Pancreatic cancer is a deadly disease and will be the second leading cause of cancer related death behind lung cancer by 2030. Over 62,000 people are diagnosed each year in the United States with about 90% succumbing to the disease within 5 years. In the metastatic setting, NALIRIFOX, FOLFIRINOX and nab-paclitaxel-gemcitabine are standard treatment options in patients with good performance status (Eastern Cooperative Oncology Group [ECOG] 0/1). All three combinations have shown a survival advantage over previously standard gemcitabine-based therapy, with 11.1 months overall survival (OS) for NALIRIFOX/FOLFIRINOX and 8.7 months for nab-paclitaxel-gemcitabine versus 6.7 months for gemcitabine alone. There is an urgent need to improve treatment of patients with current and emerging therapeutic strategies.
KRAS is the most common oncogene mutated in pancreatic adenocarcinoma, and it is mutated in nearly all tumors. Mutant KRAS is essential for PDAC growth, where the constitutive activated RAS proteins contribute to tumorigenesis, treatment resistance, and metastases. Despite research and drug development efforts focused on KRAS, no effective RAS inhibitors have been approved for the treatment of pancreatic cancer with KRAS mutation. The poor prognosis of KRAS-mutated PDAC patients and the absence of KRAS-targeted therapies, highlight the urgency to develop novel therapies aimed at KRAS.
This study will investigate onvansertib (also known as PCM-075 and NMS-1286937) as the first PLK1-specific adenosine triphosphate competitive inhibitor administered by oral route to enter clinical trials with proven antitumor activity in different preclinical models.

Start Date01 Feb 2025

Sponsor / Collaborator

University of Kansas Medical Center

[+1]

NCT06398587

/ WithdrawnPhase 2IIT

An Open-Label, Phase II Trial to Assess Efficacy and Safety of Onvansertib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated, Locally-Advanced or Unresectable Pancreatic Adenocarcinoma

This phase II trial studies how well onvansertib in combination with gemcitabine and nab-paclitaxel works in treating patients with pancreatic ductal carcinoma (PDAC) that has spread to nearby tissue or lymph nodes (locally advanced), that cannot be removed by surgery (unresectable), or that has spread from where it first started (primary site) to other places in the body (metastatic). Onvansertib is a small chemical molecule that binds and stops the function of of PLK1 in tumor cells. By attacking the PLK1 protein, onvansertib is thought to reduce tumor cells ability to replicate and grow; causing them to die. Chemotherapy drugs, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with onvansertib may kill more tumor cells in patients with locally-advanced, unresectable, or metastatic pancreatic ductal carcinoma.

Start Date01 Aug 2024

Sponsor / Collaborator

OHSU Knight Cancer Institute

[+1]

NCT06106308

/ RecruitingPhase 2

A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation

The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.

Start Date27 Feb 2024

Sponsor / Collaborator

Cardiff Oncology, Inc.

[+1]

100 Clinical Results associated with Onvansertib

100 Translational Medicine associated with Onvansertib

100 Patents (Medical) associated with Onvansertib

Literatures (Medical) associated with Onvansertib

01 May 2025·JOURNAL OF MASS SPECTROMETRY

Multi‐Omic Evaluation of PLK1 Inhibitor—Onvansertib—In Colorectal Cancer Spheroids

Article

Author: Holbrook, Joseph H. ; Hummon, Amanda B. ; Sekera, Emily R. ; Fries, Brian D.

