Palm Beach, FL – November 10, 2022 – FinancialNewsMedia.com News Commentary – The pancreatic cancer treatment market is fiercely competitive. To maintain the escalating market competition, the market participants are implementing methods including increased R&D spending, mergers, acquisitions, and product developments. While every disease has unique characteristics and challenges, pancreatic cancer can be particularly difficult to treat. Research teams around the world are working to uncover novel ways to attack this disease. Every day doctors learn more about how new treatments, such as immunotherapies, could help treat pancreatic cancer more effectively. An article from Johns Hopkins in hopkinsmedical.org, said: “Johns Hopkins surgical oncologist Kelly Lafaro, M.D., M.P.H., explains what makes pancreatic cancer so challenging and why immunotherapy may result in treatment improvements in the near future. According to Lafaro, curing pancreatic cancer means completely eliminating all cancer from the body. “In order to do this we have to address two fronts: the tumor itself as well as any microscopic cells throughout the body.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK), NeuroBo Pharmaceuticals, Inc. (NASDAQ: NRBO), Merck (NYSE: MRK), TransCode Therapeutics, Inc. (NASDAQ: RNAZ).
It said that comprehensive pancreatic cancer treatment must address the following: Local Disease & Systemic Disease. It added: “Local disease: This refers to the primary tumor in the pancreas, and is called Stage 1. If caught at an early stage, surgery (sometimes with chemotherapy after surgery) may effectively win this battle, completely removing all signs of cancer. Systemic disease: Pancreatic cancer cells can spread — undetected — to other parts of the body. At some point, cells shed off of a pancreatic tumor, enter the blood stream and circulate throughout the body. Some of these cells may spread or metastasize to other organs such as the liver or lungs. This spreading can happen before patients show symptoms. Lafaro refers to these cells as “seeds” of metastatic disease. “Just as the wind blows and spreads dandelion seeds, new ones can grow great distances away. Even though at first the seeds are in the ground and you cannot see them, they are there and ultimately will grow given the appropriate conditions,” she says. Because doctors can’t always detect this microscopic disease at first, it can be much more difficult to fight. Until recently, combinations of chemotherapy, radiation and surgery were only somewhat effective at treating systemic pancreatic cancer (cancer that has spread or metastasized to other parts of the body). Today, researchers are focused on developing biological therapies that are more targeted in how they attack pancreatic cancer cells.”
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech® Presents Updated Clinical Data at SITC Annual Meeting Showing a 69% Objective Response Rate and Confirmed Complete Response in GOBLET Study’s Pancreatic Cancer Cohort – Oncolytics Biotech® today announced updated results from the phase 1/2 GOBLET study’s first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) cohort. Patients in this cohort are treated with the combination of pelareorep, Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel. The updated data are featured in a poster presentation at the ongoing Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, which is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA.
Objective response rate (ORR) and clinical benefit rate (CBR) in GOBLET’s PDAC cohort (n=13) were 69% and 85%, respectively, as of the SITC poster’s data cutoff date (October 12, 2022). Additional data and conclusions presented in the poster are summarized below.
- One of thirteen evaluable patients achieved a confirmed CR
- Eight of thirteen evaluable patients achieved a PR
- Two of thirteen evaluable patients achieved stable disease (SD)
- The observed ORR of 69% is substantially higher than the average ORR of ~25% reported in historical control trials of gemcitabine and nab-paclitaxel in pancreatic cancer1-4
- GOBLET’s PDAC cohort exceeded the protocol-specified success criterion for Stage 1 of ≥ 3/12 objective responses
- The studied treatment combination has been well tolerated, with no safety concerns identified to date
“GOBLET’s interim results indicate pelareorep may be the key to finally improving the standard-of-care for first-line treatment of pancreatic cancer, a clear need given that treatment options have not changed for many years despite their limited benefits,” commented Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. “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. 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.”
Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., added, “The impressive results being presented at SITC, together with prior clinical data providing a strong mechanistic rationale for the apparent synergies being displayed by pelareorep, PD-L1 inhibition, and chemotherapy, support our pancreatic cancer program’s advancement into a pivotal trial. We look forward to discussions with regulators to enable these efforts and align on the optimal design for a licensure-enabling study. In parallel, we continue to make strong progress with our breast cancer program; and are thrilled to be advancing a pipeline that includes two potentially compelling registration opportunities.”
