Defence Therapeutics (OTC Pink: DTCFF) reached a milestone last week after announcing it will be conducting a series of final studies to complete all requirements needed to initiate a Phase I trial for its leading AccuTOX treatment candidate against breast cancer. For DTCFF and its investors, the next update can be a substantial value driver. In fact, the trial launch could be categorized as a catalyst, putting this thinly traded $5.40 stock into play.
Investors can expect near and long-term value to be driven through its ACCUM™ technology platform, an innovative approach to treatment initially designed to enhance the accumulation of specific proteins, antibodies (ADCs), or antigens in target cells. The excellent news is that ACCUM™ shows a unique ability to do what's intended, revealing in studies a strong therapeutic function through the delivery of free "naked" ACCUM™ (AccuTOX-001) triggered cell death of a variety of cancer cells, including breast cancer. And that data is helping accelerate its clinical ambitions.
In fact, DTCFF is actively pursuing its AccuTOX program to initiate a Phase I trial against breast cancer in Q1-Q2 of 2022. That puts a near-term catalyst in play. And it comes after compelling data showed the potent potential for AccuTOX-001 to kill breast cancer in various animal models, including the use of patient-derived xenografts (PDX). Moreover, while promising as a stand-alone treatment, secondary objectives will compare the potency of AccuTOX-001 with currently used immune-checkpoint inhibitors. To those following the biotech sector, combination therapies are attracting Big pharma's attention, which is more apt to acquire than develop new drug candidates.
And interest could come sooner rather than later, especially with the Defence team currently working to demonstrate that AccuTOX-001 can trigger the death of pre-established 4T1 breast cancer in immunocompetent mice alone or in combination with anti-PD1. Further, in parallel, the potency of the leading drug will be demonstrated in previously characterized PDX models to ensure a good translation from mice to human studies. Once completed, this data, along with the GLP study scheduled in Q4 of 2021, will be compiled and presented to the FDA to have clearance for a Phase I trial against breast cancer. Hence, DTCFF is a company in motion.
Moreover, they are making clinical headway by continuing extensive research and development programs with its ACCUM™ technology platform, including the AccuTOX program. Already, Defence has developed a DC cancer vaccine targeting 4 different indications (AccuVAC-D), two ADCs in late-stage pre-clinical development (AccuADC), and various protein-based vaccines against infectious diseases such as COVID and HPV (AccuVAC-PTs and AccuVAC-INs).
And while trial news puts the stock in play, so does its intention to submit its application to uplist to the NASDAQ market in Q2 2022. Combined with updates on trial initiation, the first part of next year could be a transformational period for DTCFF. Better still, it can help validate a platform and program that can bring substantial near and long-term value.
Some are calling its technology next-generation medicine. And rightfully so.
Ushering In A New Era Of Treatments
And its contribution in the medical sector follows a transformative period of growth in the technology sector, which ushered in smart devices, digital technology, and electric vehicles. These products and services are no longer futuristic; they're mainstream. And it happened so quickly that people hardly had the time to appreciate how powerful it can be toward future innovation. Medical and drug development programs included.
Defence Therapeutics, with its next-gen platforms, has secured its place as an innovator. And by combining technology and innovation with strategy, they are quickly advancing enhanced treatment solution candidates for cancer and infectious diseases on both the micro and macro-level. In short, they are ushering in a new era of treatment and methods that can change the therapeutic landscape.
The best part is that while its technology is forward-thinking, its potential treatment-changing therapeutics could make it to the markets sooner than many expect. If they attract partnership interest, that plan could accelerate.
That interest could be building. Last month, Defence announced its development of a "non-injectable" second-generation COVID vaccine, AccuVAC-IN002, for intranasal delivery. Indeed, it's a timely contribution that comes after vaccination against SARS2-COVID becomes less successful in slowing the viral spread as new and more infectious virus strains challenge the efficacy of current vaccines.
Defence is zeroing in on why that's happening, with plans to do something about it. They are targeting two reasons for the less potent responses to vaccines. First, detected mutations can escape generated humoral responses. That's a given.
But, second, and an area of intense focus by DTCFF, is on research showing that people infected with the Delta strain carry 1260 times more virus in their nasal cavity than the original version of the coronavirus. Therein lay the challenge to existing vaccine formulation and the opportunity that Defence intends to exploit.
The Best Vaccines Don't Always Keep The Crown
Remember, while having the best intentions, even the best vaccines administered the wrong way can be ineffective. That's proving true with COVID, with current vaccination strategies failing to effectively protect people from airborne transmission at mucosal sites, which represent the initial site of infection. Thus, despite vaccination programs essential to global recovery, the problem emerging is that vaccinated individuals can still be infected and possibly develop life-threatening symptoms. Defence Therapeutics thinks it can deliver a more comprehensive vaccine solution.
And results to date are impressive. Its new AccuVAC-IN002 formulation is inducing both IgA and IgG antibody responses both systemically and at mucosal sites. That's a significant result that ensures a transmission-blocking effect that may do more than halt initial infection; it can also facilitate close to a 100% blockade in viral shedding. Better still, its AccuVAC-IN002 formulation can be further developed to become a "universal" vaccine capable of targeting 4-8 strains simultaneously, ultimately providing adequate protection against known variants and expected future emerging strains.
Thus, with its AccuVAC-IN002 vaccine scalable, it could prove to be most effective against the progression of the SARS-COVID virus. And with new influenza-like seasonal virus potentially requiring a new vaccine every 6-12 months, Defence is better positioned than many to fight the transmission of airborne disease and other emerging pathogens through its vaccine development program. Consequently, it could almost eliminate the need for new vaccine formulations multiple times per year to target the same initial virus.
