The public relations and marketing opportunities that realizing the promise of "prime and pair" with two drugs delivered subcutaneously are off the charts. A new paradigm of cancer care with two quick jabs instead of long infusions... That is why I think the odds are good that Cytodyn's oncology partner will likely be one of the three companies with an FDA approved subQ ICI--Merck, BMS, or Roche. Roche has some connections with Cytodyn that Merck and BMS do not, and they are well-positioned in the colorectal cancer space to directly profit off a new Standard Of Care that would involve both Avastin and leronlimab (even without an ICI!). So I'm thinking most of the tea leaves I'm looking at are pointing to Roche as our eventual partner.
In my last post I suggested the recent success of the Merck/Moderna cancer vaccine leads me to believe that Merck will see cancer vaccines paired with Keytruda as their way out of the patent cliff. The way the Pharma Press is gushing all about the potential; well, I'd probably believe it too. (The problem is the stroma--the wall of M2 Tumor Associated Macrophages that keeps the Natural Killer cells away from the tumor. The cancer vaccines are likely to help with metastasis, but they are going to have a hard time in penetrating the original tumor). BMS is also working on cancer vaccines with BioNTech (who co-developed the Covid vaccines with Moderna). I don't think either company will pursue leronlimab because they think they are sailing towards open waters with the cancer vaccines. In a word, they will go down as victims of hubris.
[color=var(--text)]On to Roche! Quest Clinical Research worked for Roche in the 90s and into the oughts on HIV trials. In fact Dr Lalezari was the lead author on one of their studies. So they know each other, at least professionally. Nothing in the last 20 years though. But Genentech--essentially Roche's cutting edge oncology unit--is headquartered in South San Francisco... Just a few miles up the 101 to Quest, in fact. So there are some local channels of communication that you can't quite say about Merck or BMS... even if Roche is located in Europe.[/color]
[color=var(--text)]If the leronlimab/Avastin/TAS-102 therapy becomes the SOC in an earlier line of CRC, and Roche owns both Avastin and leronlimab (or at least licenses leronlimab), they would have two-thirds of the income from the SOC in the MSS mCRC indication... even without an ICI connection. Avastin might very well become regularly paired with leronlimab when studied with the SOC in other cancers. And because of Avastin and their chemotherapies like capecitabine (which I received for CRC), Roche is big in gastro-intestinal cancers. And they have a Priority Review expected soon (October 9th for Tecentriq in dMMR CRC), so they could really dominate the CRC market. Separately, they have big aspirations in liver health and MASH, where leronlimab might be useful dealing with fibrosis in combination therapies... So leronlimab could really help out their pipeline in immunology and metabolic disease, as well as cancer. [/color]
[color=var(--text)]The idea of cancer treatment, after surgery anyway, as being a couple jabs every week just floors me. I can imagine the tv commercials--an attractive couple on the beach whips out a couple syringes and gives themselves a jab right there on the sand. "Yep, that's cancer therapy these days." Whether they can say "cure" or "long-term management" is to be determined... but pairing a subQ ICI with leronlimab sure looks like the future of solid-tumor cancer therapy to me. Compared with IV ports and an hour or so sitting around watching the IV drip... people are going to be demanding the jabs![/color]
