Oncolytics Biotech Inc ONCY

Pelareorep in 3rd line HR+/HER2 negative breast cancer

[Noteable]

ONCY should easily be able to enroll 180-200 patients for its Phase2b -> Phase3 -> Confirmatory metastatic breast cancer patients since there is a significant unmet need for patients who will progress from Enhertu 2nd line therapy.

Given the unmet medical need in 3rd line mBC that pelareorep + paclitaxel is seeking to address, ONCY is looking to enroll study patients in the United States and EU - so there should be plenty of available clinical trial participants.
 
Adding to the straightforwardness of ONCY enrolling patients into their Phase2 -> Confirmatory trial includes factors such as:  (1) patients who have progressed from Enhertu will already have been identified as those who are eligible for 3rd line pelareorep + paclitaxel treatment making it a seamless transition from the ADC treatment to pelareorep, and (2) patients will be recruited from the United States and the EU, where patients populations are high and where patient types are diverse and demonstrated to have responded to pelareorep in several clinical trials already performed. Therefore the number of 180-200 should be easy to reach by ONCY or whatever Big Pharma company that acquires ONCY and runs the trial themselves.

ONCY will NOT be dealing with a different patient population than that trialed in the Phase 2 IND-213 and Bracelet-1 clinical trials. ONCY will be dealing with the same patient population who have failed a 2nd line breast cancer therapy, whether it was CDK4,6 inhibitors or ADC Enhertu, whose active payload is a chemotherapy - the same therapies that pelareorep was up against in various other completed ONCY trials in which pelareorep had successfully achieved effective results.
 
So those patients who have failed Enhertu will have already been identified as eligible pelareorep ready patients. Consequently clinical trial enrollment should be relatively easy by ONCY or the Big Pharma who acquires ONCY and runs the trial towards an accretive Accelerated Approval that would potentially be subsequently followed by a full approval on the same trial data.

In 2022, there were 2.3 million women diagnosed with breast cancer and 670 000 deaths globally.

https://www.who.int/news-room/fact-sheets/detail/breast-cancer

In 2024 approximately 310,720 women and 2,800 men will be diagnosed with invasive breast cancer in the United States.

There are currently more than 4 million women with a history of breast canacer in the United States. This includes women who are being treated and women who have finished treatment.

https://www.breastcancer.org/facts-statistics

In 2022, approximately 604,900 women were diagnosed with breast cancer in the WHO Europe region. Incidence in the EU-27 in 2022 was estimated to be 375,000

https://www.europadonna.org/breast-cancer/

Breast cancer is the most common cancer diagnosed in women in North America. Hormone receptor positive (HR+) and HER2 negative (HER2−) breast cancers account for at least 60% to 70% of all breast cancer.
cases.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188964/

Consequently, based on 2022 numbers, approximately 685,700 women were diagnosed with invasive breast cancer just in the United States and the EU -27. With HR+/HER2 negative accounting for approximately 65% of all breast cancers - approximately 446,000 women will be diagnosed each year with HR+/HER2 negative breast cancer in the US and EU-27.

Out of the approximate 446,000  women newly diagnosed HR+/HER2 negative breast cancer each year, ONCY has estimated that approximately 55,000 of these women will progress to 3rd line mBC therapy which ONCY has stated will be eligible for pelareorep (monotherapy) + paclitaxel treatment.

ONCY should be able to eadily enroll 180-200 patients for its Phase2b -> Phase3 -> Confirmatory metastatic breast cancer patients since there is a significant unmet need for patients who will progress from Enhertu 2nd line therapy.

Presently overall survival data has from ONCY’s  BRACELET-1 metastatic breast cancer Phase 2 study continued to mature, suggesting overall survival (OS) 2+ year data should reflect the statistical significance seen in the 12 month, and showing the clinical benefit that the FDA is needing to grant pelareorep an Accelerated Approval in 3rd line mBC. 

