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Vancouver, BC – October 11, 2023 – USA News Group – Researchers are becoming increasingly concerned with the rates of cancer on the rise among people under 50. A recent study found a nearly 80% global increase in the number of under-50s getting diagnosed with cancer from 1990 to 2019. And among the most worrying rise is in pancreatic cancer, which comes with extremely low survival rates. However, with strategies such as the “Cancer Moonshot,” a $200M boost from a newly formed VC firm, and sustained efforts from the Pancreatic Cancer Action Network (PanCAN), a leading pancreatic cancer organization, which this year noted the 5-year survival rate is approximately 12%. Many new developments are currently underway from biotech firms searching for new treatments and methods of diagnosis, including those from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Genelux Corporation (NASDAQ:GNLX), Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), Pfizer Inc. (NYSE:PFE) and Seagen Inc. (NASDAQ:SGEN).
In the process of championing its potentially revolutionary Precision Promise study, PanCAN recently selected the leading drug candidate of Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) known as pelareorep for their pivotal Phase 3 trial. Signalling even more confidence in pelareorep’s potential, PanCAN also followed up the selection by rewarding Oncolytics with its second annual PanCAN Therapeutic Accelerator Award, which comes with a US$5 million grant to further develop leading-edge treatments.
“This generous grant will enable early and late-stage patients with pancreatic cancer to potentially benefit from another commonly employed chemotherapy backbone, as FOLFIRINOX and gemcitabine + nab-paclitaxel are the most frequently used chemotherapy standards of care in both the first and second-line setting,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option.”
Near the end of 2022, pelareorep delivered a big win when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer. The FDA’s decision came almost immediately after an update on ONCY’s GOBLET study, which delivered amazing results, including a 69% objective response rate (ORR) in the first group of patients tested and one even having a rare complete response (CR).
“Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy,” said Dr. Coffey.
The $5M grant enables Oncolytics Biotech to continue the next stage of its research focused pelareorep, including pursuing a new combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor. The award came swiftly on the heels of another US$15 million ONCY successfully raised in order to continue the advancement of its pelareorep clinical programs in both pancreatic and metastatic breast cancers, with significant support from an institutional investor.
“With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options,” said Julie Fleshman, JD, MBA, President and CEO of PanCAN. “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.”
The two capital injections combined have left Oncolytics with an excellent cash runway position. According to their Q2 2023 financial results, on a pro forma basis, including the net proceeds from the public offering, Oncolytics had CAD$42.7 million on June 30, 2023, which should last them into the second half of 2024.
So far, 2023 has been a great year for Genelux Corporation (NASDAQ:GNLX), which has seen positive results from trials of its lead therapy Olvi-Vec (olvimulogene nanivacirepvec) that’s primarily been active in studies pertaining to ovarian cancer. However, Genelux has also been forthcoming about its V2ACT Immunotherapy, which incorporates Olvi-Vec and adoptive cell therapy in targeting newly diagnosed, surgically resectable pancreatic cancer patients.
Launched in late 2020, Genelux’s pancreatic cancer program is a joint venture with TVAX Biomedical to develop the V2ACT Immunotherapy, housed under the JV company called V2ACT Therapeutics LLC. It was at that time that V2ACT announced FDA clearance of an IND application to proceed with a Phase 1/2a Study of V2ACT for the treatment of pancreatic cancer.
“It is generally accepted there is no effective monotherapy for the treatment of pancreatic cancer, a devastating disease,” said Gary Wood, Chief Science Officer of V2ACT Therapeutics. “V2ACT provides complementary immunotherapies in a unique process designed to transform non-immunoreactive pancreatic cancer into an immunoreactive ‘hot spot’ with cancer neoantigen-specific T cell infiltration and cancer cell killing. Therefore, V2ACT has the potential to effectively treat any type of cancer, even those considered to be resistant to immunotherapy.”
Back in May 2022, Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) launched a study to evaluate the safety, PK, and dose response of its treatment paltusotine in subjects with carcinoid syndrome, which includes the potential for carcinoid tumor of pancreas. Now in 2023, paltusotine is in Phase 3 clinical development for acromegaly and the above-mentioned Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors, and the company was able to successfully raise $350M in new funds. Preliminary data from the Phase 2 carcinoid syndrome study is anticipated in Q4 2023.
Paltusotine has already demonstrated stable biochemical and symptom levels with two-years oral administration. Approximately 90% of participants said they preferred once-daily, oral paltusotine over current standard of care of injected SRLs when asked after one year of treatment.
“At Crinetics, our discovery scientists strive to optimize every atom in each drug candidate to craft the best possible medicine we can for patients with endocrine diseases,” said Dr. Scott Struthers, founder and CEO of Crinetics. “These efforts yielded paltusotine, which entered into its first clinical studies in 2017. Since then, the Crinetics team has developed a rich pipeline of additional small molecule drug candidates hoping to improve treatment options for patients with endocrine disorders.”
Earlier this year Pfizer Inc. (NYSE:PFE) (NEO:PFE) made a huge splash in the biotech sector by investing $43 billion to battle cancer, by acquiring Seagen Inc. (NASDAQ:SGEN).
“Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health,” said Dr. Albert Bourla, Chairman and CEO of Pfizer. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise. Oncology continues to be the largest growth driver in global medicine, and this acquisition will enhance Pfizer’s position in this important space and contribute meaningfully to the achievement of Pfizer’s near- and long-term financial goals.”
Seagen has been working on SGN-STNV, which is currently in Phase I for pancreatic cancer and other solid tumor indications. The study was launched in 2021, and is still in progress, and in 2022 reported data from preclinical models of SEA-CD40 in combination with other therapies in metastatic pancreatic ductal adenocarcinoma (PDAC), and provided an update in January 2023—two months before the Pfizer acquisition.
“Preliminary activity is encouraging based on historical chemotherapy outcomes. Further survival follow up is required to inform our next steps in pancreatic cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We are continuing to advance the ongoing phase 2 trial of SEA-CD40 in melanoma and in non-small cell lung cancer.”
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