Oncolytics Biotech Inc ONCY

AstraZeneca's ADC disappoints - on severe adverse events

[Noteable]

July 03, 2023 - "Should toxicity prove to be worse than feared, strong efficacy becomes even more important. The safety fear here is interstitial lung disease, a known problem for Daiichi Sankyo’s ADCs. The Her2-directed Enhertu carries a boxed warning about ILD, and this side-effect has also been seen in earlier datopotamab studies, albeit without causing deaths."

"Today’s cautiously worded press release, which omitted any actual numbers but included the admission of patient deaths, knocked confidence in the project’s potential. "

https://www.evaluate.com/vantage/articles/news/trial-results/astrazeneca-and-daiichis-big-reveal-disappoints

[Noteable]

In 2020 Gilead acquired ADC company Immunomedics for US$21 Billion.  https://www.gilead.com/news-and-press/press-room/press-releases/2020/9/gilead-sciences-to-acquire-immunomedics

[Noteable]

Antibody drug conjugates (ADCs) like Astrazeneca / Daiichi Sankyo's HER2-targeting Enhertu, Gilead's Trodelvy, Roche's Kadcyla, or Seagen's Adcetris/Padcev/Tivdak  are smaill-molecule drugs which have FDA black box warnings. The recently passed Inflation Reduction Act (IRA) takes an unfavorable view on small molecules, which are provided 9 years of FDA market exclusivity

[westcoast1000]

That is surprising and amazing, Noteable. We can offer a big competitive advantage and an efficacy advantage. Thanks!

[Noteable]

ADCs have their drawbacks — for example, cancer tumors can develop resistance to them over time. And not all newer ADCs in development are successful: Last month, Sanofi scrapped its only experimental ADC after it fell short in a late-stage trial in lung cancer patients. Companies from Japan and China have emerged as effective ADC developers that are rapidly “innovating

[inthno]

My thought was that if ONC had run the mbc trial when they had a chance, then the ADC's would have to have been competing with the onc standard of care in mbc. All indications are that the trial would have been successful. Now onc is waiting for the ADC' trials to get guidance. Bracelet was successful, Aware1 was successful and the AN bridging trial was successful and it would not have

[Noteable]

As already posted, ONCY has identified the importance of TILs as a biomarker, which is underscored by the developing ability to predict treatment response to ICI therapy (predictive/prognostic biomarkers) based on their density and location, which ONCY has demonstrated in their clinical trials.  The value of a change in TILs within the TME as a response to cancer immunotherapy has

[Azzak34]

Borrrrrrrinnggggggggg!!! 

[13X2413]

Oh no! Azzak has had enough of Noteable. Say it isn't so!?

[Azzak34]

Ah, see you need to follow the threads. I'm saying boring to "Not" Inthno. Yet again today he's whining about what hasn't happened in years gone by.  Noteables posts got a bog Ole thumbs up from ya boi.  Green day for us numbersxnumbers! You must be happy about that? 

[13X2413]

Ok. Thought you changed team colours. Please, give me many many more green days.  Loved the numbersxnumbers. :) It's just a SH generated ID. 

[Buckhenry]

Love reading all the worthless posts from the pumpers... it's great while sitting on the toilet. Think I will start printing their posts. Can be useful in the toilet. 

[Azzak34]

Who's writing your material? 

[Hydroqc]

I would try with Runningman.

[Noteable]

January 22, 2023 -  Gilead’s ADC Trodelvy Fails Phase III NSCLC Study  Gilead acquired ADC company Immunomedics  in 2020 for US$21 Billion.  https://www.biospace.com/article/gilead-s-adc-trodelvy-fails-phase-iii-nsclc-study-stock-drops-10-percent-/

[Noteable]

Last month, Sanofi scrapped its only experimental ADC after it fell short in a late-stage trial in lung cancer patients.  ONCY's pelareorep is capable of enhancing the performance of ADCs, particularly when combined with immune checkpoint inhibitors. A fact that shouldn't escape Roche and Pfizer.

[Noteable]

April 26, 2024 - After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, TROP2-directed antibody-drug conjugate (ADC), which serves as the cornerstone of the company’s solid tumor ambition.  [Trodelvy was added to Gilead's product portfolio through the  September 2020 acquisition of Immunomedics for US $21 Billion.] https:

[Noteable]

May 30, 2024 -  " Gilead Sciences' Trodelvy has failed a second phase 3 trial. Gilead reported Thursday that Trodelvy failed to move the needle in a bladder cancer study. The TROP2-directed antibody-drug conjugate couldn’t outperform single-agent chemotherapy at extending the lives of urothelial cancer patients who had tried prior treatment with a chemotherapy and a

[canadafan]

I like your detail. My assumption, in comparison ONCs Pelareorep has at most flu like symptoms as side effects. And yes " safe & well lollerated", The IV administration finds the cancer. Making Pelareorep very unique. It does not have to be administered to the tumour. it only replicates in a cancer cell(s). That activity , as they say turns cold tumours hot... Whst does that

[Noteable]

Pfizer's enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate currently used for the treatment of urothelial cancer in combination with the checkpoint inhibitor pembrolizumab ( Keytruda). The antibody-drug conjugate (ADC) Padcev does not have a chemotherapy payload which consequently sets up this category of ADCs for the addition of ONCY's pelareorep in

[Noteable]