ABSTRACT:

Polo‐like kinase 1 (Plk1) is a serine/threonine kinase involved in regulating the cell cycle. It is activated by aurora kinase B along with the cofactors Borealin, INCE, and survivin. Plk1 is involved in the development of resistances to chemotherapeutics such as doxorubicin, Taxol, and gemcitabine. It has been shown that patients with higher levels of Plk1 have lower survival rates. Onvansertib is a competitive ATP inhibitor for Plk1 in clinical trials for the treatment of tumors and has recently entered a trial for the treatment of KRAS mutant colorectal cancers (CRCs). In this study, we conducted an untargeted liquid chromatography–mass spectrometry (LC–MS) proteomics study as well as an untargeted lipidomics analysis of HCT 116 spheroids treated with onvansertib over a 72‐h treatment time‐course experiment. Mass spectrometry imaging (MSI) showed that onvansertib begins to accumulate most prominently after 12 h of treatment and continues to accumulate through 72 h. Proteomic results displayed alterations to cell cycle control proteins and an increasing abundance of aurora kinase B and Borealin. The proteomics data also showed alterations to many lipid metabolism enzymes. The MSI lipidomics data indicated alterations to phosphatidylcholine lipids, with many lipids increasing in abundance over time or increasing until 12 h of onvansertib treatment and decreasing after that time point. In summary, these results suggest that onvansertib is causing cells within the spheroid to halt at a certain phase of the cell cycle in accordance with previous literature. Our findings suggest the S phase is likely interrupted, with observed alterations in cell cycle control proteins and PC lipid abundance.

01 Mar 2025·JOURNAL OF CLINICAL ONCOLOGY

Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS -Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial

Article

Author: Starr, Jason S. ; Kim, Roy ; Lenz, Heinz-Josef ; Smeal, Tod ; Wu, Chu-Chiao ; Subramanian, Ramanand A. ; Croucher, Peter J.P. ; Hubbard, Joleen M. ; Cannon, Timothy L. ; Kasi, Anup ; Karki, Anju ; Kabbinavar, Fairooz F. ; Ahn, Daniel H. ; Barzi, Afsaneh ; Mendelsohn, Lawrence ; Ridinger, Maya ; Yemane, Divora ; Samuëlsz, Errin

PURPOSE:

This phase II study evaluated the efficacy and tolerability of onvansertib, a polo-like kinase 1 (PLK1) inhibitor, in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI) + bevacizumab for the second-line treatment of KRAS -mutant metastatic colorectal cancer (mCRC).

PATIENTS AND METHODS:

This multicenter, open-label, single-arm study enrolled patients with KRAS -mutated mCRC previously treated with oxaliplatin and fluorouracil with or without bevacizumab. Patients received onvansertib (15 mg/m 2 once daily on days 1-5 and 15-19 of a 28-day cycle) and FOLFIRI + bevacizumab (days 1 and 15). The primary end point was the objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), duration of response (DOR), and tolerability. Translational and preclinical studies were conducted in KRAS -mutant CRC.

RESULTS:

Among the 53 patients treated, the confirmed ORR was 26.4% (95% CI, 15.3 to 40.3). The median DOR was 11.7 months (95% CI, 9.4 to not reached). Grade 3/4 adverse events were reported in 62% of patients. A post hoc analysis revealed that patients with no prior bevacizumab treatment had a significantly higher ORR and longer PFS compared with patients with prior bevacizumab treatment: ORR of 76.9% versus 10.0% (odds ratio of 30.0, P < .001) and median PFS of 14.9 months versus 6.6 months (hazard ratio of 0.16, P < .001). Our translational findings support that prior bevacizumab exposure contributes to onvansertib resistance. Preclinically, we showed that onvansertib inhibited the hypoxia pathway and exhibited robust antitumor activity in combination with bevacizumab through the inhibition of angiogenesis.

CONCLUSION:

Onvansertib in combination with FOLFIRI + bevacizumab showed significant activity in the second-line treatment of patients with KRAS -mutant mCRC, particularly in patients with no prior bevacizumab treatment. These findings led to the evaluation of the combination in the first-line setting (ClinicalTrails.gov identifier: NCT06106308 ).

