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Last Chance for Children is Proud to Announce its Partnership with Generex Biotechnology & NuGenerex Immuno-Oncology to SAFELY and EFFECTIVELY Vaccinate Children and Pregnant Women

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Generex Biotechnology Corporation's majority-owned subsidiary, NuGenerex Immuno-Oncology, is advancing the Ii-Key-SARS-CoV-2 vaccine aimed at children and pregnant women. The vaccine utilizes natural amino acids without genetic material, addressing the unmet need for safe COVID-19 vaccination in these populations. The company plans to submit an FDA IND to initiate clinical trials by Fall 2021. Recognized for its safety in previous trials, this vaccine represents a promising option as schools reopen and vaccination efforts escalate. Fundraising efforts are underway to support clinical trials and ensure vaccine accessibility.

Positive
  • Development of Ii-Key-SARS-CoV-2 vaccine specifically targeting children and pregnant women.
  • Completed GMP manufacturing of vaccine peptides, poised for FDA IND submission.
  • Demonstrated safety profile from prior Ii-Key vaccines with successful clinical outcomes.
Negative
  • None

NEW YORK, April 08, 2021 (GLOBE NEWSWIRE) -- Last Chance for Children’s (LCFC) Mission is to help save children’s lives anywhere in the world. Due to the COVID-19 pandemic we are now focusing our efforts to help eradicate this virus so we could safely and effectively vaccinate children in need.

Why do we need a COVID-19 Vaccine for Children and Pregnant Women?

Children’s lives have been completely disrupted by the coronavirus pandemic. To date, none of the vaccines against COVID-19 are approved by the FDA for use in children under 12 years old or pregnant women.

The current vaccines approved for emergency use did not enroll children nor pregnant women in their original clinical trials, so data on the safety of these vaccines in these populations is sorely lacking. As pregnant women have a 70% increased risk of severe COVID disease, a safe vaccine is desperately needed. And even though children do not generally get severe COVID, the lack of a vaccine is keeping kids out of school, limiting social interaction, and potentially leaving many kids behind. Plus, if we want to reach herd immunity necessary to eradicate the pandemic, we need to vaccinate kids.

Furthermore, most of these vaccines are based on gene therapy using RNA and DNA vectors that have unknown questions on duration of protection and long-term safety. The NuGenerex Immuno-Oncology Ii-Key-SARS-CoV-2 vaccine is based on natural amino acids using sequences that mimic the coronavirus spike and structural proteins, and selectively regulate select immune responses that are targeted specifically against the SARS-CoV-2 virus without using genetic material.

Generex Biotechnology Corporation’s majority owned public company NuGenerex Immuno-Oncology, Inc. (“NGIO”) is developing the Ii-Key-SARS-CoV-2 vaccine with a special emphasis on the development of a safe and effective vaccine for the pediatric population and for pregnant women, populations with significant unmet need in the COVID vaccine race. The company has completed GMP manufacturing of its Ii-Key-SARS-CoV-2 peptides and plans to submit its FDA IND to initiate clinical trials as soon as possible. NGIO’s goal is to start the pediatric clinical trials by the Fall of 2021.

A Proven Safe & Effective Vaccine

The FDA recognizes the safety profile of the Ii-Key vaccine platform, which has been safely tested in hundreds of people. Generex/NGIO’s other Ii-Key vaccines AE37 for cancer and Ii-Key-H1 for influenza are based on the Ii-Key platform used to develop the Ii-Key-SARS-CoV-2 vaccine. These immunotherapeutic vaccines have been shown to be safe in clinical trials involving hundreds of healthy volunteers and cancer patients. Additionally, the AE37 vaccine has been shown to generate long-term immune memory responses and has demonstrated benefit in disease-free survival in late-stage breast cancer patients.

Anthony S. Crisci, Founder, President, and Chief Executive Officer of Last Chance for Children commented, “After months of research, education and understanding the unmet need for children, particularly children under 12 and pregnant woman from underserved populations globally in medical need. We are proud to announce we have selected the Generex/NuGenerex COVID-19 Vaccine because of the high probability of success and most importantly because of its proven safety record, NGIO’s vaccine is based on natural amino acids. NuGenerex Immuno-Oncology, Inc.’s (NGIO’s) proprietary Ii-Key technology offers a SAFE rapid path to human protection from the COVID-19 pandemic, and the long-term safety profile of Ii-Key vaccines enables NGIO to rapidly develop COVID vaccines for our most valued assets, our children and pregnant women.”

The collaboration between Generex/NuGenerex and Last Chance for Children allows for select children and pregnant women to get NGIO’s vaccine at a special 50 percent off cost…if, and once, approved by the FDA and made available to the public.

Last Chance for Children is committed to raising the necessary funds, in a fully transparent and fully disclosed model, to directly support NGIO in conducting the clinical trials required by FDA. We are following a St. Jude’s model so that 84% of donations will be targeted for our cause and the remaining 16% will go to LCFC’s administration. The more money Last Chance for Children raises for the clinical development of a safe and effective COVID-19 vaccine, the faster we can reach herd immunity and get back to a sense of normalcy. All use of donated funds shall be disclosed on Last Chance for Children’s website: www.lastchanceforchildren.org

Please visit our website https://www.lastchanceforchildren.org and our Go Fund Me page https://charity.gofundme.com/o/en/campaign/covid-19-vaccine-for-children-and-pregnant-women. This contribution is tax deductible and will save our most important assets, our pregnant mothers and their children and all children, while making sure our elderly are safe around their families and loved ones.

About Last Chance for Children
Last Chance for Children (LCFC), founded in March 2011, is a 501(c)(3) Non-Profit that steps in where the major disease foundations have fallen short in providing direct comfort and support to the Children and Families affected by life threatening diseases…and real Hope for a Cure. The major foundations are focused more on providing information or grants for sometimes arcane academic research while LCFC is actively evaluating public and private companies committed to bringing a cure to market. Please visit our website for more information https://www.lastchanceforchildren.org

About Generex Biotechnology Corp.
Generex Biotechnology Corporation (OTCQB: GNBT) is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care. Please visit, https://www.generex.com for more information.

About NuGenerex Immuno-Oncology
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program. Please visit our website at: https://www.nugenerexio.com.

Last Chance for Children Contact:
Anthony S. Crisci, Esq., CPA
President and CEO
Last Chance for Children
Tel: 914.417.9706
Email: anthony@lastchanceforchildren.org
Fax: 818.301.5165
www.lastchanceforchildren.org

Generex Contact:
Todd Falls
Tel: 1-800-391-6755 Extension 222
Email: info@nugenerexio.com 


FAQ

What is the purpose of the NuGenerex Immuno-Oncology Ii-Key-SARS-CoV-2 vaccine?

The vaccine aims to provide a safe and effective solution for COVID-19 vaccination in children under 12 and pregnant women.

When will the pediatric clinical trials for the vaccine begin?

The company plans to start the pediatric clinical trials by Fall 2021.

How does the Ii-Key-SARS-CoV-2 vaccine differ from current COVID-19 vaccines?

It is based on natural amino acids and does not use genetic material, unlike many current vaccines.

Is there funding being raised for the vaccine development?

Yes, Last Chance for Children is raising funds to support the clinical trials required by the FDA.

What is the stock symbol for Generex Biotechnology Corporation?

The stock symbol for Generex Biotechnology is GNBT.

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