May 28, 2024 - Daiichi Sankyo and antibody-drug conjugate (ADC) partner AstraZeneca unable to show OS with ADC Enhertu follow-on in lung cancer.  Datopotamab deruxtecan, or Dato-DXd for short, is a TROP2-directed ADC from the same production line that delivered the blockbuster Enhertu. The FDA accepted an application for Dato-Dxd as a treatment for non-squamous non-small cell lung

[Noteable]

July 11, 2023, ADC Therapeutics pauses ADC Zynlonta Phase II trial enrollment on reported seven patient deaths, 5 serious adverse events. ADC Therapeutics reported today that it was stopping enrollment in a study of Zynlonta after seven patients with diffuse large B cell lymphoma died from respiratory problems following treatment. https://endpts.com/adc-therapeutics-pauses-zynlonta-trial

[fox7mf]

Perhaps the FTC's interference in this PFE/Seagan transaction was a blessing in disguise for PFE with the new ADC info coming to light. Perhaps PFE will now shift its attention & massive resources towards ONCY. I'm good with half of that $43b;)

[Noteable]

One-half of US$43 Billion would certainly be acceptable.

[westcoast1000]

Great point, Fox. They have the capital to invest in something that has no real health risk and is highly positive for patients, and can be guided by biomarkers as precision medicine.  That is ONCY!

[m00nsh0ts]

Do you have information that suggests the FTC has interfered with the Pfizer Seagen deal?

[Noteable]

Further ot Fiercebiotech - Pfizer and Seagen announced their proposed merger on March 12. Then on May 12, each filed notifications with the FTC and the Department of Justice. Four days later, the FTC filed its suit in federal court to halt the proposed merger between Amgen and Horizon. The move was the first by the FTC in more than a decade against a pharma M&A deal. A month later, on

[Noteable]

The new timeline was the result of Pfizer withdrawing its merger notification paperwork, which it said it would refile the same day, according to Seagen. No refiling appears to have happened yet. https://www.biopharmadive.com/news/pfizer-refile-ftc-seagen-deal-paperwork-hsr/652962/

[Noteable]

Anti-body drug conjugates (ADCs) are small molecules. Under the IRA, Medicare can begin negotiations on these as early as nine years after they are approved by the US Food and Drug Administration approval, compared with 13 years for biologics. Pfizer is now likely weighing these new facts into any of their proposed acquisitions.

[m00nsh0ts]

Thank you for the additional information.

[Noteable]

October 24, 2023 - AstraZenecas Enhertu associated with patient deaths reported at ESMO In the lung cancer study, the pharma partners reported seven fatal episodes of interstitial lung disease (ILD), which were “adjudicated as drug-related by an independent committee,” according to the announcement. In four of these deaths, the primary cause was attributed to disease progression. One such

[Noteable]

October 27 -  ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) for the treatment of cancer, and today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant

[Noteable]

November 01, 2023 - The FDA has lifted its full clinical hold on Mersana Therapeutics Phase I study of XMT-2056, its investigational STING-directed antibody-drug conjugate, following a patient death. The clinical hold came in March 2023, following a patient death that was deemed related to XMT-2056. At the time, Mersana was assessing the candidate in a Phase I trial,

[fox7mf]

Indeed a tough yr for Mersana & their PH1 ADC cancer trial. It's out of the FDA hold, but shares have plummeted 75% & they've halved their staff. This PH1 biotech has a MC of $143m, even after a truly disastrous yr. PH3 Oncy, $113m MC...Wake up Coffey. 

[13X2413]

Unfortunately ONC has plummeted 50% without any bad news. 

[CaseyL]

Any longer I'd rather have this wrap up in May 2024. Avoiding tax season. I'm so tired though. 

[Noteable]

July 28, 2023 -  AstraZeneca revealed that Alexion has agreed a deal worth “up to $1 billion” for “a portfolio of preclinical gene therapy programs and enabling technologies from Pfizer.” https://www.fiercebiotech.com/biotech/astrazeneca-axes-assets-inks-pfizer-deal-and-loses-key-exec-friday-news-flurry In July 2021 Astrazeneca acquired Alexion for US$39 Billion. https://www

[Noteable]

November16, 2023 - [Regeneron's] Lowy says there’s a lot of room for improvement in ADCs. While he acknowledges there have been breakthroughs in prolonged, durable responses and improved survival, the therapies can be tough on patients. “At the end of the day, though, it is still a chemotherapy. Granted, the idea is to deliver this chemotherapy in a much more targeted fashion so that

[Noteable]

November 27, 2023 - Experts caution that there are challenges with ADCs that still need to be overcome, including toxicities and the tumor microenvironment itself. Nathan Tumey, associate professor at the School of Pharmacy and Pharmaceutical Sciences at Binghamton University, said there are still a lot of questions about what drives ADC toxicity. Previously, it was believed that the

[Noteable]

Correction  ....  like in advanced or metastatic breast cancer (mBC)

[Noteable]

ADCs deficiciencies consequently positions ONCYs pelareorep + CPI (i.e. atezolizumab) in 2L breast cancer in patients who have relapsed on ADC (HR)-positive, HER2- low/negative breast cancer therapy (i.e. Enhertu).

[Noteable]

Correction  .... ADC deficiencies

[Noteable]

Breast cancer heterogeneity determines cancer progression, treatment effects, and prognosis. The heterogeneity of breast cancer is attributed to differences in the genomic, epigenomic, transcriptomic, and proteomic characteristics of the cancer cells. These factors affect tumor properties such as proliferation, apoptosis, metastasis, and therapeutic response. This heterogeneity is also observed

[Noteable]

November 30, 2023 - AbbVie is shelling out $10.1 billion in cash to acquire ImmunoGen, maker of the ovarian cancer treatment Elahere, which won accelerated approval from the FDA about a year ago. The U.S. Federal Trade Commission, an antitrust agency,  has recently adopted a more aggressive stance on biopharma M&A deals, however the ImmunoGen deal

[Noteable]

Elahere black box side effects ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2&type=display

[fox7mf]

They just got $10b...apparently BP isn't worried about the side effects. 