01 Jan 2025·JOURNAL OF CLINICAL ONCOLOGY

Erratum: Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial

Article

News (Medical) associated with Onvansertib

08 Mar 2025

·www.prnewswire.com

Why the Global Cancer Market Could Surpass $900 Billion--And the Stocks Leading the Charge

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, March 8, 2025 /PRNewswire/ -- As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights. Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to the World Health Organization (WHO), breast cancer cases are projected to rise by nearly 40% by 2050. Despite the concerning trends in cancer incidence, 2025 has seen key advancements from biotech companies at the forefront of oncology research, with Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Exelixis, Inc. (NASDAQ: EXEL), Cardiff Oncology, Inc. (NASDAQ: CRDF), ALX Oncology Holdings Inc. (NASDAQ: ALXO), and Verastem, Inc. (NASDAQ: VSTM) continuing to push the boundaries of cancer treatment. Continue Reading Pelareorep Facts (PRNewsfoto/USA News Group) The article continued: Within a new research report on the Global Oncology Market from Vision Research Reports, cancer therapies are projected to surpass US$903.81 billion by 2034, growing at a 10.9% CAGR along the way. The World Economic Forum is optimistic, recently touting 12 new breakthroughs in the fight against cancer. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, has just released its Q4 and full-year 2024 financial results, providing investors with a clearer picture of its progress as it moves toward potential future FDA approvals for its lead drug, pelareorep, a promising immunotherapy designed to help the immune system recognize and destroy cancer cells more effectively. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." The data mentioned by Pisano from BRACELET-1 showed that patients receiving pelareorep and paclitaxel lived longer and responded better to treatment compared to those receiving paclitaxel alone. Given the consistency of these results, Oncolytics believes that its upcoming registration-enabling trial could pave the way for an accelerated approval submission with the FDA. This is an important development, as HR+/HER2- breast cancer is one of the most commonly diagnosed and treated breast cancers worldwide, representing a massive market opportunity for the company. Beyond breast cancer, Oncolytics is making significant progress in two other hard-to-treat cancers: pancreatic cancer and anal carcinoma. "When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients," added Pisano. Oncolytics recently presented new data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, showcasing pelareorep's potential to improve patient outcomes in these aggressive diseases. In anal cancer, results from the ongoing GOBLET study showed that 33% of patients responded to treatment when pelareorep was combined with atezolizumab, a checkpoint inhibitor. Notably, one patient experienced a complete response, with their cancer disappearing and staying undetectable for over 15 months. This level of response in such a difficult-to-treat cancer is highly encouraging, leading Oncolytics to expand the trial to enroll additional patients. Meanwhile, in pancreatic cancer, the company successfully cleared a critical safety review for its combination study using pelareorep with modified FOLFIRINOX with and without atezolizumab, allowing the trial to progress to the next phase. Pancreatic cancer has one of the lowest survival rates of any major cancer, and with few effective treatments available, pelareorep's continued success in this area could position Oncolytics as a key player in gastrointestinal oncology. From a financial standpoint, Oncolytics reported a cash position of $15.9 million at the end of 2024, giving it enough runway to continue executing on its clinical development strategy through the third quarter of 2025. While the company operates at a loss—as is typical for clinical-stage biotechs—it has been strategically managing its spending to ensure that key trials remain funded. Research and development expenses remained stable compared to the previous year, reflecting a disciplined financial approach that prioritizes high-impact studies. With several potentially transformative catalysts on the horizon, including the initiation of a registration-enabling study in breast cancer and new pancreatic cancer data expected later in the year, investors will be watching closely to see how Oncolytics navigates its next steps. The coming months will be crucial for Oncolytics as it pushes forward in its mission to bring pelareorep to market. With strong clinical results, growing regulatory support, and a well-managed cash position, the company is well-positioned to capitalize on its momentum. If its upcoming breast cancer study confirms the benefits seen in BRACELET-1, Oncolytics could find itself on a fast track to regulatory approval, potentially opening the door to a major commercial opportunity. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Exelixis, Inc. (NASDAQ: EXEL), reported promising results earlier this year from a subgroup analysis of its Phase 3 CABINET trial, which evaluated cabozantinib in patients with advanced gastrointestinal (GI) neuroendocrine tumors (NETs). The data presented at ASCO GI 2025 showed that cabozantinib significantly improved progression-free survival (PFS) compared to placebo, with a median PFS of 8.5 months versus 5.6 months. The findings highlight cabozantinib's potential to become a new standard of care for GI NETs, an area with limited treatment options. The FDA is currently reviewing Exelixis' supplemental New Drug Application (sNDA), with a decision expected by April 3, 2025. "These new data add to the robust results from the CABINET trial that demonstrate the benefits of cabozantinib across a wide range of patients with neuroendocrine tumors and further underscore the potential of cabozantinib to become a much-needed new option for those with GI NET, which accounts for the majority of real-world patients with this tumor type," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to continuing to work with the U.S. FDA as they review our regulatory application for cabozantinib for the treatment of patients with previously treated advanced neuroendocrine tumors." Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently shared its Q4 2024 and FY 2024 results and business update as it continues to advance its lead program, onvansertib, a promising PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer (mCRC). "2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., CEO of Cardiff Oncology. In its latest Phase 2 trial (CRDF-004), patients receiving the 30mg dose of onvansertib showed a 64% objective response rate, nearly doubling the 33% response rate in the control group. Cardiff also secured a new U.S. patent covering the use of onvansertib in combination with bevacizumab (bev) for previously untreated KRAS-mutant mCRC patients, adding long-term value to its intellectual property. ALX Oncology Holdings Inc. (NASDAQ: ALXO) is pushing forward with key advancements in its clinical pipeline, including the continued development of evorpacept, a CD47-blocking immunotherapy designed to enhance the effects of existing cancer treatments. The company announced plans to expand clinical trials into breast and colorectal cancer, aiming to evaluate evorpacept in combination with trastuzumab for HER2-positive breast cancer and with cetuximab for colorectal cancer. "Our conviction in evorpacept's potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data," said Jason Lettmann, CEO at ALX Oncology. "We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data." In addition to its immunotherapy efforts, ALX Oncology is preparing to advance ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), into the clinic, with an Investigational New Drug (IND) application planned for Q1 2025. Verastem, Inc. (NASDAQ: VSTM) is making strides in RAS/MAPK pathway-driven cancers, with new Phase 2 trial data on its lead combination therapy, avutometinib plus defactinib, set to be presented at the 2025 Society of Gynecologic Oncology (SGO) Annual Meeting. The investigational treatment has already earned Priority Review from the FDA, with a PDUFA decision expected by June 30, 2025, for patients with KRAS-mutant low-grade serous ovarian cancer (LGSOC). "The presentation of the RAMP 201 primary analysis, which served as the basis of the acceptance of our NDA that is under Priority Review with the FDA, includes additional subgroup analysis by KRAS mutational status," said Dan Paterson, President, and CEO of Verastem Oncology. "We also recognize the importance of these findings to the broader cancer community as part of our growing pool of data reinforcing the potential to change expectations in managing RAS/MAPK pathway-driven cancers." As Verastem moves forward with its RAMP clinical trials, the company continues to expand its pipeline, including a Phase 3 confirmatory trial (RAMP 301) in LGSOC and a collaboration with Amgen to evaluate its therapy in combination with LUMAKRAS™ for KRAS G12C mutant lung cancer. Source: CONTACT: 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. Logo: SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultASCOImmunotherapyPhase 3

20 Dec 2024

·www.prnewswire.com

Oncology Advancements Accelerate Amid Rising Early-Onset Cancer Diagnoses

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 20, 2024 /PRNewswire/ -- USA News Group News Commentary – The American Cancer Society has published its Advances in Oncology – 2024 Research Highlights, underscoring major strides in cancer research and ongoing innovation. However, the optimism is tempered by a troubling finding: a significant global rise in early-onset colorectal cancer cases. This unsettling trend comes as the medical community grapples with the lingering effects of the COVID-19 pandemic. A recent Nature article revealed how disruptions in cancer care—particularly delays in screenings, diagnoses, and treatments—have likely exacerbated the progression of advanced disease, diminished survival rates, and complicated long-term data analysis. Still, the oncology field continues to push forward with promising developments emerging from key innovators like O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cardiff Oncology, Inc. (NASDAQ: CRDF), Personalis, Inc. (NASDAQ: PSNL), Tempus AI, Inc. (NASDAQ: TEM), and Checkpoint Therapeutics, Inc. (NASDAQ: CKPT). The article continued: Additionally, the American Cancer Society has spotlighted an alarming rise in cancer incidence and mortality among younger age groups. Analysts at Exactitude Consultancy anticipate that the global Cancer Immunotherapy Market will expand at a robust 12.84% CAGR, reaching $258.22 billion by 2031—a clear indicator of oncology's rapid growth and critical importance. Oncolytics Biotech® to Present Promising Pelareorep Data in Pancreatic and Anal Cancers at ASCO GI Symposium Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the presentation of two data sets through two abstracts showcasing pelareorep's potential in difficult-to-treat gastrointestinal cancers, which were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. "We are enthusiastic about pelareorep's applicability across multiple gastrointestinal cancer indications, including pancreatic and anal cancer," said Tom Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "Pelareorep engages patients' immune systems to help make commonly used chemotherapies and checkpoint inhibitors, such as atezolizumab, more effective in fighting cancer. This offers the promise of delaying disease progression and improving survival in patients with these devasting diseases. Given the versatility of pelareorep, we see multiple clinical and regulatory options for bringing this promising medicine to patients." Oncolytics will present two key data sets from the GOBLET study, with preliminary safety and tumor response results for the relapsed anal carcinoma cohort treated with pelareorep and atezolizumab presented in Poster Session C on January 25, 2025, from 7:00 to 7:55 a.m. PT. Additionally, results from the safety run-in phase for first-line metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, modified FOLFIRINOX, with and without atezolizumab will be presented in Poster Session B on January 24, 2025, from 11:30 a.m. to 1:00 p.m. PT. Both abstracts will be available on the ASCO Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy and safety data are for all evaluable patients as of a November 26, 2024, data cut-off date, and all efficacy data are determined by a blinded, independent central review (BICR) of each patient's tumor scan. "We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial," said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. "Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses." Personalis, Inc. (NASDAQ: PSNL), a developer of advanced cancer genomic tests and analytics, and Tempus AI, Inc. (NASDAQ: TEM), an AI-powered healthcare technology company, recently announced they've expanded their commercial relationship. Both companies agreed in November 2023 to collaborate and bring ultra-sensitive MRD testing to market and launched their efforts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Tempus is serving as the exclusive commercial diagnostic partner for Personalis' ultra-sensitive tumor-informed MRD product, NeXT Personal® Dx, for broad patient adoption in breast and lung cancers, and for immunotherapy monitoring across all solid tumors. "While we already offer NeXT Personal through our own biopharma channel, we are pleased to leverage Tempus' integrated platform as well for these biopharma customers who desire to combine NeXT Personal with other Tempus products," said Chris Hall, CEO of Personalis. "We believe the expansion of the relationship with Tempus will accelerate market penetration of our leading ultra-sensitive MRD platform and allow us to better capitalize on the opportunity." Under this expanded relationship, Tempus will be enabled to offer Personalis' NeXT Personal MRD product to pharmaceutical and biotech customers who wish to bundle MRD testing with other Tempus offerings in a given study. Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), a commercial-stage immunotherapy and targeted oncology company focused on novel treatments for patients with solid tumor cancers, recently announced that the FDA approved its UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication. "[This] FDA approval of UNLOXCYT – the first marketing approval for our company – is a significant milestone both for Checkpoint and for patients with advanced cSCC," said James Oliviero, President and CEO of Checkpoint. "This approval marks Checkpoint's transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (PD-1), to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC), another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC." Source: CONTACT: 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyASCOClinical ResultPhase 2Drug Approval

