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Li-key Peptide; The Rise of Generex Biotechnology Corporation (OTCMKTS: GNBT)

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Generex Biotechnology Corporation (OTCMKTS: GNBT) is an exciting biotech trading at the bottom of its range that has a promising COVID-19 Vaccine using li-key peptide vaccines that may be getting overlooked by Investors. GNBT is an ex big board stock that we have reported on for years.

GNBT took off at the end of February after the Company reported it had received a contract from Chinese partners to develop a COVID-19 Vaccine using li-key peptide vaccines. Generex has made significant advancements since than reporting on September 18 it and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of the previously signed Memorandum of Understanding for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine. Bintai has agreed to pay Generex an up-front licensing fee of $2.5 million within two weeks. Bintai will pay 100% of the funding required for the commercial development of the Ii-Key-CoV-2 vaccine and upon approval, Bintai will pay Generex a $17.5 million milestone payment and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private sector. .

Generex Biotechnology Corporation (OTCMKTS: GNBT) is a biotech based in Miramar, Florida, with offices in Dallas, Texas, Toronto, Canada and Wellesley, Massachusetts. The Company is focused on the commercialization of Oral-lyn buccal insulin spray for diabetes. Additionally, through its wholly-owned subsidiary Antigen Express, the Comapny has a deep intellectual property portfolio of immunotherapy assets relating to the “Ii-Key” technology that activates the immune response for the treatment of cancer and infectious diseases. Generex has completed a Phase IIb clinical trial of AE37 immunotherapeutic peptide vaccine with the Ii-Key technology in over 300 women with breast cancer. The Company believes its legacy diagnostics, diabetes, cancer assets and IP portfolio have significant value which is not being recognized due to missteps in the clinical development process by previous management, resulting inability to raise capital necessary to fund further development.

Generex and its subsidiaries are currently pursuing the development of a SARS-CoV-2 vaccine using the company’s patented Ii-Key peptide vaccine technology. To this end, the Company applied for funding to BARDA in the U.S., Health Canada, and the Malaysian Ministry of Health as well as with CEPI, the international public/private consortium focused on the development of vaccines for the global market. To date, Generex has identified viral epitopes through computer vaccinology algorithms, and manufactured those peptide sequences with the Ii-Key moiety for testing in immunological screening program using convalescent blood samples from patients who have recovered from COVID-19. The immunological blood screening program is scheduled to begin shortly. Manufacturing partners have been identified for clinical and commercial supply. Completion of the ii-Key-SARS-CoV-2 peptide vaccine program is dependent on obtaining funding from government and/or private sources.

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GNBT

On September 18 GNBT reported it and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of the previously signed Memorandum of Understanding for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine. Under the terms of the Addendum, Bintai and Generex will finalize the legal and contractual documentation for the contract, partnership, and licensing & research agreement, and Bintai will pay Generex an up-front licensing fee of $2.5 million within two weeks. Additionally, Bintai will pay 100% of the funding required for the commercial development of the Ii-Key-CoV-2 vaccine including laboratory work, manufacturing, regulatory filings and the clinical development program for regulatory approval of the vaccine in Malaysia. Also, upon approval of the Ii-Key-CoV-2 vaccine in Malaysia, Bintai will pay Generex a $17.5 million milestone payment and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private sector. Further, under this new Addendum, Bintai will have the right of first refusal for the Ii-Key-SARS-CoV-2 vaccine in Australia, New Zealand, and the global HALAL markets, particularly in Southeast Asia.

Generex CEO, Joseph Moscato said, “The Ii-Key platform has demonstrated that AE37, our Ii-Key-HER2 vaccine provides long-term immune memory with cellular responses active for three years in prostate cancer1, and statistically significant benefit in disease free survival for breast cancer patients with advanced disease and low HER2 expression2. Immunologic memory is the key to providing a real solution for COVID-19. With this licensing and research agreement being finalized, we can unlock the true potential of the Ii-Key technology to provide a safe and effective vaccine to stop the SARS-CoV-2 pandemic, and to provide the long-term immune system memory needed to protect the population. Our plan is collaborative, combining U.S. and Malaysian operations to advance our Ii-Key vaccine through the clinical and regulatory process in Malaysia to eventually transfer the manufacturing to Malaysia for local production, leveraging Bintai’s expertise in industrial engineering and construction. We have initiated the blood screening program using convalescent blood and serum for COVID-19 recovered patients to select Ii-Key-SARS-CoV-2 epitopes that will comprise the final vaccine formulation, after which we will initiate GMP manufacturing for Ii-Key-SARS-CoV-2 vaccine clinical trial supply. I would like to personally thank the Bintai organization for their belief in Generex and commitment to develop a safe, effective, and universal vaccine against SARS-CoV-2 for the benefit of Malaysia, and we look forward to accelerating our COVID-19 vaccine program together.”

