For those new to the biotech sector and looking to Imugene as an investment the company is listed in the ASX as IMU. CF33 Vaxinia is the product Imugene’s company management has stated they are focusing on. News of the products ongoing development is scheduled to be released in early November this year. I trust you may find this article useful as part of your ongoing research. It does in no way constitute financial advice.
NB. Please note this thread was designed by me to post relevant information pertaining to CF33, Vaxinia and Oncarlytics. Other Imugene related information, articles or opinions may be posted on the numerous other IMU threads found on Hot Copper. Given the current state of play if we can keep this thread on topic from now throughout November it would be appreciated.
Cf33 Vaxinia background
The oncolytic Vaxinia virus was developed by researchers at the US-based City of Hope treatment centre and has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in pre-clinical laboratory and animal models. Oncolytic viruses are designed to selectively kill tumour cells and activate the immune system against cancer cells, with potential to improve clinical response and survival.
When did Imugene license CF33 Vaxinia?
Imugene acquired a worldwide exclusive licence for the highly potent, chimeric oncolytic poxvirus known as CF33 in July 2019. Back then the company strategy was viewed as being similar to that pursued by Viralytics, which was acquired by Merck for A$502m in 2018 after conducting studies of its Cavatak oncolytic virus in combination with Merck’s checkpoint inhibitor, Keytruda. The CF33 acquisition was seen to strengthen Imugene’s immuno-oncology pipeline, which was then focused on B-cell vaccines. As the CF33 deal was a related party transaction and therefore contingent on shareholder approval, the published valuation was A$159m or 4.4 cents per share.
Imugene is awarded a CF33 Vaxinia patent in the US to 2037
In July of this year, some 4 years after it was acquired, Imugene received a notice of allowance from the US Patent and Trademark Office for a patent to protect its primary oncolytic virotherapy CF33, as well as the Vaxinia (CF33-hNIS) and CheckVacc (CF33-hNIS-antiPDL1) variants. The patent titled Chimeric Poxvirus Composition and Uses Thereof protects the method of composition and method of use of the licensed candidate through to 2037.
Current Imugene CEO and Managing Director Leslie Chong noted at the time “This patent allowance from the US Patent and Trademark Office for the CF33 family of oncolytic viruses is a crucial step forward and a particularly important milestone [for us] with the US being the largest healthcare market in the world,” she said.
What is CF33 Vaxinia?
CF33 is a chimeric vaccinia poxvirus from the laboratory of inventor Professor Yuman Fong who is chair of the Sangiacomo Family Chair in Surgical Oncology at the world-renowned City of Hope Medical Centre in California. Professor Fong is a noted expert in the oncolytic virus field. Safety of all CF33 variants has been demonstrated in a number of pre-clinical trials and there is evidence for a local and systemic anti-tumor response. Oncolytic viruses are designed to selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.
CF33 Vaxinia and genome sequencing
A number of genomic sequences from multiple vaccinia virus strains have been combined to generate CF33 which Imugene calls a “new, safer and more potent virus”. CF33 Vaxinia contains the human sodium-iodide symporter (hNIS) gene, which enables imaging to track the virus in vivo and mediate targeted radiotherapy. CF33 CheckVacc also contains hNIS and is “armed” with anti PD-L1 genes which enable enhancement of anti-cancer immunotherapy.
CF33 Vaxinia and the Vaxinia (MAST) Trial
Commencing on May 18, 2022, with the support of the US Food and Drug Administration (FDA), Imugene is currently performing a Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (Vaxinia). The multi-centre Phase 1 MAST trial initially delivered a low dose of Vaxinia to patients with metastatic or advanced solid tumours, who had at least two prior cycles of standard-of-care treatment. The trial aims to recruit up to 100 patients across 10 trial sites in the US and Australia and run for 24 months, while being funded from Imugene’s existing budgets and resources.