[venture009]

That would appear to be the case, especially considering the FDA granted Accelerated Apporval.

[Peladawn]

Thanks for that Notable....can’t wait to here your opinion Elahere’s support data...I read it and although admittedly I am a total layman, the data sounded nowhere near as impressive as that of Pela

[Noteable]

https://investor.immunogen.com/news-releases/news-release-details/immunogen-announces-fda-accelerated-approval-elaheretm MIRASOL, the confirmatory Phase 3 randomized trial designed to convert the accelerated approval of ELAHERE to full approval, and top-line data was released in May 2023. MIRASOL demonstrated an ORR of 32% and mDOR 6.9 months seen in the singlearm Phase 2  

[Noteable]

MIRASOL Conclusions • MIRV is the first novel treatment to demonstrate a benefit in overall survival in platinum-resistant ovarian cancer in a phase 3 trial • MIRV demonstrated statistically significant and clinically meaningful improvement in PFS, ORR, and OS compared to IC chemotherapy, with a differentiated safety profile consisting predominantly of low-grade ocular and gastrointestinal events

[Noteable]

MIRASOL conclusions were prepared by Immunogen and the compnay downplayed the ocular and gastrointestinal events. The FDA took a more critical view and ordered that the side effects be BLACK BOXED to emphasize seriousness of these adverse events.

[Noteable]

The prescribing information for ELAHERE includes a boxed warning for ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. The most common adverse reactions (greater than or equal to 20% of patients), including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase

[Normandt]

Each 21-day cycle treatment would cost $18,000-$25,000, with an annual cost of $182,400 per patient.

[Noteable]

Breast cancer heterogeneity determines cancer progression, treatment effects, and prognosis. The heterogeneity of breast cancer is attributed to differences in the genomic, epigenomic, transcriptomic, and proteomic characteristics of the cancer cells. These factors affect tumor properties such as proliferation, apoptosis, metastasis, and therapeutic response. This heterogeneity is also observed

[Noteable]

Consequently, cancer mRNA's that only are directed at 20 neoantigens, like BioNTech/Genentech's cancer mRNA, would be significantly less effective when used on a highly heterogenetic cancer like breast cancer, than would be the more effective cancer therapy of ONCY's pelareorep in combination with a chemotherapy payload of some kind (like an ADC, such as Enhertu for example), plus an

[Noteable]

Should read: " Consequently, cancer mRNA vaccines that only are directed at 20 neoantigens, like BioNTech/Genentech's cancer mRNA, would be significantly less effective when used on a highly heterogenetic cancers like breast cancer, ...."

[Noteable]

Disease progression increasingly experienced with ADC Therapy. December 05, 2023 - “Despite the numerous HER2-tareted therapeutics approved for treating advanced or metastatic HER2-positive breast cancer, many patients ultimately have disease progression and new options for treating these individuals are urgently needed.” https://www.biospace.com/article/releases/bolt-biotherapeutics

[Noteable]

December 06, 2023 - As antibody-drug conjugates (ADCs) grow their importance in the oncology treatment space, efforts are underway to combine them with other agents. A negative overall survival trend has become a big no-no at the FDA lately. The agency has required long-term data, limited the scope of an approval, or forced market withdrawals based on any hint of data suggesting a potential

[Noteable]

New ADC payload mechanisms What differentiates next-generation ADCs from those currently on the market is the incorporation of novel features including site-specific conjugation, new payload mechanisms and new antibody formats. The success of Enhertu is serving as a driver of next-gen ADCs development. Enhertu is basically an old antibody with an old linker with a different payload,”. “That

[Noteable]

Pfizer has 12 ADCs in its pipeline that fall into one of four categories: vedotin ADCs; ADCs employing TOPO1 inhibitor payloads; next-gen auristatin ADCs with potentially improved tolerability; and ADCs with novel payload mechanisms of action.  https://www.fiercebiotech.com/biotech/after-covid-decline-pfizer-builds-out-cancer-pipeline-and-leans-adcs  Pfizer yesterday offered a

[Noteable]

As posted earlier in this thread Pfizer has 12 ADCs in its pipeline that fall into one of four categories: vedotin ADCs; ADCs employing TOPO1 inhibitor payloads; next-gen auristatin ADCs with potentially improved tolerability; and ADCs with novel payload mechanisms of action.  Earleir research work conducted in 2019 has demonstrated that combination of a oncolytic reovirus and

[Noteable]

March 06, 2024 - The U.K.’s National Institute for Health and Care Excellence said Tuesday that it will not recommend the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) to treat patients with HER2-low breast cancer. https://www.biospace.com/article/uk-s-nice-rejects-astrazeneca-daiichi-sankyo-s-enhertu-for

[Noteable]

March 04, 2024 - Pfizer stops buildout of Seagen $350 Million plant. Clinical production of Seagen’s pipeline drugs will take place at other sites in Pfizer’s network, it said. https://www.fiercepharma.com/pharma/pfizer-sacks-seagen-manufacturing-site-impacting-120-staffers

[Noteable]

