Oncolytics Biotech Inc T.ONC

TIGIT class of checkpoint inhibitors fails with Keytruda

[Noteable]

March 17, 2023 - Merck's (MSD) co-formulation of Keytruda and anti-TIGIT therapy vibostolimab did not improve progression-free survival compared to chemotherapy alone in patients with metastatic non-small cell lung cancer that had previously been treated with immunotherapy and platinum-doublet chemotherapy.

This failure suggests that the hypoxic TME was unable to be remodeled nor could the innate system be "primed" for Merck's anti-PD-1 Keytruda to work. 

These results add further credibility to the affect of ONCY's pelareorep on remodeling the TME and pelareorep's ability to "prime" both the innate and adaptive immune systems prior to the addition of a PD-(L)1 checkpoint inhibitor like Keytruda or Tecentriq or Bavencio, for example.

https://www.fiercebiotech.com/biotech/merck-tacks-another-loss-anti-tigits-company-not-losing-hope-larger-strategy

[Noteable]

In March last year Roche’s trial with their anti-TIGIT drug tiragolumab in small cell lung cancer (SCLC) also ended in failure.   Adding tiragolumab to checkpoint inhibitor Tecentriq and chemotherapy failed to improve progression-free survival in the study of 490 people undergoing first-line treatment for SCLC, causing the trial to miss one of its co-primary endpoints. https://www

[fox7mf]

Roche & Merck may be pursuing the acquisition of Oncy just a tad bit more forcibly at the moment. We'll see what Roche's new CEO has first on the M&A docket soon.

[Noteable]

April 27, 2023 - Roche is "tightlipped" on another TIGIT possible failure .....  as they dodged questions about whether their candidate has flunked yet another phase 3 trial. Roche needs to add ONCY's pelareorep to stimulate the immune system and convert an immunosuppressive tumor microenvironment (TME) to facilitate the TIGIT and PD-1 immune checkpoint inhibitor tecentriq

[Noteable]

September 14, 2023 - Bristol Myers Squibb disclosed Thursday at its R&D Day that it cut its anti-TIGIT program and is advancing its TIGIT Bispecific in NSCLC & gastric Solid Tumors program (Differentiated TIGIT bispecific antibody targeting both TIGIT and CD96) further steering Roche towards ONCYs pelareorep as an TME immunomodulator for Roches anti-TIGIT

[Noteable]

October 30, 2023 - Roche is strapped into the first car for the long haul. It’s paid off, says Charlie Fuchs, senior vice president and global head of oncology and hematology drug development at Genentech and Roche. “I believe in TIGIT,” Fuchs told Fierce Biotech on the sidelines of the European Society for Medical Oncology meeting, held Oct. 20 to 24 in Madrid. The Swiss pharma'

[Noteable]

July 04, 2024 - Roche/Genentech anti-TIGIT fails SKYSCRAPER - 06 study in NSCLC showing reduced efficacy in both PFS and OS compared to Keytruda + chemotherapy. https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=36117846

[Noteable]

Tiragolumab is an investigational novel (anti-TIGIT) immune checkpoint inhibitor with an intact Fc region, like the anti-PDL1 immune checkpoint inhibitor avelumab.

[Noteable]

July 25, 2024 - Roche used a call with the media to share an update on the fallout from the failure of its TIGIT drug candidate in a phase 2/3 non-small cell lung cancer (NSCLC) trial. Based on the setback, the company has decided to close two other studies in NSCLC, namely the phase 3 SKYSCRAPER-15 trial and the phase 2 SKYSCRAPER-05 study. https://www.fiercebiotech.com/biotech/roche-pumps

[Noteable]

August 16, 2024 - TIGIT fallout sees Roche/Genentech VP Immunology Ira Mellman on his way out. TIGIT-CD226-PVR axis: advancing immune checkpoint blockade for cancer immunotherapy Journal for ImmunoTherapy of Cancer, Eugene Y. Chiang; Ira Mellman

[Noteable]

At Genentech, Mellman oversaw the discovery and development of Tecentriq — the checkpoint inhibitor that is central to Roche’s oncology portfolio – Lunsumio, and the company’s anti-TIGIT program. ONCY has been instrumental in revealing how pelareorep is synergistic with PD-(L)1 checkpoint inhibitors, such as with Roche's PD-L1 Tecentriq.

[Noteable]

June 03, 2023 - Asco 2023 – six months on Gilead/Arcus’s Tigit deflates The anti-Tigit/PD-1 doublet that at December’s Asco virtual plenary had shown a 45% reduction in risk of progression or death, and a 6.6-month increase in median PFS versus the Arcus PD-1 alone, now stands at a 33% reduction and 3.9-month delta, today’s Asco update revealed. Not only that, but the confidence interval

[Azzak34]

Noteable would you agree with the idiot below that Pela clearly didn't do well enough woth paclitaxel and big pharma must have walked away? 

[Noteable]

The Bracelet-1 resutls were signficantly successful and have demonstrated pelareorep's single agent anti-cancer activity. As pointed out beforehand, it was necessary to differentiate pelareorep's effectiveness from other agents that pelareorep may be combined with. With respect to the Bracelet-1 study, the patients enrolled in the three cohorts were heavily pre-treated and had failed

[Noteable]

January 10, 2024 - Coherus BioSciences pulls out of TIGIT. https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-ord-shs?postid=35819574

[Noteable]

January 17, 2024 - Roche/Genentech reported positive Phase III data for its anti-TIGIT immunotherapy at this week’s American Society of Clinical Oncology Gastrointestinal Cancers Symposium.  In patients with esophageal squamous cell carcinoma (ESCC), tiragolumab improved progression free survival (PFS) and overall survival when combined with Tecentriq and chemotherapy versus chemo alone

[westcoast1000]

Thanks Azzak for asking Noteable that question. I will chime in with my non technical views that it is obvious pela improved pfs over the standard of care Paclitaxol by 50%. Pfs is correlated with OS but with pela OS may well be stronger and and relatively better as the immune response comes forward after about 4 months, as seen in the waterfall graphs for former trials. Then there is the panc

[13X2413]

I like your positivity, but it appears that the big investors aren't buying what the company is selling.  Way too much selling for something that's supposed to look promising. The results don't seem to be impressing people.  Need something from the company to prop this up. $1 land is way to close now. Like $3 territory much better. Much easier to sleep. 