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Currently trading at the bottom of its range GNBT took off at the end of February after the Company reported it had received a contract from Chinese partners to develop a COVID-19 Vaccine using li-key peptide vaccines. Generex has made significant advancements since than reporting on September 18 it and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of the previously signed Memorandum of Understanding for the development and commercialization of the I-Key-SARS-CoV-2 coronavirus vaccine. Bintai has agreed to pay Generex an up-front licensing fee of $2.5 million within two weeks. Bintai will pay 100% of the funding required for the commercial development of the Ii-Key-CoV-2 vaccine and upon approval, Bintai will pay Generex a $17.5 million milestone payment and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private sector. GNBT is an ex big board stock that we have reported on for years. We will be updating GNBT as events unfold so make sure you are subscribed to Microcapdaily so you know what is going on with GNBT.

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

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1 Comment

  1. Rose Perri

    September 21, 2020 at 7:04 am

    This company Generex is a pump and dump securities scam. Stay away.

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Enveric Biosciences (NASDAQ: ENVB) Pioneering the Future of Anxiety Disorder Treatment

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Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news.

Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news. The United States Patent and Trademark Office has granted them a notice of allowance for their patent application concerning a groundbreaking chemical compound called EB-373. This compound is being developed to address the treatment of anxiety disorders.

The forthcoming patent, titled “C4-Carbonothioate-Substituted Tryptamine Derivatives and Methods of Using,” encompasses claims for the composition of matter of a family of revolutionary prodrug derivatives of psilocin. Enveric’s lead product candidate, EB-373, stands out among these derivatives. A Notice of Allowance signifies that the USPTO has determined that a patent should be granted based on the submitted application.

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Enveric’s commitment to innovation extends beyond EB-373. They have also submitted additional patent applications to the USPTO, exploring psilocin prodrugs with unique crystalline molecular structures. Moreover, they have taken proactive steps to pursue global coverage of the EVM201 and EVM301 Series through companion Patent Cooperation Treaty and non-US national patent applications. Encouragingly, positive International Search Reports and written opinions have been received under the Patent Cooperation Treaty for most of these applications.

Joseph Tucker, Ph.D., Enveric’s director and CEO, underlined the significance of the USPTO’s favorable decision concerning their lead candidate, EB-373. He highlighted the innovative designs of their psilocin prodrugs within the EVM201 series, differentiating them from conventional counterparts like psilocybin. These novel designs hold the potential to deliver more rapid therapeutic effects, precise control, and reduced gastrointestinal side effects. Tucker emphasized that securing a robust intellectual property portfolio for their new chemical entity prodrugs is pivotal to Enveric’s value proposition and integral to their business strategy of developing cutting-edge small-molecule therapeutics to address mental health disorders.

We will update you on ENVB 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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Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) Secure Partnership

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Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) today announced a multi-year collaboration that will use TScan's proprietary target discovery platform.

TScan to Receive $30 Million Upfront With Potential Development and Commercial Milestone Payments of Over $500 Million.

Collaboration Brings Together TScan’s Proprietary Target Discovery Platform and Amgen’s Inflammation Therapeutic Expertise and Research Capabilities

Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) today announced a multi-year collaboration that will use TScan’s proprietary target discovery platform, TargetScan, to identify the antigens recognized by T cells in patients with Crohn’s disease.

All things considered, this is among one of the largest deals you’ll see for a micro-cap biopharma company. As many of you know, companies in this sector of this size and scale are typically not profitable – mainly focusing on R&D until their drug or technology is fully approved/commercially viable. 

The critical thing to note with this deal between TScan and Amgen is that the cash milestones ensure a cash runway for TCRX, potentially even until they become commercially viable and profitable. 

Here’s a breakdown of the press release in layman’s terms, so anyone without background or knowledge in this space can better understand: 

Amgen and TScan Therapeutics are teaming up to find new treatments for Crohn’s disease, a chronic condition that causes inflammation in the gut. TScan has a unique platform called TargetScan that can identify the proteins recognized by the immune system in people with the disease. Amgen will use this information to create new drugs to treat Crohn’s disease.

As part of the deal, TScan will get an upfront payment of $30 million from Amgen and could earn more than $500 million if the collaboration is successful. Amgen will have the rights to develop and sell any new drugs from this partnership.

