RSSDefence Therapeutics (OTC Pink: DTCFF) is on a development-stage roll. And with a series of final studies concluding to advance to its Phase I trial for its leading AccuTOX treatment against breast cancer, positive momentum should continue. Better still, its highly anticipated trial will be more than a new milestone reached; it will be a catalyst that ignites the beginning of a transformational moment in its history. And, once this trial begins, know that its stock will likely follow. Thus, for a clinical-stage company targeting a massive need, its current price tag of $5.17 leaves money on the valuation table.
Defence is also making a case for when being different is good. In fact, DTCFF's ACCUM™ technology platform, a unique treatment method initially developed to enhance the accumulation of particular proteins, antibodies (ADCs), or antigens in target cells, is not only different, but it's also potentially better than current standards of care. Of course, that's what trials want to prove. And DTCFF may hit that high bar.
Why be so confident? Because the ACCUM™ platform produced initial data showing potentially best-in-class treatment results, demonstrating in studies a robust therapeutic function through the delivery of free "naked" ACCUM™ (AccuTOX-001) triggered cell death of a variety of cancer cells, including breast cancer. And, it's this data that has medical professionals and investors eagerly supporting its clinical ambitions. After all, it's a result not often seen.
Best of all, DTCFF is on track to begin its Phase I trial of AccuTOX in breast cancer treatment during Q1-Q2 of 2022, putting a potentially transformational event in the company's crosshairs. And this trial can be more than a catalyst; results, even interim, can substantially raise the platform's value. Know this, too. Data already indicates the potent potential for AccuTOX-001 to kill breast cancer in various animal models, including the use of patient-derived xenografts (PDX).
Furthermore, while already demonstrating its worth as a standalone treatment, secondary objectives of the trial will compare the efficacy of AccuTOX-001 when combined with currently used immune-checkpoint inhibitors. This secondary objective, by the way, could be equally transformational, benefitting from broad sector interest of value gained from combination therapies. Big Pharma is lining up to combine their own drugs with the next big thing. Hence, DTCFF could benefit from both endpoints of the trial.
Abd more excellent news, attention to its development stage program could come sooner rather than later, especially with the Defence team working to show that AccuTOX-001 can trigger the death of pre-established 4T1 breast cancer in immunocompetent mice alone or in combination with anti-PD1. Hence, moving into clinical-stage status could open several new strategic discussions. And DTCFF isn't taking shortcuts.
To substantiate the accuracy of its results, the potency of the leading drug will also be demonstrated in previously characterized PDX models to ensure a good translation from mice to human studies. This data and the company's GLP study scheduled for Q4 of 2021 will be compiled and submitted to the FDA to obtain FDA approval to commence a Phase I breast cancer trial. Indeed, it's easy to conclude at least one broad fact- DTCFF is a company in motion. And with several potentially significant milestones expected in the first part of 2022, investors are right to take notice.
Moreover, investors that are looking are witnessing great things happening. DTCFF is making long strides in its research and development programs involving its ACCUM™ technology platform, including the AccuTOX program. Further, Defence has already developed a DC cancer vaccine (AccuVAC-D) that targets four different indications, two ADCs in late-stage preclinical development (AccuADC), and multiple protein-based vaccines for infectious illnesses as COVID and HPV (AccuVAC-PTs and AccuVAC-INs). Thus, there's a lot of potential pipeline firepower.
Even better, while its trials will indeed take center stage in the coming weeks and quarters, its expected uplist to a more senior NASDAQ market in Q2 of 2022 is an additional value event close timewise to its planned Phase 1 launch. Thus, DTCFF can deliver a powerful one-two punch of value, with both events having the ability to drive share prices higher. And knowing these near-term milestones are only about two quarters away, positioning now and not watching the ticker can be a wise consideration. Thus, while the stock may churn for a while longer, as the trial date nears, expect its share price to follow.
Some argue that it's a Phase 1 trial, so why the interest. Simple, its ACCUM platform has the potential to change the treatment landscape. And at its least, it could be a tremendous asset to leverage in a deal with Big Pharma.
Interestingly enough, some refer to the technology being developed by DTCFF as "next-generation medicine." And, based on the unique mechanisms of its programs, quite rightfully so.
Paving the Way to a New Era Of Treatments
DTCFF's exciting contributions to the medical sector aren't going unnoticed. And through its next-generation platforms, Defence Therapeutics is establishing itself as a true innovator in the medical industry. Moreover, by leveraging their expertise with cutting-edge medical technologies, DTCFF can quickly advance potentially best-in-class treatment solutions for cancer and infectious diseases on both the micro and macro-level. In other words, DTCFF is looking to transform the therapeutic landscape by ushering in a new era of treatment methods. As noted, the sector is watching.
