FinancialNewsMedia.com News Commentary

PALM BEACH, Fla., June 22, 2023 /PRNewswire/ — Pancreatic cancer is one of the leading causes of cancer death globally. The increasing incidence of this cancer across the U.S. and other parts of the world is one of the factors driving the need for the drugs used in the treatment. The increase in the geriatric population is one factor driving the pancreatic cancer treatment market growth. The incidence is significantly higher in the geriatric population above 65 years of age compared to other types of cancers. The increase in the number of patients suffering from the condition has increased the demand for the drugs used in treatment. A report from Fortune Business Insights said that this factor will be driving the growth for the next several years. The report projected that the global pancreatic cancer treatment market size was valued at USD 2.48 billion in 2022 and will grow to USD 6.85 billion by 2029, exhibiting a CAGR of 15.7% during the forecast period. The report continued: “Companies engaged in manufacturing cancer drugs have increased their focus on R&D activities to develop new drugs for pancreatic cancer treatment. Additionally, the companies operating in the market have received approval from several regulatory bodies, such as the U.S. Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) (U.K.), among others, thereby propelling the growth of the market. Moreover, new testing technologies are being adopted by hospitals and diagnostic centers to diagnose cancer. The increase in the diagnosis rates is driving the demand for drugs, thereby providing opportunities for the players.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), Talaris Therapeutics, Inc. (NASDAQ: TALS), Predictive Oncology Inc. (NASDAQ: POAI), Mirati Therapeutics, Inc.^® (NASDAQ: MRTX).

Fortune Business Insights continued: “Shifting the focus of key players in extensive R&D activities to develop new drugs and an increase in funding for cancer research led to the development of new drugs for treatment. research led to the development of new drugs for treatment. Additionally, several pharmaceutical companies are involved in clinical trials to develop new drugs and explore the potential of the molecule to treat the disease. It concluded: “Thus, with the increased funding for R&D activities, companies are focused on developing new drugs, thereby contributing to the overall rise in demand for drugs for pancreatic type of cancer treatment through 2029.”

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech’s® Pelareorep Selected for Inclusion in Precision PromiseSM Pivotal Phase 3 Platform Trial –

• Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial
• If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic cancer
• Data presented at SITC 2022 showed a near tripling of overall response rate for pelareorep + gemcitabine + nab-paclitaxel + a PD-L1 inhibitor compared to historical control trials

Oncolytics Biotech^® today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).

Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to pre-specified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials.

“We are delighted at being selected by the Precision Promise panel of experts,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. “Our next step is to engage with stakeholders to finalize the protocol for Precision Promise’s pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval.”

Julie Fleshman, JD, MBA, President and CEO of PanCAN commented, “With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care.”

Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech, commented, “Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one and two-year survival and objective response rate. In addition, mechanistic data from these studies highlight how pelareorep’s immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option.” CONTINUED… Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/

Other recent breast cancer developments in the biotech industry of note include:

Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE) recently announced it has completed the acquisition of Spyre Therapeutics, Inc. (“Spyre”), a privately held biotechnology company advancing a robust pipeline of antibody therapeutics with the potential to transform the treatment of inflammatory bowel disease (IBD). Concurrent with the acquisition of Spyre, Aeglea entered into a definitive agreement for the sale of Series A non-voting convertible preferred stock (the “Series A preferred stock”) in a private placement to a group of institutional accredited investors led by Fairmount Funds Management LLC (“Fairmount Funds”), with participation from Fidelity Management & Research Company, Venrock Healthcare Capital Partners, Commodore Capital, Deep Track Capital, Perceptive Advisors, RTW Investments, Cormorant Asset Management, Driehaus Capital Management, Ecor1 Capital, RA Capital Management, Surveyor Capital (a Citadel company), and Wellington Management Company LLP, as well as additional undisclosed institutional investors. The private placement is expected to result in gross proceeds to Aeglea of approximately $210 million before deducting placement agent and other offering expenses.

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The proceeds from the private placement are intended to be used to advance Spyre’s portfolio of potentially best-in-class IBD products through multiple data milestones and are expected to fund operations into 2026.

Talaris Therapeutics, Inc. (NASDAQ: TALS) and Tourmaline Bio, Inc. (“Tourmaline”), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune diseases, recently announced that the companies have entered into a definitive agreement under which Tourmaline will combine with Talaris in an all-stock transaction (the “Merger”). The combined company will focus on advancing Tourmaline’s lead program, TOUR006, a potentially best-in-class anti-IL-6 antibody, for the treatment of thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD). Upon completion of the Merger, the combined company will operate under the name Tourmaline Bio, Inc. and trade on the Nasdaq under the ticker symbol “TRML.” In addition, Talaris anticipates making a cash dividend of up to approximately $64.8 million to its stockholders prior to the closing of the Merger.

“We are thrilled to be entering into this transaction with Talaris,” said Sandeep Kulkarni, MD, Chief Executive Officer of Tourmaline. “We have assembled a world-class team with deep experience developing antibodies for immune disorders and are now on the verge of beginning our Phase 2 development campaign in multiple indications. We believe that TOUR006 has best-in-class potential and could be a transformative treatment option for millions of patients suffering from immune disorders. This merger and the support from leading life sciences investors will allow us to accelerate our development plans in TED, heart disease, and potentially other indications.”

Predictive Oncology Inc. (NASDAQ: POAI), a science-driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, Clinical Laboratory Improvement Amendments (CLIA) laboratory and Good Manufacturing Practices (GMP) facility, to accelerate oncology drug discovery and enable drug development, recently announced the appointment of Dr. Bernard A. Harris, Jr. to its newly-formed Business Advisory Board (BAB).

“I am very pleased to welcome Dr. Harris to our new Business Advisory Board,” said Raymond F. Vennare, Chief Executive Officer of Predictive Oncology. “As we continue to advance our mission to be a leader in the rapidly growing field of AI-driven drug discovery, with a unique portfolio of assets and capabilities that includes an extensive biobank of heterogeneous tumor samples and CLIA lab, we can benefit from a broad range of backgrounds and perspectives. Dr. Harris brings a wealth of clinical, business and operational healthcare expertise to our BAB, and I look forward to his contributions as we pursue both existing and new opportunities for our technology.”

Mirati Therapeutics, Inc.^® (NASDAQ: MRTX), a commercial stage biotechnology company, recently announced the Journal of Clinical Oncology published clinical results from the KRYSTAL-1 study of adagrasib, a potent and selective KRAS^G12C inhibitor, demonstrating durable IC activity in patients living with KRAS^G12C-mutated NSCLC with untreated CNS metastases. This result is clinically meaningful as CNS metastases are present in 27%-42% of patients living with KRAS^G12C-mutated NSCLC at diagnosis and are linked to worse prognosis and higher rates of disease progression in the CNS. Read the publication, here.

Data with adagrasib from KRYSTAL-1 demonstrating the first prospective evaluation of a KRAS^G12C inhibitor in untreated CNS metastases were based on 25 enrolled patients (19 radiographically evaluable per CNS RECIST v1.1) who had received a median of 1 prior systemic therapy. Results showed an IC objective response rate (ORR) of 42% and IC disease control rate of 90%. High concordance between IC and systemic activity was observed. The median IC progression-free survival was 5.4 months and median overall survival 11.4 months. Notably, findings demonstrate a manageable safety profile consistent with previous reports of adagrasib with few CNS-specific adverse events. The publication of this data follows the recent inclusion of adagrasib in the NCCN guidelines for CNS Cancers.

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