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Defence Therapeutics Scores Again With New Planned Phase 1 Trial Evaluating Its DC Cancer AccuVAC-D002 Against Melanoma; Puts Second Catalyst In Play (OTCMKTS: DTCFF)

Defence Therapeutics (OTC Pink: DTCFF) has reached a second milestone in as many weeks after announcing they are close to finalizing the required processes ahead of a pre-IND meeting to initiate a Phase I trial evaluating its DC cancer vaccine candidate AccuVAC-D002 against melanoma. 

In that quest, Defence is also advancing a promising program, having already exploited the use of its ACCUM™ technology platform to develop an impressive pipeline of products in immune-oncology and infectious diseases. Now, one of its lead products, AccuVAC-D002, is taking its turn in the limelight, hoping to demonstrate its best-in-class potential as a DC-based cancer vaccine to treat melanoma. Moreover, its ACCUM™ technology platform is again showing why it is earning investor and sector analyst interest. That, indeed, is the value driver at Defence.

Also intriguing to investors is that Defence is positioned exceptionally well to tackle the complex issues faced when evaluating treatment targeting cancers and infectious diseases. And invoking that outside interest is its star attraction- ACCUM™ technology. It's earning praises showing itself very efficient at enhancing intracellular delivery of proteins of pharmacological interests such as ADCs or vaccine antigens. Better still, Defence's scientific team also identified a novel function for the use of "free" ACCUM™ and its recently developed variants as anti-cancer molecules. And that takes the program a significant step forward.

In fact, DTCFF is an entire company in motion, moving its product pipeline forward by developing various cancer vaccines, including AccuVAC-D002. Now, supported with compelling data in hand, they have established dialogue with a large and well-established CRO in the United States to identify and set up the site for its planned Phase I against melanoma in the first half of 2022. Hence, that trial start reaches more than its next milestone; it becomes a catalyst.

Better still, there are several now in play.

Advancing Promising Antibody Drug And Vaccine Candidates

In fact, with Defence Therapeutics having antibody-drug conjugates and vaccines in late-stage pre-clinical development and/or undergoing GLP studies, more good news can come sooner rather than later. Better yet, with two of its cancer vaccines (AccuVAC-D001 and D002) undergoing manufacturing in clean rooms, DTCFF is expecting to initiate additional Phase I trials before the middle of next year. Hence, its current market cap of roughly $178 million may soon be up for a raise.

And a raise would be well deserved, especially with DTCFF positioning itself to do well in a more than $14.55 billion skin cancer treatment market. Moreover, that market is increasing by 7.5% per year, leading it to more than double in the ten years. Still, there's more in its pipeline that makes its recent $5.11 stock price look cheap.

In September, DTCFF announced conducting a series of final studies to complete all requirements needed to initiate a Phase I trial for one of its leading AccuTOX candidates against breast cancer. It's leveraging the strength of its ACCUM™ technology platform. 

That platform, by the way, was initially designed to enhance the accumulation of specific proteins, antibodies (ADCs), or antigens in target cells. And as studies advanced, Defence saw a strong therapeutic function for ACCUM™when delivered on its own. More explicitly, the delivery of free "naked" ACCUM™(AccuTOX-001) from the study triggered cell death of a variety of cancer cells, including breast cancer. Noteworthy, too, the treatment was well tolerated by animals under the same treatment regiment. Of course, now DTCFF is out to prove it can be just as effective in humans. It would be a substantial win for patients, the DTCFF platform, and investors.

Moving Quickly With Compelling Data

Keep in mind, too, that DTCFF is working from the fast lane to expedite its AccuTOX program and initiate its Phase I trial against breast cancer also by the middle of 2022. The plan now is to re-enforce its data by showing how potent AccuTOX-001 can be at killing breast cancer in various animal models, including patient-derived xenografts (PDX). Also, part of the study design is to evaluate secondary objectives that compare the potency of AccuTOX-001 as stand-alone or combination therapy with currently used immune-checkpoint inhibitors. In that sense, partnership and licensing opportunities should be applied when evaluating the value proposition. In other words, increasing the beta to allow for "interested party" upside is warranted.

In the meantime, DTCFF is staying busy. Currently, the DTCFF team is focused on demonstrating that AccuTOX-001 can trigger the death of pre-established 4T1 breast cancer in immunocompetent mice alone or in combination with anti-PD1. Also important, 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 and bid for clearance for a Phase I trial against breast cancer. Hence, DTCFF has a busy calendar, and with early-stage biotech stocks typically moving on trial news and updates, DTCFF is likely to get a push higher by staying true to its project timeline.

The value proposition doesn't' stop there. Defence is further continuing extensive research and development programs utilizing its ACCUM™technology platform, including the AccuTOX program to develop what they believe can be best-in-class treatment alternatives to the standard of care. 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 to make sure the right institutional investors are paying attention, DTCFF is also expecting to submit its NASDAQ listing application by the start of Q2 next year. Hence, DTCFF is working to create value from both the operational and from its corporate side. Combining both missions is even better.

Better still, Defence Therapeutics is proving that being different can attract the right attention.

Investing In Trail Blazers

From an investor's perspective, finding and investing in the trail-blazers in any industry often results in exponential returns. Opportunities in our generation came through Tesla (NASDAQ: TSLA), Apple (NASDAQ: AAPL), and Amazon (NASDAQ: AMZN), to name a few, when small investments turned people into millionaires; even billionaires. 

