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Swift Rise of Biotech IPIX (Innovation Pharmaceuticals) as Potent Therapeutic Brilacidin Begins Clinical Trials

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2 years ago

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IPIX (Innovation Pharmaceuticals) is making a major run up the charts in recent weeks making a move towards its June highs of $0.65 per share on fast growing volume topping several million in dollar volume per day. IPIX has been under heavy accumulation recently and volume has picked up substantially since early December as a new era of penny stock speculators fueled by the robinhood app and its brand new 100 million trading accounts take on the bulletin boards. These are different times than just a few short years ago; now penny stocks such as TSNP can achieve a $6 billion plus market valuation and trade $375 million in dollar volume in a day on the bulletin boards. And TSNP has no stronger fundamentals than IPIX does. IPIX has a long history of legendary runs skyrocketing to $4.93 per share when it was trading as CTIX. Currently making a move on its recent highs, investors are looking for a break over $0.65 for confirmation of the next big leg up. 

It’s easy to get excited about IPIX; the Company’s flagship Brilacidin is quickly emerging as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials for other clinical indications, providing established safety and efficacy data. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). Earlier this month IPIX began its Phase 2 clinical trial of Brilacidin for treating COVID-19. The Phase 2 randomized, placebo-controlled clinical trial includes approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intravenous treatment arms were enrolled—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale.  A non-peer-reviewed study recently reported that Brilacidin Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2. A peer-reviewed study recently published reported that Brilacidin Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2.

Innovation Pharmaceuticals (OTCQB: IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently initiated a Phase 1 study with their formulation. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated as a potential treatment for COVID-19.  

Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1β, TNF-α and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential.  

Microcapdaily has been covering IPIX for years starting with CTIX back in 2015 reporting on the stocks legendary run to $4.93 per share. We stated on CTIX back in the day: “As anyone in the industry knows, regulating the p53 pathway has long been the holy grail of cancer research and big pharma has spent hundreds of millions of dollars researching ways to achieve this with no success thus far. It seems Kevetrin(TM) has accomplished this; extensive preclinical research on Kevetrin shows the re-activation of p53 across a wide spectrum of cancer lines including colon, lung, breast and pancreatic cancers. The market potential for Kevetrin in treating drug-resistant cancers is worth $5 billion a year. Other cancers could easily represent an additional $5 billion annually, he adds.”

Investor sentiment in IPIX is high:

https://twitter.com/TopCincoSpaZz/status/1361901994680733697

IPIX has established a valuable intellectual property portfolio: 

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IPIX

Earlier this month IPIX began its Phase 2 clinical trial of Brilacidin for treating COVID-19. The Phase 2 randomized, placebo-controlled clinical trial includes approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intravenous treatment arms were enrolled—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale. Other endpoints include: in-hospital outcomes, all-cause mortality, measurement of inflammation-related biomarkers, changes to SARS-CoV-2 viral load, and other key measures. The Company believes Brilacidin holds tremendous promise to help address the global pandemic, particularly given the emergence of contagious and virulent coronavirus variants. Data increasingly are showing these variants can significantly lessen the effectiveness of COVID-19 treatments and vaccines. For example, a Phase 2b trial in South Africa showed the Novavax vaccine was less than 50 percent effective against a new coronavirus variant originally identified in that country. 

A key differentiating aspect of Brilacidin’s antiviral mechanism of action is its ability to attack the coronavirus directly by disrupting viral membrane integrity. This suggests Brilacidin would be less prone to resistance developing due to viral mutations. Brilacidin already has been shown to inhibit the Washington and Italian strains of the coronavirus and multiple strains of endemic human coronaviruses (H-CoVs), with additional laboratory testing of Brilacidin planned against new coronavirus variants. Novel therapeutics with broad-spectrum anti-coronavirus properties are, and will continue to be, much-needed as the world confronts the coronavirus pandemic and prepares for the likelihood of future viral pandemics. 