The better news is that partnership interest could already be forming. Last month, Defence announced the development of AccuVAC-IN002, a "non-injectable" second-generation COVID vaccine for intranasal delivery. It's a timely contribution, as vaccination against SARS2-COVID has become less effective in slowing viral spread as new and more infectious virus strains challenge the efficacy of existing vaccines.
Defence is looking deeper than most to find out why, focused on the potential factors causing this loss in efficacy, and then developing a solution to fix them. They've identified two critical reasons why vaccine responses aren't as strong as they used to be. The first and well-known fact is that newer mutations of the virus are better able to elude generated humoral responses.
However, DTCFF is primarily focused on addressing the second potential cause, which involves 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. Consequently, the substantially more contagious strain poses a significant challenge to existing vaccine formulations, creating a critical worldwide need that Defence believes it can meet.
Addressing the Limitations of Traditional Vaccines
Remember, even though vaccines can provide a tremendous amount of protection, it's still possible to contract the disease they are designed to protect against. Although they will help reduce the severity of symptoms in these patients, the incredibly high transmission rate of the COVID-19 Delta variant creates an undeniable problem as airborne transmission at mucosal sites still represents the vulnerable and initial site of infection. As a result, even though vaccination programs are essential to worldwide recovery, the difficulty is that even those vaccinated still take on some risk, especially to potential new variants in the future. In response, Defence Therapeutics believes that its new AccuVAC-IN002 vaccine could deliver life-saving results to patients worldwide while adapting to new variants. If so, share prices would likely turn into rockets. Even better, DTCFF can support the optimism.
Initial results have already proved impressive. DTCFF's new AccuVAC-IN002 formulation is inducing both IgA and IgG antibody responses systemically and at mucosal sites. These results are significant because the simultaneous reactions of these antibodies ensure a transmission-blocking effect that works to stop the initial infection and facilitates close to a 100% blockade in viral shedding. If that's not enough, Defence's AccuVAC-IN002 formulation can be further developed to become a "universal" vaccine capable of targeting 4-8 strains simultaneously, ultimately providing strong protection against known variants while also addressing the issue of any potential strain evolution in the future.
Thus, the unprecedented adaptability of the AccuVAC-IN002 vaccine gives it the potential to become a future-proof treatment against the progression of the SARS-COVID virus. And, with new influenza-like seasonal viruses 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. Therefore, the platform could nearly eliminate the need for new vaccine formulations to be developed multiple times per year to target the same initial virus.
Of course, these impressive features and promising development-stage programs are deservedly attracting the interest of the medical industry and investors alike. The stock is currently targeting its 52-week high of $6.41 and trading higher by about 112% since May of this year. While these numbers are impressive enough, the expected near-term catalysts stemming from its potentially revolutionary arsenal of pipeline assets will help to keep the bias decidedly bullish. Thus, there's plenty of upside left in the tank.
And there's still more to like.
Innovative Platforms, Impressive Results
Alongside its innovative vaccine development program targeting infectious diseases, Defence is also making impressive strides in developing its DC vaccine program against cancer with its AccuVAC-D001 treatment candidate. Still early in its development phase, the treatment's promise lies in its scalable ACCUM™ technology platform, putting DTCFF in a position to effectively develop universal therapeutic vaccines for cancer and infectious diseases. This is an incredible possibility that would've sounded unbelievable just years ago. Still, as analysts and investors come to understand the inherent value and potential within DTCFF's portfolio, Defence's valuation could soar to unprecedented levels as assets move through the development pipeline.
Also, keep in mind that by maintaining 100% ownership of its technology and IP, Defence is ideally positioned to license its technology and capitalize upon worldwide partnership opportunities. Notably, small biotechs have made hundreds of millions of dollars by partnering and letting Big Pharma fund the work. With DTCFF programs showing compelling features, don't discount that happening as a near term strategic option.
Remember, owning assets and IP is a big deal nowadays, especially since Big Pharma is no longer hiding its interests to acquire novel drugs rather than develop them. Deals like these happen almost every day in the sector, and in the case of Defence, there's plenty of innovative, wholly-owned technology to pique the interest of potential partners. Indeed, keep the thought in mind.
Advantages Of Being a Market Innovator
Here's one of the best little-known facts about Defence Therapeutics: They are the first known company to develop a combined technology using precision and efficient cell nuclei for targeted drug delivery. Even better, their proprietary and scalable technology already shows the potential to outperform other industry-leading programs targeting disease and infection.
Additionally, DTCFF's two innovative and proprietary drug candidates should also keep the company on Big Pharma's radar, with both having an ability to add significant intrinsic and inherent value for the near- and long-term. Here's something that's not a secret.
