AE37/Keytruda study news Generex Biotechnology
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Generex Biotechnology Announces IND Filing for a Phase II Clinical Trial of AE37 in Combination with Pembrolizumab (Keytruda®) for the Treatment of Triple-Negative Breast Cancer
Business Wire•October 29, 2018
MIRAMAR, Fla.--(BUSINESS WIRE)--
Generex Biotechnology Corporation (www.generex.com) (GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the Company filed an investigational new drug application (IND) with the U.S. Food & Drug Administration (FDA) to initiate A Phase II Clinical Trial of Pembrolizumab (Keytruda®) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer. The trial, sponsored by Generex wholly-owned subsidiary Antigen Express, Inc. (www.antigenexpress.com) and conducted in conjunction with research partners Merck and the NSABP Foundation, Inc. (NSABP), is scheduled to initiate sites in the fourth quarter and to begin enrolling patients in the first quarter of 2019.
Dr. Eric von Hofe, President of Antigen Express, commented, “This is an important milestone in the development of AE37. Combining our promising immunotherapeutic with Merck’s checkpoint inhibitor Keytruda® (pembrolizumab) for the treatment of triple-negative breast cancer represents a novel treatment strategy for a cancer of high unmet need. Previous studies with each agent alone showed promising signs of efficacy. Their complementary mechanisms of action are particularly exciting and point to the importance of the current trial.”
Richard Purcell, Executive Vice President – Research & Development of Generex, commented, “This IND filing represents the culmination of a committed effort by the team at Antigen Express and our research partners at the NSABP Foundation. Antigen Express has been a pioneer at the forefront of immuno-oncology for over a decade with our Ii-Key platform that ensures CD4 T-cell activation against any tumor antigen to which the Ii-Key is attached. We are advancing this technology with our lead product AE37 for breast cancer, but also for the treatment of prostate and potentially other cancers that express even low levels of HER2/neu. The Ii-Key platform holds great promise, and we plan to explore collaborations and partnerships in the field of personalized immuno-oncology to maximize value for our investors.”
About AE37
AE37 is an investigational therapeutic cancer vaccine being developed to treat cancer in women with certain types of breast cancer. It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.
Up to 80 percent of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options. AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.
AE37 does not directly target HER2, but instead acts as a vaccine to activate the immune system to recognize the HER2 protein that is expressed on cancer cells as foreign.
AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells. The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response.
About Generex Biotechnology Corporation
Generex is a strategic, diversified healthcare holdings company with offerings in a variety of services, diagnostics, medical devices, and pharmaceutical development.
The Company’s direct-to-patient services support its strategy of all-inclusive access to doctors, diagnostics, therapeutics, and additional health-related services to greatly improve the patient experience in receiving care.
On the provider side, Generex’s management services remove administrative burdens in multiple provider settings, including private practice and hospital, allowing doctors to devote more time to patient care.
Revenue from the Company’s subsidiaries will support clinical advancement of its wholly owned therapeutic products with a focus in immunotherapeutics based on stimulating critical members of the immune response, known as T helper cells, and its proprietary buccal administration of insulin.
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Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181029005198/en/
Contact:
Generex Biotechnology Corporation
Joseph Moscato, 646-599-6222
or
Todd Falls, 800-391-6755 Extension 222
investor@generex.com
or
Russo Partners
Investor / Media Contacts:
Alex Fudukidis, 646-942-5632
alex.fudukidis@russopartnersllc.com
or
Caroline Cunningham, 212-845-4292
Caroline.Cunningham@russopartnersllc.com
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Generex Confirms & Clarifies 20:1 Common Stock Dividend
Business Wire•October 22, 2018
MIRAMAR, Fla.--(BUSINESS WIRE)--
CEO Explains Difference Between Stock Dividend & Forward Spilt; Addresses Investor Inquiries
Generex Biotechnology Corporation (www.generex.com) (GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today confirmed its previously announced plan to issue a 20:1 stock dividend. The announcement today includes a clarification of the stock dividend process and how it is different from a forward spilt.
On October 10, 2018 the Company announced that its Board of Directors had approved the issuance of 20 shares of common stock for every one share of issued and outstanding common stock. As of today, there are 1,068,100 shares of the Company’s common stock issued and outstanding. The Company has an obligation to issue additional shares to satisfy certain outstanding option, warrant and convertible security commitments. All options, warrants, and convertible securities of the Company outstanding on the record date will be proportionally adjusted to reflect the dividend.
