Tapping into Immune Systems for Next Generation Treatments

February 15, 2024 Investorideas.com, a global investor news source covering biotech and pharma stocks issues a sector snapshot on cancer immunotherapy featuring Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology.

According to the American Association for Cancer Research “Cancer immunotherapeutics work by unleashing the power of a patient’s immune system to fight cancer and, over the last decade, have emerged as one of the most exciting new approaches to cancer treatment.”

“The prolific growth in the cancer immunotherapy sector, fuelled by technological advances and a high prevalence of cancer-related cases, is set to significantly enhance the global market landscape. The market, which was valued at US$ 96.40 billion in 2023, is estimated to achieve a remarkable CAGR of 10.02% between the years 2023 and 2030, with projections placing its value at approximately US$ 188.11 billion by the end of the decade,” reports ResearchandMarkets.

Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) is developing pelareorep, a unique immunotherapy with the power to awaken the immune system and unlock its antitumor potential. Pelareorep is delivered intravenously and is systemically active, setting it apart from other immunotherapies that must be injected into the tumor.

The Company just announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

“These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer. The results reported at IMACC 2023 showed that the combination of pelareorep and atezolizumab provided a 37.5% objective response rate, including one patient with a long-lasting complete response, and good overall tolerability. These data represent a meaningful contrast to recent clinical trial results which show that patients with second-line or later anal carcinoma treated with checkpoint inhibitor therapy experienced response rates of 10-14%1-3,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.

“We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer. There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment. Continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway in this rare and significantly under-served patient population,” continued Dr. Coffey.

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial, commented, “One of the most difficult challenges in my practice is the limited number of treatment options that are available for patients with advanced anal cancer who have progressed on first-line therapy. I am enthusiastic about the expansion of this cohort because it will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease.”

“We look forward to building on the oncology community’s enthusiastic reception of the IMACC 2023 data by expanding enrollment in the anal carcinoma cohort and incorporating additional sites into the study,” commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Careful consideration of recently published clinical trial results indicates that a modest expansion of fewer than 20 patients will be sufficient to solidify the efficacy signal we have observed to date and lay the groundwork for a potential future registrational study in this population. We look forward to continuing our excellent collaboration with the clinical sites and investigators at AIO and hope to report additional results in 2025.”

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups:

  1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
  2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
  3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients; and
  4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients.

Candel Therapeutics, Inc.(Nasdaq:CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer had big gains on news as it announced that the US Food and Drug Administration (FDA) granted Fast Track Designation for CAN-3110 — a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate – for the treatment of patients with recurrent high-grade glioma (HGG) to improve overall survival.

“Receiving FDA Fast Track Designation for CAN-3110 reinforces the critical need to find effective treatment options for patients with recurrent HGG and further supports the potential of CAN-3110 to address the challenges that the standard of care and conventional therapies have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “As recently published in Nature, a strong local and systemic anti-tumoral response and improved survival in patients with recurrent HGG was observed following a single injection of CAN-3110. We look forward to reporting additional data, including the potential benefits from multiple injections of CAN-3110, from the ongoing phase 1b clinical trial in the second half of 2024.”

From the news continued: In October 2023, Candel and academic collaborators at the Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial in Nature, demonstrating that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a nearly doubling of the expected median overall survival (mOS) after a single CAN-3110 injection, achieving a mOS of ~12 months, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. Positive HSV-1 serology was a predictor of response and was associated with improved survival (mOS in this population reached 14 months). Increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after administration were also associated with improved survival, suggesting that CAN-3110 can elicit both a local and systemic antitumoral response.

“Recurrent HGG is one of the most aggressive malignancies for which there is no cure, representing a significant and urgent unmet need,” said Antonio Chiocca, MD, PhD, Head of Department of Neurosurgery at Brigham and Women’s Hospital, Professor at Harvard Medical School, and Principal Investigator. “With Fast Track Designation, I look forward to the potential of accelerating the development of CAN-3110 and the possibility of bringing this differentiated therapy to patients with recurrent high-grade glioma as we strive to improve outcomes and provide hope for patients and their families.”

BioNTech (Nasdaq:BNTX), an immunotherapy company pioneering novel therapies for cancer and other serious diseases and Autolus Therapeutics plc, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, recently announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

“The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way. Autolus’ state-of-the-art manufacturing facilities’ set-up for clinical and commercial supply will enhance our own capacities in addition to our existing U.S. supply network and the ongoing expansion of our site in Gaithersburg, Maryland,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Furthermore, this collaboration grants us access to Autolus’ precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates.”

From the news continued: “We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies,” said Dr. Christian Itin, CEO of Autolus. “We look forward to investing a portion of the capital raised on delivering on obe-cel’s path in adult acute lymphoblastic leukemia, potentially offering another treatment option for patients where there is still an unmet medical need. This collaboration creates a path for accelerating our respective oncology pipeline programs and broadening the use of Autolus’ technology outside of autologous cell therapy applications.”

BioNTech has agreed to purchase $200 million of Autolus’ American Depositary Shares in a private placement. BioNTech will have a right to appoint a director to the Board of Autolus.

Pharmaceutical Technology reports, “Immatics (NASDAQ: IMTX) is one of the leading patent filers in cancer immunotherapy. The biopharmaceutical company is focused on the development of T cell immunotherapies to fight against cancer. Immatics combines the discovery of targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against targets. It is committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Bristol-Myers Squibb and Fate Therapeutics are some of the other key patent filers in cancer immunotherapy.”

In mid-January Immatics announced the pricing of an underwritten public offering of 15,925,000 ordinary shares at a public offering price of $11.00 per share. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be approximately $175 million.

For investors looking for the next trends in biotech, Pharmaceutical Technology also reports, “Cancer immunotherapy has shown remarkable success in treating various types of cancers and has revolutionized cancer treatment in recent years.”

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