March 06, 2024 - " In patients with HR+/HER2- (negative) breast cancer – comprising approximately 60% to 70% of all breast cancers – an oncolytic virus called pelareorep has the potential to work in synergy with chemotherapy, hormonal therapies and immune checkpoint inhibitors (ICIs) to improve treatment outcomes where current therapies fall short." https://www.benzinga.com

[Noteable]

A recent market report published by Precedence Research, which analyzed from the base year 2022 to the forecast period of 2023–2032, revealed that in 2022 the breast cancer market size was estimated to be $28.8 billion (USD). Research projections anticipate the market will be valued at $73.68 billion (USD) by 2032 with a compound annual growth rate (CAGR) of 9.9%

[Noteable]

An unmet need exists in pre-treated metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, which is a highly aggressive form of cancer. In ONCY's Bracelet-1 study - pelareorep demonstrated that it was effective as a monotherapy when combined with paclitaxel versus paclitaxel alone.   https://oncolyticsbiotech.com/press

[Noteable]

Upon Pelareorep's Accelerated Approval for HER2- negative Breast Cancer in 2024,  market exclusivity would extend until 2037. And with market research projections indicating that the overall breast cancer market will be valued at US$73.68 billion by 2032, with a compound annual growth rate (CAGR) of 9.9%, the market is projected to grow to approximately US$118.56 billion by

[Noteable]

The reality is that the breast cancer market is projected to grow to approximately US$118.56 billion by 2037. 60% to 70% of the above US$118.56 Billion is represented by HER-2 negative breast cancer

[Noteable]

March 06, 2024 - The U.K.’s National Institute for Health and Care Excellence said Tuesday that it will not recommend the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) to treat patients with HER2-low breast cancer. https://www.biospace.com/article/uk-s-nice-rejects-astrazeneca-daiichi-sankyo-s-enhertu-for

[Noteable]

December 12, 2023 - Pfizer expects to complete its US$ 43 Billion acquisition of Seagen on Thursday December 14, 2023, it said in a release.  Pfizer also revealed a restructuring of its organization, establishing the Pfizer Oncology Division, which will combine oncology commercial and R&D operations. It will be led by Chris Boshoff, M.D., Ph.D., who has been Pfizer’s

[Noteable]

December 13, 2023 - Pfizer CEO Albert Bourla plans to bring the “lightspeed principles” from Covid to other diseases, notwithstanding Pfizers disappointing performance in 2023. https://endpts.com/pfizer-struggles-as-a-covid-boom-in-2022-evolves-into-one-of-markets-worst-drugmakers-in-2023/  

[Noteable]

https://www.cnbc.com/2023/12/13/pfizer-forecasts-2024-revenue-below-wall-street-expectations.html

[13X2413]

Who cares?

[Noteable]

December 22, 2023 - Mersana Therapeutics, the antibody-drug conjugate (ADC) biotech, and Merck KGaA have severed ties for a licensing pact related to one of Mersana’s tech platforms.  Under the 2014 agreement, Merck provided monoclonal antibodies to Mersana so the biotech could generate ADCs and conduct discovery and preclinical development activities.  This March, the FDA hit

[Noteable]

December 21, 2023  - Sanofi pulls the plug on ADC after lung cancer PhIII disappoints.  The ADC, called tusamitamab ravtansine, originated from a long running deal with ImmunoGen. The trial in question was evaluating the drug as a monotherapy in previously treated patients with metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors express high levels of

[Noteable]

The search for better target tumor antigens (Ags,) particularly for solid tumors, is ongoing, as well as an effort to develop better linkers and payloads for ADCs. Given the speed of progress in each of these areas, it is likely that new and active ADCs will continue to be developed and evaluated. However, “old” challenges may still threaten ADCs development, like patient selection and biomarker

[Noteable]

The only published randomized trial evaluating the combination of an ADC and ICI is the KATE2 trial. This study evaluated the efficacy of T-DM1 plus atezolizumab and compared it with T-DM1 (Trastuzumab emtansine ) plus placebo. The study was conducted in patients who had previously been treated for HER2-positive breast cancer and, disappointingly, the combination therapy did not result in a

[Quentin30]

Great news, we can start Phase I safety trials all over again...  so, 6-12 months to get going. if any efficacy were to be observed, we could be in a Phase III for this combo by [add date] Just by way of example, for the IND 213 trial that ONCY uses to underpin how effective Pela is in mBC,investors should bear in mind that that Phase II trial started in 2012. and 12 years on it has

[Noteable]

Any Big Pharma company with an ADC has added interest in acquiring ONCY given pelareorep's ability to synergize the effectiveness of a checkpoint inhibitor in combination with the ADC. An Accelerated Approval in pancreatic cancer in combination with an immune checkpoint inhibitor sets the table for this combination to be combined with an ADC without significant further clinical testing, given

[Noteable]

Furthermore, in 2020 Arulanadam et al. demonstrated in a proof-of-concept study using a clinically approved antibody-drug conjugate (ADC), such as Roche/Genentech's Kadcyla®, in combination with an oncolytic virus, enhanced oncolytic virus activity was achieved and provided rationale for translation of this approach.

[Noteable]

A better mechanistic understanding of how the TME responds to ADC treatment could lead to durable responses because of amplification of the immune system. The next era of ADCs will be focused on strategies to overcome resistance and enhance efficacy by pairing ADCs with signaling pathway inhibitors, ICIs, other TME modifiers, such as ONCY's pelareorep, and emerging payloads. And while

[Noteable]

https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-ord-shs?threadid=35885855

[Noteable]

Should read: " ....ONCY's biomarker studies have validated biomarkers that can facilitate what ADC therapy is currently missing. ..."