18 Dec 2024

·www.prnewswire.com

Cancer Care Disruptions Highlight Growing Demand for Innovative Oncology Treatments

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 18, 2024 /PRNewswire/ -- USA News Group News Commentary – The American Cancer Society recently released its Advances in Oncology – 2024 Research Highlights report that highlighted how their scientists continued to set the standard for research and innovation over the course of the year. However, along with the report's optimism, the American Cancer Society also recently released a study finding that early-onset colorectal cancer cases are surging globally, signaling an alarming trend. A new article published in Nature showed that the COVID-19 pandemic severely disrupted cancer care, causing delays in diagnosis, treatment, and screening services, which likely led to more advanced disease stages, poorer survival outcomes, and significant challenges in accurately interpreting long-term cancer survival data. In the world of oncology, there are still several challenges that need to be addressed and new treatments to be rolled out, but thankfully, there have been several recent developments coming out from innovators, including O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cardiff Oncology, Inc. (NASDAQ: CRDF), OS Therapies, Inc. (NYSE-American: OSTX), Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), and Eli Lilly and Company (Lilly) (NYSE: LLY). The article continued: Not long ago, the American Cancer Society sounded the alarm on a surging rise in cancer diagnoses and fatalities among younger. For the industry targeting the alarming issue, analysts at Exactitude Consultancy project the Cancer Immunotherapy Market to expand at a 12.84% CAGR, reaching $258.22 billion by the end of 2031, further solidifying oncology as a dynamic and evolving sector. Oncolytics Biotech® to Present Promising Pelareorep Data in Pancreatic and Anal Cancers at ASCO GI Symposium Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the presentation of two data sets through two abstracts showcasing pelareorep's potential in difficult-to-treat gastrointestinal cancers, which were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. "We are enthusiastic about pelareorep's applicability across multiple gastrointestinal cancer indications, including pancreatic and anal cancer," said Tom Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "Pelareorep engages patients' immune systems to help make commonly used chemotherapies and checkpoint inhibitors, such as atezolizumab, more effective in fighting cancer. This offers the promise of delaying disease progression and improving survival in patients with these devasting diseases. Given the versatility of pelareorep, we see multiple clinical and regulatory options for bringing this promising medicine to patients." Oncolytics will present two key data sets from the GOBLET study, with preliminary safety and tumor response results for the relapsed anal carcinoma cohort treated with pelareorep and atezolizumab presented in Poster Session C on January 25, 2025, from 7:00 to 7:55 a.m. PT. Additionally, results from the safety run-in phase for first-line metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, modified FOLFIRINOX, with and without atezolizumab will be presented in Poster Session B on January 24, 2025, from 11:30 a.m. to 1:00 p.m. PT. Both abstracts will be available on the ASCO Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy and safety data are for all evaluable patients as of a November 26, 2024, data cut-off date, and all efficacy data are determined by a blinded, independent central review (BICR) of each patient's tumor