Increased R&D Activities Have Fueled Growth and Promise for Pancreatic Cancer Treatment

PALM BEACH,  Fla., May 20, 2021 /PRNewswire/ -- Sadly, for patients, the pancreatic cancer market has been steadily rising over the past several years and will most likely continue to grow over the next couple of years. Revenues will increase but so will money flow into R&D efforts to treat this condition. Pancreatic cancer is one of the most dangerous malignancies and is the fourth most common cause of cancer deaths in the U.S.  Increasing tobacco consumption, smoking, obesity, and growing awareness pertaining to various treatment options available are propelling the market growth at a global level. The peak incidence of pancreatic cancer is seen in the age group of 65 to 75 years. Thus, growing geriatric population is also expected to drive the growth during the forecast period. Furthermore, pancreatic cancer is expected to be the second common cause of death in the U.S., by 2030. These factors together would propel the market growth in the forecast period.  The global pancreatic cancer treatment market is expected to reach USD 4.2 billion in 2025, according to a new report by Grand View Research, Inc.  Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Athenex, Inc. (NASDAQ: ATNX), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Trillium Therapeutics Inc. (NASDAQ: TRIL ) (TSX: TRIL), Marker Therapeutics, Inc. (NASDAQ: MRKR).

Another report by Market Research Future adds that: "Pancreatic cancer is hard to catch, even if we are aware of the symptoms to search for. This leads to a late diagnosis and makes treatment more difficult. Many treatments for pancreatic cancer are available in the market such as chemotherapy, surgery, radiotherapy, and targeted therapy. Whereas the surgery is considered as a first treatment option for pancreatic cancer, just like any other cancer. Pancreatic cancer is one of the painful cancers, and the survivor gets relief only if they get treatment on early stage. Furthermore, these treatments prolong the lifespan of the patient if treated on time. Thus, the earlier it is detected, the better would be the prognosis.  Moreover, advancing technology in medical devices is adding fuel to the growth of the market. Furthermore, increasing prevalence of cancer drives the market growth."

Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® Announces Clinical and Biomarker Data Demonstrating Clinical Proof-of-Concept for Pelareorep-Checkpoint Inhibitor Combination in Pancreatic Cancer - Oncolytics Biotech® today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer. The data will be featured in an upcoming electronic poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place virtually from June 4 – 8, 2021.

The newly announced data are from a phase 2 trial evaluating pelareorep in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in pancreatic adenocarcinoma patients who progressed after first-line treatment. Findings from the trial indicate that pelareorep and pembrolizumab synergize and show anti-cancer activity in these difficult-to-treat patients, which is mediated through the complementary immunotherapeutic effects of the two agents.

"These results are very promising, particularly considering the extremely challenging patient population enrolled in the trial. That we saw a response signal in select patients, despite the absence of chemotherapy, provides evidence of the considerable anti-cancer activity of pelareorep-pembrolizumab combination therapy," said Principal Investigator, Devalingam Mahalingam, M.D., Ph.D., Associate Professor of Medicine at The Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "We notably observed an association between treatment-induced anti-cancer immune responses and improved tumor control in some patients, which demonstrates pelareorep's underlying immunologic mechanism of action and validates the strategy of combining it with checkpoint inhibition. I look forward to discussing these data with the scientific community at the upcoming ASCO conference and to the continued evaluation of pelareorep-checkpoint inhibitor combination therapy in select patients with pancreatic and other gastrointestinal cancers."

The data presented in the upcoming ASCO poster represent an update based on additional data that was collected after the cutoff date used for the poster's corresponding abstract. Key data and conclusions that will be featured in this upcoming poster include:

  • Disease control was achieved in 42% (5/12) of patients, with one patient achieving a partial response and four patients achieving stable disease
  • On-treatment tumor biopsies showed pelareorep replication and increased infiltration of CD8+ T cells and PD-L1+ cells relative to pre-treatment samples
  • Patients achieving disease control showed reductions in pro-tumor regulatory T (T­reg) cells in the peripheral blood and tumor tissue compared to those with progressive disease
  • Patients achieving disease control showed increased activation of anti-cancer CD8+ T cells in the peripheral blood compared to those with progressive disease
  • Pelareorep-pembrolizumab combination therapy was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2

Bin Zhang, M.D., Ph.D., Professor at The Northwestern University Feinberg School of Medicine, commented, "These data show that pelareorep can train the immune system to target pancreatic cancer while simultaneously promoting the infiltration of T cells into the tumor and remodeling the tumor microenvironments (TMEs) to be less immunosuppressive. This positions pelareorep to synergistically combine with both checkpoint inhibitors as well as a broad range of other immuno-oncology agents." today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer. The data will be featured in an upcoming electronic poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place virtually from June 4 – 8, 2021.

The newly announced data are from a phase 2 trial evaluating pelareorep in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in pancreatic adenocarcinoma patients who progressed after first-line treatment. Findings from the trial indicate that pelareorep and pembrolizumab synergize and show anti-cancer activity in these difficult-to-treat patients, which is mediated through the complementary immunotherapeutic effects of the two agents.