[Noteable]

June 18, 2024 - FDA halts BioNTech's ADC Phase 1 clinical trial due to safety issues.  The FDA has slammed the brakes on a trial of MediLink Therapeutics’ BioNTech-partnered antibody-drug conjugate (ADC) that has already seen three fatalities, with the agency citing a risk of “unreasonable and significant risk of illness or injuries.”  The German drugmaker announced in a SEC

[Noteable]

January 17, 2024 - U.S. PTO invalidates Seagen ADC patent and rule in foavor of Daiichi Sankyo..   In its final decision, the U.S. PTO invalidated all of the claims in Seagen’s patent 10,808,039, which covers the use of auristatin peptides connected to antibody-drug conjugates (ADCs) via a specific linker technology. The patent dispute between Daiichi Sankyo and Seagen goes back

[Noteable]

March 01, 2024 - Pfizer is pivoting from Covid-19 to zoom in on cancer, with a laser focus on next-gen antibody-drug conjugates (ADCs), small molecules and bispecific antibodies. Pfizer’s new emphasis is in four main types of cancer: breast cancer, including three main hormonal subtypes; genitourinary cancer, such as prostate and urothelial cancers; hematology-oncology, including multiple

[Noteable]

Last year, Roche’s breast cancer ADC Kadcyla topped the ADC leaderboard with $3 billion in sales. An Evaluate generated report calls the antibody-drug conjugate (ADC) market the “hottest real estate in oncology” that will continue to attract big pharma investment over the next few years. In 2023, ADC-focused M&A and partnership activity totaled almost $100 billion in total in 2023, more than

[Noteable]

March 01, 2024 - A federal judge in Delaware on Friday ruled in favor of the Biden administration in a case brought by AstraZeneca seeking to overturn parts of the drug price negotiations established by the Inflation Reduction Act. https://www.fiercepharma.com/pharma/astrazeneca-gears-battle-ira-court-novos-own-challenge-faces-hhs-rebuke

[Noteable]

The IRA mandates that certain small molecule drugs be subject to Medicare drug-pricing negotiations after nine years, while biologics can enjoy 13 years on the market before they’re up for price reductions. AZ argued its Merck-partnered cancer drug Lynparza is one example of how the IRA's framework is flawed. Lynparza is a small molecule PARP inhibitor. Today a federal

[Noteable]

Then there's Soliris, a drug cleared to treat four rare diseases that AZ picked up in its $39 billion buyout of Alexion. After its original 2007 approval in the rare chronic blood disorder paroxysmal nocturnal haemoglobinuria, the drug scored a new use in rare autoimmune disease neuromyelitis optica spectrum disorder more than a decade later in 2019. Under the IRA Soliris

[Noteable]

In addressing Pfizer's loss of marketing exclusivity due to patent expiration of its main revenue drivers and the loss of small molecule predominance with the passing of the IRA in 2022,  Pfizer's new plan is to focus on four main cancer types—breast cancer, genitourinary cancer, blood cancer and thoracic cancers—all of which the company already has commercial products in. Before the

[Noteable]

February 20, 2023 - " .....We’re also heading into the period, theoretically, when the Medicare drug price negotiations kick in in either 2026 or 2028, depending on whether it’s a similar or small molecule. The major players are looking at that period and that’s what’s caused a spurt of M&A. It’s returned strongly in 2023, and we expect that to continue in 2024. Given how strongly it’s

[13X2413]

Seeing that MC and tram couldn't make an effort to attend their own presentation yesterday, you think he could find the time to show up at the negotiation table? Might be an inconvenience. Golf season starting soon. 

[Buckhenry]

I think canuckfan etal think this is a personals site or something... I could freaking care less how long you been here and then give a full account thereof. 

[Azzak34]

You can block him so you don't have to read his messages. Everyone has freedom to speak and everyone has freedom to not see it.  I'll never block you Bucky, we're always going to be together. 

[Noteable]

Roche currently has two commercial ADCs, both built with other companies’ technologies. HER2-targeted Kadcyla was made with ImmunoGen’s platform, and large B-cell lymphoma drug Polivy has Seagen to thank. But since forming those partnerships over a decade ago, the Swiss company had stayed quiet on the ADC deal-making scene, while the likes of Merck & Co., AstraZeneca, Eli Lilly and AbbVie

[Noteable]

Should read : February 20, 2024 ....  The major players are looking at that period and that’s what’s caused a spurt of M&A. It’s returned strongly in 2023, and we expect that to continue in 2024. Given how strongly it’s returned, especially with the number of companies who have made major moves, the first half of 2024 will be back to the tuck in mode. This is just because a lot

[Noteable]

March 06, 2024 - Since U.K.’s National Institute for Health and Care Excellence (NICE) said Tuesday that it will not recommend the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) to treat patients with HER2-low breast cancer, it also follows that Enhertu will not be recommended for HER2-negative breast cancer, which

[Noteable]

Further to the potential of ONCY's pelareorep in combination with PD-(L)1 and ADCs, it is important to consider that tumor infiltrating lymphocytes (TILs), reflect the local tumor microenvironment and may prove to be a superior endpoint in cancer vaccine/oncolytic virus trials.   As outlined earlier, TILs are lymphocytes that have left the bloodstream, migrated to a tumor, and are at

[Noteable]