The innovative nature of its development stage programs is certainly attracting interest. Currently, its stock is targeting its 52-week high of $6.41 and trading higher by about 116% since May of this year. Still, while impressive, potential near-term catalysts from its formidable product pipeline can help keep the bias decidedly bullish.
Impressive Pipeline Leveraging Innovative Platforms
In addition to its innovative vaccine development program targeting infectious disease, Defence is advancing its DC vaccine program against cancer with its AccuVAC-D001 treatment candidate. While still early in its development phase, the promise lay in its scalable ACCUM™ technology platform, putting DTCFF in a position to efficiently develop universal therapeutic vaccines for cancer and infectious diseases. And as the markets and analysts come to better understand the power and potential of its technology, Defence's valuation could follow higher.
And that would be well-deserved through programs evaluating innovative pathways focused on drug development research's intricacies, utilizing cell nucleus drug delivery technology as a priority. It's a novel approach. Moreover, its solutions could fill a treatment gap currently left exposed by Big Pharma. Even better, by maintaining 100% ownership of its technology, Defence is well-positioned to license its technology to take advantage of global treatment opportunities.
That IP ownership can also accelerate the potential of its platform, especially with Big Pharma no longer hiding its interest in acquiring new drugs instead of developing them. These deals happen nearly every day in the sector, and in Defence's case, there's plenty for technology to support broad interest from potential partners.
Owning The Markets
Keep in mind, Defence is the first known company to develop a combined technology using precision and efficient cell nucleus for targeted drug delivery. And this proprietary and scalable technology could already rival other best-in-class programs targeting disease and infection.
Moreover, its two innovative and proprietary pathways to get its drug candidates to market should keep the company on the radar screens of Big Pharma, as both have significant intrinsic and inherent near and long-term value.
Its ACCUM™ Technology is indeed impressive and is the delivery platform making its vaccines accessible across multiple channels. It's also a scalable delivery platform with an enormous multiplier effect that diversifies its market opportunities.
Most importantly, its ACCUM™ Technology is a proprietary platform technology with proven enhanced drug delivery methods with inherent applications to target oncology, vaccine development, and nanotechnologies. Notably, the ACCUM™ technology has already helped develop its SARS2- COVID-19 and cancer vaccine. Hence, substantial value from that program could be generated from its next update.
The other part of its scalable drug development model comes through its Vaccine Development program. There, Defence engages with its team and collaborators to develop vaccine formulations that can treat multiple viral strains in a single version. In development is priority research focused on developing effective and novel vaccines for COVID-19 and cancers.
The program, by the way, is a collaboration with the University of Montreal, which could be a means to expedite vaccine and drug development.
Developing Better Treatments
Of course, the mission to develop next-gen innovations for enhanced patient treatment options is now in focus. And if Defence can show its platform's ability to overcome current limitations of marketed treatments by having an inherent means to treat viral mutations, its stock could be off to the races. Keep in mind, Defence's data already shows that a viable and scalable biopharmaceutical solution is within reach to compensate for what are becoming ineffective long-term treatments.
Further, its platform shows an ability to provide robust therapeutic value without radiation and chemotherapy, which kill both cancer and healthy cells simultaneously. Included in that effort is a workaround from Nuclear-targeted biopharmaceuticals, which struggle with molecular obstacles, limiting those discoveries' potential to become a therapeutic standard for human diseases.
Best of all, continued research is making each of its programs stronger. And that research supports Defence believing its ACCUM™ Technology can overcome the challenges that antibody-drug conjugates (ADC's) present.
Already, its technology shows that its drug delivery abilities are 10x over current ADC's, making its ACCUM™ platform an ideal contributor for current and future drug treatments. Better still, by having the inherent ability to treat many indications, Defence is positioning ACCUM™ as a global treatment solution. And it can be a treatment game-changer in many targeted conditions.
Still, understand that the power of the treatment comes from combining its two programs. And Defence expects that the synergistic nature of the two can help it become the therapeutic standard for human diseases. The most important part of that proposition is that the platform shows it can work.
In fact, ACCUM™Technology shows an ability to deliver better results compared to competitors in the market. That's primarily because ACCUM™ Technology takes its therapeutic firepower directly to the diseased cells. As noted, they are leveraging the power of collective interest.
Collaborative Interest Drives Innovation And Value
They are building on impressive results through a partnership with the academic laboratory and resources available through Dr. Moutih Rafei at the University of Montreal (Canada). The focus is on infectious disease and virus vaccine development utilizing the ACCUM™ platform for targeted drug delivery and effective treatments.
Data to date is impressive, showing that by using ACCUM™, more potent drug delivery is prominent and that vaccine solutions can be applied to any virus or infectious disease. More notable, tapping into the resources made available to expedite trials is substantial, utilizing state-of-the-art facilities at the University of Montreal's ample laboratory space that accommodates 12 highly qualified personnel and a wide range of equipment.
Keep this in mind, too. Expediting research can add significant near-term value. Last October, Gilead acquired Immunomedics for $21 billion. That drove valuations at BioNTech (NASDAQ: BNTX) and Mersana Therapeutics (NASDAQ: MRSN) higher as well. That interest could bode well for Defence, and despite shares higher by 116% over the past five months, there is still plenty of room to run.
Value-Opportunity From Powerful Pipeline In-Play
Hence, from an investor's perspective, DTCFF stock still presents a compelling value opportunity. And with potential catalysts in sight combined with a small float and tight liquidity, its stock could move higher sooner rather than later. Remember, DTCFF has a habit of delivering good news to the markets.
Further, by owning its assets, having a proven track record of progress and success, and advancing collaborations with University partners, Defence is better positioned than ever to continue that trend.
In fact, with updates from multiple programs potentially imminent, they are likely to deliver on that front sooner than many expect. Hence, the value today may not be there tomorrow, making investment consideration in DTCFF both timely and compelling.
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