total addressable and target markets for our product candidates might be smaller than we are presently estimating; that Secura Bio, Inc. will fail to fully perform under the asset purchase agreement with Secura Bio, Inc., including in relation to milestone payments; that we will 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 will fail to fully perform under the agreement; that we may not be able to establish new or expand on existing collaborations or partnerships, including with respect to in-licensing of our product candidates, on favorable terms, or at all; that we may be unable to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity, debt financing or otherwise; that we will not pursue or submit regulatory filings for our product candidates; and that our product candidates will not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients. As a result of these and other factors, we may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Other risks and uncertainties include those identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (SEC) on March 14, 2024, and in any subsequent filings with the SEC, which are available at and .

12 Jun 2024

·www.prnewswire.com

Pancreatic Cancer on the Rise: How Biotech Firms are Developing Groundbreaking Treatments

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2024 /PRNewswire/ -- After looking at public health records for 3.8 million patients with invasive spreading cancer, researchers recently discovered that Generation X may be experiencing larger per-capita increases in the incidence of leading cancers, including the very deadly pancreatic cancer, compared to previous generations. The startling revelations come from a study conducted by experts at the National Cancer Institute's Division of Epidemiology and Genetics and was published in JAMA Network Open. Compared with baby boomers, Gen X women had projected increases in pancreatic, thyroid, kidney, rectal, uterine, colon, and ovarian cancers, as well as non-Hodgkin's lymphoma and leukemia. Among those, pancreatic cancer is generally considered the deadliest, with its very low five-year survival rate, typically late diagnosis, and aggressive nature. In order to significantly enhance patient health outcomes, several biotech developers are actively working on innovative solutions, including recent developments coming from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Verastem, Inc. (NASDAQ: VSTM), Candel Therapeutics, Inc. (NASDAQ: CADL), FibroGen, Inc. (NASDAQ: FGEN), and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN). Presented recently at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented two abstracts related to their novel immunotherapy, pelareorep, an intravenously delivered immunotherapeutic agent. One of the abstracts presented was a trial-in-progress for cohort 5 of the GOBLET study. This cohort will examine the effectiveness of combining pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab —made by Roche Holding AG (OTCQX: RHHBY)— in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The cohort is funded by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN). Oncolytics Biotech expects to begin enrollment for this cohort this quarter, having received regulatory clearance to begin the enrollment process in May. "The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company's pancreatic cancer program," said Dr. Matt Coffey, President and CEO of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy." The GOBLET cohort 5 abstract and poster outline a study evaluating new treatments for patients with newly diagnosed metastatic PDAC using a Simon two-stage design. This design helps determine if a treatment is promising enough to continue testing. In the first stage, 15 patients in each treatment arm will be randomly assigned to receive either pelareorep with mFOLFIRINOX or pelareorep with mFOLFIRINOX and atezolizumab. The main goals are to measure how well the treatments work and their safety. Additionally, the study will look at progression-free survival (how long patients live without the cancer getting worse), overall survival (how long patients live overall), and biomarkers (indicators of how the body responds to the treatment). If the first stage is successful, one