Oncolytics Biotech Inc T.ONC

EU approves first I/O combination

[Noteable]

The European Commission (EC) has approved the first frontline immuno-oncology treatment in the EU for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.

GSK’s Jemperli (dostarlimab) plus carboplatin-paclitaxel chemotherapy is indicated for these patients who are suitable for systemic ttherapy. 

[ ONCY's pelareorep + immune checkpoint inhibitors + nab-paclitaxel is an I/O combination that is Phase 3 ready for several rare and orphan diseases that will before the US and EU regulators for Accelerated Approval even sooner now than before ]

Jemperli (dostarlimab) is programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2, as highlighted by research subsequently published in the European Journal of Cancer in 2016.

https://www.europeanpharmaceuticalreview.com/news/189965/gsk-immuno-oncology-treatment-achieves-novel-eu-approval/

[Noteable]

ONCY's pelareorep in combination with CPIs and chemotherapy (n-paclitaxel) results in priming of the immune system,  an increase in TiLs and T-cell clonality, and the remodeling of the TME to facilitate the addition of CPIs. Patients developed new T-cell clones and increased peripheral T-cell clonality, leading to an inflamed tumour.  “We see a lot more T cells around the tumor

[13X2413]

All sounds promising, but why are we trading at $1.63? You've been relentless with medical science updates during the ride up to $4+ and all the way back down to where we are now. The medical investment community clearly has given up on good old ONC. It hurts to admit that. 

[Azzak34]

Could be any number of reasons. However, they've assembled a team of big names for a reason. Andrews and Bizzari would have been approached and presented with our results and plan for taking Pela to market. They both agreed to attach their name and reputation to us, why do you think that is?  Pancan picked us and even after they backed out they gave us a substantial amount of their

[fox7mf]

The more astute bashers will quickly point out that supporters trumpeted the arrival of Parsons and Rigby in much the same way as the most recent addition, but the question remains relevant with Andrews: why would a person of this BP pedigree hook her cart to anything other than a shining star? My opinion, but perhaps PFE or Incyte suggested her addition to facilitate the BD negotiations. 

[Lesalpes29]

Facilitate negociations is probably the goal behind this addition. Matt is probably a mess to negociate with! More rationnal negociations probably. GLTAL

[Noteable]

Negotiations usually involve an investment bank providing advice and is not the sole responsibility of any company management team . Surprising how naive some posters appear to be.

[Noteable]

In concert with the EU, the FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a

[Noteable]

December 2023 -   2023 roundup: 5 of our most important cancer research stories of the year (3). Improving immunotherapies While chemotherapy, surgery and radiotherapy are the cornerstones of cancer treatment, advances in immunotherapy are making it an increasingly effective option. Immunotherapy uses our own immune systems to fight cancer. 

[Noteable]

January 16, 2024 -  Halozyme Announces Roche Receives European Commission Approval of Tecentriq® SC with ENHANZE® Representing the EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy for Multiple Cancer Types https://www.biospace.com/article/releases/halozyme-announces-roche-receives-european-commission-approval-of-tecentriq-sc-with-enhanze-representing-the-eu-s-first

[Noteable]

Pfizer is also developing a SC immune checkpoint inhibitor in sasanlimab. https://www.sciencedirect.com/science/article/pii/S2059702923008232

[Noteable]

" Major catalysts are approaching in this field [of anti-PD-(L)1 drugs]– for Merck and other big pharma developers of anti-PD-(L)1 drugs alike. The most immediate is a 15 September US FDA action date to decide on the approvability of a SC formulation of Roche’s Tecentriq, on the basis of the phase 3 Imscin-01 trial that the Swiss group quietly toplined as positive a year ago."

[Noteable]

" Last December Imscin-001 data were quietly presented at the ESMO-IO meeting. The study’s phase 1 stage showed the SC form to have similar serum trough concentration to IV, and the phase 3 portion demonstrated pharmacokinetic exposure of SC to be non-inferior to IV. But here’s the key detail: though Imscin-001 concerned second-line, post-chemo NSCLC, the data it generated are

[CMHarring218431]

So, we have some history with both Pfizer and Roche. Are these drugs a threat to the success of Pela or do they help to verify the science behind Pela. My question really is the following, is Oncy  competing to get to market with other therapies or does their targeted approach put Pela on a track that is not pursued by other biotechs, as far as we know?  Another question I have.... 

[Noteable]

As I have repeated stated ONCY's pelareorep enhances the effectiveness of immune checkpoint inhibitors and now that Roche, Pfizer and Merck are developing subcutaneous formulations, the likely strategy is to combine pelareorep with one or all of the respective checkpoint inhibitors, (through subsequent out-licensing of pelareorep after the acquisition of ONCY), in both IV as well as

[Noteable]

... repeatedly ....

[Noteable]

The essence of these developments is that the state of the immuno-oncology sector is dynamic and is positively moving forward, towards an increasing recognition of the benefit of selectively combining I/O agents such as immuno-modulators (i.e. pelareorep) + immune checkpoint inhibitors + chemotherapy (i.e nab-paciltaxel) in the effective treatment of multiple cancers. Furthermore pelareorep is

[itntdf]

pela is not a standalone (yet) but it has been shown, when used first in a combo treatment, to enhance some of those other combo drugs. so it would seem that would be attractive to the likes of roche, pfizer, merck etc. can't have a p&b sandwich without both ingredients.  seems that is what oncy is attempting to sell, but the sale would certainly be enhanced with some type of

[Noteable]

The European Medicines Agency (EMA) said it recommended 77 drugs for marketing authorization last year. The list of drugs recommended for authorization by EMA's Committee for Medical Products for Human Use (CHMP) includes 39 new active substances, 17 orphan drugs, 8 biosimilars, 15 generics, and 3 drugs that were recommended under accelerated assessments. The report highlighted the