The CF33, Vaxinia and Oncarlytics Deal, page-922

Oncolytic virus therapies, T - Vec and Vaxinia

According to nature.com oncolytic viruses (OVs) are an emerging class of cancer therapeutics that offer the benefits of selective replication in tumour cells, delivery of multiple eukaryotic transgene payloads, induction of immunogenic cell death and promotion of antitumour immunity, and a tolerable safety profile that largely does not overlap with that of other cancer therapeutics. The website states that to date four OVs and one non-oncolytic virus have been approved for the treatment of cancer globally although talimogene laherparepvec (T-VEC) remains the only widely approved therapy.

Whilst there is much discussion on these threads pertaining to Imugene’s lack of revenue, their early stage trials and the fact they are years away from a
result, Imugene’s own oncolytic virus, Vaxinia, may not be as far away from a pay day as many are anticipating. In my opinion, as noted yesterday, there is already a significant intrinsic value attached to the drug. Vaxinia is a strain of the cowpox virus, (see https://hotcopper.com.au/threads/the-cf33-vaxinia-and-oncarlytics-deal.7300418/page-762?post_id=68800869), whereas T-Vec, the first FDA approved oncolytic virus, stems from a strain of the herpes virus. forbes.com notes that T-VEC, which is injected directly into melanoma tumours, has been genetically modified so it only replicates in cancer cells, destroying tumors while sparing healthy tissues. Vaxinia founder Professor Yuman Fong makes similar claims when outlining the way Vaxinia works. Last year frontiersin.org when discussing T - Vec noted the durable response rate was 36.1% for patients treated with T-VEC compared to 3.8% for GM-CSF and 16.3% for all patients treated with T-VEC). The drug, administered by owners Amgen for approximately $65,000 US per patient, has application in the cancer indications of non Hodgkins lymphoma and leukaemia as well. Vaxinia’s inventor Professor Yuman Fong believes his oncolytic virus could have broader application, across the wide spectrum of solid tumour indications. This assumption comes from Vaxinia’s preclinical studies wherein it killed all cancer indications against the NC1 60.




Vaxinia Founder Professor Yuman Fong - Photo courtesy of https://rscsummit.com/yuman-fong-md-facs/

Early stages of development, no revenue - so what

T Vec’s history points to the fact that just because Imugene is trading at 4.3 cents doesn’t mean there isn’t a big dollar appearing for it in the near term. Back in 2011, when T-VEC was in the early stages of development, as Vaxinia is now, Amgen paid a remarkable $425 million plus $575 million in milestone commitments to acquire its inventor, Biovex. At the time, there were a few hopeful signs: The FDA had granted the drug “fast-track” designation, indicating the potential to speed up its path to market. Imugene’s Vaxinia is at a similar inflection point this November, too that of the oncolytic virus T-Vec in 2011.

Clearly T Vec had never earned a cent when acquired by Amgen. In fact it wasn’t until 2015, some four years later, that T Vec was granted the thumbs up for approval by the FDA. So therefore I would suggest for those who are of the opinion there is no value in IP, that the market wants purely revenue, or that early stage development is not worth a bumper, take a good hard look at what actually happens in the real world of biotech. Remember if something is good, if it has application and engenders durable responses within patients, it's worth a bomb, even if it is in early stage development and pre revenue, as was the situation with T - Vec. Were someone to appear from left field and offer the upfront payment of $665 million AUD Amgen paid for T Vec (i.e., Biovex) way back when, with a lazy $900 million AUD in milestone payments down the track, IMU would all of a sudden be worth billions more than it is today. But would shareholders accept a few billion AUD for Vaxinia? Based on todays valuation maybe they probably would. It’s a pity really. For Imugene has enormous value within their pipeline, you only need to look a little closer. Vaxinia is a good place to start.

Vaxinia and the competition

Keep in mind Vaxinia isn’t the only oncolytic virus looking to enter the market in the coming years. biospace.com notes oncolytic viruses from Transgene/Sillajen, Oncolytic Biotech and other players are in the late phase III stage of clinical trials, and are expected to enter the oncolytic virus immunotherapy market in the coming years. If all else fails Imugene shall at least possess a manufacturing facility to process some of these drugs.

DYOR Seek investment advice as and when required Opinions only