12 month data from the BRACELET-1 study has already validated the results of IND-213, a prior phase 2 trial that showed a statistically significant which demonstrated a near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep combined with paclitaxel (21.0 months, n = 28) vs. those treated with paclitaxel alone (10.8 months, n = 29).

An ASCO Meeting Abstract from the 2022 ASCO Annual Meeting has cited that the average cost for the first year of HR+/HER2 negative was US$192,367 per patient. With ONCY stating that approximately 55,000 women would become eligible for 3rd line pelareorep + paclitaxel treatment, and a per patient cost of US$192K, this patient group would translate into approximately US$10.56 Billion in annual sales for pelareorep or a significant percentage of this gross sales value, in HR+/Her2 – mBC, that  ONCY or a Big Pharma acquirer of ONCY would seek to achieve.

https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e18834

The long view is eventually moving pelareorep into first line therapy in combination with a variation of immune checkpoint inhibitors +/-  bispecifics +/- ADCs  +/-  small molecule inhibitors  +/-  CAR-T therapy, for example.

[Noteable]

this patient group would translate into approximately US$10.56 Billion in annual sales for pelareorep or a significant percentage of this gross sales value

[Noteable]

While the ASCO Meeting Abstract from the 2022 ASCO Annual Meeting has cited that the average cost for the first year of HR+/HER2 negative was US$192,367 per patient, it also referenced that the 2nd year of treament cost for HR+/HER2 negative breast cancer would be approximately US$169,0000 per patient for those who benefited from treatment and continued on with their lives. The third

[inthno]

That would be nice but a lot of if's but let's first get a trial approved before we get ahead of ourselves as we have done this before getting our hopes up. Big thing out of this is that the company has never run a quick trial and if it does not get started until sometime in 2025 depending upon enrollment and then waiting for results from let's say the first 100 patients to show some

[inthno]

That would be nice but a lot of if's but let's first get a trial approved before we get ahead of ourselves as we have done this before getting our hopes up. Big thing out of this is that the company has never run a quick trial and if it does not get started until sometime in 2025 depending upon enrollment and then waiting for results from let's say the first 100 patients to show some

[Noteable]

Unfortunately most of the stuff that you posted is incorrect, starting with your claim that these 3rd line patients are immune compromised. Simply wrong. 

[inthno]

Well that is most interesting as it has always been stated that we felt that 1st line patients would most likely do better as they had a stronger immune system compared to patients that had gone through previous chemo and were therefore had a more compromised immune system. So note u are saying that 3rd line patients immune systems are as good as 1st line. Hmmm

[Noteable]

Once again the 3rd line patients are not immune compromised as you have tried to improperly construe. But hey, at least you recognize that an Accelerated Approval is probable on the matured overall survival data emerging from the completed Phase 2 Bracelet-1 mBC clinical trial whereby the surrogate endpoints of ORR, PFS and mOS were achieved in the treatment arm beyond what the paclitaxel control

[Noteable]

Multiple courses of chemotherapy are required to become immune compromised. Those eligible patients who will go into the ONCY Phase 2b->Phase3->Confirmatory clinical trial will have failed both hormone and 2nd line ADC therapy and could not have had more than one course of the ADC Enhertu treatment. These strict trial inclusion conditions preclude the enrollment of compromised patients who

[inthno]

This might be a meaning back and forth as I always thought that AA was possible with the right trial setup and at least you have finally recognized that AA was not possible with the previous trials that onc had done as you had always touted that they were applying for AA with the results they had so at least we are getting somewhere. So moving on As for how quickly they could enrol is subjective

[Noteable]

ONCY  has unequivocally stated that it would be seeking Accelerated Approval in this "adaptive" Phase2b->Phase3->Confirmatory trial given that the surrogate endpoint of progression free survival (PFS) will be the primary objective. ONCY has the capacity to conduct this trial on its own OR a Big Pharma may become involved instead. An Accelerated Approval request can be made as