The poster (#650), entitled, Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study, will be available for live viewing at the SITC meeting tomorrow, November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET. A copy of the poster will also be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the meeting. CONTINUED… Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/
Other recent developments in the biotech industry of note include:
Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) recently announced its third quarter 2022 financial results for the period ended September 30, 2022. “During the third quarter we continued to see the benefits of reduced operating expenses,” said Gary Crocker, Chairman of Merrimack’s Board of Directors. “We will continue to monitor developments in Ipsen’s Onivyde® (irinotecan liposomal injection) program and Elevation’s seribantumab program.”
Shares of Merrimack Pharmaceuticals Inc. skyrocketed 199.5% toward a 4 1/2-year high in morning trading Wednesday, after the France-based biopharmaceutical company Ipsen said overnight that its Onivyde pancreatic cancer treatment met the primary endpoint of a Phase 3 trial. Ipsen said it plans to file a supplemental New Drug Application (NDA) with the U.S. Food and Drug Administration for Onivyde.
NeuroBo Pharmaceuticals, Inc. (NASDAQ: NRBO) announced the closing of an underwritten public offering of units with gross proceeds of approximately $17.3 million, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by NeuroBo. NeuroBo also announced the closing of the concurrent private placement of Series A Convertible Preferred Stock and warrants with gross proceeds of $15 million, prior to deducting placement fees and offering expenses payable by NeuroBo.
In addition, NeuroBo today announced the closing under the license agreement with Dong-A ST Co., Ltd. (“Dong-A”), pursuant to which NeuroBo has obtained an exclusive license to develop and commercialize DA-1241 and DA-1726, which are currently being evaluated for the treatment of nonalcoholic steatohepatitis (NASH), obesity and type 2 diabetes. Under the license agreement, NeuroBo will be responsible for global development, regulatory and commercial activities other than for certain Asian-Pacific geographies. Dong-A will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Korea.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, recently announced that an updated systematic literature review examining the global impact and effectiveness of HPV vaccination using GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was published online in the journal Expert Review of Vaccines. This systematic review observed that use of GARDASIL led to reductions in the rates of high-grade (precancerous) and low-grade cervical lesions, as well as reductions in certain non-cervical HPV-related diseases and HPV infection in women and men. The systematic review included 138 peer-reviewed studies, published between March 1, 2016, and March 31, 2020. It details the impact and effectiveness of GARDASIL through immunization programs in 23 countries, across Africa, Asia, Europe, Australia, South America and North America and builds on a prior review of real-world data published in 2016. The previous real-world analysis was based on 58 peer-reviewed studies published between Jan. 1, 2007, and Feb. 29, 2016, across Australia/New Zealand, Europe and North America. Studies examining GARDASIL 9® (Human Papillomavirus 9-valent Vaccine, Recombinant) were not included in this review.
In the U.S., GARDASIL1 is indicated for use in females 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved for use in males 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18, for the prevention of anal dysplasia and precancerous lesions caused by HPV types 6, 11, 16 and 18, and for the prevention of genital warts caused by HPV types 6 and 11. GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL
TransCode Therapeutics, Inc. (NASDAQ: RNAZ), an RNA oncology company committed to more effectively treating cancer using RNA therapeutics, recently reported positive preclinical results with its immunotherapy candidate, TTX-siPDL1, in pancreatic adenocarcinoma.
After two weekly treatments with TTX-siPDL1 combined with the standard-of-care chemotherapeutic, gemcitabine, tumor volumes were 25% of those in untreated animals. By the fifth week of treatment, 75% of animals treated with TTX-siPDL1 plus gemcitabine were still alive versus 25% of those that were treated with gemcitabine alone. This is the second drug candidate from TransCode’s platform to show positive preclinical results in pancreatic cancer. The animal model used in this latest study involving TransCode’s siRNA immunotherapy candidate involved implantation of a highly aggressive murine cell line directly into the pancreata of recipient mice. Body weight and histopathology assessments provided preliminary evidence that the treatment was tolerated. Finally, immune cell profiling of tumors from the treated animals indicated successful PD-L1 inhibition and immune cell activation, consistent with the known mechanism-of-action (MOA) of checkpoint inhibitors. Because TTX-siPDL1 incorporates a siRNA against PD-L1 as its functional component, it has the potential to trigger the degradation and/or translational repression of the PD-L1 messenger RNA (mRNA), preventing the cell from expressing the PD-L1 antigen.
Pancreatic cancer has proven difficult to treat with conventional drugs and has been resistant to initial immunotherapy approaches. The reason pancreatic cancer is challenging to treat with immunotherapy is in part due to the presence of a thick fibrous corona surrounding the tumor. In human pancreatic ductal adenocarcinoma, or PDAC, up to 90% of the total volume of the tumor is represented by fibrous tissue, inhibiting access of therapeutics and immune cells into the tumor.
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