“With a stock dividend, an in-kind dividend is declared by the Board of Directors,” explained President & Chief Executive Officer Joseph Moscato. “Existing shareholders on the record date will not have to do anything, they will receive the additional shares, on a pro-rata basis, in the amount of the dividend. For every share of stock a shareholder owns on the record date, they will receive twenty new dividend shares. For every one share of stock a shareholder owns, following the dividend, they will own 21 shares. For shares held in a brokerage account, the dividend shares will show up in that account. For shares held in certificate format, the dividend shares will be issued via book entry and shareholders will have the option of requesting a physical certificate.”
Mr. Moscato continued, “A stock dividend of this nature is different from a forward split. If the Company were executing a forward split, all shares owned by shareholders would be collected and new shares would be issued. For instance, in a 20:1 forward split, for every share a shareholder returned to the Company, that shareholder would be issued 20 new shares. After a forward split, for every share held by shareholders they would own 20 shares of a newly issued stock. Generex is executing a stock dividend, not a forward spilt.”
It is important to note that this pro rata common stock dividend is not a forward stock split. There will be no change in: the Company’s ticker symbol; the Company’s CUSIP number; the par or stated value of the Company’s common stock; or the Company’s Restated Certificate of Incorporation. In addition, there will be no automatic adjustment of the stock price as there would be with a forward split and the newly issued stock will have the same trading characteristics as the underlying securities.
No shareholder action will be required in respect of this in-kind dividend.
The Company will announce record and payment dates in respect of the stock dividend in due course following the completion of requisite regulatory filings.
Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181022005284/en/
Contact:
Generex Biotechnology Corporation
Joseph Moscato, 646-599-6222
or
Todd Falls, 800-391-6755 Extension 222
investor@generex.com
or
Russo Partners
Investor / Media Contacts:
Alex Fudukidis, 646-942-5632
alex.fudukidis@russopartnersllc.com
or
Caroline Cunningham, 212-845-4292
Caroline.Cunningham@russopartnersllc.com
Start the conversation
Sign in to post a message.
Generex Announces Launch of NuGenerex Distribution Solutions
Business Wire•October 17, 2018
MIRAMAR, Fla.--(BUSINESS WIRE)--
Company Provides Details on Service Offerings for Doctors, Hospitals, Health Systems and Patients
Generex Biotechnology Corporation (www.generex.com) (GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is pleased to announce the launch of NuGenerex Distribution Solutions, and the commencement of business operations enabled through the acquisition of certain operating assets of Veneto Holdings, L.L.C., as announced on October 9, 2018.
NuGenerex Distribution Solutions (NDS), an affiliate of Generex, has begun implementing its plan to provide essential management services to an extensive network of top-tier ancillary service providers, including pharmacies, laboratories, diagnostic imaging centers, and durable medical equipment manufacturers.
Generex Chief Operating Officer, Terry Thompson, stated, “Generex will be providing centralized insurance adjudication, product procurement, and other support services that allow the acquired assets to increase revenue and service quality, decreasing costs, while focusing on providing better patient care. On November 1, 2018, when the anticipated second phase of the acquisition of the Veneto assets is completed, NDS will be able to expand its management services to include legal and regulatory compliance, accounting, HR, IT and other support services to the current and future acquired assets. One of the key benefits of the acquired assets is that they will allow NDS to begin developing its chronic care management and medication therapy management service initiatives by utilizing their dedicated call centers and technology infrastructure in 2019.”
Mr. Thompson continued, “NDS benefits the medical community by providing cost effective ancillary services that ultimately deliver better outcomes and enhance the doctor-patient relationship. Utilizing our proprietary pharmacy workflow management systems and dedicated call centers, we will be able help our ancillary service providers, physicians, and patients to better coordinate healthcare services from diagnosis through treatment and follow-up. Over and above the services we provide to pharmacies, one of the keys to the historical success of this model is managing how the pharmacy network provides topical non-opioid treatments that physicians can utilize for their patients for pain management. This helps combat the current opioid epidemic by significantly reducing the risk of addiction to oral pain medications, lowering overall cost to the healthcare system and providing better patient outcomes. We are excited about the repurposing of the Generex family of companies and look forward to growing this proven model that provides compliant operational efficiency for providers, transparency for payers, and convenience that enhances patient satisfaction throughout the continuum of care,” Mr. Thompson concluded.
Generex Chief Medical and Scientific Officer, Dr. Jason Terrell, added, “NDS will provide a broad range of outstanding services to benefit patients and physicians alike. The launch of NDS allows us to have an immediate impact on patient care and provides the foundation to support our rapid growth and expansion into other areas in healthcare. NDS represents another successful advancement to our overall goal to improve patient care through innovative products and services.”
Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181017005233/en/
Contact:
Generex Biotechnology Corporation
Joseph Moscato, 646-599-6222
or
Todd Falls, 800-391-6755 Extension 222
investor@generex.com