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Posted On: 06/26/2022 4:49:07 PM
Post# of 148899
When I was looking for the Forbes article, I ran across an article from Bioprocess Online dated Feb. 10, 2020. It gives some interesting background about Nader, Pro140, Dr. Ray, etc. Here are a few excerpts and link.
The Perilous Development Of A Potential Biologic Blockbuster
In May 2019, the U.S. FDA granted Fast Track Designation for a drug called leronlimab for use in combination with carboplatin for the treatment of patients with CCR5-positive mTNBC. Last month, the maker of leronlimab filed for Breakthrough Therapy status for the drug as a treatment for metastatic triple-negative breast cancer. The road it took to this point was bumpy at best.
CytoDyn, the maker of leronlimab, was resurrected from the ashes in 2008 by an immigrant teacher with a PhD in mechanical engineering named Nader Pourhassan.
At the time, the company’s lead molecule, cytolin, was being developed for HIV. That molecule was in a phase one clinical trial when it hit a snag. The FDA had put a hold on the trial, asking CytoDyn to humanize it. Pourhassan set to work, but soon his research led him to redirect his efforts. He caught wind that Progenics planned to sell off a molecule called PRO 140, a phase 2 product it was developing for HIV indication, so the company could focus on its cancer program. PRO 140, a humanized mAb directed against the molecular portal that HIV uses to enter cells (CCR5), is a viral-entry inhibitor intended to protect healthy cells from viral infection. The Progenics PRO 140 project that caught Pourhassan’s eye was underwritten in part by a $28 million award from NIH. It had received Fast Track designation per FDA findings that it was better than the standard of care in resistance, toxicity, compliance, and side effects. But, Progenics had already moved through $22 million of that NIH funding at the time of purchase. Some, including a handful of CytoDyn’s board members, called the product a high risk.
Where others saw risk, however, Pourhassan saw opportunity to advance a molecule that was closer to commercialization than CytoDyn’s own cytoline. He convinced his board to take that risk. With some notable dissent, and with the stipulation that he assume the role of CEO, he proceeded to raise $7 million from private backers in fewer than thirty days. On October 10, 2012, he wired three and a half million dollars to Progenics to acquire PRO 140. “Then,” he tells me, “I gave the remaining $6 million Progenics had been awarded back to the NIH.”
Back to that dissent Pourhassan faced at PRO 140’s prospects. Two of his board members in particular—a pair of ex-Gilead guys—were less than impressed with what hired analysts deemed the molecule’s likely path to market as a combination therapy. “Four of the five paths they forecasted led to between $2 million and $3 million in annual revenue,” recalls Pourhassan. “The fifth path showed $20 million per year. This from a project that Progenics spent $200 million on, and which we anticipated spending another $200 million on. It just didn’t make financial sense, and more than a few on our board threw their hands in the air,” he says.
Those board members—many of them pharma’s old guard—grew even more irate when Pourhassan, without an M.D. or more than a mere undergraduate course in biology, had the audacity to suggest a solution. At least one board member jumped ship. Other industry colleagues continued to pressure Nader to cut his losses, to abandon the product altogether, or take the path of lesser resistance and press on with PRO 140 as a potential combination therapy.
Pourhassan pressed on, proceeding to convince his board what a host of expert consultants—including a preeminent HIV authority in Dr. Robert Schooley and Progenics founder and discoverer of PRO-140’s interaction with HIV, Dr. Paul Maddon—had told him; if PRO 140 could find its way to approval as a monotherapy, it could change the HIV paradigm. As all of this played out, the company had yet to manufacture a single batch of the stuff.
For a minute, let’s set aside the risk that PRO 140 might be a dud. On the immediate heels of the company’s acquisition of the molecule, CytoDyn couldn’t even produce it. “Progenics hadn’t manufactured the drug in five years. When we tried to duplicate the process, we couldn't find the molecule because the company that made it was out of business,” explains Pourhassan. “We brought some new partners on board who had introduced a new production process, but when you do that, the FDA wants every aspect of that production process to be presented from scratch again,” he laments. “The administration asked for 11 new assays to be developed.” In the end, rather than suffer the setback, Pourhassan says he “went through hell” to find, and subsequently hire, Dr. Nitya Ray, the man who developed the PRO 140 manufacturing process for Progenics. Ray, who now serves as Chief Technology Officer and Head of Process Sciences, Manufacturing & Supply Chain at CytoDyn, righted the wrongs and re-addressed the FDA with his original production processes. Crisis averted.
CytoDyn’s journey with leronlimab has certainly been a tumultuous one. It effectively took a back-burnered product deemed virtually worthless and re-discovered its promise. Pourhassan started with nothing more than a penny stock acquisition—CytoDyn was in a perilous Over-The-Counter Bulletin Board position when he came aboard—and through grit and determination, raised some $240 million to resurrect the company. $140 million of that came through multiple transactions brokered by Paulson Investment Company, LLC, while $100 million was generated from Pourhassan’s own relentless pursuit of private individual investments. “Rallying these funds was the most difficult thing I’ve ever done in my life,” admits Pourhassan. The most difficult thing up until now, perhaps, as he anxiously awaits the FDA’s ruling on CytoDyn’s Breakthrough Therapy Designation application for leronlimab. It’s an important milestone for a drug he believes has blockbuster potential. But if there’s one thing Pourhassan’s story makes clear in the interim, it’s this; should the FDA’s decision not fall CytoDyn’s way, it won’t be enough to temper the man’s tenacity.
https://www.bioprocessonline.com/doc/the-peri...Via-Rucz2M
The Perilous Development Of A Potential Biologic Blockbuster
In May 2019, the U.S. FDA granted Fast Track Designation for a drug called leronlimab for use in combination with carboplatin for the treatment of patients with CCR5-positive mTNBC. Last month, the maker of leronlimab filed for Breakthrough Therapy status for the drug as a treatment for metastatic triple-negative breast cancer. The road it took to this point was bumpy at best.