April 08, 2024 - Merck (MSD) has acquired biotech startup Abceutics in a bid to develop safer antibody-drug conjugates and minimize their off-target effects on healthy cells, according to a Friday announcement from the University at Buffalo, whose laboratory created the spin-off company. https://www.biospace.com/article/merck-snaps-up-small-startup-in-208m-deal-seeks-to-improve-safety

[Noteable]

Repost - Further to the potential of ONCY's pelareorep in combination with PD-(L)1 and ADCs, it is important to consider that tumor infiltrating lymphocytes (TILs), reflect the local tumor microenvironment and may prove to be a superior endpoint in cancer vaccine/oncolytic virus trials.   As outlined earlier, TILs are lymphocytes that have left the bloodstream, migrated to a tumor

[Noteable]

June 27, 2024 -  FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody-drug conjugate (ADC) patritumab deruxtecan. The FDA’s complete response letter is related to problems found during an inspection of a contractor’s manufacturing facility, rather than any issues with the efficacy or safety data, the two firms said.  This issue with the contractor's

[Noteable]

Today's news oer the FDA rejecting Daiichi Sankyo's Merck & Co. - partnered ADV raises questions about why companies of Merck and Daiichi’s stature couldn’t get such a seemingly technical issue right first time, especially after making such a large investment in the project. So don't go off about something simple like ONCY's POA SEC filing when Big Pharma can't seem to get

[Noteable]

Should read: " Today's news over the FDA's rejecting Daiichi Sankyo's Merck & Co. - partnered ADC .."

[Noteable]

Recently a SOLTI sponsored WoW clinical trial (TOT-HER3) with Daiichi Sankyo's Merck & Co. - partnered ADC patritumab deruxtecan (HER3-DXd) demonstrated that 96% of patients treated for HR+/Her2 negative breast cancer developed treatment-emergent adverse events (AEs) with 14% being grade ≥3; most common were nausea, fatigue, alopecia, diarrhea, abdominal pane and

[Noteable]

Sanofi's struggling ADCs oncology portfolio would significantly benefit from the addition of ONCY's pelareorep, particularly since Sanofi has guided that its corporate objective is to increase the number of Phase 3 clinical studies the company has by 50%, by the year 2026, notwithstanding that Sanofi's current R&D oncology portfoilo does not have the products to help reach this

[Noteable]

July 2024 - Bristol Myers Squibb (BMS) has ended their global strategic agreement with Eisai for their antibody-drug conjugate (ADC). The Japanese pharma will now exclusively own and be responsible for the investigational antibody-drug conjugate farletuzumab ecteribulin.  As part of the termination, Eisai will also refund BMS $200 million, which represents the unused portion of the initial R

[Noteable]

July 01, 2024 - Daiichi Sankyo wins patent dispute with Pfizer/Seagen over technologies used in the Japanese pharma's AstraZeneca-partnered antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan). https://www.biospace.com/article/daiichi-sankyo-wins-47m-in-adc-patent-arbitration-with-seagen-pfizer-dispute-looms/

[Noteable]

July 01, 2024 - Gilead's antibody-drug conjugate (ADC) Trodelvy fails to reach the primary endpoint in a confirmatory Phase III trial (TROPICS-04) in patients with metastatic urothelial cancer. Gilead reported a higher nujmber of deaths in the Trodelvy arm of the TROPICS-04 study. Trodelvy, which is also FDA-approved for the treatment of breast cancer, earlier this year also failed 

[fasttrack5]

The question is when or if ONC is going to get.  Pelareorep to market???

[Peladawn]

Democrats crying and wetting their pants today because the Supreme Court isn't towing the line to their idiotic political ideology........it's time to obliterate the big mouths in the Demautocratic Party once and for all before their stupidity destroys this country.

[Noteable]

March 11, 2024 - Zymeworks halts plans for Phase 2 ADC clinical trial. Zymeworks bispecific ADC combines Zymework’s lead asset, a HER2-targeted bispecific antibody called zanidatamab, with a toxic chemotherapy, zovodotin, resulting in zanidatamab zovodotin, also known as ZW49.  The HER2 ADC market is dominated by AstraZeneca and Daiichi Sankyo’s Enhertu as well as Roche’s Kadcyla.

[Noteable]

March 06, 2024 -  Rapid Relapse of PD-L1–Negative TNBC After Neoadjuvant Therapy and antibody drug conjugate (ADC) Sacituzumab Govitecan - the next steps are not as clear Sacituzumab govitecan, a TOP1 inhibitor antibody-drug conjugate (ADC) against Trop-2, emerged as a next line of therapy for patients who have developed metastatic disease after prior chemotherapy. For

[Noteable]

April 03, 2024 - Genmab on Wednesday announced that it will acquire the privately owned Phase 2 antibody drug conjugate (ADC) biotech ProfoundBio for $1.8 billion in cash. The deal is meant to help the Danish pharma deepen its cancer pipeline with next-generation antibody-drug conjugate therapies. https://www.biospace.com/article/genmab-leans-into-hot-adc-space

[Noteable]

April 05, 2024 - Astrazeneca is planning to take steps to transform cancer outcomes by attacking cancers from multiple angles. As such, their plan is to develop a portfolio that spans multiple scientific platforms, with different modalities and mechanisms to kill cancer cells directly or activate the immune system against cancer: https://www.astrazeneca.com/media-centre/articles/2024

[Noteable]

AstraZeneca's mistake is in exploring the use of circulating tumour DNA (ctDNA) as a biomarker (surrogate endpoint) to detect cancer, as Gritstone Biologics found out earlier this week. https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=35967983

[Noteable]

