Palm Beach, FL – October 23, 2023 – FinancialNewsMedia.com News Commentary – Pancreatic ductal adenocarcinoma (PDAC) is a fatal malignancy of both the digestive system and endocrine system with disappointing prognoses. The number of newly diagnosed PDAC cases worldwide is approaching five million each year. As the seventh leading cause of cancer-related deaths, PDAC also accounts for more than 4.6 million new deaths. Given the increase in the incidence of PDAC, it is estimated that PDAC will surpass breast cancer as the third leading cause of cancer death by 2025. Currently, standard therapy for patients with PDAC focuses on conventional chemotherapeutic regimens and curative-intent surgical resection if possible; yet, outcomes are disappointing with a 5-year survival rate of 6%. The few choices of therapeutic options with limited effects, the advanced stage at presentation due to late detection, and the vicious behavior of PDAC contribute to the high mortality rate. Therefore, developing novel therapies for PDAC are direly needed.  A recent open access research article on the effect of chimeric antigen receptor T cells against protease-activated receptor 1 for treating pancreatic cancer on the BMC Medicine website addressed the current state of some cutting edge research for effective therapies.  BMC Medicine said: “PDAC is an aggressive disease with unfavorable prognoses despite improvements in multimodality therapy thus far, and additional novel therapeutic targets and candidate molecules to escalate the treatment response are urgently needed. There are major barriers to applying CAR-T therapy for PDAC, including a lack of specific cancer-associated antigen expressions, complex logistics, an immune-suppressive TME, toxicity concerns, and manufacturing/financial restrictions. The role of immunotherapy in PDAC has yet to be determined.”  Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Cardiff Oncology, Inc. (NASDAQ: CRDF), Eli Lilly and Company (NYSE: LLY), AbbVie (NYSE: ABBV), Lipella Pharmaceuticals Inc. (NASDAQ: LIPO).

BMC Medicine continued: “PAR1 overexpression was found to be closely associated with tumor progression and poor survival outcomes in PDAC. Rather than being specific to tumor cells, PAR1 is expressed by the surrounding stroma that consists of endothelial cells, fibroblasts, and macrophages. Activation of stromal cell-associated PAR1 expression in the TME leads to increased vascular permeability, ECM production, and cytokine secretion, thereby promoting tumorigenesis. In this study, we developed PAR1-targeted CAR-T cells using third-generation CARs containing additional signaling domains, including CD28, CD137 (4-1BB), and CD247, to augment activation of cytokine production and a tumor-eradication ability. PAR1-targeted CAR-T cells demonstrated specific killing potency both in vitro and in a xenograft murine model, accompanied by cytokine release.  Our analyses revealed that the cytotoxic activity of PAR1CAR-T cells toward PDAC cells was significantly correlated with the targeting specificity. Furthermore, in our cell line xenograft murine model, compared to mice treated with mock-transduced T cells, non-transduced CD3+ T cells, or 1 × PBS, PAR1CAR-T-cell-treated mice had significantly greater TME infiltration, cytokine and chemokine induction, and tumor-eliminating effects. The engineered CAR-T-cell affinity and efficacy were affected by the PAR1 antigen density on target cells in PDAC cell lines and the xenograft animal model. In the current study, we not only examined the influence of CAR affinity and antigen density on primary T cell activation but also its cytotoxic ability in vivo. A highly promising beginning was exhibited in the present study that suggests future applications of PAR1-targeted CAR-T-cell-based immunotherapy to human PDAC.”

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study – Oncolytics Biotech® Inc., a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.

“The results presented at ESMO met the criteria to advance the study to the next stage, with 4 of 14 enrolled patients demonstrating stable disease at week 16. These data demonstrated a 40% overall disease control rate and provided further encouraging data for pelareorep,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “In a patient population that had failed multiple rounds of treatment, we continue to see pelareorep’s ability to synergize with atezolizumab by generating an immune response, including the expansion of T cell clones. The translational data from this cohort are consistent with the observed clinical response, providing further support for pelareorep’s mechanism of action as a potential backbone immunotherapy for patients with gastrointestinal and other forms of cancer.”

“We designed the GOBLET study to evaluate pelareorep’s ability to improve clinical outcomes in different gastrointestinal cancers, including at different disease stages, and to better understand pelareorep’s mechanism of action by generating strong translational data. The data from this arm of the study demonstrate that pelareorep is taken up by tumor cells and stimulates T cell expansion even in heavily pre-treated colorectal cancer patients,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “These patients demonstrated a 40% disease control rate, a progression-free survival of 2.8 months, a median overall survival of 8.0 months, and a 12-month survival rate of 33%, exceeding historical results1-3. These findings are encouraging given that exhaustion of tumor-infiltrating lymphocytes, resulting from late stage of disease and extensive prior chemotherapy, may have limited their ability to expand in response to treatment. Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep’s ability to synergize with atezolizumab. These data also support pelareorep’s immunologic mechanism of action and will inform our plans for further development.”