[inthno]

That would be great if they could apply for AA by the end of this year. Can u tell me where they said that so I can add it to my library of information. I do know in the recent fireside that I just listened to that kirk stated that they could apply for AA during the new trial but it would be a function of the results at that time and not a given that the fda would accept that. And no where in the

[Noteable]

Da_man/inthno keep on thinking what you want to think. The Bracelet-1 OS clinical benefit will dictate what comes next. Since your thinking has been quite contentious and set in concrete, nothing much will change your mind now. You Homer, should spend some time and Google to see that nobody has been eating either cats or dogs in Sprinfield. Bye

[inthno]

No problem, I guess what u r telling me is u don't know the answer which is fine. And t least I m realistic and give both sides  chance. Go he'd ND keep posting redundant material and.talking about 10 billion dollar buy outs.

[Quentin30]

ithno, the timeline for AA will be H1 2026 at the very best.  1) trial has to start - Q2 2025 given history of oNCY is reasonable. 2) they need enough statisically relevant data, and again 3) the differentiator between PFS for Pela+Pax and Pax alone is 3 months, 9 MO PFS for the former, 6 Mo for the latter 4) So patients will need to have been on study for 9 months min to show this

[inthno]

Quentin your timelines are more than reasonable given the history of onc and I have expressed similar to Notable although for some reason this person thinks that they willl apply for AA after the mbc bracelet os comes out. Also one thing to remember is that when the trial is up and going and they have their first set of results that there is no guarantee that the fda will approve AA so all must be

[Buckhenry]

Ole unnoteable just can stand it when someone has a different opinion or thought. He strongly believes in DEI as long as you agree with everything he says. He has become the term that just won't flush. 

[Noteable]

https://stockhouse.com/companies/bullboard?symbol=oncy&postid=36227894

[Buckhenry]

One would incorrectly think that ole unnoteable is head of oncology at John's Hopkins... but he just another investor that invests his money wishfully and backs it up with Google and AI searches and has to post many times daily to keep his ego stoked... just look how long he has been pushing this stock...  he should have bought nividia or one of the magnificent seven years ago instead

[Noteable]

Post by Noteable on Sep 15, 2024 4:43pm Pelareorep in 3rd line HR+/HER2 negative breast cancer ONCY should easily be able to enroll 180-200 patients for its Phase2b -> Phase3 -> Confirmatory metastatic breast cancer patients since there is a significant unmet need for patients who will progress from Enhertu 2nd line therapy. Given the unmet medical need in 3rd line mBC that

[Noteable]

An ASCO Meeting Abstract from the 2022 ASCO Annual Meeting has cited that the average cost for the first year of HR+/HER2 negative was US$192,367 per patient. With ONCY stating that approximately 55,000 women would become eligible for 3rd line pelareorep + paclitaxel treatment, and a per patient cost of US$192K, this patient group would translate into approximately US$10

[Noteable]

Since some have difficulty seeing, I'll repost the following assessment for their benefit... ONCY should easily be able to enroll 180-200 patients for its Phase2b -> Phase3 -> Confirmatory metastatic breast cancer patients since there is a significant unmet need for patients who will progress from Enhertu 2nd line therapy. Given the unmet medical need in 3rd line mBC that pelareorep

[Noteable]

September 18, 2024 - Post ESMO 2024 Dr. Alessandra Curioni-Fontecedro, professor of oncology at the University of Fribourg and director of oncology at the Hospital of Fribourg, Switzerland, made the following observation "At ESMO 2024 we are seeing many studies in many different cancers showing that immunotherapy can work for a long time." Improved overall survival with

[Noteable]

September 19, 2024 - At the Cantor Fiztgerald Global Healthcare Conference fireside chat today, ONCY's Kirk Look stated that the company only targeted & modeled the market size for pelareorep + paclitaxel treatment in the United States - with 55,000 HR+/HER2- patients in the US  as the patient population target for pelareorep.  The 55,000 HR+/HER2- patients modeled for 3rd line