It happens in biotech as well, with dozens of one-time penny stocks developing a breakthrough drug that takes them from clinical-stage companies to blockbuster market kingpins. It's not as rare in the biotech sector, either. But one common element is that the company needs to be doing things differently from its ambitious competition. Defence Therapeutics is.

And they are proving that distinction with its ACCUM™ technology platform, a unique treatment which, as noted, was initially developed to enhance the accumulation of particular proteins, antibodies (ADCs), or antigens in target cells. The more excellent news is that it is not only different, but it's also potentially better than current standards of care. Most importantly, its imminent trials may prove that assumption. 

Trading ahead of data may be wise. After all, in almost every case for drug developers, companies benefit from the doubt until they fail. It's not unlikely to see a company entering a Phase 3 trial skyrocketing in value at the start of the study. The end results determine where it goes from there.

With that said, there is reason to be optimistic about DTCFF's clinical prospects. At the same time, its thinly traded shares could be pushed higher on its near-term trial launch news. Why be so confident? Because the ACCUM™ platform already showed potentially best-in-class treatment results, demonstrating in studies a robust therapeutic function through the delivery of free "naked" ACCUM™ (AccuTOX-001) triggering cell death of a variety of cancer cells, including breast cancer. And, that data, specifically, has medical professionals and investors eager to see the results in the next stage of the study. Keep in mind, the data produced are results not often seen.

Best of all, DTCFF is on track to begin its Phase I trial of AccuTOX in breast cancer treatment within the next few months, putting a transformational event in its history in the crosshairs. And here's the best part, results, even interim, can substantially raise the platform's value. Even better, couple positive results with its data already indicating the potential for AccuTOX-001 to kill breast cancer in various animal models, including using patient-derived xenografts (PDX), DTCFF could run exponentially higher considering its thinly traded float.

Early Stage-Early Opportunity

Still, with Defence Therapeutics about to be a Phase 1 clinical-stage company, why the massive interest? Simple answer- 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, several industry insiders are calling the DTCFF technology "next-generation medicine." And that draws the eye as well. Better yet, it keeps DTCFF on the radar screens of Big Pharma, who tend to acquire new drugs instead of developing them. 

Moreover, by leveraging their expertise with cutting-edge medical technologies, DTCFF can keep parties interested by quickly advancing 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. 

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 harder 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 more intensely 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.

By the way, that trial is generating compelling data.

Addressing Traditional Vaccine Limitations

When evaluating any vaccine, it's essential to keep in mind that while a vaccine can provide a tremendous amount of protection, it's still possible to contract the disease they are designed to protect against. That's proving true with COVID-19. 

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 critical to worldwide recovery, today's challenges come from even those fully vaccinated still taking on some risk. And as new variants emerge, so will the need for new vaccines. 

In response, Defence Therapeutics is developing what it believes can be a life-saving treatment that could deliver durable and lasting treatment to patients worldwide. Its new AccuVAC-IN002 vaccine is the star of the show, and its interim data is nothing short of impressive. 

Initial results have shown its new AccuVAC-IN002 formulation can induce 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. Better still, 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. Simply put, the platform could nearly eliminate the need for new vaccine formulations to be developed multiple times per year to target the same initial virus.

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 again 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 and intrinsic value within DTCFF's portfolio and platform, Defence's valuation could soar to unprecedented levels as assets move through the development pipeline.

And with DTCFF maintaining 100% ownership of its technology and IP, they are ideally positioned to license its assets 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.

In fact, IP ownership is an essential asset to value, especially with Big Pharma primarily acquiring novel drugs rather than develop them. Deals and partnerships in the sector happen almost daily. And to Defence's credit, there's plenty of innovative, wholly-owned technology to pique the interest of potential partners. Indeed, keep the thought in mind.

Here's more excellent news. Ongoing research has only made a case for DTCFF technology stronger, with interim data supporting Defence's belief that 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.

The rewards of proving that can be substantial. And interest in the vaccine space is surging. For example, Gilead acquired Immunomedics for $21 billion last October, driving valuations at BioNTech (NASDAQ: BNTX) and Mersana Therapeutics (NASDAQ: MRSN) higher as well. Could it be DTCFF's turn? Maybe, keeping in mind its potentially unrivaled capabilities from an innovative and scalable platform that can tackle multiple viruses and strains in a single formulation. Hence, with consolidation happening, its share price surge of over 112% over the past five months, while indeed impressive, could be a prelude to more gains to come.

A Powerful 2021 With A Bust 2022 In Sight

The bottom line here is a straightforward one – investment consideration in DTCFF stock timely. It also presents a compelling value-based proposition. And, with near-term catalysts lining up for arrival as early as Q1 2022, consideration would be wise sooner than later. Know this, too. DTCFF has established a pattern of delivering good news to the markets. And if this pattern continues, the next few months could be a tremendous period of growth for the company and its stock. 

In fact, with updates from multiple programs expected soon, its growth spurt could come faster than many expect. In fact, a new update combined with thin trading could make the value present today extinct by tomorrow. But as biotech investors know, when news is good, biotech stocks can fly. Hence, with DTCFF news imminent, they, too, are just a single update away from potentially exponential share price gains. It's a great reason to invest in the sector. And Defence Therapeutics may be the next in play.


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