What the HIPAA Privacy Rule Allows (A Health Law Scholar Explains)

 

The Health Insurance Portability and Accountability Act’s Privacy Rule is a federal law prohibiting health care providers, businesses and the people working with them – including administrative staff, laboratories, pharmacies, health insurers and so on – from disclosing your health information without your permission.

When people talk about HIPAA, they typically refer to the Privacy Rule provision established in 2003, which is just one part of a broader law initially passed by Congress in 1996. The Privacy Rule came into force after tennis star Arthur Ashe’s HIV status was publicly revealed and country music star Tammy Wynette’s health records were sold to tabloids. People were starting to worry about genetic privacy. And Congress recognized that the internet would make it easier for health care privacy breaches to occur.

 

Why the
HIPAA Privacy Rule Matters

The HIPAA Privacy Rule gives you the right to control your health information disclosures so you can tell your health care provider what to share. If you don’t want to share some of your health information with your family members, you can tell your health care provider to withhold that information from them.

However, HIPAA only protects health care information held by specific kinds of health care providers. For example, health care data on your Apple Watch or Fitbit is not usually covered by HIPAA. Genetic data you enter on websites like Ancestry.com is also not covered by HIPAA. Other laws or agreements like the privacy disclosures required on many apps may protect that information, but HIPAA does not.

 

Replay – Virtual Roadshow with DLH Holdings CEO Zachary Parker and CFO Kathryn JohnBull This Virtual Road Show Presentation features a formal corporate overview from DLH CEO Zachary Parker & CFO Kathryn JohnBull. Afterwards, they are joined by Noble Capital Markets Senior Research Analyst Joe Gomes for a Q & A session featuring questions asked by the live audience throughout the event. Watch the replay, and get Noble’s research on DLHC, as well as news and advanced market data at the link below. View All Upcoming Road Shows

 

Sometimes people try to use HIPAA as an excuse for actions it doesn’t actually cover. For instance, some people who refused to comply with coronavirus-related mask rules in stores asserted that they couldn’t be asked to explain why because of HIPAA protections. But that’s not how this privacy law works: It’s legal for someone to ask you about your vaccination status. And anyone can provide information about their own vaccination status (or any personal health information) without violating HIPAA. Are there exceptions to the HIPAA Privacy Rule?

Certain exceptions to HIPAA’s nondisclosure requirements allow covered health care providers to disclose patient information to help treat another person, protect public health and aid in certain law enforcement investigations.

During a pandemic, for instance, public health departments can provide information about how many people have tested positive for a disease, but they cannot mention specific names to the general public unless it’s necessary to alert particular people that they may have been exposed. This is because HIPAA and other privacy laws require them not to release any more information than is needed to keep people safe.

This article was republished with permission
from The Conversation, a news site
dedicated to sharing ideas from academic experts. It represents the research-based
findings and opinions Margaret Riley

Professor of Law, Public Health Sciences, and Public Policy, University of Virginia

 

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Ocugen to Host Conference Call on Friday, August 6 at 8:30 a.m. ET to Discuss Second Quarter 2021 Financial Results and Provide Business Update

 

MALVERN, Pa., July 30, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it will host a conference call to discuss its second quarter 2021 financial results and provide a business update at 8:30 a.m. ET on Friday, August 6, 2021.

Ocugen will issue a pre-market earnings announcement on the same day. Investors are invited to participate on the call using the following details:

• Dial-In Number: (844) 873-7330 (U.S.) or (602) 563-8473 (international)
• Conference ID: 6663619
• Webcast: Available in the “Investors” section of the Ocugen website and archived for approximately 45 days following the call
  

About?Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing?a vaccine to?save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.?We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets.?For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, the intended use of net proceeds from the registered direct offering. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com

Friday, July 30, 2021

Cocrystal Pharma Inc. (COCP)
CDI-45205 Shows Broad Activity Against COVID-19 Variants

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

CDI-45205 Shows Efficacy Against Delta Variant.  Cocrystal announced that its protease inhibitor against the COVID-19 virus, CDI-45205, showed potent in vitro activity against all four major variants.  These include the Delta (India or B.1.617.2), Alpha (UK or B.1.1.7), Beta (South African or B.1.351) and Gamma (Brazil or P.1). We believe these data show that the company’s technology platform for developing RNA protease inhibitors that block viral replication has broad efficacy.