Recently after the FDA approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19 the Company’s CEO Leo Ehrlich stated: “It’s clear from comments of infectious disease experts like Dr. Anthony Fauci and recent news reports on emerging COVID-19 variants that we are not out of the woods yet with the coronavirus, by any stretch of the imagination. Even with vaccines starting to be rolled-out, it is going to be many more months for them to reach the masses and potentially years before vaccines are available worldwide. There is now and will be into the foreseeable future a real need for new therapeutics to treat people who contract the infection. We have great hopes Brilacidin will emerge as a novel therapeutic to help fight the global pandemic.”

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IPIX is making a major run up the charts in recent weeks making a move towards its June highs of $0.65 per share on fast growing volume topping several million in dollar volume per day. IPIX has been under heavy accumulation recently and volume has picked up substantially since early December as a new era of penny stock speculators fueled by the robinhood app and its brand new 100 million trading accounts take on the bulletin boards. These are different times than just a few short years ago; now penny stocks such as TSNP can achieve a $6 billion plus market valuation and trade $375 million in dollar volume in a day on the bulletin boards. And TSNP has no stronger fundamentals than IPIX does. IPIX has a long history of legendary runs skyrocketing to $4.93 per share when it was trading as CTIX. Currently making a move on its recent highs, investors are looking for a break over $0.65 for confirmation of the next big leg up. It’s easy to get excited about IPIX; the Company’s flagship Brilacidin is quickly emerging as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials for other clinical indications, providing established safety and efficacy data. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). Earlier this month IPIX began its Phase 2 clinical trial of Brilacidin for treating COVID-19. The Phase 2 randomized, placebo-controlled clinical trial includes approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intravenous treatment arms were enrolled—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale.  A peer-reviewed study recently published reported that Brilacidin Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2. We will be updating on IPIX when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with IPIX.

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Disclosure: we hold no position in IPIX either long or short and we have not been compensated for this article.

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1 Comment

1 Comment

  1. John Bach

    February 20, 2021 at 8:27 am

    BOE… sorry to tell you but your article on Innovation Pharmaceuticals and Brilacidin….is incorrect…

    the ARTICLE published from George Mason University … IS “PEER REVIEWED” and published

    see link: https://www.mdpi.com/1999-4915/13/2/271

    Reply

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Featured

LAVA Therapeutics (NASDAQ: LVTX) Gammabody™ Platform Gains Momentum

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10 hours ago

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June 4, 2023

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LAVA Therapeutics N.V. (NASDAQ: LVTX) shares soared 106% as the company announced that Janssen Biotech, Inc. chose a lead candidate.

LAVA Therapeutics N.V. (NASDAQ: LVTX) shares soared 106% as the company announced that Janssen Biotech, Inc., a part of the Janssen Pharmaceutical Companies of Johnson & Johnson, chose a lead candidate aimed at an undisclosed tumor-associated antigen for further development towards clinical settings.

GAMMABODY™ PLATFORM

LAVA primarily focuses on revolutionizing cancer therapy by developing its Gammabody™ platform. This platform enables them to create bispecific gamma delta T cell engagers that can activate a specific subset of gamma-delta T cells called Vγ9Vδ2 (Vgamma9 Vdelta2) T cells. By utilizing this approach, they aim to enhance the natural recognition of tumors, guide Vγ9Vδ2 T cells to target the tumor cells directly and trigger a cascade of immune responses.

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What sets their Gammabody™ drug candidates apart is their exceptional performance and safety profiles observed in preclinical studies. Compared to other bispecific T cell engager approaches, their candidates have demonstrated superior efficacy and preferred targeting tumor cells. This targeted approach has the potential to minimize toxicity in healthy tissues.

In May 2020, LAVA entered into a research collaboration and license agreement with Janssen, a subsidiary of the Janssen Pharmaceutical Companies of Johnson & Johnson. This collaboration aimed to discover and develop novel bispecific antibody-based gamma delta T cell engagers for cancer treatment. The agreement was facilitated by Johnson & Johnson Innovation, emphasizing their commitment to fostering innovation in the field.

As part of the collaboration, LAVA had the opportunity to receive potential milestone payments and royalties based on the successful development, regulatory approvals, and commercialization of the candidates. This incentivized LAVA to actively pursue the discovery and advancement of promising lead candidates. 

