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Roughly five years after selling its flagship cancer asset Onivyde from to French biotech giant Ipsen S.A. for approximately $1 billion, Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) is still reaping the drug's benefit despite being a shuttered drug company with no employees or any active research programs. As Ipsen prepares to file a supplemental New Drug Application (sNDA) for pancreatic cancer, Merrimack saw its shares soar toward a 4.5-year high on account of future cash payments that were contingent on Onivyde winning additional regulatory approvals. As the Centers for Disease Control and Prevention reports cancer deaths trending downward, there have been modest improvements in survival for pancreatic cancer, thanks to developments from the biotech sector from innovators such as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Mirati Therapeutics, Inc. (NASDAQ:MRTX), Amgen Inc. (NASDAQ:AMGN), and Seagen Inc. (NASDAQ:SGEN).
For Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) a catalyst event may be on the horizon sparked by promising data sets coming from the company's flagship asset pelareorep.
The optimism comes from statistically significant results from Oncolytics Biotech's ongoing multi-indication phase 1/2 GOBLET study, patients treated with a combination of pelareorep, with chemotherapy (gemcitabine, and nab-paclitaxel) and atezolizumab.
"The robust efficacy signal in GOBLET markedly exceeded expectations based on historical results and is especially encouraging as most responding patients had their tumor regressions confirmed by subsequent evaluations," said Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech. "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."
The "historical results" the company is comparing to come from 2013 study titled Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine study by Dr. Von Hoff in the New England Journal of Medicine, which later that year led to the FDA approval of the chemotherapy combination of nab-paclitaxel with gemcitabine to treat patients with metastatic pancreatic cancer.
Using the 2013 data as a historical control, analysts can now see how the pelareorep combination's data truly stands out—delivering nearly triple the objective response rate (ORR) with 69% vs the 2013 study's 23-29%.
"Even the company didn't anticipate this type of news"said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Incin an interview with Departures Capital.
While the near 70% ORR is statistically significant, so too was the confirmed presence of a complete response (CR)—defined as the disappearance of all signs of cancer in response to treatment.
"In talking with key opinion leaders, they were astounded with these results, [with one saying] anything that approaches 40% will get everyone in the community excited. We're reporting at 69% ORR, with a complete response," added Dr. Coffey added. "Now in terms of this complete response, I think it's important to recognize, we've looked at over 1000 patients of historical responses, and a complete response is typically seen in 0.2-0.4% of the population, and we're reporting 1 out of 13 (7.69%). So, I think this is a very encouraging clinical sign."
For comparison, Oncolytic Biotech's pelareorep trials produced a 7.7% CR (1 in 13) of test patients, compared to only 0.12% CR (1 in 861) from the 2013 group.
Earlier in 2022, the biotech sector also received positive clinical data from multiple other developers, beginning with Seagen Inc. (NASDAQ:SGEN) in mid-January that reported data from its phase 1 clinical trial combining their asset SEA-CD40 with chemotherapy (same as Oncolytics) and an anti-PD-1 (pembrolizumab) in patients with pancreatic ductal adenocarcinoma (PDAC).
Activity of SEA-CD40 in combination with chemotherapy and the anti-PD-1 was observed in both doses of SEA-CD40 tested. The overall (N = 61) cORR was 44%, median progressions free survivability (PFS) was 7.4 months (95% CI: 5.6-9.0), and median overall survival (OS) was 15.0 months (95% CI: 7.8-19.9). This combination also showed evidence of immune activation consistent with the SEA-CD40 mechanism of action.
"Preliminary activity is encouraging based on historical chemotherapy outcomes," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Further survival follow up is required to inform our next steps in pancreatic cancer."
Later in January 2022, Mirati Therapeutics, Inc. (NASDAQ:MRTX) presented its own positive clinical data with investigational adagrasib in patients with KRASG12C-Mutated Gastrointestinal cancers.
The data came from a Phase 2 cohort of the KRYSTAL-1 study evaluating the drug at the 600mg BID dose in patients with pretreated PDAC and other gastrointestinal tumors harboring a KRAS mutating.
Of the evaluable patients (n=27), the ORR was 41% and the disease control rate (DCR) was 100%. In evaluable patients with pancreatic cancer (n=10), the RR was 50%, including 1 unconfirmed PR; the median duration of response (mDOR) was 7.0 months, with a median follow up of 8.1 months.
"New clinical data presented at ASCO GI show thatadagrasib, an inhibitor of KRASG12C, demonstrated promising clinical activity in patients with pancreatic cancer and other GI tumors," said Dr. Tanios S. Bekaii-Saab, an investigator of the KRYSTAL-1 study. "These findings build on the previously reported positiveadagrasibclinical data in colorectal and pancreatic cancers, and are highly encouraging, warranting further investigation ofadagrasibin this setting."
The following month, Amgen Inc. (NASDAQ:AMGN) reportedly saw potential for its own KRAS drug LUMAKRAS in treating pancreatic cancer, through encouraging and clinically meaningful anticancer activity from its CodeBreaK 100 Phase 1/2 trial in patients with KRASG12C mutated advanced pancreatic cancer.
Within the February 2022 data, Amgen reported LUMAKRAS demonstrated centrally confirmed ORR of 21% and DCR of 84% across 38 heavily pre-treated advanced pancreatic cancer patients. Nearly 80% of patients received LUMAKRAS as a third-line or later therapy.
"CodeBreaK is the largest and broadest global clinical trial program to date with one of the most robust, centrally reviewed datasets," saidDavid M. Reese, M.D., executive vice president of Research and Development atAmgen. "As we learn more from the extensive data that we collect, we'll continue to invest in the program by expanding cohorts and exploring new combinations so that we can help as many patients as possible."
As the market witnesses these developments, it has shown it rewards successes in the field of pancreatic cancer. Upon the Ipsen's latest data release from its Onivyde regimen demonstrating statistically significant improvement in OS in previously untreated metastatic PDAC patients, the market responded by more than doubling shares of Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) sending them to a 4-year high.
Because Ipsen and Onivyde met its primary and key secondary endpoint, Merrimack is eligible for up to $450 million in milestone payments for the pancreatic cancer treatment.
"During the third quarter we continued to see the benefits of reduced operating expenses," said Gary Crocker, Chairman of Merrimack's Board of Directors in the company's Q3 2022 financial results press release. "We will continue to monitor developments in Ipsen's Onivyde(R) (irinotecan liposomal injection) program and Elevation's seribantumab program."
As of this publication, the FDA has officially approved 18 drugs or pancreatic cancer, and 4 drug combinations used in pancreatic cancer, as well as 5 drugs approved for gastroenteropancreatic neuroendocrine tumors, and 2 drugs for pancreatic neuroendocrine tumors.
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