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Both companies will be responsible for their research costs, and Amgen can expand the collaboration to include another condition called ulcerative colitis. This partnership could lead to new and better treatments for people with Crohn’s disease, who currently have limited options for managing their symptoms.

Here are a couple of blurbs from the management team

“Anti-inflammatory drugs have traditionally been the standard of care for patients suffering from inflammatory bowel disease, but often lack efficacy and durability,” said Raymond Deshaies, Ph.D., senior vice president of Global Research at Amgen. “TScan’s platform provides a best-in-class approach to identify non-conventional drug targets to enable the development of potential first-in-class therapeutics to address unmet medical needs.”

“We’re excited to apply our target discovery platform to the autoimmunity space,” said Gavin MacBeath, Ph.D., acting chief executive officer and chief scientific and operating officer at TScan. “Our TargetScan platform, which we have now extended to identify MHC class II targets of CD4+ T cells, is well-suited for the discovery of antigens targeted by the immune system in inflammatory bowel disease. We look forward to developing the value of our platform both in this partnership with Amgen and in other autoimmune diseases.”

What’s retail saying?

As per usual, with gains of around 135%, you can probably guess that retail is all over it. Investors practically all over the internet keep their eye on the stock for potential entry points utilizing various day trading techniques. 

Interestingly, some traders are surprised it managed to trade such massive volumes early intraday. If you look at their chart from the prior months, the average volume was relatively minuscule – sometimes trading as low as 5K shares a day.  Compared to the ~27M shares traded at the time of writing, that’s a massive shift.

We will update you on TCRX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening with TCRX.

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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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ContraFect Corp (NASDAQ: CFRX): A Low Float Runner

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On April 27, 2023, shares of ContraFect Corp (NASDAQ: CFRX) skyrocketed by 125% in pre-market trading, which is quite unusual.

On April 27, 2023, shares of ContraFect Corp (NASDAQ: CFRX) skyrocketed by 125% in pre-market trading, which is quite unusual. Although the surge may be linked to the news from the previous day, it is difficult to determine as there was not much movement on April 26.

However, sometimes it only takes the right attention from investors to create such positive rallies. It is worth noting that $CFRX has a low float of 1.53M, which can lead to extreme volatility and provide retail traders an opportunity to make significant gains.

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Summary of latest PR on April 26, 2023

ContraFect Corporation is a clinical-stage biotechnology company developing new treatments for antibiotic-resistant infections. They recently announced that they initiated a Phase 1b/2 study to test the safety, drug disposition, and efficacy of their drug candidate, Exebacase, in patients with chronic prosthetic joint infections (PJI) of the knee. The study is in France and is randomized, double-blind, and placebo-controlled, meaning some patients will receive the drug, while others will receive a placebo. The study will have two parts: Part I will evaluate the drug’s efficacy, safety, and pharmacokinetics at an early six-week time point, while Part II will assess the long-term clinical safety and efficacy of the drug for up to two years. The CEO of ContraFect Corporation is optimistic about the potential of Exebacase to replace the current surgical treatment for chronic PJI, which has not shown significant improvement in clinical outcomes in recent decades.

What are retail traders saying?

https://twitter.com/RealWillTopol/status/1651553835801001986?s=20

It is worth noting that there has been some speculation about the events that have unfolded and the underlying factors that have led to them. 

We’ve observed a subset of traders that capitalize on the volatility by adopting a watchful approach towards stocks, including $CFRX, to generate quick profits. 

However, it is essential to exercise caution when considering following their lead, given the high risk associated with their investment strategies and the prevailing market conditions. While we do not typically recommend emulating their investment decisions, it may be an intriguing endeavor for those willing to assume a certain level of financial risk with funds they can afford to lose.

About ContraFect Corp (NASDAQ: CFRX)

ContraFect is a company that focuses on finding new ways to treat life-threatening infections resistant to antibiotics. Antibiotic-resistant infections are responsible for an estimated 700,000 deaths each year worldwide. ContraFect is developing new medical treatments called DLAs that include lysins and amurin peptides. Lysins are antimicrobial proteins that can quickly kill target bacteria, including those in biofilms, and can work with traditional antibiotics. Amurin peptides can fight many antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, Acinetobacter baumannii, and Enterobacter species. ContraFect believes that lysins and amurin peptides will effectively fight antibiotic-resistant organisms, such as MRSA and P. aeruginosa, which can cause serious infections. The company has completed a Phase 2 clinical trial for their lead lysin candidate, exebacase, designated by the FDA as a Breakthrough Therapy for treating MRSA bloodstream infections, including right-sided endocarditis, when combined with traditional antibiotics.

We will update you on CFRX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening with CFRX.

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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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