Its ACCUM™ technology is truly remarkable, serving as the delivery platform for its proprietary vaccines across multiple channels. Notably, Defence's ACCUM™ technology has played an instrumental role in developing their SARS2- COVID-19 and cancer vaccine. The technology provides a scalable delivery platform with an enormous multiplier effect that diversifies its market opportunities. Above all, Defence's ACCUM™ Technology is a proprietary platform with proven enhanced drug delivery methods that can be used in applications such as oncology, vaccine development, and nanotechnologies.
Furthermore, the company's Vaccine Development program is also a scalable platform. And that's important as Defence works with its team and partners to develop vaccine formulations that can treat multiple viral strains in a single dose. The program's top priority at the moment is on developing effective and next-generation vaccines for COVID-19 and various cancers.
And by collaborating with a team of medical professionals at the University of Montreal, the programs targeting an urgent medical need could benefit from near-unlimited resources, which could help expedite studies to help get a treatment to market. Remember, COVID-19 is far from beaten. Vaccines that work today may need help tomorrow. That reality keeps Defence in the picture as a potential Covid play as well.
Delivering Potentially Best-In-Class Treatments
While already mentioning a "best part" of Defence Therpautics platforms, it would be remiss to not add another compelling program with next-generation innovations to improve patient treatment options. Remember, it's already noted that Defence's data shows that a viable and scalable biopharmaceutical solution to compensate for increasingly ineffective long-term treatments is within reach.
But, if Defence takes things a step further and successfully demonstrates its platform's ability to easily be adaptable to treat viral mutations, it would blow the limitations of current treatments out of the water, sending DTCFF's stock to the moon. Notably, the rocket is ready from its other programs as well. Thus, two valuable shots on revenue-generating goals could be maximized sooner rather than later.
Best of all, its platform can achieve this 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 have struggled with molecular obstacles, limiting the potential of those discoveries to become a therapeutic standard for human diseases.
Also, ongoing research has only made a case for its program's efficacy stronger. Early data support Defence's belief that its ACCUM™ Technology can overcome the challenges presented by antibody-drug conjugates (ADC's). Its technology has already demonstrated that its drug delivery capabilities are 10x over current ADC's, making the ACCUM™ platform an ideal base for current and future drug treatments. Better still, by having the inherent ability to treat a variety of present and future indications, Defence is positioning ACCUM™ as a global treatment solution. And, for many underrepresented areas of treatment, the platform could be a game-changer for patients in need.
One of the most critical takeaways from the DTCFF portfolio and opportunity is that the power of its treatment comes from combining its two programs. Defence believes that the synergistic nature of the two will help it eventually become the therapeutic standard for human diseases. And, as the ACCUM™ Technology takes its therapeutic firepower directly to the diseased cells, its ability to outperform the current standards of care is a likely proposition.
Collaborative Ventures Enhance Emerging Opportunities
Finally, being a small-cap biotech with a team of collaborators is a bonus indeed. And Defence has that, with ongoing work to build upon its impressive early data through its access to a university lab and resources provided by collaborating with Dr. Moutih Rafei of the University of Montreal (Canada). The goal of the collaboration is to further explore the capabilities of the ACCUM™ platform for targeted drug delivery and effective treatments for infectious diseases.
Early data from this program have been going well, showing that ACCUM™ Technology can provide more potent drug delivery and that vaccine solutions can be applied to any virus or infectious disease. The resources provided through the collaboration have been instrumental in expediting the program's development, thanks to the 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.
The best aspect of this collaboration is that the acceleration of program development can result in much higher near-term prospects. For example, Gilead acquired Immunomedics for $21 billion last October, driving valuations at BioNTech (NASDAQ: BNTX) and Mersana Therapeutics (NASDAQ: MRSN) higher as well. The potentially unrivaled capabilities of Defence could result in a similar situation, and even with shares surging by 114% over the past five months, there is still plenty more success to be had.
A Powerful 2021 With A Bust 2022 In Sight
DTCFF stock is more than a compelling value proposition at current levels; it's a timely one. And, with multiple near-term catalysts arriving as soon as Q1 2022, combined with a small float and tight liquidity, its stock could jump higher sooner than one might expect. By the way, DTCFF has a habit of delivering good news to the markets, and if this pattern continues, they could quickly see a surge in popularity as their programs commence, mature, and near completion.
If so, with its wholly-owned and next-generation assets, a proven track record of progress and success, and door-opening collaborations with University partners, Defence would benefit as a company, a partner, and a potentially significant contributor to the drug treatment community.
In fact, with updates from multiple programs expected soon, there's no need to look too far ahead. Defence Therapeutics has the pieces in place now to justify a substantially higher price tag. Thus, a new update combined with thin trading could make the value present today disappear by tomorrow. But that's the great thing about investing in biotechs. They are always just a single release away from potentially exponential share price gains.
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