100% agree with you, that the HER-Vaxx ship hasn't sailed yet, in fact we're accelerating towards our goal of a licensing deal/possible buyout for the drug. I think Merino's question was more about the 'Merck ship' sailing rather than HER-Vaxx as a viable option itself.. But even then I don't think it has entirely for a few reasons I'll go into more below.
I've been doing some DD on Seagen, why Merck USA would want to buy them out? What drugs do they have under their banner and what clinical trials do they currently have ongoing. The closest candidate Seagen have to HER-Vaxx is their drug Tucatinib (TUKYSA), which like HER-Vaxx targets tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
In a recent clinical trial treating patients with HER2-positive breast cancer and where the tumours were metastatic with cancer spreading to the brain in some patients. TUKYSA showed signs of increased survival, with improved OS for patients with brain metastases by 9.1 months compared to trastuzumab and capecitabine alone (21.6 months vs. 12.5 months). However the side effects were horrendous on top of chemo which is already very nasty. Here is an extract from the Seagen website under Warnings and Precautions:
Extract from Seagen website - Seagen - Seagen Announces Updated Results from Pivotal HER2CLIMB Trial Evaluating TUKYSA® (tucatinib) in Patients with HER2-Positive Breast Cancer with Brain Metastases
Seagen also have two on-going clinical trials where they are treating patients with TUKYSA in combination with Trastuzumab (Roche) or Pembrolizumab (Merck USA). It's important to note that these trials are huge with far more participants than the trial Imugene is about to commence with its nextHERIZON study, which will have 30 participants (estimated) meaning we will get findings much sooner than both the on-going trials Seagen are undertaking, with estimated primary completion date July 31, 2023. This is the strategy LC is pursuing and its been given the ethical green light by IDMC and now the CRC confirming dose escalation to 100μg. Below is a brief summary of the two trials I mentioned above:
Clinical trial - NCT04430738 - Tucatinib Plus Trastuzumab (Roche) and Oxaliplatin-based Chemotherapy or Pembrolizumab (Merck USA) -containing Combinations for HER2+ Gastrointestinal Cancers.
Estimated Enrollment: 120 participants
Actual Study Start Date: September 15, 2020
Estimated Primary Completion Date: May 30, 2024
Estimated Study Completion Date: October 31, 2025
Clinical trial - NCT04499924 - Tucatinib, Trastuzumab (Roche), Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer (MOUNTAINEER-02).
Estimated Enrollment : 578 participants
Actual Study Start Date: March 22, 2021
Estimated Primary Completion Date: May 31, 2025
Estimated Study Completion Date: March 31, 2027
Keytruda's patent ends in 2028, and it is their biggest money maker by far as it equates to a 3rd of their total earnings for the 2021 financial year. They want to protect their nest egg and if it means a $40Billion investment to do so which gets them their whole pipeline mind you, including medications to treat Hodgkin lymphoma and Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), then it seems like good business right now, in 2022! It cuts Roche or any other BP out of the equation.
The beauty of HER-Vaxx, which has been discussed infinitum, is that it adds ZERO TOXICITY and promotes the bodies own antibodies to find the cancer for you. So depending on the results of the netxHERIZON study you could see an arm wrestle for it no questions asked. I wouldn't say Merck USA would shy away if it meant beating Roche to the punch. $40B for a whole company, not just a HER-Vaxx competitor.
As I've mentioned previously, we could be seeing combination's which have 3, 4 or 5 drugs being used together. If we added HER-Vaxx in combo, it will add no adverse side effects to the other medications. Its really a masterstroke in science and I look forward to seeing how it performs with a larger dose.
One final point, the HER-Vaxx Phase 2 trial was conducted at multiple sites across Eastern Europe and India where clinicians have difficulty accessing approved antibody treatments such as Herceptin® and Perjeta®, marketed by Swiss multinational Roche Holding AG. There is also a high prevalence of gastric cancer in the countries selected. The Seagen studies are all conducted in the USA and the access to Keytruda would probably be very easy, hence the sheer numbers of the trial.
DYOR and GLTAH's!
Cheers, Tin-tin
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