[westcoast1000]

You have no way of knowing what big investors think, nor what they want to buy from the company.  You have no way of knowing whether the results are impressing people, except to look at the results, which are impressive. The share price will stay low until progress is announced. 

[Noteable]

From these developments one can see that Big Pharma is having significant difficulty in finding novel cancer therapies, at the same time that Big Pharma is faced with a looming patent cliff. We also see that Roche has bet heavily on the TIGIT class of checkpoint inhibitors.

[Noteable]

July 11, 2023 - Novaartis retreats from TIGIT - hands Tigit candidate back to Chinese company BiGene. In a SEC filing today, the Chinese drugmaker said the two companies agreed yesterday to mutually terminate the option agreement for ociperlimab with immediate effect. As a result, BeiGene’s Swiss unit will regain full global rights to the drug.   The end of the agreement means the

[Noteable]

December 08, 2023 -  A combination of Merck’s blockbuster anti-PD-1 drug Keytruda and its experimental anti-TIGIT antibody vibostolimab failed to meet endpoints in a Phase II study of metastatic non-small cell lung cancer patients with progressive disease after treatment with immunotherapy and chemotherapy, the pharma giant reported Thursday.  The results showed

[Noteable]

Merck & Co. has failed its phase 2 TIGIT clinical trial, revealing that neither combination featuring its anti-TIGIT (T cell immunoglobulin and ITIM domain) antibody vibostolimab as monotherapy or in combination with pembrolizumab. improved progression-free or overall survival (PFS/OS).   The study enrolled patients with metastatic non-small cell lung cancer

[Noteable]

May 13, 2024 - Merck ends Phase III Anti-Tigit + Keytruda melanoma study with high dropouts. The late-stage study was evaluating vibostolimab as an adjuvant treatment to Keytruda in patients with resected, high-risk melanoma. https://www.biospace.com/article/merck-halts-phase-iii-anti-tigit-keytruda-skin-cancer-study-with-high-dropouts-/

[Noteable]

August 05, 2024 - Agenus created a TIGIT bispecific antibody candidate to overcome the limitations of anti-TIGIT antibodies. BMS however has terminated the deal for Agenus’ TIGIT bispecific antibody three years after paying $200 million to buy into the program. https://www.fiercebiotech.com/biotech/bms-ditches-tigit-walking-away-200m-bet-agenus-bispecific

[Noteable]

BMS effectively paid Agenus $245 million for the chance to advance the bispecific, which was yet to enter the clinic at the time of the deal.

[Noteable]

BMS/ Agenus TIGIT bispecific antibody BMS-986442 (AGEN1777), is a  fully human Fc-enhanced bispecific antibody, which ONCY's Phase 2 Bracelet-1 mBC demonstrated fails when the fully human Fc-enhanced region is left active in a PD-(L)1 immune checkpoint inhibitor like avelumab (Bavencio) . https://finance.yahoo.com/news/bristol-myers-squibb-terminates-cancer-183111963.html

[Noteable]

June 20, 2024 - Genentech CEO Alexander Hardy spoke to Endpoints News-  "We're in TIGIT, for example, and the latest count is 10 other companies developing TIGIT molecules, so we're going to be first, but the question is how long we're going to be best for. ...." Since June 2024 a number of those Big Pharma companies referred to have dropped their TIGIT programs

[Noteable]

Correction - June 20, 2023. Since then Ashley Maragee has become Genentech's new CEO. 

[Noteable]

July 25, 2024 - Roche used a call with the media to share an update on the fallout from the failure of its TIGIT drug candidate in a phase 2/3 non-small cell lung cancer (NSCLC) trial. Based on the setback, the company has decided to close two other studies in NSCLC, namely the phase 3 SKYSCRAPER-15 trial and the phase 2 SKYSCRAPER-05 study. https://www.fiercebiotech.com/biotech/roche-pumps

[Noteable]

August 05, 2024 - Consequently, BMS plans to cut 117 jobs at their corporate headquarters, as well as in early discovery functions, and in the company’s commercial and late-stage development teams. BMS recently embarked on a dealmaking streak, striking three acquisitions worth about $23 billion in aggregate. And with these takeovers came consolidations. In March, BMS said it would lay

[Noteable]

August 08, 2024 - Merck has stopped its Phase 3 TIGIT study. Merck & Co.’s TIGIT program has suffered another setback. Months after shuttering a phase 3 melanoma trial, the Big Pharma has terminated a pivotal lung cancer study after an interim review revealed efficacy and safety problems.  The action is the second big blow to Merck’s work on TIGIT, a target that has

[Noteable]

  Aug 8, 2024 (Reuters) – Merck (MRK.N) said on Thursday it had discontinued a trial testing a combination immunotherapy treatment in patients with a type of lung cancer after an interim analysis showed the drug was unlikely to succeed.   The patients tested with a combination of its experimental drug, vibostolimab, with Keytruda experienced a higher rate of