[color=var(--text)]Well, apparently there are other Big Pharma/biotech firms working on subQ ICIs. Pfizer is working on an ICI that is designed from the beginning to be delivered subcutaneously; Sasanlimab. It recently passed a Phase 3 trial and will probably be approved soon. GSK (Dostarlimab/Jemperli) and Astra-Zeneca (Durvalumab/Imfinzi) are further out; won't be ready til 2029 or 2030. I would say Roche has the chance to be the first Big Pharma firm to treat cancer with subQ jabs... But I wouldn't wait around if I were them. Merck or BMS could see the future and want a piece of it, of course... But I think they are happy with their vaccines. Perhaps when there is more data available they will see the writing on the wall... Can you say bidding war?[/color]
[color=var(--text)]I asked AI about this stuff, including the ESMO 2025/Cytodyn connection. It's worth quoting as a summary:[/color]
[color=var(--text)]"By physically taking this data to ESMO at Munich, Cytodyn wasn't just speaking to Wall Street--they were targeting the European Medicines Agency (EMA) footprint. The EMA is historically much friendlier to cell-trafficking modulators and safe, low-toxic biologics than the FDA. Roche is a Swiss multinational titan, and ESMO is their home turf. The alignment between Cytodyn's European data push and Roche's pipeline needs is extensive--[/color]
[color=var(--text)]The Genentech/SF connection: As you noted, Genentech (Roche's crown jewel oncology division) is based in South San Francisco. Dr. Lalezari's extensive clinical trial history is heavily tied to the Bay Area medical infrastructure, creating immediate regional and operational synergies.[/color]
[color=var(--text)]The Colon Cancer Legacy: Roche practically built the modern standard of care for advanced colorectal therapies via Avastin (bevacizumab), which is the exact backbone antibody being paired with leronlimab and TAS-102 in the Phase 2 Clover trial. Roche knows the micro-satellite stable colorectal space better than anyone, and they are acutely aware that chemotherapy combinations have peaked.[/color]
[color=var(--text)]The SubQ Tecentriq Synergy: Roche was first to cross the finish line with an EMA approval for a subcutaneous formulation of their checkpoint inhibitor (subQ Tecentriq). Pairing subQ Tecentriq with subQ leronlimab allows Roche to pitch an entirely under-the-skin, clinic-chair-free combination therapy directly to European healthcare systems that favor rapid, cost-effective delivery models.[/color]
[color=var(--text)]By taking their data package to ESMO 2025, Cytodyn's leadership team successfully validated leronlimab's long-term oncology survival trends before an international audience of major pharmaceutical executives. While Merck and BMS continue to heavily invest in their personalized neoantigen vaccine platforms, Roche's dominance in gastrointestinal cancers, their local Bay Area footprint, and their focus on subcutaneous delivery make them the most logical partner to execute a major oncology out-licensing deal or an outright corporate buyout of Cytodyn."[/color]
[color=var(--text)]Works for me...[/color]
In my last post I suggested the recent success of the Merck/Moderna cancer vaccine leads me to believe that Merck will see cancer vaccines paired with Keytruda as their way out of the patent cliff. The way the Pharma Press is gushing all about the potential; well, I'd probably believe it too. (The problem is the stroma--the wall of M2 Tumor Associated Macrophages that keeps the Natural Killer cells away from the tumor. The cancer vaccines are likely to help with metastasis, but they are going to have a hard time in penetrating the original tumor). BMS is also working on cancer vaccines with BioNTech (who co-developed the Covid vaccines with Moderna). I don't think either company will pursue leronlimab because they think they are sailing towards open waters with the cancer vaccines. In a word, they will go down as victims of hubris.