CytoDyn, the maker of leronlimab, was resurrected from the ashes in 2008 by an immigrant teacher with a PhD in mechanical engineering named Nader Pourhassan.
At the time, the company’s lead molecule, cytolin, was being developed for HIV. That molecule was in a phase one clinical trial when it hit a snag. The FDA had put a hold on the trial, asking CytoDyn to humanize it. Pourhassan set to work, but soon his research led him to redirect his efforts. He caught wind that Progenics planned to sell off a molecule called PRO 140, a phase 2 product it was developing for HIV indication, so the company could focus on its cancer program. PRO 140, a humanized mAb directed against the molecular portal that HIV uses to enter cells (CCR5), is a viral-entry inhibitor intended to protect healthy cells from viral infection. The Progenics PRO 140 project that caught Pourhassan’s eye was underwritten in part by a $28 million award from NIH. It had received Fast Track designation per FDA findings that it was better than the standard of care in resistance, toxicity, compliance, and side effects. But, Progenics had already moved through $22 million of that NIH funding at the time of purchase. Some, including a handful of CytoDyn’s board members, called the product a high risk.
Where others saw risk, however, Pourhassan saw opportunity to advance a molecule that was closer to commercialization than CytoDyn’s own cytoline. He convinced his board to take that risk. With some notable dissent, and with the stipulation that he assume the role of CEO, he proceeded to raise $7 million from private backers in fewer than thirty days. On October 10, 2012, he wired three and a half million dollars to Progenics to acquire PRO 140. “Then,” he tells me, “I gave the remaining $6 million Progenics had been awarded back to the NIH.”
Back to that dissent Pourhassan faced at PRO 140’s prospects. Two of his board members in particular—a pair of ex-Gilead guys—were less than impressed with what hired analysts deemed the molecule’s likely path to market as a combination therapy. “Four of the five paths they forecasted led to between $2 million and $3 million in annual revenue,” recalls Pourhassan. “The fifth path showed $20 million per year. This from a project that Progenics spent $200 million on, and which we anticipated spending another $200 million on. It just didn’t make financial sense, and more than a few on our board threw their hands in the air,” he says.
Those board members—many of them pharma’s old guard—grew even more irate when Pourhassan, without an M.D. or more than a mere undergraduate course in biology, had the audacity to suggest a solution. At least one board member jumped ship. Other industry colleagues continued to pressure Nader to cut his losses, to abandon the product altogether, or take the path of lesser resistance and press on with PRO 140 as a potential combination therapy.
Pourhassan pressed on, proceeding to convince his board what a host of expert consultants—including a preeminent HIV authority in Dr. Robert Schooley and Progenics founder and discoverer of PRO-140’s interaction with HIV, Dr. Paul Maddon—had told him; if PRO 140 could find its way to approval as a monotherapy, it could change the HIV paradigm. As all of this played out, the company had yet to manufacture a single batch of the stuff.
For a minute, let’s set aside the risk that PRO 140 might be a dud. On the immediate heels of the company’s acquisition of the molecule, CytoDyn couldn’t even produce it. “Progenics hadn’t manufactured the drug in five years. When we tried to duplicate the process, we couldn't find the molecule because the company that made it was out of business,” explains Pourhassan. “We brought some new partners on board who had introduced a new production process, but when you do that, the FDA wants every aspect of that production process to be presented from scratch again,” he laments. “The administration asked for 11 new assays to be developed.” In the end, rather than suffer the setback, Pourhassan says he “went through hell” to find, and subsequently hire, Dr. Nitya Ray, the man who developed the PRO 140 manufacturing process for Progenics. Ray, who now serves as Chief Technology Officer and Head of Process Sciences, Manufacturing & Supply Chain at CytoDyn, righted the wrongs and re-addressed the FDA with his original production processes. Crisis averted.
CytoDyn’s journey with leronlimab has certainly been a tumultuous one. It effectively took a back-burnered product deemed virtually worthless and re-discovered its promise. Pourhassan started with nothing more than a penny stock acquisition—CytoDyn was in a perilous Over-The-Counter Bulletin Board position when he came aboard—and through grit and determination, raised some $240 million to resurrect the company. $140 million of that came through multiple transactions brokered by Paulson Investment Company, LLC, while $100 million was generated from Pourhassan’s own relentless pursuit of private individual investments. “Rallying these funds was the most difficult thing I’ve ever done in my life,” admits Pourhassan. The most difficult thing up until now, perhaps, as he anxiously awaits the FDA’s ruling on CytoDyn’s Breakthrough Therapy Designation application for leronlimab. It’s an important milestone for a drug he believes has blockbuster potential. But if there’s one thing Pourhassan’s story makes clear in the interim, it’s this; should the FDA’s decision not fall CytoDyn’s way, it won’t be enough to temper the man’s tenacity.
https://www.bioprocessonline.com/doc/the-peri...Via-Rucz2M
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