or both groups may proceed to Stage 2, which will include 17 more patients per treatment arm. Blood and tumor samples will be collected for further analysis throughout the study. Also presented at ASCO's meeting were positive initial interim safety and efficacy results from Verastem, Inc. (NASDAQ: VSTM) in an ongoing Phase 1/2 trial evaluating its avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel for first-line treatment in patients with metastatic pancreatic cancer. Like Oncolytics' pelareorep, Verastem's avutometinib received funding from PanCAN through its Therapeutic Accelerator Award. " Verastem was the inaugural recipient of the PanCAN Therapeutic Accelerator Award, which has been an important part of PanCAN's approach to advancing innovative treatments for pancreatic cancer," said Anna Berkenblit, M.D., MMSc, Chief Scientific and Medical Officer at PanCAN. "There is a critical need for new treatment options in this disease, and we hope that the results from this study lead to improved outcomes for patients with pancreatic cancer." As of May 14, 2024, Verastem reported that patients receiving the combination therapy achieved a confirmed overall response rate (ORR) of 83%, with 5 out of 6 patients responding positively. The release of these results led to a positive market reaction, boosting Verastem's shares in pre-market trading in the process. Notably, there was one case of dose-limiting toxicity (febrile neutropenia) in the dose level 1 cohort. However, this dose level was cleared after enrolling additional patients in three other cohorts of the study. "The initial interim results from the RAMP 205 trial evaluating avutometinib and defactinib in combination with standard of care first-line chemotherapy are encouraging and demonstrate the importance of targeting the RAS/MAPK pathway, as more than 90% of pancreatic tumors have a KRAS mutation," said John Hayslip, M.D., Chief Medical Officer of Verastem Oncology. "We continue to progress the study evaluating other dose and schedule regimens to determine the recommended Phase 2 dose in the trial." In another recent update, Candel Therapeutics, Inc. (NASDAQ: CADL) reported "very encouraging results" from its phase 2 clinical trial of CAN-2409, which targets borderline resectable pancreatic cancer. The data showed that patients treated with CAN-2409 had an estimated median overall survival of 28.8 months, compared to just 12.5 months for the control group. Furthermore, at 24 months, the survival rate was 71.4% for those treated with CAN-2409, whereas the control group had a survival rate of only 16.7% following chemoradiation. "Given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed," said Garrett Nichols, MD, MS, Chief Medical Officer of Candel. "We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to SoC chemoradiation." Because pancreatic cancer is considered a solid tumor, news of a joint effort between FibroGen, Inc. (NASDAQ: FGEN) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announcing a supply agreement to evaluate FG-3165 as a monotherapy and in combination with LIBTAYO in patients with select solid tumors is relevant. Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial. Each company retains all rights to their respective compounds, including as a monotherapy or as combination therapies. "We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors," said Deyaa Adib, M.D., Chief Medical Officer of FibroGen. "We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients. We look forward to building a collaborative relationship with Regeneron, who is a leader in oncology therapeutic products development and commercialization." In their Q1 2024 financial results, FibroGen announced several upcoming milestones. The company expects to release topline data from the PanCAN Precision Promise Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer by mid-2024. Additionally, they anticipate delivering topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) in Q3 2024. "Looking ahead, we expect to report topline data from our two late-stage clinical trials of pamrevlumab in pancreatic cancer in the coming months," said Thane Wettig, CEO of FibroGen. Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Clinical ResultPhase 1Phase 2ASCOImmunotherapy

