Emerging Oncology Breakthroughs Signal Opportunity Despite Research Funding Crunch
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – Budget cuts are on the horizon for funding scientific research, and if supported by Congress, the development of cures for cancer will be in jeopardy. As well, there is “tremendous uncertainty” for cancer research as US regulators have begun to re-examine mRNA vaccines at both the federal and state levels. With a rise in rates for certain types of cancer, in particular colorectal and other GI cancers in younger people, there is an urgency to provide new solutions in oncology, despite bureaucratic setbacks. On the ground, a new wave of biotechs is emerging with potential milestones in the near future that may shift the tide in the space, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cardiff Oncology, Inc. (NASDAQ: CRDF), CytomX Therapeutics, Inc. (NASDAQ: CTMX), Nuvation Bio Inc. (NYSE: NUVB), and Immuneering Corporation (NASDAQ: IMRX).
Analysts now project the global oncology drug market could surpass US$900 billion in revenue by 2034. Precedence Research estimates that the next-generation cancer therapeutics market (driven by personalized and precision medicine) will hit US$175.2 billion by 2034, expanding at a 7.35% CAGR.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just rolled out an expanded translational data review package that tightens the scientific case for pelareorep, its intravenously delivered oncolytic virus.
Fresh analyses from the GOBLET gastrointestinal‑cancer study and the AWARE‑1 breast‑cancer study shows pelareorep actively replicating inside tumors, switching on interferon signaling in the immune system, and drawing tumor‑infiltrating lymphocytes into the cancer microenvironment.
“This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep’s immune-mediated mechanism of action,” said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. “We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep.”
Investigators also recorded a clear increase in PD‑L1 expression, a checkpoint marker that helps immune cells recognize tumors, and tracked newly expanded T‑cell clones in the blood that matched those inside shrinking lesions. Together, these findings suggest pelareorep can convert “cold” tumors into “hot” ones that respond better to modern immunotherapies.
“The collection of data here show that pelareorep works how a cancer immunotherapy should work,” said Jared Kelly, CEO of Oncolytics. “Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs.”
Two GOBLET cohorts—metastatic pancreatic ductal adenocarcinoma (mPDAC) and anal cancer—remain open. Management plans to outline the next clinical milestones before the end of the third quarter.
Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a two‑year overall‑survival rate of 21.9%, compared with the historical benchmark of 9.2%. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective response rate. No immune checkpoint therapy is approved in this cancer today, which makes the signal especially noteworthy.
Progress extends to hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC). Across two randomized trials, pelareorep added more than ten months of median overall survival. In BRACELET‑1, the drug nearly doubled median progression‑free survival to 12.1 months versus 6.4 months in the control arm, suggesting durable disease control.
Next week, Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep’s data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial’s primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep’s mechanism and outcomes.
To steer these data toward value‑creating deals and late‑stage trials, Oncolytics Biotech strengthened its leadership earlier this year. The board tapped industry veteran Jared Kelly for the CEO seat and named Andrew Aromando Chief Business Officer. Both executives helped guide Ambrx Biopharma into a $2‑billion sale to Johnson & Johnson, giving them a playbook for capital‑efficient development and strategic partnering.
“Pelareorep’s clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications,” said Kelly. “With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy.”
As CBO, Aromando is now leading global business development and helping shape the company’s corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep’s growing clinical profile.
“I’m thrilled to join Oncolytics at such a pivotal moment in its evolution,” said Aromando. “With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term.”
Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
Cardiff Oncology, Inc. (NASDAQ: CRDF) recently reported Phase 1b data at ASCO showing that onvansertib combined with paclitaxel achieved a 40% objective response rate in metastatic triple‑negative breast cancer (mTNBC) patients, the majority of which were heavily pretreated.
“Triple-negative breast cancer is among the most aggressive subtypes of breast cancer, and represents a significant unmet medical need for women worldwide,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “This underscores the urgency to develop novel therapies with enhanced efficacy and improved tolerability for patients with mTNBC. We are highly encouraged by the robust efficacy signal and the tolerable safety profile observed with onvansertib plus paclitaxel in patients with mTNBC.”
All responses occurred at the highest onvansertib dose, and the regimen was well tolerated, with manageable myelosuppression as the most common side effect. The findings bolster the case for advancing the PLK1 inhibitor in aggressive breast cancer settings.
Back in May, CytomX Therapeutics, Inc. (NASDAQ: CTMX) dosed the first patient in the combination arm of its Phase 1 study evaluating CX‑801 with KEYTRUDA in metastatic melanoma.
“We are excited to begin evaluating this combination therapy that has the potential to provide significant clinical benefit to patients with PD-1 refractory melanoma, which remains an area of high unmet need,” said Dr. Wayne Chu, M.D., chief medical officer of CytomX Therapeutics. “Utilizing CytomX’s proprietary conditional activation platform to maintain potency and widen interferon’s therapeutic index, CX-801 is well suited to combine with KEYTRUDA® and could become an important component of combination immuno-oncology therapy. We look forward to initial Phase 1a translational and biomarker data in advanced melanoma in the second half of 2025.”
CX‑801 is a dually masked interferon alpha‑2b Probody® cytokine engineered to concentrate immune‑stimulating activity inside tumors while curbing systemic side effects. The combination arm follows successful monotherapy dose‑escalation cohorts, and initial translational and biomarker readouts are expected in 2H 2025.
Nuvation Bio Inc. (NYSE: NUVB) announced that taletrectinib (IBTROZI) has been added as a Preferred Agent across all lines of therapy in the latest National Comprehensive Cancer Network (NCCN) Guidelines for ROS1‑positive non‑small cell lung cancer, including patients who have brain metastases or resistance mutations.
"We are very pleased the NCCN acted with such urgency to review and update the NCCN Guidelines to include taletrectinib (IBTROZI) as a preferred option for advanced ROS1-positive NSCLC across treatment lines, with particular recognition of benefit for patients with brain metastases and those with acquired resistance after first-line therapy," said David Hung, M.D., Founder, President and CEO of Nuvation Bio. "These updates address critical needs for patients across their treatment journeys, especially with the prevalence of CNS involvement for those living with ROS1+ NSCLC.”
Immuneering Corporation (NASDAQ: IMRX) recently secured a U.S. composition‑of‑matter patent for atebimetinib, granting exclusivity into 2042 with potential extensions that could stretch protection to 2044.
“Our priorities are to make medicines that keep working, so cancer patients keep living, and to make medicines that have fewer side effects, so cancer patients can feel like themselves and live normal lives,” said Ben Zeskind, Ph.D., Co-founder and CEO of Immuneering. “We have already observed exceptional durability and a markedly favorable tolerability profile in first-line pancreatic cancer patients treated with atebimetinib+mGnP, and this is just the beginning of the important impact that we believe atebimetinib and our entire pipeline of deep cyclic inhibitors will have on the treatment of cancer.”
Atebimetinib is a once‑daily “deep cyclic” MEK inhibitor that showed a 94% 6‑month survival probability in first‑line pancreatic‑cancer patients when combined with modified gemcitabine/nab‑paclitaxel in an ongoing Phase 2a trial. The patent solidifies intellectual‑property coverage as the company pursues additional studies and leverages its existing FDA Fast Track and Orphan Drug designations.
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