This Sunday, September 8, the HARMONI-2 Trial data will be presented at World Lung by Akeso, a China based pharmaceutical company. This will be the big reveal of the $5 Billion bet by U.S. company Summit Therapeutics (and their Billionaire Founder Bob Duggan). In 2022, Summit bet $500 Million in Cash and $5 Billion in total on the bet that ivonescimab would displace Merk's Keytruda and perhaps overturn the entire immunotherapy market for cancer therapeutics. For many in Biotecch, this is the equivalent of taking out the king.
In exchange for the gargantuan offer, Summit is receiving the rights to develop and commercialize ivonescimab—known as SMT112 stateside—in the U.S., Canada, Europe and Japan. The company says it plans to start treating lung cancer patients in clinical studies by the second quarter of 2023. - from Fierce Biotech
HARMONI-2 isn't just any clinical trial. This trial is going head to head versus perhaps the greatest breakthrough product in Cancer Therapy ever, Merk's Keytruda, or pembrolizumab, in 1st Line advanced non-small cell lung cancer. This trial would perhaps deliver a change in the standard of care and new research and development direction for pharmaceutical companies around the world.
Below is a statement from the SUMMIT Therapeutics press release placing an exclamation point on their own success:
Summit Therapeutics made a very interesting hire about 9 months prior to their great reveal at #ASCO24. Dr. Jack West from City of Hope Hospital joined the Summit Therapeutics team in October, 2023.
Dr. West isn't just any academic researcher. He perhaps pioneered the role of a social influencer in medicine. Dr. West has been a critical voice on clinical trials in Lung Cancer and has never shied away from casting shade on the decisions by large pharma companies. He's been active on Twitter (or X) for over a decade, created his own education platform known as GRACE, and has an active video presence on YouTube.
Prior to his move to Summit Therapeutics, Dr. West had been a consistent voice in the discussion and criticism of cancer trials and has also been a paid consultant/speaker for various Pharma companies over the years. He has collected nearly $700K in general payments from Pharma since 2017. This is well above both the U.S. mean and the over10X the mean for his specialty.....source openpyaments.gov
So what has Dr. West said about Summit Therapeutics' clinical trials and ivonescimab—known as SMT112?
Dr. West also had an interesting post regarding his most recent clinical position prior to the move to Summit Therapeutics. Is he casting shade on City of Hope oncologists?
So who is Bob Duggan? Apparently he is a swashbuckling billionaire. Below is an excerpt from seeking alpha back in April 2023, just a few months before they hired Dr. Jack West.
Summit Therapeutics (NASDAQ:SMMT) is a project of Bob Duggan of Pharmacyclics fame. This is what keeps our hopes in the future of this company alive, even though the company keeps changing so much that it is difficult to keep up.
Ok so, let's get this straight, a company with a failed pipeline for infectious disease agents, bought the rights to a cancer drug from a China based company and now they have the drug that may upend the entire global treatment landscape in cancer therapy. Also, we will find out more about these data on Sunday.WOW!!!
Apparently, Bob Duggan is a Billionaire genius and also one of the largest donors in history to the Church of Scientology
Interestingly, his ex wife was recently in the social media news for a strange situation with another scientology donor in Switzerland
Trish Duggan also seems to be one of the driving forces behind Donald Trump's campaign according to Politico..
Akeso, the Chinese pharmaceutical company presenting the HARMONI-2 data may face a tough challenge with the FDA. The FDA has recently rejected two submissions with clinical trial data from China.
The Key Opinion Leader community are well aware of the FDA's concerns of these data submitted from China. In fact, Richard Pazdur of the FDA outlined these concerns with STATNews
Here is Pazdur discussing the "data where we don't have confidence" with regards to clinical trial data from China
Also, when the HARMONI-A data were presented at #ASCO24, there were some concerns about ivonescimab. Dr. Aggarwal from Penn Medicine mentioned her worry about lack of CNS penetration.
In the context of other trials combining immunotherapy with VEGF inhibitors, Dr. Patil of UCHealth Anschutz Medical Campus found the HARMONI-A data confusing based on the mechanism of action of ivonescimab.
It's pretty obvious that #ASCO24 got played by Summit Therapeutics. The Summit Therapeutics press release at ASCO regarding HARMONI-2 drove the $SMMT stock price to the moon, without needing to present the data behind the press release. Summit Therapeutics stole the show, and made their investors and senior leadership rich (or more rich) overnight.
So what will World Lung bring? Pazdur from the FDA has made it very clear that the FDA has a concern with their lack of confidence in the data from the clinical trial sites in China. Have the leadership at IASLC done anything to alleviate these concerns? If not, is it irresponsible for the World Lung Conference leaders to place HARMONI-2 as a plenary at this meeting? Is World Lung now the Robinhooder's choice for clinical trial data rollouts?
I guess you can't blame the IASLC leadership if they did not visit China to generate confidence in the HARMONI-2 clinical trial sites?. Just look at what happened to those AstraZeneca employees this week!!
Are you ready for World Lung? Will the Key Opinion Leaders bring their insights on these data?
Brian Shields : Nov 6, 2024 4:05:10 PM
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