03 Jun 2024

·www.prnewswire.com

Biotech Advances in 2024: Innovative Treatments Aim to Boost Pancreatic Cancer Survival Rates

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 3, 2024 /PRNewswire/ -- USA News Group – Recognized as one of the most lethal cancers, researchers are striving to improve survival rates for pancreatic cancer patients by focusing on earlier detection. According to Johns Hopkins Medicine, up to 80% of patients are diagnosed at advanced stages, which are significantly harder to treat. A new study published in the journal Cell Genomics demonstrates that researchers have identified key protein biomarkers for early detection of pancreatic cancer. Analysts at Towards Healthcare project the pancreatic cancer market to grow at a rate of 13.7% CAGR, hitting US$7.4 billion by 2032. Meanwhile, biotech developers are fervently working on groundbreaking medical treatments to greatly improve patient health outcomes. Recent updates include developments from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Verastem, Inc. (NASDAQ: VSTM), CytomX Therapeutics, Inc. (NASDAQ: CTMX), BioNTech SE (NASDAQ: BNTX), and FibroGen, Inc. (NASDAQ: FGEN). During this year's American Society of Clinical Oncology (ASCO) Annual Meeting, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) highlighted two abstracts related to their novel immunotherapy, pelareorep. Among these was a trial-in-progress abstract for cohort 5 of the GOBLET study. This cohort will explore the effectiveness of combining pelareorep with modified FOLFIRINOX (mFOLFIRINOX), with and without atezolizumab, in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (PDAC). "The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company's pancreatic cancer program," said Dr. Matt Coffey, President and CEO of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy." The cohort is supported by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN). Oncolytics Biotech expects enrollment for this cohort to start this quarter. The GOBLET cohort 5 abstract and poster detail important elements of a study using a Simon two-stage design to assess patients with newly diagnosed metastatic PDAC. In the first stage, 15 evaluable patients per arm are randomly assigned to one of two treatments: pelareorep with mFOLFIRINOX, or pelareorep with mFOLFIRINOX and atezolizumab. The co-primary endpoints of the study are objective response rate and safety. Secondary and exploratory endpoints include further efficacy evaluations, such as progression-free and overall survival, along with biomarker assessments. If the first stage achieves its success criteria, one or both treatment arms may proceed to Stage 2, enrolling an additional 17 evaluable patients per arm. Throughout the study, blood and tumor samples will be collected for translational analyses. Another important ASCO presentation came from Verastem, Inc. (NASDAQ: VSTM), which presented positive initial interim safety and efficacy results from an ongoing Phase 1/2 trial evaluating its avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the first-line in patients with metastatic pancreatic cancer. Like with Oncolytics' pelareorep, Verastem received funding from PanCAN through its Therapeutic Accelerator Award for avutometinib. " Verastem was the inaugural recipient of the PanCAN Therapeutic Accelerator Award, which has been an important part of PanCAN's approach to advancing innovative treatments for pancreatic cancer," said Anna Berkenblit, M.D., MMSc, Chief Scientific and Medical Officer at PanCAN. "There is a critical need for new treatment options in this disease, and we hope that the results from this study lead to improved outcomes for patients with pancreatic cancer." As of May 14, 2024, Verastem states that patients receiving this combination achieved a confirmed overall response rate (ORR) of 83% coming from 5 out of 6 patients. Upon the release of the results, the market responded positively boosting shares in the pharma company in pre-market trading. It should be noted that Verastem reported one dose-limiting toxicity of febrile neutropenia in the dose level 1 cohort, however the dose level was cleared after additional patients were enrolled in three other cohorts of the study. "The initial interim results from the RAMP 205 trial evaluating avutometinib and defactinib in combination with standard of care first-line chemotherapy are encouraging and demonstrate the importance of targeting the RAS/MAPK pathway, as more than 90% of pancreatic tumors have a KRAS mutation," said John Hayslip, M.D., Chief Medical Officer of Verastem Oncology. "We continue to progress the study evaluating other dose and schedule regimens to determine the recommended Phase 2 dose in the trial." Earlier in May, CytomX Therapeutics, Inc. (NASDAQ: CTMX) announced positive initial data from its ongoing Phase 1a dose escalation clinical study for its investigational, masked, conditionally activated PROBODY T-cell engager, CX-904, demonstrating a favorable safety profile and confirmed anti-cancer activity. Within the results, CytomX shared that 2 out of 6 patients (33%) showed a confirmed partial response, and all 6 patients (100%) with disease control in advanced pancreatic cancer. "These data build on more than a decade of innovation at CytomX, and, we believe, open broad new possibilities for T-cell engagers across many targets and cancer types," said Sean McCarthy, D.Phil., CEO and Chairman of CytomX. "We look forward to continuing to explore the potential of this exciting agent in multiple EGFR (epidermal growth factor receptor) positive cancers and to determining longer term strategy with our global development partner, Amgen." Three years after receiving the experimental cancer vaccine in a phase 1 trial from BioNTech SE (NASDAQ: BNTX), patients with pancreatic cancer continue to have T-cell responses. For 8 out of 16 patients with resected PDAC, BioNTech's mRNA vaccine, autogene cevumeran, demonstrated persistence of T cells, which is associated with a longer median recurrence-free survival in cancer vaccine responders. Currently, BioNTech is enrolling patients for a phase 2 trial of the therapy, autogene cevumeran, in combination with atezolizumab and chemotherapy, compared to modified FOLFIRINOX in PDAC patients. "These new data are an early signal for the potential of our individualized mRNA cancer vaccine approach in this indication with an unmet medical need," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "The results indicate that our uridine mRNA-LPX technology can promote activation of cytotoxic T cells that may help to eliminate residual tumor foci at early stages of the disease to delay or prevent recurrence." Later this year, FibroGen, Inc. (NASDAQ: FGEN) expects to deliver important topline data involving its potential first-in-class antibody pamrevlumab for two different types of pancreatic cancer. "Looking ahead, we expect to report topline data from our two late-stage clinical trials of pamrevlumab in pancreatic cancer in the coming months," said Thane Wettig, CEO of FibroGen. Among the upcoming milestones within FibroGen's Q1 2024 financial results, the company said they expect to deliver topline data from the PanCAN Precision Promise Phase 2/3 study of pamrevlumab in metastatic pancreatic in mid-2024, and topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) in Q3 2024. Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Clinical ResultASCOVaccineImmunotherapyPhase 1

