USA News Group – Optimism is on the rise as the American Cancer Society is reporting that the five-year survival rate for those diagnosed with pancreatic has increased to 12%—representing an increase of 1% over the prior year. While 1% may not seem like much, it certainly will mean a lot to the families of the 641 more people that will enjoy life’s moments for at least 5 years or more after their devastating diagnosis. The improvement marks the first time since 2017 that this survival rate rose for two years in a row, and 2023 is showing promise in the clinic, as new developments at the end of 2022 and in the opening of this year are keeping the momentum rolling, including from biotech companies such as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Biomea Fusion, Inc. (NASDAQ:BMEA), AIM ImmunoTech Inc. (NYSE-American:AIM), AstraZeneca PLC (NASDAQ:AZN), and Novartis AG (NYSE:NVS).
One of the most promising series of events in pancreatic cancer treatment came at the tail end of 2022, as biotechnology company Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) received a Fast Track Designation (FTD) from the FDA for its flagship asset, pelareorep, a first-in-class intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies.
The FTD was issued shortly after Oncolytics reported interim clinical data in November showing a 69% objective response rate (ORR), including a complete response in a cohort of first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) patients in Oncolytics’ phase 1/2 GOBLET study.
Pelareorep’s FTD was given for the treatment of advanced/metastatic PDAC, in combination with the chemotherapies gemcitabine and nab-paclitaxel, and Roche Holdings AG’s (OTCMKTS:RHHBY) anti-PD-L1 checkpoint inhibitor, atezolizumab.
"Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication," stated Dr. Matt Coffey, President and CEO of Oncolytics. "With our core programs in breast and pancreatic cancer both nearing pivotal trials, and eligible for the Fast Track program's numerous benefits, we believe we are at a crucial point in Oncolytics' evolution and are excited for what's ahead."
It's worth noting that pelareorep’s ORR of 69% is nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer. However, it was the complete response that came in that was pleasantly unexpected.
"We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy,” said Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech.
The FDA’s Fast Track process was designed to facilitate the development and to expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan. Drugs with Fast Track designation may also qualify for accelerated approval and priority review if relevant criteria are met.
When it comes to the use of what are known as KRAS inhibitors, Biomea Fusion, Inc. (NASDAQ:BMEA) recently announced that the first patient has been dosed in the phase 1/2b COVALENT-102 trial, examining BMF-219 in adults with KRAS-mutated unresectable, locally advanced or metastatic non-small cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma.
This work builds off of pre-clinical studies (meaning those that were not done in humans), suggesting the BMF-219 broadly inhibits the KRAS mutation, which could play a role in the growth and spread of cancer cells.
“We are eager to explore the potential of BMF-219 as a pan-KRAS inhibitor in patients with three of the most prominent KRAS-mutant solid tumor types, including those with tumors that have failed to respond to investigational and approved mutation-specific KRAS inhibitors,” said Dr. Steve Morris, Chief Medical Officer of Biomea.
The initial goal of the COVALENT-102 trial is to determine the proper dosing of the drug. Then, that dose will be used in a larger patient population, where safety and tolerability will be studied. BMF-219 will be administered either once daily or twice daily in 28-day cycles.
Immuno-pharma company AIM ImmunoTech Inc. (NYSE-American:AIM) recently announced it has entered into pancreatic cancer clinical research agreements with AstraZeneca PLC (NASDAQ:AZN) and Erasmus Medical Cancer.
Under the agreement, Erasmus MC is planning to perform an investigator-initiated clinical study, entitled “Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect. DURIPANC Study,” in which it will use both AstraZeneca’s durvalumab and AIM ImmunoTech’s ampligen as study drugs.
Ampligen is AIM’s dsRNA drug currently being developed for globally important cancers. Ampligen has shown therapeutic synergy with checkpoint inhibitors, including increasing survival rates and efficacy, in the treatment of animal tumors when used in combination with checkpoint blockade therapies.
“In the previously conducted human clinical studies, Ampligen has shown synergistic potential with PD-1 checkpoint blockade therapeutics,” said Thomas K. Equels, MS JD, CEO of AIM. “We are thrilled to take this important step forward in clinical development in collaboration with AstraZeneca and its PDL-1 therapy, durvalumab, and further unlock the potential of Ampligen for the treatment of pancreatic cancer where there remains significant unmet need.”
New data presented at the 2022 ESMO Congress showed that the use of peptide receptor radionuclide therapy (PRRT) with lutetium Lu 177 dotatate (Lutathera) improved progression-free survival (PFS) in patients with unresectable, progressive neuroendocrine pancreatic tumors, according to data from the Phase 2 OCCLURANDOM trial (NCT02230176).
In January 2023, Novartis also posted it is recruiting for a Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2.
The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line mPDAC, and the study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.
Article Source: https://usanewsgroup.com/2022/11/27/market-uncertainty-is-creating-opportunities-that-have-somehow-been-overlooked/
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