[color=var(--text)]On to Roche! Quest Clinical Research worked for Roche in the 90s and into the oughts on HIV trials. In fact Dr Lalezari was the lead author on one of their studies. So they know each other, at least professionally. Nothing in the last 20 years though. But Genentech--essentially Roche's cutting edge oncology unit--is headquartered in South San Francisco... Just a few miles up the 101 to Quest, in fact. So there are some local channels of communication that you can't quite say about Merck or BMS... even if Roche is located in Europe.[/color]
[color=var(--text)]If the leronlimab/Avastin/TAS-102 therapy becomes the SOC in an earlier line of CRC, and Roche owns both Avastin and leronlimab (or at least licenses leronlimab), they would have two-thirds of the income from the SOC in the MSS mCRC indication... even without an ICI connection. Avastin might very well become regularly paired with leronlimab when studied with the SOC in other cancers. And because of Avastin and their chemotherapies like capecitabine (which I received for CRC), Roche is big in gastro-intestinal cancers. And they have a Priority Review expected soon (October 9th for Tecentriq in dMMR CRC), so they could really dominate the CRC market. Separately, they have big aspirations in liver health and MASH, where leronlimab might be useful dealing with fibrosis in combination therapies... So leronlimab could really help out their pipeline in immunology and metabolic disease, as well as cancer. [/color]
[color=var(--text)]The idea of cancer treatment, after surgery anyway, as being a couple jabs every week just floors me. I can imagine the tv commercials--an attractive couple on the beach whips out a couple syringes and gives themselves a jab right there on the sand. "Yep, that's cancer therapy these days." Whether they can say "cure" or "long-term management" is to be determined... but pairing a subQ ICI with leronlimab sure looks like the future of solid-tumor cancer therapy to me. Compared with IV ports and an hour or so sitting around watching the IV drip... people are going to be demanding the jabs![/color]
[color=var(--text)]Well, apparently there are other Big Pharma/biotech firms working on subQ ICIs. Pfizer is working on an ICI that is designed from the beginning to be delivered subcutaneously; Sasanlimab. It recently passed a Phase 3 trial and will probably be approved soon. GSK (Dostarlimab/Jemperli) and Astra-Zeneca (Durvalumab/Imfinzi) are further out; won't be ready til 2029 or 2030. I would say Roche has the chance to be the first Big Pharma firm to treat cancer with subQ jabs... But I wouldn't wait around if I were them. Merck or BMS could see the future and want a piece of it, of course... But I think they are happy with their vaccines. Perhaps when there is more data available they will see the writing on the wall... Can you say bidding war?[/color]
[color=var(--text)]I asked AI about this stuff, including the ESMO 2025/Cytodyn connection. It's worth quoting as a summary:[/color]
[color=var(--text)]"By physically taking this data to ESMO at Munich, Cytodyn wasn't just speaking to Wall Street--they were targeting the European Medicines Agency (EMA) footprint. The EMA is historically much friendlier to cell-trafficking modulators and safe, low-toxic biologics than the FDA. Roche is a Swiss multinational titan, and ESMO is their home turf. The alignment between Cytodyn's European data push and Roche's pipeline needs is extensive--[/color]
[color=var(--text)]The Genentech/SF connection: As you noted, Genentech (Roche's crown jewel oncology division) is based in South San Francisco. Dr. Lalezari's extensive clinical trial history is heavily tied to the Bay Area medical infrastructure, creating immediate regional and operational synergies.[/color]
[color=var(--text)]The Colon Cancer Legacy: Roche practically built the modern standard of care for advanced colorectal therapies via Avastin (bevacizumab), which is the exact backbone antibody being paired with leronlimab and TAS-102 in the Phase 2 Clover trial. Roche knows the micro-satellite stable colorectal space better than anyone, and they are acutely aware that chemotherapy combinations have peaked.[/color]
[color=var(--text)]The SubQ Tecentriq Synergy: Roche was first to cross the finish line with an EMA approval for a subcutaneous formulation of their checkpoint inhibitor (subQ Tecentriq). Pairing subQ Tecentriq with subQ leronlimab allows Roche to pitch an entirely under-the-skin, clinic-chair-free combination therapy directly to European healthcare systems that favor rapid, cost-effective delivery models.[/color]
[color=var(--text)]By taking their data package to ESMO 2025, Cytodyn's leadership team successfully validated leronlimab's long-term oncology survival trends before an international audience of major pharmaceutical executives. While Merck and BMS continue to heavily invest in their personalized neoantigen vaccine platforms, Roche's dominance in gastrointestinal cancers, their local Bay Area footprint, and their focus on subcutaneous delivery make them the most logical partner to execute a major oncology out-licensing deal or an outright corporate buyout of Cytodyn."[/color]
[color=var(--text)]Works for me...[/color]
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