On Friday April 05, 2024, Enhertu became the first tumor-agnostic HER2-directed therapy authorized for administration, and the first antibody-drug conjugate (ADC) to win such an indication. Data from the Phase 2 Destiny study showed that in HER2-positve solid tumors, Enhertu had an ORR of 37.1% after a median follow-up of 12.75 months, while its overall DOR was 11.3 months. https://www.biospace

[Noteable]

Many current ADC-based treatments are associated with high discontinuation rates, especially those with the more established payload classes such as auristatins, maytansinoids and pyrrolobenzodiazepine (PBD) dimers. Another payload class that has emerged in recent years and represents a promising alternative in the treatment of several types of cancer is camptothecins. There are currently two

[Noteable]

April 09, 2024 - AACR24 -  An AACR poster on Vincerx's VIP236, a small-molecule drug conjugate that targets αvβ3 and is the company’s most advanced asset, has revealed zero objective responses among 15 patients, prompting a 70% share price collapse in Vincerx this morning.  The AACR poster concerned a phase 1 study, which enrolled patients with solid tumours not preselected for

[Noteable]

 ....drug resistance remains an unresolved problem with ADCs, and there is interest in developing better-tolerated and more effective therapeutics for breast cancer. "HER2-positive breast cancer remains an aggressive disease with historically poor outcomes. HER2-targeted ADCs have emerged as a promising strategy for breast cancer treatment, with a particular focus on enhancing outcomes

[Noteable]

The future of ADCs in breast cancer, as in other solid tumors, is to have a landscape of multiple ADCs targeting different tumor antigens with different payloads, in combination with novel sequences and combinations (such as OVs like pelareorep + immune checkpoint inhibiotors) ) some even targeting antigens that are expressed by the tumor microenvironments and the tumor cells (which a combination

[Noteable]

Emerging data suggest that mechanisms of resistance to ADCs may be linked to both the choice of target and the characteristics of the payload. Notably, the full extent of the effects of the payloads, though substantial, remains incompletely characterized because while the payload facilitates the homing effect of the ADC toward the tumor and detaches itself from the antibody while circulating

[CMHarring218431]

Note ....I am very curious as to your credentials, so to speak. Not that I would expect you to divulge your background in biotech but unlike many here who are not paying attention, your analysis of complex discoveries and the connections to to Pela has certainly reinforced my belief that this has potential to more than dramatically change the prospects for cancer suffering individuals. I cannot

[Noteable]

What should add further excitement to our already anticipatory states is the fact that AACR2024 that took place early this month, focused its attention on "vaccines" for the treatment of cancer, and in particular orphan cancers and those cancers with "unmet treatment needs", such as metastatic pancreatic cancer (mPDAC), and of course, advanced/metastatic HER2 negative breast

[Noteable]

July 25, 2024 - Stalling sales underscore the challenges facing Astrazeneca-Daiichi-Sankyo's HER2 drug Enhertu. https://www.fiercepharma.com/pharma/enhertu-stalls-astrazeneca-daiichi-charts-harder-yards-adc

[Noteable]

The development of ADCs sfaces challenges. Certain types of cancer lack effective neoantigens. For instance, the discovery and validation of neoantigens are time-consuming, and the expression of antigens varies among individuals. Additionally, tumors may alter the expression of their surface antigens to evade the immune system’s attack, which can make it difficult to identify suitable antibodies

[Noteable]

July 29. 2024 - England’s National Institute for Health and Care Excellence (NICE) turns away AstraZeneca and its antibody-drug conjugate partner Daiichi Sankyo saying that the company won’t “offer a fair price” on Enhertu to treat advanced HER2-low breast cancer.  For its part, NICE noted that Enhertu is the first breast cancer therapy it has been unable to approve in 6 years. The rejection

[Noteable]

June 2024 -  AstraZeneca and Daiichi Sankyo are now developing datopotamab deruxtecan (Dato-DXd). In October 2023, results presented at the European Society for Medical Oncology Congress showed datopotamab deruxtecan reduced the risk of disease progression or death by 37% in patients with previously treated HR+, HER2-low or HER2–breast cancer, providing a 2-month median PFS benefit, and

[Noteable]

New bioconjugates (i.e. bispecifics) could effectively pair ONCY's reovirus, with different polysaccharides resulting in increased trafficking tof revirus to the tumor cell surface and further facilitate pushing biologics and cancer therapy into the next generation of personalized/precision medicine that reovirus brings to the treatment of various cancers, including metastatic breast

[Noteable]

Should read: ..The use of cellular architecture by reovirus at two distinct steps in the viral life cycle, namely reovirus entry and egress ... converage on virual manipulation of intracellualr vesicular and cytoskeletal trafficking systems ..."

[Noteable]

https://stockhouse.com/companies/bullboard?symbol=oncy&postid=36216700

[Noteable]

May 10, 2024 - Phase 2 MacroGeneic's ADC clinical trial in metastatic prostate cancer results in 5 deaths.  https://www.fiercebiotech.com/biotech/macrogenics-stock-crashes-after-5-deaths-seen-adc-trial

[Noteable]

ADC fads follow the same path as others https://finance.yahoo.com/news/why-trends-are-so-intoxicating-for-investors--and-dangerous-morning-brief-100000442.html

[Noteable]

May 06, 2024 - The money pouring into ADCs is a reminder of just how important oncology is to the pharmaceutical sector, even as obesity steals the limelight. It is the industry’s biggest source of sales, with projected 2028 revenues of $440bn, says data provider IQVIA. Drugs that precisely target cancerous cells look set to play a crucial role in treating the disease, unleashing another wave of