The collaboration represents a remarkable milestone many early-stage biotech companies aspire to achieve. Partnering with a program brings numerous benefits, including reduced risk of dilution through milestone payments as the trials advance and streamlined commercialization once the product receives approval.

Under the terms of the agreement, Janssen will assume responsibility for the selected candidate’s future clinical development, manufacturing, and commercialization. This includes bearing the costs and expenses associated with these activities.

Stephen Hurly, LAVA Therapeutics’s president and chief executive officer, expressed satisfaction with Janssen’s selection of a lead candidate for clinical studies. He emphasized LAVA’s pioneering role in developing gamma-delta bispecific antibodies through their proprietary Gammabody platform. This platform and LAVA’s extensive expertise in bispecific antibody development position them at the forefront of advancing novel therapies for cancer patients.

In summary, LAVA Therapeutics’ collaboration with Janssen has reached a significant milestone in selecting a lead candidate for further development toward clinical studies. This progress underscores LAVA’s dedication to leveraging its Gammabody platform and expertise in bispecific antibody development to revolutionize cancer treatment.

We will update you on LVTX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Reunion Neuroscience Inc.’s (NASDAQ: REUN) Take-Private Agreement and Its Impact on Mental Health Solutions

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2 days ago

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June 2, 2023

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Reunion Neuroscience (NASDAQ: REUN) shares jump 119% as they announce an exciting new development.

Reunion Neuroscience (NASDAQ: REUN) shares jump 119% as they announce an exciting new development. The clinical-stage biopharmaceutical company has entered into a take-private transaction with MPM BioImpact, representing a significant milestone for Reunion Neuroscience. The transaction is valued at $13.1 million, a 43.1% premium to Reunion’s common shares’ 30-day volume-weighted average price.

Going private is a significant step for Reunion Neuroscience, as it means that a sizeable private-equity group or consortium of private-equity firms will purchase or acquire the stock of the publicly traded corporation.

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Under the terms of the Arrangement Agreement, all holders of outstanding common shares of Reunion will be entitled to receive $1.12 in cash for each share held immediately before the effective time of the Arrangement. However, the agreement’s closing is subject to several conditions, which must be met before the transaction can be completed.

Hostile takeover?

While management and the board think it is a significant milestone achieved, others think differently – an investor rights law firm, Halper Sadeh LLC, is currently investigating it… The sale of Reunion Neuroscience to affiliates of MPM BioImpact for $1.12 per share in cash is currently being investigated by Halper Sadeh LLC.

The investigation concerns whether Reunion and its board of directors violated the federal securities laws and/or breached their fiduciary duties to shareholders by failing to, among other things: (1) obtain the best possible consideration for Reunion shareholders; (2) determine whether MPM is underpaying for Reunion; and (3) disclose all material information necessary for Reunion shareholders to assess and value the merger consideration adequately. On behalf of Reunion shareholders, Halper Sadeh LLC may seek increased consideration for shareholders, additional disclosures and information concerning the proposed transaction, or other relief and benefits.

Reunion Neuroscience’s stock performance has been relatively volatile in recent years. The stock’s median target price, according to analysts’ forecasts, is $5.00, but there is a wide range of estimates, with a high of $20.00 and a low of $0.73. The current consensus among polled investment analysts is to buy $REUN stock. However, they’re a pre-revenue clinical-stage biopharmaceutical company, which means the last earnings reported a loss in the current quarter’s earnings per share – they’ve yet to generate any significant revenue. Until recently, shareholders experienced a significant decline in the stock’s value this year and were down ~54%  prior to the acquisition. There are ~9M shares in the float, with ~28% and ~13% held by insiders and institutional investors, respectively.

Overall, investors should carefully consider the potential risks and rewards associated with investing in Reunion Neuroscience, considering the wide range of price estimates and the company’s current financial performance. Thorough research and the advice of a financial professional are recommended before making any investment decisions.

We will update you on REUN when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Marker Therapeutics, Inc. (NASDAQ: MRKR) Unveils Exciting Pre-Clinical Findings of MT-601 T Cell Therapy in Lymphoma Cells

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4 days ago

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June 1, 2023

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Marker Therapeutics, Inc. (Nasdaq: MRKR) shares surged by 45% as the company released positive pre-clinical Data on one of its candidates, MT-601.

