PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination in Advanced HPV-Associated Cancers

Research, News, and Market Data on PDS Biotech

NCI achieves the enrollment objective of thirty patients in the checkpoint inhibitor refractory arm of the study

FLORHAM PARK, N.J., March 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly-targeted cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced that the National Cancer Institute (NCI) has achieved the intended enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the NCI-Led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune^®+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers. Currently, the study has enrolled 45 patients and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.

The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers in patients who have not been treated with CPIs (CPI naïve) and have failed at least one standard of care therapy. Secondly, in third-line treatment of the above-listed recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment (CPI refractory).

The NCI, part of the National Institutes of Health, presented highly promising preliminary efficacy and safety data from the trial at the June 2021 American Society of Clinical Oncology (ASCO) Conference. The NCI plans to present an update in the near future. It was reported earlier this year that median survival of these patients now exceeds 12 months.

“We are pleased the NCI has achieved this important milestone as CPI refractory patients with various HPV-associated cancers have very few effective treatment options and the study data have shown the potential to extend the lives of these patients,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “All of us at PDS Biotech would like to thank the NCI for all of their efforts in the achievement of this enrollment objective.” 

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

Our Versamune^®-based molecularly targeted products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers. 

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance,” “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital

PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as Part of Its Ongoing Impact Investment Strategy

Research, News, and Market Data on PsyBio

PsyBio Therapeutics to Make Significant Environmental, Social, and Governance (ESG) Commitment to Promote Mental and Neurological Health While Working to Develop State of the Art Technologies, Process Skills and Capabilities in Lesotho and Across Africa

OXFORD, Ohio and COCONUT CREEK, Fla., March 15, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that it has entered into a definitive agreement (the “Agreement“) to acquire all of the issued and outstanding shares of Everest Pharma (Pty) Ltd. (“Everest“), a Lesotho Company located in Southern Africa, as part of its ongoing Impact Investment Strategy (the “Acquisition“). The Acquisition will increase new research and development capabilities for PsyBio, while promoting the development of local knowledge and expertise in Lesotho. Everest is one of the select and limited companies with a psychedelic product license.

PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry. The filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. This Acquisition will add to PsyBio’s abilities which encompass fully translational capabilities in its current scientific laboratory and animal testing facilities. The PsyBio team has extensive experience in drug discovery and development based on synthetic biology, metabolic engineering, medicinal chemistry and clinical pharmacology, as well as clinical and regulatory expertise progressing drugs through human studies and governmental protocols. The team collectively has managed thousands of clinical trials and has achieved numerous regulatory approvals including therapeutics, diagnostics and devices and the Company has filed sixteen patent applications to date on its discovery accomplishments.

“Acquiring Everest is the next step of an important growth strategy for PsyBio, following the initial licensing of development technology of psychedelic compounds and their derivatives,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “The next step is for PsyBio to collaborate with Everest’s current leadership and management team to develop local scientific and manufacturing capabilities as part of our Impact Investment Strategy. This will allow for the production, licensing, sales and distribution of psycho-targeted therapeutics intended to potentially improve mental and neurological health to be undertaken not only in the United States and Europe, but also in Africa. It will also augment our research capabilities and contribute to the local health and economies of such jurisdictions.”

Upon completion of the Acquisition, PsyBio will acquire Everest’s active License to Trade covering a portfolio of: growing of spices, aromatics, drugs, and pharmaceutical crops; manufacture of pharmaceuticals, medicinal chemical and botanical products; retail sale of pharmaceutical and medical goods, cosmetic and toilet articles in specialized stores, as well as other topics covered under its general business of growing, cultivating and exporting psilocybin mushrooms and resins.

“The opportunity to demonstrate our environmental, social, and governance commitments while we produce readily manufacturable psycho-targeted therapeutic candidates, furthers PsyBio’s role as one of the only biotechnology companies in the psychoactive therapeutic industry developing its own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The ability to help committed and talented local individuals develop their skills and provide for their families and extended communities fits well within our impact investment objectives and we are extremely excited to see this type of expansion continue forward once the Acquisition closes.”

The aggregate consideration paid by the Company pursuant to the Agreement includes: (i) US$100,000; and (ii) 2,100,000 subordinate voting shares of the Company (the “SVS“), at a deemed issuance price of C$0.14 per SVS. In addition, PsyBio has agreed to pay the seller rent in the amount of US$30,000 per annum for rental of the facilities currently used by Everest, and US$30,000 per annum for consulting fees. Closing of the Acquisition is expected to occur on or about March 31, 2022, and is subject to certain conditions including, but not limited to, the approval of regulatory authorities, including the TSX Venture Exchange (“TSXV“).

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development activities are currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psycho-targeted compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the closing of the Acquisition; the timing of closing of the Acquisition; the anticipated benefits and implications of the Acquisition; the ability of PsyBio to increase its research and development capabilities while promoting the development of local knowledge and expertise in Lesotho; the ability of PsyBio to expand its operations beyond the United States; the ability of PsyBio to comply with local laws and regulations that may be applicable to Everest; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be able to successfully integrate Everest as a subsidiary; PsyBio will benefit from the Acquisition; PsyBio will be successful in complying with local laws and regulations that may be applicable to Everest; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as Part of Its Ongoing Impact Investment Strategy

Research, News, and Market Data on PsyBio

PsyBio Therapeutics to Make Significant Environmental, Social, and Governance (ESG) Commitment to Promote Mental and Neurological Health While Working to Develop State of the Art Technologies, Process Skills and Capabilities in Lesotho and Across Africa

OXFORD, Ohio and COCONUT CREEK, Fla., March 15, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that it has entered into a definitive agreement (the “Agreement“) to acquire all of the issued and outstanding shares of Everest Pharma (Pty) Ltd. (“Everest“), a Lesotho Company located in Southern Africa, as part of its ongoing Impact Investment Strategy (the “Acquisition“). The Acquisition will increase new research and development capabilities for PsyBio, while promoting the development of local knowledge and expertise in Lesotho. Everest is one of the select and limited companies with a psychedelic product license.

PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry. The filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. This Acquisition will add to PsyBio’s abilities which encompass fully translational capabilities in its current scientific laboratory and animal testing facilities. The PsyBio team has extensive experience in drug discovery and development based on synthetic biology, metabolic engineering, medicinal chemistry and clinical pharmacology, as well as clinical and regulatory expertise progressing drugs through human studies and governmental protocols. The team collectively has managed thousands of clinical trials and has achieved numerous regulatory approvals including therapeutics, diagnostics and devices and the Company has filed sixteen patent applications to date on its discovery accomplishments.

“Acquiring Everest is the next step of an important growth strategy for PsyBio, following the initial licensing of development technology of psychedelic compounds and their derivatives,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “The next step is for PsyBio to collaborate with Everest’s current leadership and management team to develop local scientific and manufacturing capabilities as part of our Impact Investment Strategy. This will allow for the production, licensing, sales and distribution of psycho-targeted therapeutics intended to potentially improve mental and neurological health to be undertaken not only in the United States and Europe, but also in Africa. It will also augment our research capabilities and contribute to the local health and economies of such jurisdictions.”

Upon completion of the Acquisition, PsyBio will acquire Everest’s active License to Trade covering a portfolio of: growing of spices, aromatics, drugs, and pharmaceutical crops; manufacture of pharmaceuticals, medicinal chemical and botanical products; retail sale of pharmaceutical and medical goods, cosmetic and toilet articles in specialized stores, as well as other topics covered under its general business of growing, cultivating and exporting psilocybin mushrooms and resins.

“The opportunity to demonstrate our environmental, social, and governance commitments while we produce readily manufacturable psycho-targeted therapeutic candidates, furthers PsyBio’s role as one of the only biotechnology companies in the psychoactive therapeutic industry developing its own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The ability to help committed and talented local individuals develop their skills and provide for their families and extended communities fits well within our impact investment objectives and we are extremely excited to see this type of expansion continue forward once the Acquisition closes.”

The aggregate consideration paid by the Company pursuant to the Agreement includes: (i) US$100,000; and (ii) 2,100,000 subordinate voting shares of the Company (the “SVS“), at a deemed issuance price of C$0.14 per SVS. In addition, PsyBio has agreed to pay the seller rent in the amount of US$30,000 per annum for rental of the facilities currently used by Everest, and US$30,000 per annum for consulting fees. Closing of the Acquisition is expected to occur on or about March 31, 2022, and is subject to certain conditions including, but not limited to, the approval of regulatory authorities, including the TSX Venture Exchange (“TSXV“).

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development activities are currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psycho-targeted compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the closing of the Acquisition; the timing of closing of the Acquisition; the anticipated benefits and implications of the Acquisition; the ability of PsyBio to increase its research and development capabilities while promoting the development of local knowledge and expertise in Lesotho; the ability of PsyBio to expand its operations beyond the United States; the ability of PsyBio to comply with local laws and regulations that may be applicable to Everest; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be able to successfully integrate Everest as a subsidiary; PsyBio will benefit from the Acquisition; PsyBio will be successful in complying with local laws and regulations that may be applicable to Everest; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination in Advanced HPV-Associated Cancers

Research, News, and Market Data on PDS Biotech

NCI achieves the enrollment objective of thirty patients in the checkpoint inhibitor refractory arm of the study

FLORHAM PARK, N.J., March 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly-targeted cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced that the National Cancer Institute (NCI) has achieved the intended enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the NCI-Led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune^®+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers. Currently, the study has enrolled 45 patients and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.

The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers in patients who have not been treated with CPIs (CPI naïve) and have failed at least one standard of care therapy. Secondly, in third-line treatment of the above-listed recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment (CPI refractory).

The NCI, part of the National Institutes of Health, presented highly promising preliminary efficacy and safety data from the trial at the June 2021 American Society of Clinical Oncology (ASCO) Conference. The NCI plans to present an update in the near future. It was reported earlier this year that median survival of these patients now exceeds 12 months.

“We are pleased the NCI has achieved this important milestone as CPI refractory patients with various HPV-associated cancers have very few effective treatment options and the study data have shown the potential to extend the lives of these patients,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “All of us at PDS Biotech would like to thank the NCI for all of their efforts in the achievement of this enrollment objective.” 

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

Our Versamune^®-based molecularly targeted products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers. 

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance,” “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital

Tuesday, March 15, 2022

Ayala Pharmaceuticals (AYLA)
Buying Opportunity With Clinical Trial Milestones Ahead

Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company’s current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Ayala Is Developing Drugs To Block Activation Of The Notch Pathway.  Under normal conditions, the Notch pathway provides signals that regulate cell growth and maintenance. Mutations in the Notch pathway can lead to loss of regulation and proliferation of cancerous cells. Ayala has developed drugs that block gamma secretase, an enzyme that activates the Notch pathway.

AL102 and AL102 Act By Inhibiting An Activation Step In The Notch Pathway.  Ayala has developed AL101 and AL102, two drugs that block gamma secretase, an enzyme needed to activate the Notch pathway. This stops the signaling steps that lead to overactivity and proliferation of cancer cells …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.