scan. "We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial," said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. "Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses." OS Therapies, Inc. (NYSE-American: OSTX), a clinical-stage cancer immunotherapy and antibody-drug conjugate biotechnology company, recently reported its Q3 2024 financial results for the quarter and provided a business update. Within the quarter, OS Therapies completed dosing all patients in its potentially pivotal Phase 2b clinical trial of OST-HER2 for resected, recurrent osteosarcoma and is preparing to release topline data in December. The company also joined Johnson & Johnson's JLABS program, completed its IPO on the NYSE American, and is in active discussions with the FDA regarding Breakthrough Therapy Designation for OST-HER2. "The third quarter was pivotal for OS Therapies as we completed our initial public offering and finished dosing the final patient enrolled in our Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma," said Paul Romness, MHP, Chairman and CEO of OS Therapies. "We are now looking forward to releasing topline data in December and then engaging with the FDA regarding getting this potentially life-saving cancer immunotherapy to patients that have no other potential treatment options as quickly as possible." Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), a commercial-stage immunotherapy and targeted oncology company focused on novel treatments for patients with solid tumor cancers, recently announced that the FDA approved its UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication. "[This] FDA approval of UNLOXCYT – the first marketing approval for our company – is a significant milestone both for Checkpoint and for patients with advanced cSCC," said James Oliviero, President and CEO of Checkpoint. "This approval marks Checkpoint's transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (PD-1), to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC), another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC." Eli Lilly and Company (Lilly) (NYSE: LLY), a medicine company turning science into healing to make life better for people around the world, recently announced results from its Phase 3 BRUIN CLL-321 trial, which tested pirtobrutinib, a next-generation treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had previously been treated with a similar type of drug. The study showed that pirtobrutinib significantly reduced the risk of disease progression or death by 46% compared to standard treatments (idelalisib plus rituximab or bendamustine plus rituximab). These promising results were presented at the 66th American Society of Hematology (ASH) Annual Meeting. "BRUIN CLL-321 is the only randomized CLL or SLL study ever conducted exclusively in the BTK-inhibitor pre-treated population, where there is significant need for new treatment options, and these data illustrate pirtobrutinib's ability to meaningfully delay disease progression and time to next treatment in this setting," said David Hyman, M.D., Chief Medical Officer of Lilly. "This is the first in our suite of randomized Phase 3 trials for pirtobrutinib to readout and we look forward to continuing to build the body of evidence supporting the role of pirtobrutinib in advancing care for people with B-cell malignancies." Source: CONTACT: 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 2	United States	Cardiff Oncology, Inc.	17 Mar 2023
HER2-negative breast cancer	Phase 2	United States	Cardiff Oncology, Inc.	30 Sep 2022
Hormone Receptor Positive Breast Adenocarcinoma	Phase 2	United States	Cardiff Oncology, Inc.	30 Sep 2022
hormone receptor/growth factor receptor-negative breast cancer	Phase 2	United States	Cardiff Oncology, Inc.	30 Sep 2022
