Oncolytics Biotech Inc T.ONC

ONCY pelareorep demonstrates 69% ORR in pancreatic cancer

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ONCY pelareorep biomarker data in pancreatic cancer

"Using patient blood samples from our REO 024 study in second line pancreatic cancer, T cell receptor sequencing was performed with Adaptive Biotechnologies' immunoSEQ Assay to measure the diversity or clonality of the T cell population,'' said Dr. Rita Laeufle, CMO of Oncolytics Biotech. ''Results from this analysis demonstrate that higher clonality after one three-week cycle of treatment can identify patients likely to respond to combination treatment of pelareorep and a checkpoint inhibitor.''

https://www.accesswire.com/537346/Oncolytics-BiotechR-Presents-Biomarker-Data-in-Second-line-Pancreatic-Cancer-at-AACR

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https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-ord-shs?threadid=35674709

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https://www.drugs.com/clinical_trials/pelareorep-selected-inclusion-phase-3-pancreatic-cancer-trial-20881.html

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On October 16, 2023  the ESMO metastatic pancreatic cancer abstract was released preliminary updated PDAC data showing a 6-month surivial rate of 82% in a patient population comprised of patients where 92% presented with metastatic disease, 69% in the liver - the worst of the worst - which historically only 10% survive longer than one (1) year.   The

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In another phase 2 randomized clinical trial of 65 patients, durvalumab (Imfinzi - Astrazeneca) plus tremelimumab therapy was tolerated in patients with metastatic pancreatic ductal adenocarcinoma and had an objective response rate of 3.1%, and no patients responded to the checkpoint inhibitor durvalumab as monotherapy.

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The observed efficacy of durvalumab plus tremelimumab therapy and durvalumab monotherapy in a 65 patient Phase 2 study reflective of a population of patients with mPDAC who had poor prognoses and rapidly progressing disease, the objective response rate was only 3.1%, and no patients (0.0%) responded to durvalumab monotherapy. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647002/ In

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Thus far pelareorep in combination with a checkpoint inhibitor .. ONCYs GOBLET Phase 1/2  with pelareorep reported an objective response rate (ORR) of 62% and a 6-month progression-free survival (PFS) rate of 72.9%, and a 6-month overall survival (OS) rate of  82.1% in a Phase 2 study

[fox7mf]

Where's the CR?

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I repeat -- on October 16, 2023  the ESMO metastatic pancreatic cancer abstract was released preliminary updated PDAC data showing a 6-month surivial rate of 82% in a patient population comprised of patients where 92% presented with metastatic disease, 69% in the liver - the worst of the worst - which historically only 10% survive longer than one (1) year

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A complete response (CR) is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions.  By definition a 99% decrease in the sum of the target lesions is still defined as a partial response (PR).

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Background .... mPDAC is a biologically aggressive cancer that is often characterized by clinically evident disease progression during first-line treatment (pain, fatigue, anorexia, weight loss, constipation, fever, diabetic decompensation, etc.) with a deterioration of the patient performance status (PS) that limits subsequent treatments. Several complications can also arise, such as

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However, to date, chemotherapy remains the second-line standard of care, and before pelareorep + CPI, neither personalized medicine nor immunotherapy had in fact provided important positive results in the treatment of pancreatic cancer. 

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PDAC are characterized by the presence of an abundant desmoplastic stroma composed of fibroblasts, extracellular matrix, immune cells and stellate cells. Immune cells infiltrating this stroma are mostly represented by tumour-associated macrophages, myeloid-derived suppressor cells and Treg cells, with very few effector T cells.  Whereas, in ONCYs Goblet -1 mPC cohort, T cell

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The Global pancreatic cancer market was valued at USD 2.05 billion in 2022 will expand to USD 7.40 billion by 2032.  Globally, the pancreatic cancer market is increasing due to rising cancer prevalence, change in lifestyle, for example increase in the consumption of alcohol and smoking.  The global Breast Cancer Market size is expected to be worth

[fox7mf]

Oncy's acquisition valuation still in the multi billions says an anonymous poster on a discourse board, not BP. I'm still long, still bullish on the science but I'm skeptical that this BD team can get us to the finish line:buyout. Thanks Note, I always appreciate your opinion, but at the end of the day these are all just opinions. 

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The absolute opinion is that ONCY's pelareorep platform is worth billions. Too bad you are a sell out fox.mf.

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Should read: Nothing has changed for ONCY other than pelareorep will be used as second line treatment in HR+/HER2- (or HER2 low) advanced or metastatic breast cancer , when combined with a CPI, plus possibly a CDK4/6 and PARP inhibitor, on the expected treatment relapes/failures/adverse effects on the anti-body drug conjugate (ADC

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A few expected news releases and an Accelerated Approval in mPDAC should help move things along .

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The FDA’s Accelerated Approval (AA) pathway allows the use of surrogate endpoints, also called biomarkers, to evaluate the safety and efficacy of therapies for serious conditions with unmet needs 1. Surrogate endpoints are used when clinical outcomes might take a very long time to study or in cases where the clinical benefit of improving the surrogate endpoint, such as controlling blood

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ONCY reported on TCR sequencing in the recent GOBLET Phase 1/2 clinical trial in metastatic pancreatic cancer. TCR sequencing is a technique that measures the diversity and clonality of T cell receptors (TCRs) in a sample. TCRs are molecules on the surface of T cells that recognize and bind to antigens, which are foreign substances that trigger an immune response. TCR

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https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-ord-shs?postid=33638710

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Bracelet-1 PR  "Given this exciting finding, our next step is to discuss our data with the FDA to investigate incorporating dual PFS and OS endpoints into our breast cancer program's registrational study. Including a PFS endpoint could substantially reduce the time to a pivotal readout from the registrational trial, thereby accelerating pelareorep's path to potential approval as

