Oncolytics Biotech Inc T.ONC

ADCs - excess toxicities & unfavorable risk-benefit profiles

[Noteable]

Antibody-drug conjugates (ADC) are a rapidly expanding class of anti-cancer drugs, with twelve agents in current clinical use. Despite recent successes, many ADCs fail during clinical development due to excessive toxicities and unfavorable risk-benefit profiles. Even for those ADCs that have been approved for clinical use, a substantial fraction of treated patients require dose reduction, treatment delays, or treatment discontinuation due to intolerable ADC-associated toxicity.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9913659/

[Noteable]

Antibody-drug conjugate (ADC) technology is not new. The first ADC, Pfizer's Mylotarg, reached the market two decades ago. The field has undergone slow but transformative enhancements. “ADC development has historically not been without its setbacks,” Datamonitor Healthcare analysts noted in a 2019 report. The concept of delivering a potent cytotoxic payload directly to tumor cells and

[Noteable]

Should read:  "Enter ONCY's pelareorep in combination with bi-specific ADCs, and ADCs with dual payloads."

[Noteable]

What is real is having a Phase 3 ready commercial product with the potential for expanding earlier lines of treatment, which pelareorep is capable of accomplishing, and the ability of ONCY's pelareorep to serve as an immunostimulant for drug therapies such as immune checpoint inhibitors, bispecifics and antibody drug conjugates (ADCs), as just several examples, into which Pfizer and other Big

[fox7mf]

Where do you think the SP would head to after just one accelerated approval/FDA ph3 guidance NR?

[Lesalpes29]

Canadafan said one P3 has a value of 1B. Who knows. GL

[fox7mf]

Indeed Lesalpes. I think a few of us use Bay Bridge Bio & their biotech valuation material. They attribute a $1.248b usd valuation for a ph3 ready/approved biotech. They also mention the average cost of getting through a ph3 to market is about $405m. Interesting information. If we had 2 AA/ph3 ready trials we, according to Bay Bridge, should have a $35-$40 SP.

[westcoast1000]

Thanks, fox. I was wondering about valuation for a p3.

[Noteable]

The Limitations of Complexity Despite their success in clinical trials, ADCs are not a magic bullet. The main drawback is that tumors develop resistance to them over time. Toxicity is also a concern, especially as cytotoxic payloads become more and more potent.  “The clinical pharmacology of ADCs highly complex,” said William D. Figg, an oncologist at the National Institutes of

[Noteable]

Repost from April 22, 2023 - Despite recent successes, many ADCs fail during clinical development due to excessive toxicities and unfavorable risk-benefit profiles. Even for those ADCs that have been approved for clinical use, a substantial fraction of treated patients require dose reduction, treatment delays, or treatment discontinuation due to intolerable ADC-associated toxicity. https