[Noteable]

Demand is hot for big results in key markets like mBC with an unmet treatment need.  As for Big Pharma, the emphasis now is on finding therapies that have been de-risked with human data, as ONCY has been demonstrating over time, and as had been accomplished and reported on today in HR+/HER2- Breast Cancer. Analysis shows that around 122,000  HR+/HER2- mBC patients will be 

[Noteable]

FACT: In 2022, there were 2.3 million women diagnosed with breast cancer and 670 000 deaths globally. https://www.who.int/news-room/fact-sheets/detail/breast-cancer In 2024 approximately 310,720 women and 2,800 men will be diagnosed with invasive breast cancer in the United States. There are currently more than 4 million women with a history of breast canacer in the United States

[Noteable]

The reported incidence of breast cancer is currently based on 2022 numbers,which approximates 685,700 women being diagnosed with invasive breast cancer just in the United States and the EU -27. On 2022 global numbers -  HR+/HER2 negative breasat cancer accounts for approximately 65% of all breast cancers (60-70%), thus translating into approximately 446,000 women who are diagnosed each year

[Noteable]

The patent expiry date for Daichii-Sanyo / AstraZeneca's antibody-drug conjugate (ADC) Enhertu (T-DM1) in Europe was June 2020. The patent is set to expire in September 2026

[Noteable]

Correction: Enhertu (trastuzumab deruxtecan) is T-DMx while Kadcyla (trastuzumab emtansine) is T-DM1.

[Noteable]

The Enhertu patent in the United States expires in November 2024. https://www.fiercepharma.com/pharma/seagen-awarded-418-million-royalties-enhertu-patent-case-against-daiichi-sankyo

[Noteable]

Clarification: Enhertu (trastuzumab deruxtecan) is T-DXd

[13X2413]

Clarification: Down again today on a whopping 20,000 shares. No interest in what ONC allegedly has. 

[Buckhenry]

Putting all my hope in the analyst price targets????  Any word on that buyout unnoteable??

[Noteable]

Correction: Out of the approximate 446,000  women newly diagnosed with HR+/HER2 negative breast cancer globally each year, ONCY has estimated that approximately 55,000 women with HER2- mBC in the United States will progress to 3rd line mBC therapy which ONCY has stated will be eligible for pelareorep (monotherapy) + paclitaxel treatment.

[Noteable]

September 30, 2024 - Roche/Genentech is beginning to turn on its acquistion tap with an $850 million upfront for Regor Pharmaceuticals’ Phase 1 portfolio of CDK inhibitors, taking ownership of a breast cancer candidate (RGT-419B) that has shown signs of single-agent efficacy in patients failed by existing options.  ONCY is demonstrating pelareorep's single agent effectiveness in

[Noteable]

RGT-419B, is in Phase 1 testing in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients who progressed on prior CDK4/6 inhibitors. All 12 of the women in the analysis had previously received Pfizer’s CDK4/6 inhibitor Ibrance. Two patients had also taken Novartis’ Kisqali or Eli Lilly’s Verzenio, other approved CDK inhibitors.

[Noteable]

December 7, 2023 -- Regor Therapeutics Group ("Regor"), announced the results from a 12 patient Phase 1A single agent dose escalation study of RGT-419B, a next generation CDK4 inhibitor, in HR+ HER2- ABC patients who have progressed on prior CDK4/6is and ET. Today Roche/Genentech announced an US$850 up-front cash payment for the acquisition of this single indication breast cancer

[13X2413]

Are you giving us this info to help explain the run to a new 3 year low?

[Buckhenry]

But but but..... the forever pumpers are not concerned with... how low can you go... 

[Buckhenry]

Well we went from dreams of a buyout with a B to an M.. bargain basement sale. 

[Buckhenry]

Fact:  living is hazardous to your health!!