Marker Therapeutics, Inc. (Nasdaq: MRKR) shares surged by 45% as the company released positive pre-clinical Data on one of its candidates, MT-601. They tested it on lymphoma cells in the lab, and the results showed that MT-601 can kill lymphoma cells resistant to another treatment called CD19 CAR T therapy, which is fascinating news considering many patients who receive CD19 CAR T therapy still experience a relapse within a year. 

“We have recently developed a long-term in vitro model to monitor the interaction of T cells with cancerous cells. Data from a lymphoma cell line utilizing this model demonstrated that MT-601 inhibited the growth of lymphoma cells as well as the growth of CD19 CAR-resistant lymphoma cells,” said Eric A. Smith, Ph.D., Director of Research and Development at Marker Therapeutics. Marker has posted further details about this preclinical study on the Investor Relations section of its website.

Dr. Smith continued, “Specifically, we have developed an in vitro model which reproduces the CD19 antigen-negative tumor that causes relapse and observed the following:

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In this in vitro model, 98% of lymphoma cells were eliminated after a CD19-targeting CAR T cell product was administered.

While the CAR T cells significantly controlled lymphoma cell growth, we observed that three weeks after the start of anti-CD19 CAR T cell administration, a population of lymphoma cells resistant to CD19 CAR T cell administration started to grow.

These CD19 CAR-resistant lymphoma cells were tested for CD19 expression. They were shown to be negative for the CD19 surface antigen, which explained why they were no longer controlled with a second administration of anti-C19 CAR T cells, thus recapitulating the antigen-negative relapse observations in CAR relapsed/refractory lymphoma patients.

However, when MT-601, with its broad antigen recognition (Survivin, NY-ESO-1, WT-1, PRAME, MAGE-A4, SSX2), was added to this anti-CD19 CAR T cell resistant cell population, complete growth inhibition was observed.

These data highlight that MT-601 can potentially eliminate CD19 CAR T cell refractory tumors, indicating that MT-601 might offer a viable therapeutic option for lymphoma patients that have relapsed from previous CAR T cell interventions.”

MT-601 targets multiple substances on cancer cells and may provide longer-lasting results than CD19 CAR T therapy. Marker Therapeutics has started a clinical trial to test MT-601 on lymphoma patients who have relapsed after CD19 CAR T therapy or cannot receive it. The early lab results showed that MT-601 could inhibit the growth of lymphoma cells, including those resistant to CD19 CAR T therapy. The initial results have shown remarkable promise, and the team is thrilled to advance the testing of MT-601 in further clinical trials to evaluate its effectiveness and safety.

About Marker Therapeutics, Inc.

Marker Therapeutics is a company currently in the advanced stages of clinical research for developing innovative treatments in immuno-oncology. Their primary focus is on creating next-generation immunotherapies that utilize T cells, a type of immune cell, to target and fight against hematological malignancies (cancers of the blood, such as leukemia and lymphoma) and solid tumors (cancers that form in tissues or organs). These therapies aim to harness the immune system’s power to specifically recognize and eliminate cancer cells, offering potential new treatment options for patients with these types of cancers.

Capital structure

Marker Therapeutics has an outstanding total of 8.8M shares and presents a relatively small float of 6.64M shares available for public trading. Insiders hold approximately 12.82% of the shares, while institutional investors hold around 22.63%. Examining their trading history, the average volume typically hovers around 100,000 shares. In light of the positive news today, the trading activity trended much higher, with an impressive 27M shares traded at time of writing. This translates to a 270-fold increase compared to their average volume, also 4x their float.

It is essential to recognize the high volatility and rapid movements associated with Marker Therapeutics’ stock, primarily driven by the limited availability of shares. Such stocks tend to attract the interest of day and swing traders, given their propensity for swift gains or losses based on trading strategies. As evidence, a single positive news catalyst in the biotech sector can trigger a substantial surge in stock price and exponentially increase trading volume to unprecedented levels.

We will update you on MRKR when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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