The trial has four arms, firstly Vaxinia is being administered as a stand alone monotherapy through either intratumoral injection (IT), or intravenously (IV). Secondly Vaxinia is being administered in combination with Merck’s Keytruda in (IT) and (IV) format. The trial is progressing nicely, with Cohort 4 in the monotherapy arm currently being treated, alongside Cohort 2 in the combination arm of the trial. Recently Imugene CEO and Managing Director Leslie Chong noted “We remain incredibly eager to bring the results of this trial to our shareholders, patients and the wider public.”
CF33 Vaxinia industry recognition and public awareness
CF33 Vaxinia will be featured at an annual meeting of the Society for Immunotherapy of Cancer to be held in San Diego in November.
Considered to be one of the most prestigious immunotherapy events on the calendar, it features cutting-edge research talks by various experts; oral and poster abstract presentations; and opportunities for networking and discussion with members of the oncology community.
What is CF33 Vaxinia worth to Imugene’s Balance Sheet?
At present there is little or no value attributed to CF33 Vaxinia by shareholders on the Imugene (IMU - ASX) register. In fact the company share price has fallen considerably since they commenced their CF33 Vaxinia Trial. The stock is currently trading at less than twice the company’s current cash at bank valuation. It’s probably fair to say until recently many market pundits, given the oncolytic viruses potency, were unclear as to CF33 Vaxinia’s safety when dosed in humans.
Given the virtual non existence of a market valuation for the CF33 Vaxinia intellectual property, current Imugene stock pricing appears commensurate with valuations for the company’s first immunotherapy treatment, Her Vaxx, a B cell vaccine in the midst of a Phase 2 combination trial with Keytruda. Imugene (IMU ASX) Chairman Paul Hopper has expressed a desire to sell his company’s therapies toward the end of Phase 2 clinical trials, therefore markets are effectively only pricing a prospective valuation for Her Vaxx at present, as opposed to Imugene’s other suite of immunotherapies (see the company’s pipeline at www.imugene.com).
The current neglect of CF33 Vaxinia may be due to the fact that whilst the virus is well know in oncology markets, relatively few people worldwide are aware of its presence. Imugene as a company has only a few thousand page views on the internet or their YouTube channel when it comes to CF33 Vaxinia. Whilst over 36% of the company’s shares are owned by only 20 shareholders. Therefore despite having a large number of shares on issue its fair to say outside of Australia relatively few retail or sophisticated investors own the stock, or are indeed aware of it. Many shareholders have been pushing the IMU Board to pursue a Nasdaq Listing with a view to increasing media, public and most importantly market awareness of their immunotherapies, in particular CF33 Vaxinia, however their endeavours to date have been thwarted.
What is CF33 Vaxinia worth in the marketplace?
According to AARP The Magazine, the total cost of cancer treatment on average is $150,000. However, this number may be much greater or smaller depending on the patient's cancer, treatments, insurance, and resources. The American Cancer Society recently noted that in 2022, there will be an estimated 1.9 millionnew cancer cases diagnosed and 609,360 cancer deaths in the United States. That equates to a market size of approximately 285 billion dollars US flowing into cancer treatment in the US alone, where Imugene’s CF33 Vaxinia patent is granted to 2037. 90 percent of these diagnosis are for solid tumour indications, those being treated by CF33 Vaxinia in the company’s current Vaxinia (MAST) Trial.
Big Pharma companies are the major acquirers of oncology treatment arms, which are currently in demand. That said they enjoy the opportunity to purchase later stage therapies, as opposed to those at preclinical, or even phase 1 stage. However if a therapy is unique, and possesses the potential to obtain Fast Track FDA approval as a significant breakthrough therapy, then the market is more interested, irrespective of the stage of product development. As a preliminary guide Amgen acquired T-Vec, a re-engineered virus designed to destroy cancer cells while spurring an immune response, in a $1 billion buyout of BioVex, a 2009 Fierce 15 company. The deal included USD $million USD up front. Just as CF33 Vaxinia is currently combining with Merck’s Keytruda, for T-VEC, back then interest was around the concept of combining the virus with PD-1-targeting immunotherapies such as BMS' nivolumab and Merck & Co's lambrolizumab. If someone were to pay US$1bn for CF33 Vaxinia today, that would equate to approximately 23 cents per share for IMU holders.