[Noteable]

Should read: Today September 30, 2024 - Roche/Genentech announced an US$850 Million up-front cash payment for the acquisition of this single indication breast cancer product base on only one Phase 1 clinical trial results involving 12 patients.

[Noteable]

September 30, 2024 - Roche/Genentech announced an US$850 Million up-front cash payment (with future follow-on development milestone payments) for the acquisition of Regor Therapeutics single indication small molecule breast cancer product that is in early stage development. Furthermore, Roche/Genetech's acquisition of Rigor's RGT-419B CDK 4 inhibitor is on the basis of 

[Noteable]

September 30, 2024 - Roche/Genentech announced an US$850 Million up-front cash payment (with future follow-on development milestone payments) for the acquisition of Regor Therapeutics single indication small molecule breast cancer product that is in early stage development. Furthermore, Roche/Genetech's acquisition of Rigor's RGT-419B CDK 4 inhibitor is on the basis of 

[Noteable]

Pfizer continues to advance its aim of developing next generation therapies and has initiated a Phase 3 trial that will evaluate a combination of its novel CDK4 inhibitor  PF-07220060 and Faslodex versus investigator's choice of Faslodex alone or everolimus plus exemestane in advanced or metastatic HR-positive/HER2-negative breast cancer patients progressed on prior CDK4/6 inhibitor-based

[Noteable]

 Roche/Genentech announced an US$850 Million up-front cash payment (with future follow-on development milestone payments) for the acquisition of Regor Therapeutics single indication small molecule breast cancer product that is in early stage development had nothing to do with share price since Regor is not listed on any stock exchange, which the naysayers keep deliberately missing.

[13X2413]

More evidence....ONC has nothing to offer. Being left in the dust. 

[Noteable]

As reminder regarding the acquisition of an early stage Phase 1 single agent drug candidate - on September 30, 2024  Roche/Genentech announced an US$850 Million up-front cash payment (with future follow-on development milestone payments) for the acquisition of Regor Therapeutics single agent, and single indication small molecule breast cancer product that is in early stage

[Noteable]

October 11, 2024 - Roche's drug, inavolisib, has gained FDA approval as part of a first-line treatment for HR-positive, HER2-negative breast cancer that has a PIK3CA mutation and is resistant to adjuvant endocrine therapy. The oral med is to be used in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex.  Itovebi is part of a bigger pipeline that Roche hopes could

[Noteable]

Oct. 1, 2024 Rates of breast cancer — the second leading cause of cancer deaths in U.S. women — climbed by 1 percent a year from 2012 to 2021, and even more sharply among women under age 50 and among Asian American/Pacific Islander women of all ages, according to an American Cancer Society report published on Tuesday. Cancer is generally considered a disease of aging, and that hasn’t changed

[Noteable]

November 27, 2024 - Roche announces that the EC approves the company's small molecule CDK4/6 Kisqali (ribociclib) in the treatment of HR+/HER2 negative early breast cancer patients at high risk of recurrence. https://www.biospace.com/press-releases/novartis-kisqali-receives-european-commission-approval-in-a-broad-population-of-patients-with-hr-her2-early-breast-cancer-at-high-risk-of

[Noteable]

This month both Roche and Novartis acquired early stage CAR-T therapy companies for bilions$. Now that both Roche and Novartis have CAR-T therapies that can only treat liquid cancers and not solid tumors, they are both likely circling ONCY for pelareorep's ability to "cure" solid tumors when combined with those therapies. The proposed acquisition will establish a new core

[Noteable]

Both Roche and Novartis are cognizant ONCY's potential as a late-stage clinical development company, particularly with pelareorep's ability to synergize with other biologics like immune checkpoint inhibitors, bispecifics, ADCs, CAR-T therapies, as well as small molecules like CDK4, CDK6, and PARP inhibitors, as just several examples.   Now that ONCY has the ACCELERATED APPROVAL