Next-Gen Cancer Treatments Gain Steam Amid Oncology Industry Shakeups

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER – Baystreet.ca News Commentary – Cancer rates are climbing across the U.S., with stark disparities from state to state. Recent CDC data shows Maine now leads the nation in cancer incidence, while Utah remains the lowest. But survival outcomes aren’t just about geography; they’re increasingly tied to insurance status, with access to immunotherapy varying sharply between private, Medicaid, and uninsured patients. As public funding for cancer research faces deep cuts, potentially slashing the National Cancer Institute’s budget by up to 40%, the burden of innovation is shifting to the private sector. A new wave of biotechs is rising to meet the moment, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Mustang Bio, Inc. (NASDAQ: MBIO), Enliven Therapeutics, Inc. (NASDAQ: ELVN), IN8bio, Inc. (NASDAQ: INAB), and Tango Therapeutics, Inc. (NASDAQ: TNGX).

U.S. cancer death rates may be falling, but the global cancer burden is rising fast. Early-onset diagnoses are increasing at an alarming rate, particularly among younger patients. At the same time, analysts now project the global oncology drug market could surpass US$900 billion in revenue by 2034.

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently highlighted survival data and an upcoming KOL webinar that together underscore growing expert and clinical support for its virus-based immunotherapy, pelareorep, in hard-to-treat cancers like metastatic pancreatic and breast cancer.

In first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), pelareorep-based treatment regimens have shown a two-year overall survival rate of 21.9% across pooled data from more than 100 patients—more than double the historical benchmark of 9.2%. In a separate single-arm study combining pelareorep with chemotherapy and a checkpoint inhibitor, the objective response rate reached 62% in evaluable patients. No immunotherapy is currently approved in this indication.

“We are no longer in the business of funding proof-of-concept studies,” said Jared Kelly, newly-appointed CEO 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.”

HR+/HER2- metastatic breast cancer (mBC) has also shown strong survival numbers. In HR+/HER2- mBC, pelareorep extended median overall survival by more than 10 months across two randomized trials. The BRACELET-1 trial also showed median progression-free survival of 12.1 months, nearly double the 6.4 months in the control arm.

The company recently reinforced its leadership bench with two high-profile appointments—naming Jared Kelly as Chief Executive Officer and Andrew Aromando as Chief Business Officer—as it sharpens its focus on late-stage development and strategic transactions. Both Kelly and Aromando played instrumental roles in Ambrx Biopharma’s $2 billion acquisition by Johnson & Johnson, and bring deep experience in value creation, partnerships, and registration pathways in oncology.

“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.”

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.

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.

Across more than 1,100 patients treated to date, pelareorep has maintained a favorable safety profile, with most adverse events limited to flu-like symptoms. The drug has shown broad synergy with checkpoint inhibitors and chemotherapies and continues to generate immune responses in multiple solid tumor types.

Oncolytics is advancing toward registration-enabling trials and partnership opportunities with a disciplined, investor-aligned approach to growth.

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:

Mustang Bio, Inc. (NASDAQ: MBIO) has received Orphan Drug Designation from the FDA for its MB-101 CAR T-cell therapy targeting IL13Ra2, a promising approach for treating astrocytomas and glioblastoma. Early clinical results showed that MB-101 was well-tolerated, with 50% of patients achieving stable disease or better, including two complete responses lasting over 7.5 and 66 months.

“We are thrilled that MB-101 received Orphan Drug Designation on time and with a designation that is broader than the indication proposed,” said Manuel Litchman, M.D., President and CEO of Mustang. “The Orphan Drug Designation for MB-101, coupled with the Orphan Drug Designation granted previously for MB-108, is strong validation for our science, as we hope to advance MB-101, in combination with MB-108, as a potential treatment option for patients living with malignant glioma, including patients with recurrent glioblastoma (“GBM”) and high-grade astrocytomas.”

The company is exploring a novel combination with its MB-108 oncolytic virus to convert “cold” tumors into “hot” and improve therapeutic outcomes.

Enliven Therapeutics, Inc. (NASDAQ: ELVN) reported updated data from its Phase 1 ENABLE trial of ELVN-001 in chronic myeloid leukemia (CML), showing a cumulative major molecular response (MMR) rate of 47% by 24 weeks in heavily pretreated patients.

“We are highly encouraged by the ELVN-001 data, specifically as it relates to the consistency of the cumulative and achieved MMR rates as the Phase 1 trial progresses, with more evaluable patients and longer duration of treatment,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “While MMR is the efficacy endpoint in CML, safety and tolerability are equally critical given the chronic nature of the disease. We believe ELVN-001 has the potential to offer best-in-class efficacy and tolerability, which are key attributes for people living with CML. We look forward to sharing additional data in the future.”

The small-molecule kinase inhibitor designed to specifically target BCR::ABL1 gene fusion was well tolerated, with low rates of dose reductions and discontinuations, and no treatment-related arterial occlusive events reported. The company is planning to initiate a pivotal head-to-head Phase 3 trial in 2026.