T-VEC, like CF33 Vaxinia, is an oncolytic virus therapy, a treatment that uses a virus to infect and kill cancer cells while avoiding normal, healthy cells. However despite being first approved in 2015 by the FDA, now eight years on T-VEC (Imlygic®): a modified herpes simplex virus (HSV) that infects tumor cells and promotes their destruction; approved for subsets of patients, is predominately still used to treat melanoma patients. Whereas Professor Yuman Fong is currently trialling CF33 Vaxinia to treat multiple solid tumour cancer indications, including but not limited to breast, colon, colectoral cancer and so on. Indeed CF33 Vaxinia was shown to kill all cancer indications against the NCI 60 in preclinical trials for the drug.
Therefore, in previous posts on this thread I had suggested that if the results for CF33 Vaxinia were promising this November 1-5 at the forthcoming Society for Immunotherapy of Cancer to be held in San Diego, CF33 Vaxinia should propel the IMU share price by a figure of more than four to five times that of T-Vec’s original sale price, given the broader treatment potential of CF33 Vaxinia. In other words in my opinion it would be reasonable to attribute a value of well over $1 per share for CF33 Vaxinia, if the commercial history pertaining to the oncolytic virus T - Vec is anything to go by.
Outcomes for CF33 Vaxinia
Oncolytic viral therapy is a relatively new type of cancer treatment, hence there may be some scepticism surrounding its ultimate success as a therapy provider. Keep in mind T - Vec is to date the only oncolytic virus approved by the US FDA. Further to which Imugene, the market and shareholders alike, need to see definitive signs of efficacy before the aforementioned valuations for CF33 Vaxinia can take effect. Until then it is difficult to accurately assess the quantum value of the treatment arm.
It should however be noted that in addition to acting as a stand alone operative, CF33 Vaxinia has succeeded in producing significant tumour killing when combined pre-clinically with several CAR T and allogenic therapy providers. This additional product application enables such providers, who are currently only operating in approximately 10% of the cancer treatment market (I.e., blood borne cancers), to participate in the much broader and more lucrative solid tumour market (I.e., 90% of the cancer market), wherein CF33 Vaxinia holds the most promise, according to Founder Professor Yuman Fong. CF33 Vaxinia therefore may hold a much greater value than when it was first licensed by Imugene back in July 2019.
On a positive note Professor Fong has displayed optimism with the initial results in Imugene’s current CF33 Vaxinia MAST Trial.He continues to hold the view his oncolytic virus shall change the way cancer is treated in years to come. He sees CF33 Vaxinia in combination with many, many other therapies as one day becoming human therapy. If this were to be the ultimate outcome in compensation for all his years of considerable hard work, then no doubt Imugene’s valuation would appear somewhat irrelevant. Leslie Chong is on record as saying, “Through the use of CF33, we hope to improve the clinical benefits and quality of life for patients with cancers that are difficult to treat using current therapeutic approaches.” In November investors and patients shall be one step closer to ascertaining if this goal is to be realised. If so the 4.4 cents Imugene originally paid to acquire the CF33 Vaxinia license would be classed as what we call a bargain. Based on what Amgen paid all those years ago for T-Vec, when it too was in the early stages of development, one would think so.
Any existing holders thoughts on the upcoming conference and CF33 Vaxinia would be most appreciated.
Enjoy your weekend….WMHB
DYOR Seek investment advice as and when required Opinions only
P.s Praying this weekend for those of all religions in Ukraine, Russia, Israel, Palestine and Lebanon touched by war as either adversaries, combatants or unwilling third parties without a say in developments...
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