[Noteable]

[  While ADCs induce tumor-specific adaptrive immunity, increasing the infiltration of T cells into the tumor microenvironment, ADC's ultimately lose their effectiveness, as a result of T cell resistance and exhaustion, due to the slow-release of the chemotherapy payload and increasing level of side effects, thus precluding optimal sequencing with other immunotherapy agents such as

[Noteable]

"Clinical data so far have unexpectedly shown that ADCs fail to increase their payloads’ maximum tolerated dose, as previously thought.80 Indeed, a thorough elucidation of ADC mechanisms of action, as well as their PK and PD profiles, is largely lacking, warranting for the introduction of more reliable in vivo and in vitro models. In addition, research and innovations in the field of ADC

[Noteable]

May 21, 2024 - Today AstraZeneca revealed its bold ambition to deliver $80 billion in Total Revenue by 2030, up from $45.8 billion in 2023. This will be achieved through significant growth in its existing oncology, biopharmaceuticals and rare disease portfolio, and by launching an expected 20 new medicines before the end of the decade. To drive sustained growth beyond 2030, the Company will

[Noteable]

May 21, 2024 -"The $80 billion figure is rare air. Last year, Johnson & Johnson was the lone company in the biopharma industry to top the mark with its $85.2 billion in sales, including contribtion from its medtech business."  [ I guess that the French company AstraZeneca is banking on taking their old (off-patent) Enhertu ADC technology to China for sale - which is how their

[Noteable]

May 21, 2024 - "AstraZeneca counts on ‘difficult-to-copy’ therapies for big 2030 goal and beyond" 'At the drugmaker’s Discovery Centre in Cambridge, UK, the CEO, self-assured as ever, underscored his vision for “long-term growth” by centering certain drug modalities that could be less vulnerable to generic and biosimilar competition.' https://endpts.com/astrazeneca-outlines

[Noteable]

May 28, 2024 - Daiichi Sankyo's Enhertu and antibody-drug conjugate (ADC) partner AstraZeneca has failed to prove overall survival (OS) benefit in Phase 3 clinical trial.  Datopotamab deruxtecan, or Dato-DXd for short, is a TROP2-directed ADC from the same production line that delivered the blockbuster Enhertu. The FDA accepted an application for Dato-Dxd as a treatment

[Noteable]

" The TROPION-Lung01 trial has already raised other issues in the past, most notably an undetermined number of deaths attributed to interstitial lung disease that AstraZeneca and Daiichi discussed at last year’s European Society for Medical Oncology (ESMO) Congress.  In his same conversation with Fierce Biotech three months ago, Fredrickson accepted that the FDA will be taking

[Noteable]

May 29, 2024 - How Realistic is AstraZeneca's US$80 Billion Revenue Target by 2030 " But what new products will get across the finish line for AstraZeneca to start reaching its $80 billion goal? Darout estimates that the company has several programs in the mid-to-late stage of development, with at least seven new drugs from its cohort of over 30 in its pipeline that can deliver on

[Noteable]

May 29, 2024 -  Amgen Wins FDA Approval for First Biosimilar to AstraZeneca’s Soliris Soliris was first approved by the FDA in 2007 for PNH. At the time, it was still owned by rare disease player Alexion Pharmaceuticals, which AstraZeneca acquired in 2020 for $39 billion. The investment has been paying off for AstraZeneca with Soliris consistently serving as one of its

[Noteable]

September 23, 2024 - Daiichi Sankyo and AstraZeneca’s TROP2 directed ADC datopotamab deruxtecan (Data-DXd) fails in the treatment of HR+/HER2 low or negative metastatic breast cancer. Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths

[Noteable]

September 23, 2023 -   AstraZeneca, Daiichi’s Enhertu successor faces more questions after latest stumble The partners said their antibody-drug conjugate datopotomab deruxtecan didn’t extend survival in a breast cancer study, fueling doubts about its approval prospects.  But the future of datopotomab deruxtecan, or dato-dxd for short, is now unclear. In

[Noteable]

July 08, 2024 - Companies like Pfizer is in early clinical trials with its auristatin-based  (ex. chemotherapy) ADC with a checkpoint inhibitor for a synergistic effect - providing further insight that ONCY's pelareorep is prepared to facilitate the effectiveness of the ADC - anti-PD-(L)1 CPI doublet by remodeling the TME thus preparing the extracellular envionment for the addition

[Noteable]

Biopharma companies are beginningg to target a number of pathways to activate the innate immune system. Mersana, for example, is developing a stimulator of interferon genes (STING) agonist. While STING activation (IL-1β) has known anti-cancer effects, it’s been a historically difficult target because activating it throughout the body can be toxic. Mersana, for example, has partnerships

[Noteable]

Pelareorep therapy offers a means to directly expand TILs without the need for tumor resection, ex vivo TIL expansion, T cell ablation and IL-2 therapy.

[13X2413]

Mersana!? Why bring up another struggling company in this field? Was over $4 in April, now under $2. Are there any winners in this field out there?

[Noteable]

" Are there any winners in this field " ... Think ONCY. 

[Noteable]

September 13, 2024 - Daiichi Sanyo and AstraZeneca report positive results from the phase 3b/4 DESTINY-Breast12 study, which saw Enhertu chart substantial overall and intracranial clinical activity in a large clutch of patients with HER2-positive metastatic breast cancer who have brain metastases and received two or less lines of therapy in the metastatic setting. The data on the antibody-drug