Vaxinia the FDA and the value withinEven at relatively low doses...

Vaxinia the FDA and the value within

Even at relatively low doses Vaxinia enabled a patient to survive free of bile duct cancer for 350 days. 17 others had their disease stabilise or respond to Vaxinia.

The outcome? The FDA determined Vaxinia showed some advantage over available therapy, such as:

• Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
• Avoiding serious side effects of an available therapy
• Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
• Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
• Ability to address emerging or anticipated public health need

Now we move into higher doses and the prospect of an FDA Approval for Professor Fong’s astounding Oncolytic Virus as early as 2024. An important factor in the FDA Approval process is the experience of those assigned the task within an organisation. Dr Jakob Dupont and Leslie Chong have multiple FDA product approvals under their collective belts. Paul Woodard, Bradley Glover and most importantly Professor Yuman Fong have spent years in close contact with the regulatory body. Therefore Imugene is in safe hands.

What is of perhaps more interest is the not only the pending success of Vaxinia at higher doses, but which if any fast track and priority review designations shall be afforded to Vaxinia with respect to further cancer indications. The initial findings at relatively low doses within the gastro intestinal category of cancers may warrant additional Imugene applications, should Vaxinia continue to produce positive signals and immune responses in existing patients .

I am amazed at how these results and indeed todays announcement have been met with nothing short of ambivalence from an obviously money hungry market. Although trading volumes have increased in recent weeks I am confident the majority have failed to assess the veracity of the situation at hand. Vaxinia’s results have been achieved in not only late stage patients with metasticized conditions, the drug has proven itself to be efficacious in patients diagnosed with solid tumours. Monoclonal antibodies aside, contemporary immunotherapies, CAR T’s and oncolytic viruses have failed to exhibit such impressive results when treating this huge unmet need. As we know pancreatic, colorectal and liver cancer patients, all have an exceptionally low chance of living past 5 years once their cancers have spread. I guess the market is awaiting a formal FDA approval for Vaxinia, at which time the drug shall be worth anything up to 100 times its price today, if other leading cancer drug revenue is any indication. I certainly wouldn’t be betting against an approval following todays FDA decision. Particularly considering the lack of side effects present within existing Vaxinia patients. Not to forget we are yet to see results of Vaxinia at its now escalated dosage rates.

Unlike the ASX Big Pharma can read the play when it comes to the FDA and their approval process, as a sign of things to come. As an example in October 2022 Eli Lilly NYSE LLY announced the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for the investigation of Tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner. LLY was trading at about $362 USD at the time. Then a few weeks ago on November 8, 2023 the FDA approved tirzepatide injection for chronic weight management in adults with obesity.

Eli Lilly is trading at close to $600 USD. Now not all the incremental gains are attributable to the recent FDA decisions in respect of tirzapede, but given obesity is prevalent in the US, as is cancer, (i.e.,the disease Vaxinia treats,) the numbers stack up from an investment perspective. Future revenue looks like it should be good for a drug proving effective in combatting weight loss and therein obesity. Analysts have pegged its peak sales in this indication at a staggering $25 billion. That brings the drug value to a little over $100 billion USD dollars or thereabouts to Eli Lilly, or close to 200 times Imugene’s market cap as of today.

Could a cancer drug earn as much as an obesity drug? Merck’s Keytruda is definitely giving it a good shake. On Evaluate's list of top 10 drugs by sales in 2028, Keytruda is expected to reach the US $30 billion mark.

Another example closer to home in terms of FDA fast tracking and cancer indications was Novartis’ Pluvicto, developed to treat prostrate cancer. On March 23, 2022, the FDA accelerated the approval of Pluvicto for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after receiving an androgen receptor (AR) inhibitor and taxane-based chemotherapy. The FDA granted this application a priority review and a breakthrough therapy designation. Novartis is anticipating $2 billion dollars in peak revenue for the drug, placing its value on the open market at approximately $9 BN USD. In Imugene market cap speak that would add about another $2.70 on top of todays IMU share price. Keep in mind however Professor Fong is aiming to be able treat ALL cancer indications at the now higher dose of Vaxinia, as he did pre clinically.

Whatever way you look at it the market is still factoring in a fail for Vaxinia, at a market cap for IMU of about $500 BN USD. Given the speed at which the FDA now has fast track approvals moving through to full approvals, I’m kind of thinking someone has it wrong. And this time I don’t think it’s me…

DYOR Seek investment advice Opinions only