Her Vaxx, Pd1 Vaxx and my ideal scenario
Following on from my post yesterday thank you for your comments. My view is that Imugene were aware of PD1 Vaxx’s success as early as 2021, and now at the end of 2023 we are not much further down the track with the drugs development. I appreciate we are in combination with Roche’s Tercentriq in the lung cancer indication, but with adequate resources that trial could have progressed at a much faster clip. Similarly with Her Vaxx, things have progressed at a snail’s pace. Meanwhile Keytruda, Opdivo and as you are no doubt aware Enhertu, have all had success in having HER 2 expressing cancer treatments approved, at the same time Imugene has in my opinion been sitting on their hands.
Of note is the fact that having initially proved unsuccessful in treating stomach cancer, Merck's Keytruda did prove successful when combined with Roche’s Herceptin to treat gastric cancer. The FDA approved the Keytruda Herceptin combination based on early data from a phase 3 Keynote-811 trial. Of the 264 patients randomized in the 692-subject trial, the Keytruda regimen significantly shrunk tumors in 74% of patients, a 22-percentage-point improvement over the Herceptin-chemo group. On the other side of the HER 2 divide Bristol Myers Squibb (BMS) has had success in the untreated gastric cancer designation. Whilst Enhertu was approved for the treatment of HER2-overexpressing breast cancer.
Despite these recent approvals and advancements I believe Her Vaxx, designed to treat Human epidermal growth factor receptor 2 (HER2), the gene that can promote cancer progression when mutated or expressed at high levels, does have a role to play given it’s efficacy and most importantly impeccable safety record. Back in 2020 The American Association for Cancer noted “HER2-targeted therapies have proven successful for patients with breast and gastric cancers; however, there are no approved HER2-targeted therapies available for patients with other HER2-overexpressing or HER2-mutated malignancies,” said Bob Li, MD, medical oncologist at Memorial Sloan Kettering Cancer Center and senior author on the study. “Conventional therapies for these other HER2-overexpressing cancers tend to have limited efficacy and considerable side effects. Additional treatment options are urgently needed for these patients.”
There is a large market out there awaiting Her Vaxx. High expression levels of HER2 have been observed in many different cancer types, including breast, gastric, lung, and colorectal cancers. My view is that Her Vaxx should be combined in some way shape or firm with Imugene’s PD1 Vaxx, to take on some of these indications. Having established proof of concept Imugene’s B cell therapies should no longer be sold, but combined and developed, due to their lack of side effects, effectively placing them ahead of the competition. The downside is they are starting behind the competition, and would have to prove themselves in later stage cancer patients, but I still see room for their development. Particularly in the huge unmet need that is lung cancer. But how can Imugene afford it?
The answer to this question may be found in the answer to the question posed by my fellow poster @Thailat who asked of me yesterday What's your thoughts on IMU going it alone and getting CF33 on the shelves without BP?
@Thailat went on to say I have read your material in the past that went into depth with regards to my question, but I think the approach and possible way this could play out is of coarse ever changing, I really believe that this is where they seem to be steering the ship now!
In answer to both my question, and @Thailat’s, I do not think there is a way Imugene can progress to market of their own accord, given their lack of marketing expertise, capital and resources. Therefore rather than selling and out licensing their B cell platform, or eventually their Oncolytic virus and Oncarlytics platforms, I would prefer to see a mutually beneficial partnership with a large Big Pharma such as Merck, BMS or Roche. In my ideal world they could acquire say 40 or even 45% in Imugene for say 12 billion USD. 5 could be in cash, with 3 paid as milestone payments payable on the FDA approval for Vaxinia, PD1 Vaxx (in combination with Tercentriq), and Oncarlytics (in combination with BLINCYTO), (i.e., 1 each). The remaining 4 billion should be set aside for the development of a Her Vaxx/ PD1 Vaxx combination (see above), the progression of Vaxinia and Oncarlytics, and the eventual marketing of Azer Cel. There would be no need for royalty payments as in my scenario Imugene’s Big Pharma partner would have skin in the game. A new company could be formed to list on the NASDAQ, (call it say Imu2) with the Big Pharma being afforded 2 if not 3 seats on the Board. That way Imugene would have the capital, marketing expertise and Board experience to become the oncology powerhouse many of us have longed for. The company could be self funding as azer cel came on line with revenue from 2025 onwards.
In a recent Reuters article (See https://www.reuters.com/legal/transactional/cash-is-king-biotech-ma-will-clinical-data-be-saving-grace-2023-03-10/), it is noted But biotech companies should beware of the risks as well. If the buyer isn't dedicating the necessary resources to the product's development post-acquisition, the seller might not hit the milestone targets needed to receive the full purchase price. That is why of my 12 Billion USD asking price a heavy chunk of the change needs to be set aside for further product development, to satisfy Imugene’s incoming partner their drugs shall eventually reach FDA Approval status, and therein milestone payments. Either way their risk is somewhat mitigated by Imugene’s large number of shots on goal. Whilst on Imugene’s side of the coin it goes without saying 5 billion USD upfront in cash is a nice return for Imugene shareholders who wouldn’t mind pocketing the $1 per share or thereabouts in the meantime, particularly with the upside associated in having Big Pharma partner backing, a NASDAQ listing afoot, and the potential for milestone payments down the track.
Anyway, if Monil and PH aren’t up for doing such a deal I’m happy to avail them of my services, and hop on my bike to visit Merck, Roche or BMS. It's high time they made something happen on the commercial front. With Big Pharma's collective patents expiring by the day, and Imugene’s success with Vaxinia now public knowledge, it shouldn’t be too hard to get the deal over the line. It would give them first bite at the cherry if and when Imugene’s products do reach their full potential. And 12 billion USD isn’t much to outlay for a crack at the solid tumour market, given what they’ve been splashing out on smaller market segments of late. I might see if I can take YF, SP and even Ursula McCurry along to close the deal. It could be good to have a female in the room.
Enjoy your Sunday
WMHB
DYOR Seek investment advice as and when required Opinions Only
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