Oncolytics Biotech Inc T.ONC

IV OV+ICI sequential administration in clinical trials

[Noteable]

Mercck (MSD) has learned that along with the IT OV Cavatak being an oncolytic virus that is injected intratumorally and that clinical trials with Cavatak + Merck's pembrolizumab (Keytruda) lacking the sequenced administration of the OV then the ICI is not an effective approach to reach efficcacy.

In contrast ONCY's pelareorep is administered through an IV infusion in advance of the administration of an immune checkpoint inhibitor like pembrolizumab, or atezolizumab or avelumab or others.

The combination of Merck's Keytruda + Amgen's T-Vec also failed to show efficacy because the oncolytic virus T-Vec was injected intratumorally (IT) and also because both T-Vec and Keytruda were also administered simultaneously rather than sequenctially.

ONCY's pelareorep "primes" the immune system and remodels the TME to make the tumor microenvironment more receptive to checkpoint blockade which happens with the sequencing in an immune checkpoint inhibitor seeral days after pelareorep is first infused. 

Furthermore Merck has replaced its CEO on October26, 2022 who has "cleaned the deck" of poorly designed clinical trials like those that were carried out for Cavatak + Keytruda. 

https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-ceo-succeed-ken-frazier-chairman-2022-10-26/

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Noteable (995)

October 01, 2022 - 03:31 PM

147 Reads

Post# 34999582

RE:RE:EY sees bolt-ons in the single to double digit billions now

Should read: - ONCY is demonstrating that the sequential administration of intravenous (IV) pelareorep with immune checkpoint inhibitors in patients who have been identified with predicitve/prognostic biomarkers that find changes in blood T cell populations (CeLTiLs/T-cell clonality) to predict patient response is proving to be a significantly effective.

This approach has proven more effective than other OVs which, in contrast, have been  administered simultaneously with immune checkpoint inhibitors, such as Amgen's Imlygic that was given together with Merck's Keytruda. This Imlygic/Keytruda combination trialed relapsed/refractory melanoma failed because the virus was administered intratumorally (IT) with Keytruda in a broad population of melanoma patients, who were not previously identified by any biomarker for patient response to this therapy and who had peviously failed 2-3 courses of PD-1 therapy before they were included in this IT OV / IV ICI combo trial. Unfortunately, the Amgen/Merck OV/ICI study design was flawed from the start. 

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Noteable (995)

 

October 02, 2022 - 02:27 PM

163 Reads

Post# 35000322

RE:RE:RE:RE:EY sees bolt-ons in the single to double digit billions now

The failure of the Imlygic / Keytruda (Amgen / Merck USD) melanoma Phase III study announced in September 2022, for reasons already provided, adds further strength to the rationale that ONCY is worth North of US$8 billion, now that IV pelareorep is emerging as a leader in immuno-oncology (I/O) combination therapy, particularly since pelareorep is demonstrating synergy with immune checkpoint inhibitors, CAR-T therapy, bispecifics, and small molecules like CD4/6, PARP and proteasome inhibitors, for example, in an immuno-oncology market that is expected to reach US$120.37 Billion by 2026.

Notwithstanding the recent "goings-on" in the broader market, the science in immuno oncology has been "on-going" - and according to recent market research by The Business Research Company ("TBRC") the focus areas for many companies in the immune-oncology drugs market have shifted to increasing acquisitions to enhance their market presence. Large players are buying small or midsized companies to acquire new capabilities, or gain access to new markets. Players are also acquiring competitors to curb competition and increase market share.

https://www.prnewswire.com/news-releases/immuno-oncology-drug-market-players--trends-opportunities-strategies-301508957.html

[Noteable]

Candel is another OV company that injects its HSV vectors directly into the tumor or surrounding tissue. https://www.biospace.com/article/carl-june-s-upenn-lab-teams-up-with-candel-to-combine-viral-immunotherapy-with-car-t/

[inthno]

I always thought and hoped that maybe onc would have success with a 2 pronged approach by intravenous and direct injection at the same time along with a CI and chemo combo. They used direct injection many years ago and even with the science progessing would never hurt to try this combo.

[Noteable]

Using a dual administration approach with ONCY's pelareorep involving intravenous delivery + intratumoral injection is being explored, however the most effective approach that is currently being employed is IV pelareorep + IV immune checkpoint inhibitor, both for effectivenss and the convenience of delivery.  Over time I would expect that both ONCY's pelareorep + immune checkpoint