"These results are very promising, particularly considering the extremely challenging patient population enrolled in the trial. That we saw a response signal in select patients, despite the absence of chemotherapy, provides evidence of the considerable anti-cancer activity of pelareorep-pembrolizumab combination therapy," said Principal Investigator, Devalingam Mahalingam, M.D., Ph.D., Associate Professor of Medicine at The Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "We notably observed an association between treatment-induced anti-cancer immune responses and improved tumor control in some patients, which demonstrates pelareorep's underlying immunologic mechanism of action and validates the strategy of combining it with checkpoint inhibition. I look forward to discussing these data with the scientific community at the upcoming ASCO conference and to the continued evaluation of pelareorep-checkpoint inhibitor combination therapy in select patients with pancreatic and other gastrointestinal cancers."

The data presented in the upcoming ASCO poster represent an update based on additional data that was collected after the cutoff date used for the poster's corresponding abstract. Key data and conclusions that will be featured in this upcoming poster include:

  • Disease control was achieved in 42% (5/12) of patients, with one patient achieving a partial response and four patients achieving stable disease
  • On-treatment tumor biopsies showed pelareorep replication and increased infiltration of CD8+ T cells and PD-L1+ cells relative to pre-treatment samples
  • Patients achieving disease control showed reductions in pro-tumor regulatory T (T­reg) cells in the peripheral blood and tumor tissue compared to those with progressive disease
  • Patients achieving disease control showed increased activation of anti-cancer CD8+ T cells in the peripheral blood compared to those with progressive disease
  • Pelareorep-pembrolizumab combination therapy was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2

Bin Zhang, M.D., Ph.D., Professor at The Northwestern University Feinberg School of Medicine, commented, "These data show that pelareorep can train the immune system to target pancreatic cancer while simultaneously promoting the infiltration of T cells into the tumor and remodeling the tumor microenvironments (TMEs) to be less immunosuppressive. This positions pelareorep to synergistically combine with both checkpoint inhibitors as well as a broad range of other immuno-oncology agents."  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:

Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, led by its Orascovery platform, recently announced that investigators from Texas Children's Cancer Center and the Center for Cell and Gene Therapy at Baylor College of Medicine presented new clinical data from the ongoing GINAKIT2 phase 1 study of Athenex's cell therapy candidate KUR-501 targeting GD2 in neuroblastoma at the American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting on Friday, May 14, at 11 am ET.

Observed responses to date in 11 evaluable, heavily pretreated patients with neuroblastoma, include one complete response (CR) and one partial response (PR). Four additional patients have exhibited stable disease (SD). The durations of response for the CR and PR were approximately 5 and 3 months, respectively. No patients experienced grade 2 or higher toxicities related to the GD2-CAR NKTs. Post-treatment tumor biopsies showed GD2-CAR NKTs homing to metastatic lesions at all dose levels. The CAR-NKT AUC normalized to disease burden (AUC/Curie score using MIBG scan quantified tumor burden) appears to be associated with response to therapy.

Seelos Therapeutics, Inc. (NASDAQ: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, recently  announced positive data from Part 1, the open-label cohort, of its potentially registrational Proof-of-Concept study of SLS-002 (intranasal racemic ketamine) demonstrating a significant treatment effect and a well-tolerated safety profile for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

"Rapid and clinically meaningful efficacy both as an anti-depressive and anti-suicidal therapeutic after a single dose"  This study enrolled 17 subjects diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide with a baseline score of ≥ 28 points on the Montgomery-Åsberg Depression Rating Scale (MADRS), a score of 5 or 6 on MADRS Item-10, a score of ≥ 15 points on the Sheehan-Suicidality Tracking Scale (S-STS) total score and a history of previous suicide attempt(s), as confirmed on the Columbia Suicide Severity Rating Scale (C-SSRS) with a history of at least one actual attempt, or if the attempt was interrupted or aborted, is judged to have been serious in intent.

Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, recently announced that it has dosed the first multiple myeloma patient with TTI-622 (SIRPα-IgG4 Fc), an investigational checkpoint inhibitor of the innate immune system, in combination with the proteasome inhibitor carfilzomib and dexamethasone.   TTI-622 is a fusion protein that is designed to block the inhibitory activity of CD47, a molecule that is overexpressed by a wide variety of tumors. CD47 binds to SIRPα on macrophages and delivers a "don't eat me" signal that inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that TTI-622 exhibits anti-myeloma activity as a monotherapy that is enhanced when combined with proteasome inhibitors.

"With the dosing of this patient we have begun an exciting new phase of development for TTI-622," commented Dr. Ingmar Bruns, Trillium's Chief Medical Officer. "This is the first patient to receive TTI-622 in combination with another anti-cancer agent, and we are eager to build upon the monotherapy activity that we have observed in multiple hematologic cancers. More broadly, this marks the start of a comprehensive Phase 1b/2 program that will evaluate TTI-622 with various combination agents in five indications and six patient settings."

Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, recently provided a corporate update and reported financial results for the first quarter ended March 31, 2021.

"We had a productive first quarter supported by our recently completed financing, strengthening our overall cash position and enabling continued growth and expansion of our Multi-TAA pipeline," said Peter L. Hoang, President & CEO of Marker Therapeutics. "In addition, we continue to make strong progress on both the clinical and manufacturing fronts. In March, we dosed the first patient in the safety lead-in portion of our Phase 2 trial in post-transplant acute myeloid leukemia, or AML, and continue to activate clinical sites. In parallel, we continue to optimize the MT-401 cell therapy manufacturing process, which we believe could result in an increase in the number of T cells available for patient administration—among other benefits—as we prepare to operationalize our new in-house cGMP facility in the first half of the year."

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