100 Deals associated with Avutometinib

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Serous Tumor	NDA/BLA	US	Verastem, Inc.	24 May 2024
Brain metastases	Phase 2	US	Verastem, Inc.	08 Feb 2024
Secondary malignant neoplasm of pancreas	Phase 2	US	Verastem, Inc.	22 Mar 2023
Mesonephroma	Phase 2	US	Verastem, Inc.	15 Mar 2023
Hormone receptor positive breast cancer	Phase 2	US	Verastem, Inc.	23 Feb 2023
Hormone receptor positive breast cancer	Phase 2	US	Eli Lilly & Co.	23 Feb 2023
Hormone receptor positive HER2 negative breast cancer	Phase 2	US	Verastem, Inc.	23 Feb 2023
Hormone receptor positive HER2 negative breast cancer	Phase 2	US	Eli Lilly & Co.	23 Feb 2023
Endometrial Carcinoma	Phase 2	US	Verastem, Inc.	06 Feb 2023
Ovarian Mucinous Adenocarcinoma	Phase 2	US	Verastem, Inc.	06 Feb 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05669482 (RAMP 205, ASCO2024) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	18	Avutometinib/defactinib + gemcitabine/nab-paclitaxel	mitbghgwje(eqlapwhlzs) = aouplheqwp frucissfim (iqsxdpvdls ) View more	Positive	24 May 2024
NCT05074810 (RAMP 203, Corporate Publications) Manual	Phase 1/2	KRAS G12C mutant Non-small Cell Lung Cancer KRAS G12C	-	Avutometinib+sotorasib	exueerfvzg(hcyltvuqhm) = Avutometinib 4.0 mg PO BIW 21/28 days + sotorasib 960 mg PO QD 28/28 days motindwddd (jvnnicafjj )	Positive	14 Oct 2023
NCT04625270 (ENGOT-Ov60/GOG-3052/RAMP 201, ESGO2023)	Phase 2	Ovarian Cancer KRAS mutant \| KRAS wild-type	151	Avutometinib	bhkzwxoyub(thtgcqfqrx) = hpoogpohxd rplqkmddup (dfhwznmyyr ) View more	Positive	27 Sep 2023
				Avutometinib + Defactinib	bhkzwxoyub(thtgcqfqrx) = ejdkkwfbiz rplqkmddup (dfhwznmyyr ) View more
NCT04625270 (RAMP 201, ASCO2023) Manual	Phase 2	Ovarian Cancer	121	avutometinib 4 mg	gipdwlmlrm(iqwokqepzh) = neierelcvv amxbhjjaqq (xzycrkeaho ) View more	Positive	31 May 2023
				avutometinib 3.2 mg+defactinib 200 mg	gipdwlmlrm(iqwokqepzh) = fpnismfhpt amxbhjjaqq (xzycrkeaho ) View more
NCT04620330 (RAMP 202, ASCO2023) Manual	Phase 2	KRAS mutant Non-small Cell Lung Cancer KRAS G12V Mutantion	35	Avutometinib	wckoklrqmr(kfcfpwuhyp) = zqokaoqxbr rkbhgrixpp (doieorlnan )	Negative	26 May 2023
				Defactinib+Avutometinib	wckoklrqmr(kfcfpwuhyp) = awvvyltceh rkbhgrixpp (doieorlnan )
NCT04620330 (RAMP 202, Corporate Publications) Manual	Phase 2	Non-Small Cell Lung Cancer	56	VS-6766+defactinib (KRAS G12V NSCLC)	kleahchdbl(chgahbnyop) = ilidubhcmh lsnxpjmnny (otasujmpgn ) View more	Negative	04 Oct 2022
				VS-6766+defactinib (non-G12V KRAS mutations)	kleahchdbl(chgahbnyop) = xaufdlfxnw lsnxpjmnny (otasujmpgn ) View more
NCT03875820 (AACR2022)	Phase 1	Ovarian Cancer	87	VS-6766 (dual RAF/MEK inhibitor)	oqvpvlgjsh(cjzwoocwms) = qajlskyvlv mypuelavjl (myovogtrmv )	-	15 Jun 2022
				Defactinib (FAK inhibitor)	oqvpvlgjsh(cjzwoocwms) = nklqhsmdol mypuelavjl (myovogtrmv )
NCT02407509 (ASCO2022) Manual	Phase 1	Non-Small Cell Lung Cancer KRAS Mutation	16	everolimus+VS-6766 (dose escalation )	cpoaexkmlz(utyhnlgjsq) = jjekfzawco zeyknqjlad (dxfnlbopwp ) View more	Positive	02 Jun 2022
				everolimus+VS-6766 (KRAS mt NSCLC )	znzowdvgfg(bqdjojqsxn) = igwtiwyzsw aznjtmuvet (kjzvtsqrdh, 3.52 - NR) View more
NCT03875820 (ESMO2021) Manual	Phase 1	Ovarian Cancer	25	VS-6766+defactinib	iuhuoknkiy(vnilmnstbu) = vzqzdkspdr slvvdgfzpa (gtfoznxblx ) View more	Positive	19 Sep 2021
				VS-6766+defactinib (pts with KRAS mutations)	ikupdqhkrh(qprjxuruta) = uvspoxwylz lshbdggpac (ymvlcltyem, 35 - 85)
AACR2021 Manual	Phase 1	KRAS mutation-related tumors KRAS G12V Mutation	19	VS-6766 3.2-4 mg+defactinib 200 mg	zypqbnhwlv(ssexnxeoea) = fkduchjwxw vqvgwbkpbb (smvvworakt ) View more	Positive	10 Apr 2021

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