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May 15, 2024 - RBC Capital Markets Global Healthcare Conference - Matt Coffey reaffirming a LONG-TERM ORR of 62% 

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So what does the expansion of new and pre-existing T-cell clones with the oncolytic virus pelareorep mean?  Well, T cells are a type of white blood cell that play a crucial role in the immune system. T-cell clones are groups of T cells that have the same antigen receptor, which allows them to recognize and respond to specific antigens. The expansion of new and pre-existing T-cell clones

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Cancer Res (2019)  Abstract 2272: Exploratory analysis of T cell repertoire dynamics upon systemic treatment with the oncolytic virus pelareorep in combination with pembrolizumab and chemotherapy in patients with advanced pancreatic adenocarcinoma | Cancer Research | American Association for Cancer Research (aacrjournals.org) Conclusions: High levels of peripheral T-cell repertoire

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T cell clonality assays are of increasing interest in the field of T cell immunotherapy. In this context, the identification of a tumour-specific T cell clone, typified by a specific T cell clonotype, can be critical to the success and monitoring of therapy.   It is conceivable that future clinical need for T cell clonality assessment will be dominated by

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T cell receptor sequencing (TCR-seq) in ONCYs GOBLET Phase 1/2 clinical trial in metastatic pancreatic cancer showed an expansion of new and pre-existing T-cell clones.  TCR sequencing is a technique that measures the diversity and clonality of T cell receptors (TCRs) in a sample. TCRs are molecules on the surface of T cells that recognize and bind to antigens, which are

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TCRs typically recognise antigen within the context of an MHC molecule and the expansion of cytotoxic CD8+ immune effector T cells ONCY Aware-1 and Bracelet-1 breast cancer clinical studies tat treatment with pelareorep demonstrated the expansion of cytotoxic CD8+ immune effector T cells vs immunosuppressive Treg cells. In so doing, ONCY showed how

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Should read : TCRs typically recognise antigen within the context of an MHC molecule and the expansion of cytotoxic CD8+ immune effector T cells. which serves both as an adhesion molecule for class I MHC molecules and as a coreceptor with the TCR for T cell activation. ONCY Aware-1 and Bracelet-1 breast cancer clinical studies tat treatment with pelareorep 

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Should read : TCRs typically recognise antigen within the context of an MHC molecule and the expansion of cytotoxic CD8+ immune effector T cells. which serves both as an adhesion molecule for class I MHC molecules and as a coreceptor with the TCR for T cell activation. ONCY Aware-1 and Bracelet-1 breast cancer clinical studies showed that treatment with 

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ONCY reported on TCR sequencing in the recent GOBLET Phase 1/2 clinical trial in metastatic pancreatic cancer. TCR sequencing is a technique that measures the diversity and clonality of T cell receptors (TCRs) in a sample. TCRs are molecules on the surface of T cells that recognize and bind to antigens, which are foreign substances that trigger an immune response. TCR sequencing can

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https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=35937603 The Scientist - regarding CAR-T cells on TiLs - TCR complex Dr. Michel Sadelian, originally from Alberta Canada, and now an immunologist at Memorial Sloan Kettering Cancer Center (MSKCC), is the original developer of CAR-T therapy and received the 2024 Breakthrough Prize in Life Sciences with Carl June who is

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From FDA 2023 - A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.  The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an

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October 2023 - " The data from this study show a correlation between the expansion of TIL-specific clones and tumor response, which provides compelling support for the use of pelareorep-based therapies in immunologically "cold" tumors. In particular, these data, along with the impressive clinical results, support the ability of pelareorep-checkpoint inhibitor combination

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Oct 2023, the good old days when the share price was at $3. 

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So this is the current status -- on October 16, 2023  the ESMO metastatic pancreatic cancer abstract was released preliminary updated PDAC data showing a 6-month surivial rate of 82% in a patient population comprised of patients where 92% presented with metastatic disease, 69% in the liver - the worst of the worst - which historically only 10% survive

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May 24, 2024 - Phase 2 Merus stock price is trading at US$58.92 per share on a reponse rate of 60% in 10 evaluable head & neck patients. https://www.fiercebiotech.com/biotech/asco-early-peak-merus-bispecific-cancer-data-lives-investors-expectations

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https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-inc?postid=36056114

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Metastatic pancreatic cancer is a rare and orphan disease state that is proving to be the best route for pelareorep to achieve approval based on the Accelerated Approval proces involving ONCY's CelTils biomarker work that the Aware-1 study identified as surrogate endpoints.

[Peladawn]

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[Azzak34]

Twas a rough one, no doubt. 

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ONCY presented biomarker pancreatic cancer data at AACR 2019 found the following, before going on in May 2024 to demonstrate pelareorep's ability to expand TiL in both the blood and tumor cells. "Using patient blood samples from our REO 024 study in second line pancreatic cancer, T cell receptor sequencing was performed with Adaptive Biotechnologies' immunoSEQ Assay to measure

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Of particular interestr is ONCY's pelareorep preferential infectivity on "basal-like" pancreatic cells, which is a particular characteristic in 1/10 pancreatic cancer patients in which pancreatic cancer cells appear to lose their identify and the features of pancreatic cells, and basically becoming "basal" akin to skin or espophageal or GI or breast cancer cells. 

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ONCY presented biomarker pancreatic cancer data at AACR 2019 found the following, before going on in May 2024 to demonstrate pelareorep's ability to expand TiL in both the blood and tumor cells. "Using patient blood samples from our REO 024 study in second line pancreatic cancer, T cell receptor sequencing was performed with Adaptive Biotechnologies' immunoSEQ Assay to measure