Additional ONCY Breaking News:  Oncolytics Presents Positive Updated Pancreatic Cancer Data from GOBLET Phase 1/2 Study at ESMO – Oncolytics Biotech® Inc. today also announced the poster presentation of positive, updated results from the Phase 1/2 GOBLET study evaluating pelareorep-based combination therapy in patients with pancreatic ductal adenocarcinoma (PDAC) at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.

“We are very pleased to share such positive and consistent data on pelareorep from the PDAC arm of the GOBLET study, including an impressive overall response rate, 7.2 months of median progression-free survival, interim median overall survival of 10.6 months, and expansion of both pre-existing and new T-cell clones. These data build upon results from previous studies showing the clinical benefit of pelareorep combination therapy in PDAC and support the decision to move to a licensure-enabling study in pancreatic cancer,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “Everything we do at Oncolytics is focused on advancing the development of our immunotherapy candidate, pelareorep, with a goal of providing improved care and longer survival for patients with pancreatic cancer and other tumor types. The data we are presenting at ESMO provide a solid foundation as we advance our pancreatic cancer program through the Precision PromiseSM Phase 3 trial in this indication.”   CONTINUED… Read these full press releases and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/

Other recent developments in the biotech industry of note include:

Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced positive clinical data with onvansertib monotherapy and combination therapy in our ongoing trials in metastatic pancreatic ductal adenocarcinoma (mPDAC) and small cell lung cancer (SCLC), as well as plans for a mPDAC first-line investigator-initiated trial (IIT) of the combination of onvansertib plus standard-of-care (SoC).

“We are excited that the data released from these trials, in two challenging cancers with low survival rates, expands the opportunity for onvansertib beyond our lead program in RAS-mutated mCRC,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “In pancreatic cancer, the strength of the data provides a clear rationale for a first-line trial using onvansertib in combination with standard of care, which we believe provides the greatest opportunity for a positive impact on patients. In small cell lung cancer, we are encouraged to observe single-agent activity with onvansertib monotherapy in this difficult-to-treat extensive stage refractory setting.”

Eli Lilly and Company (NYSE: LLY) recently announced five-year outcomes from a pre-planned analysis of the Phase 3 monarchE study evaluating two years of adjuvant Verzenio® (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer (EBC) at a high risk of recurrence. These data were shared in a late-breaking presentation at the 2023 European Society for Medical Oncology (ESMO) Congress.

“The five-year time period is an established landmark for adjuvant breast cancer clinical trials and is an important milestone for patients and physicians in this curative setting,” said Nadia Harbeck, M.D., Ph.D, Director of the Breast Center and Chair for Conservative Oncology, Department of OB&GYN, LMU University Hospital (Munich, Germany), monarchE investigator, and presenter of the results at the 2023 ESMO Congress. “These five-year monarchE data clearly demonstrate a carryover effect beyond the completion of two years of abemaciclib treatment, with the IDFS and DRFS curves continuing to separate, reinforcing confidence in the role of abemaciclib added to endocrine therapy in the adjuvant setting for those with a high risk of recurrence.”

AbbVie (NYSE: ABBV) recently announced that EPKINLY (epcoritamab injection/epcoritamab for injection) has received Health Canada authorization with conditions. It is the first and only subcutaneous (SC) T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL transformed from indolent lymphoma, high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL) or follicular lymphoma Grade 3B(FLG3b) after two or more lines of systemic therapy and who have previously received or are unable to receive CAR-T cell therapy. EPKINLY has been issued marketing authorization with conditions, pending the results of clinical trials to verify its clinical benefit. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration.

DLBCL is a type of aggressive, fast-growing non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL. Although DLBCL is often curable, many patients are refractory to, or relapse after first-line treatment with standard chemoimmunotherapy.2 For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged. However, convenient and readily-available subcutaneous single agent therapies or off-the-shelf treatment options are limited.

Lipella Pharmaceuticals Inc. (NASDAQ: LIPO), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, recently announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for a multi-center, phase-2a, dose-escalation clinical trial to assess the safety and efficacy of LP-310 in patients with symptomatic oral lichen planus (OLP), a highly morbid condition with no effective treatment.

In March 2023, Lipella created a five-member Scientific Advisory Board in Oral Health, made up of a group of highly regarded experts in oral medicine, to focus on the development of LP-310. This team helped craft the clinical strategy and will be involved in the recruitment of high-quality clinical sites.  Dr. Jonathan Kaufman, CEO of Lipella, said, “This FDA approval demonstrates our ability to significantly advance our value proposition by adding a phase-2, clinical-stage asset to our pipeline.”

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