Inflammatory Breast Neoplasms	Phase 2	United States	Cardiff Oncology, Inc.	30 Sep 2022
Invasive Mammary Carcinoma	Phase 2	United States	Cardiff Oncology, Inc.	30 Sep 2022
Locally advanced breast cancer	Phase 2	United States	Cardiff Oncology, Inc.	30 Sep 2022
Metastatic breast cancer	Phase 2	United States	Cardiff Oncology, Inc.	30 Sep 2022
Unresectable Breast Carcinoma	Phase 2	United States	Cardiff Oncology, Inc.	30 Sep 2022
Triple Negative Breast Cancer	Phase 2	United States	Cardiff Oncology, Inc.	12 Sep 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06106308 (CRDF-004, GlobeNewswire) Manual	Phase 2	RAS mutant Colorectal Cancer First line KRAS Mutation \| NRAS Mutation	30	Onvansertib 20mg + SoC	jdbcfpapvy(ochvlbyuuw) = tfshzvjybe umqisjqcze (zkrzthmlia )	Positive	10 Dec 2024
				Onvansertib 30mg + SoC	jdbcfpapvy(ochvlbyuuw) = qpdghwxini umqisjqcze (zkrzthmlia )
NCT03414034 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	72	Prednisone+Abiraterone+Onvansertib (Arm A: Onvansertib + Abiraterone and Prednisone)	rlcojttpbo = lpabhnhzyc vvmrmhanfp (wugjyjxnna, cbckxpvbko - wzmlaoocck) View more	-	07 Nov 2024
				Prednisone+Abiraterone+Onvansertib (Arm B: Onvansertib + Abiraterone and Prednisone)	rlcojttpbo = rsylubmcgd vvmrmhanfp (wugjyjxnna, onbunoxtwg - hhtcmuldts) View more
NCT03829410 (CRDF-004, GlobeNewswire) Manual	Phase 2	KRAS mutant Colorectal Cancer Second line KRAS Mutation	-	Onvansertib with FOLFIRI and bevacizumab (bev-naïve patients)	lsdgyqqdxq(grjisvfdmz) = wbkjwfldvi aklakxtgqk (yebzrmwjrj ) View more	Positive	30 Oct 2024
				onvansertib with FOLFIRI and bevacizumab (bev-exposed patients)	lsdgyqqdxq(grjisvfdmz) = ymazdowenq aklakxtgqk (yebzrmwjrj ) View more
NCT06106308 (Pubmed \| J Clin Oncol)	Phase 2	KRAS mutant Colorectal Cancer Second line KRAS Mutant	53	Onvansertib + FOLFIRI + Bevacizumab	zneabvmngs(vfdevjbhjb) = waasghttij ljpwktnvnt (nwccinplbc, 15.3 - 40.3) View more	Positive	30 Oct 2024
				Onvansertib + FOLFIRI + Bevacizumab (revealed bevacizumab)	zneabvmngs(vfdevjbhjb) = ldtjmljpul ljpwktnvnt (nwccinplbc ) View more
Phase Ib Clinical Study (Pubmed \| Clin Cancer Res)	Phase 1	Second line KRAS-mutant	18	Onvansertib 12 mg/m2	ctszzwwccj(sjupuoavmh) = Grade 3 and 4 adverse events (AE) represented 15% of all treatment-related AEs, with neutropenia being the most common zvykwkptcu (lpxertexwh ) View more	Positive	15 May 2024
				Onvansertib 15 mg/m2
NCT03829410 (AACR2024) Manual	Phase 1/2	KRAS mutant Colorectal Cancer Second line KRAS-mutant	66	Onvansertibbevacizumab	szrijpxoog(fffgvifihk) = lrtteosbnp arcktynuuj (ordslcowpz ) View more	Positive	22 Mar 2024
NCT05593328 (ONSEMBLE, GlobeNewswire) Manual	Phase 2	Metastatic Colorectal Carcinoma Second line KRAS Mutation \| NRAS Mutation	23	Onvansertib+SoC	udvwuucrtx(ersteyzbkz) = fkfitzmwxj qngachzlgd (scozervlqk ) View more	Positive	29 Feb 2024
				Onvansertib+SoC (Bev Naïve patients)	udvwuucrtx(ersteyzbkz) = gjgypqprxf qngachzlgd (scozervlqk )
Literature Manual	Phase 1	KRAS mutant Colorectal Cancer Second line KRAS Mutation	18	Onvansertib+FOLFIRI+Bevacizumab	mcdxpzajig(rqcpklbsok) = bymetwallv njbvksnrdr (mldwlczbgw ) View more	Positive	17 Jan 2024
NCT04752696 (CRDF-001, Corporate Publications) Manual	Phase 2	Small Cell Lung Cancer \| Pancreatic Cancer Second line	-	Onvansertib+nanoliposomal irinotecan+leucovorin+fluorouracil	wedbazxzmt(vzfrqbjmqg) = rlyyiunepk mntbvfeinp (tmyiwfrunf ) View more	Positive	26 Sep 2023
				Standard-of-care	wedbazxzmt(vzfrqbjmqg) = otelwldugh mntbvfeinp (tmyiwfrunf ) View more
NCT03829410 (ESMO2022)	Phase 2	Metastatic Colorectal Carcinoma	48	Onvansertib + FOLFIRI/bev	vqzbjawllz(egykczrynq) = vjplggzbnn vsxetqnfzf (midwfafgar ) View more	-	10 Sep 2022

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