On July 8, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company’s intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies (Press release, Oncolytics Biotech, JUL 8, 2025, View Source [SID1234654284]).

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"We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, Chief Executive Officer of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology."

Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone. In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. These results collectively represent promising efficacy for a therapeutic regimen that includes an immunotherapy in this difficult-to-treat cancer. Currently, there are no approved immunotherapies for first-line treatment of mPDAC.

Clinical results of pelareorep in first-line mPDAC studies
Company
(Study)
Description
(Patients) 1-Year Survival 2-Year Survival Notes
Oncolytics
(REO 017)
Pelareorep+ Gemcitabine
(34 patients)
45% vs. 22% 24% vs. 4%
Disease Control Rate (DCR): 83% vs. 33%
Single arm vs. gemcitabine benchmark

Oncolytics
(NCI 8601)
Paclitaxel/Carboplatin + Pelareorep
(36 patients) vs.
Paclitaxel/Carboplatin
(37 patients)
34% vs. 28% 20% vs. 6%
Randomized study vs. control arm
(excluding crossover)
Oncolytics
(REO 029)
Pelareorep+ Gemcitabine/
Nab-Paclitaxel+ Atezolizumab
(13 patients)
45% vs. 35% N/A
ORR: 62% vs. 23%
Single arm vs. gemcitabine/
nab-paclitaxel benchmark

Pelareorep’s clinical activity in HR+/HER2- metastatic breast cancer – a large indication with continued significant unmet medical need and no currently approved immunotherapies – has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). In the randomized, controlled BRACELET-1 study, pelareorep combined with paclitaxel yielded a 12.1-month median progression-free survival (PFS) compared to 6.4 months in the paclitaxel alone control arm.

"Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies like mPDAC and unresectable HR+/HER2- breast cancer, creating new oncology entry points for immune-based combination therapies."

Data from more than 1,100 patients enrolled in multiple studies across several tumor types affirm that pelareorep has a favorable, well-understood safety profile. The most common treatment-related adverse events (TRAEs) are "flu-like" symptoms, such as fever, chills, headache, fatigue, myalgia, cough, anorexia, nausea, diarrhea, or vomiting, and rarely resulted in clinically significant grade ≥3 TRAEs. Adverse events are typically transient and manageable with over-the-counter medications.

Pelareorep received Fast Track designations from the U.S. Food and Drug Administration (FDA) in 2017 for metastatic breast cancer and in 2022 for mPDAC in combination with chemotherapy and atezolizumab. In 2015, pelareorep also received Orphan Drug Designations from the FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer.

The Company released a new corporate presentation, available on its website, that provides detailed clinical and translational data.

On July 8, 2025 Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing, reported its support to CERo Therapeutics Holdings, Inc., an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms (Press release, Invivoscribe Technologies, JUL 8, 2025, View Source [SID1234654283]).

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Through this collaboration, LabPMM (Invivoscribe’s global reference laboratories), have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to support CERo’s clinical trial of its lead compound, CER-1236. The trial targets Acute Myeloid Leukemia (AML) in patients who are relapsed/refractory, in remission with MRD, or newly diagnosed with TP53-mutated MDS/AML.

AML is an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis.1 Treating AML is especially complex due to its genetic heterogeneity and the high risk of relapse. CAR-T (chimeric antigen receptor T-cells) and Chimeric Engulfment Receptor T-cells ("CER-T") therapies, which involve engineering a patient’s own T-cells to recognize and attack cancer cells, have shown promise in other hematologic malignancies and are now being explored for AML. However, because these therapies are manufactured from patient-derived cells, it’s critical to confirm that leukemic blasts are not inadvertently included in the final therapeutic product – underscoring the need for sensitive, validated assays like those offered by Invivoscribe and its global accredited regional laboratories, LabPMM.

LabPMM’s CAP/CLIA-Validated AML MRD MFC assay which was designed to quantify residual leukemic cells in patients undergoing treatment, was customized to meet two critical needs in CERo’s drug development program: (1) assessing the purity of the manufactured T-cell product by detecting residual AML blasts prior to infusion, and (2) evaluating therapeutic response to CER-1236 during the trial.

Kristen Pierce, Ph.D., CERo Chief Development Officer, commented, "Invivoscribe has played an integral role in the execution of this clinical trial. Its technology and expertise have facilitated our advancement into the clinic by helping to ensure the purity of our investigational product, and now we are reaping the benefits of our collaboration as the trial is underway and we seek to assess therapeutic response."

This collaborative effort was instrumental in advancing CER-1236, which recently received FDA Orphan Drug Designation for the treatment of AML2. The designation highlights the growing urgency of integrated diagnostic support in the advancement of personalized immunotherapies and reflects Invivoscribe’s commitment to driving innovation and standardization across the oncology treatment landscape – now helping bring immunotherapies to patients faster.

For more information about LabPMM’s flow cytometry and molecular testing services, please visit View Source or contact us at [email protected] and follow us on LinkedIn.

On July 8, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it has commenced an underwritten public offering of $150 million of its shares of common stock (Press release, Cogent Biosciences, JUL 8, 2025, View Source [SID1234654282]). In addition, Cogent intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of its shares of common stock on the same terms and conditions. All of the securities in the offering are being offered by Cogent. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

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Cogent intends to use the net proceeds from the offering for continued development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, activities to support the planned commercial launch of bezuclastinib, as well as for working capital and general corporate purposes.

J.P. Morgan, Leerink Partners and Guggenheim Securities are acting as joint book-running managers for the offering. LifeSci Capital is also acting as lead manager for the offering.

The securities described above will be offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-269707), which was filed with the Securities and Exchange Commission (SEC) on February 10, 2023 and automatically became effective upon filing.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

On July 8, 2025 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported a new collaboration with Merck, known as MSD outside of the United States and Canada, that expands Merck’s use of the Certara Pinnacle 21 software platform to include a metadata repository and data standards workflow management (Press release, Certara, JUL 8, 2025, View Source [SID1234654281]). This agreement builds upon Merck’s existing technology collaboration with Certara to aid in regulatory submissions.

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Reducing the time from data collection to validated, analysis-ready datasets has become more complex across drug development. Phase III clinical trials now average 3.6 million datapoints, a threefold increase over the last decade.1 The Certara Pinnacle 21 platform is designed to solve the data standardization challenges of modern digital trials at scale.

"We are pleased to strengthen our ongoing collaboration with Merck to assist with data standards management and to expand the value of the Pinnacle 21 platform," said William F. Feehery, Chief Executive Officer. "Merck is a premier research-intensive company, and our teams are well-aligned in the goal of delivering high-quality research data faster to help save and improve lives around the world."

On July 8, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported that the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical study evaluating its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, AVZO-1418, in patients with advanced solid tumors (Press release, Avenzo Therapeutics, JUL 8, 2025, View Source [SID1234654280]).

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"AVZO-1418 represents a unique approach to deliver a single targeted therapy to patients with diverse tumor types driven by EGFR and HER3 co-expression," said Anthony Tolcher, M.D., FRCPC, CEO and Founder, NEXT Oncology. "We believe this bispecific approach has the potential to improve tumor cell selectivity and maximize therapeutic impact across multiple solid tumor types that share this biology."

The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

"We are proud to have dosed the first patient just over a month after receiving IND clearance," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This milestone highlights the strong momentum behind our program. We plan to evaluate this bispecific ADC in a range of indications – including lung, breast, and head and neck cancers – where treatment options remain limited, including for patients who have progressed on standard therapies."