Efficacy Data Provides Proof of Concept.  CDI-45205 is based on Cocrystal’s proprietary platform for developing molecules to inhibit RNA polymerases needed for viral replication.  Inhibition of these enzymes is an early step in the viral reproductive cycle that prevents replication and stops production of new viral particles. This differs from the current COVID-19 vaccines that stimulate an immune …

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. 

Cocrystal Pharma’s SARS-CoV-2 3CL Protease Lead CDI-45205 Demonstrates Broad-Spectrum Activity Against the SARS-CoV-2 Delta and Gamma Variants

 

BOTHELL, Wash., July 29, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its SARS-CoV-2 3CL protease lead CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2) and Gamma (Brazil/P.1) variants. Cocrystal previously announced that CDI-45205 and analogs exhibited broad-spectrum activity against the SARS-CoV-2 Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the Wuhan strain.

“These in vitro SARS-CoV-2 results further indicate that Cocrystal’s SARS-CoV-2 3CL protease inhibitor CDI-45205 may be an effective treatment for COVID-19 caused by SARS-CoV-2 and its emerging variants, including the fast-spreading Delta variant that is becoming the dominant COVID-19 variant globally,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “The broad-spectrum activity against these SARS-CoV-2 variants is highly encouraging as CDI-45205 previously demonstrated excellent in vivo efficacy in a MERS-CoV-2 infected animal model.”

“CDI-45205 has now shown antiviral activity in preclinical testing against SARS-CoV-2 and all four major variants,” said James Martin, CFO and interim co-CEO, “Our next steps are to scale-up synthesis and manufacture active pharmaceutical ingredient (API) to support Investigational New Drug (IND)-enabling studies to advance CDI-45205 into clinical trials.”

The Company continues to develop SARS-CoV-2 oral protease inhibitors and replication inhibitors using its proprietary drug discovery platform technology. Cocrystal’s approach to drug discovery provides a unique path for designing broad-spectrum coronavirus antivirals against SARS-CoV-2 and emerging variants.

About CDI-45205
Cocrystal announced agreements in February and April 2020 with Kansas State University Research Foundation (KSURF) for certain proprietary broad-spectrum CL3 antiviral compounds for the treatment of norovirus and coronavirus infections. In December 2020 Cocrystal announced the selection of CDI-45205 as its lead coronavirus development candidate from a group of protease inhibitors obtained under the KSURF agreements. CDI-45205 showed good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and also no cytotoxicity against a variety of human cell lines. CDI-45205 has also demonstrated a strong synergistic effect with remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-infected mice. Cocrystal has obtained promising preliminary pharmacokinetic results and is continuing to evaluate CDI-45205.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our beliefs related to the effectiveness of CDI-45205 against SARS-CoV-2 and its major variants, and the anticipated clinical development of CDI-45205. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the impact of the COVID-19 pandemic on the national and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our coronavirus program, our ability to complete the preclinical and clinical trials of CDI-45205, the results of such future preclinical and clinical studies, and general risks arising from clinical trials and more generally, the development of investigational drugs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Cocrystal Pharma’s SARS-CoV-2 3CL Protease Lead CDI-45205 Demonstrates Broad-Spectrum Activity Against the SARS-CoV-2 Delta and Gamma Variants

 

BOTHELL, Wash., July 29, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its SARS-CoV-2 3CL protease lead CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2) and Gamma (Brazil/P.1) variants. Cocrystal previously announced that CDI-45205 and analogs exhibited broad-spectrum activity against the SARS-CoV-2 Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the Wuhan strain.

“These in vitro SARS-CoV-2 results further indicate that Cocrystal’s SARS-CoV-2 3CL protease inhibitor CDI-45205 may be an effective treatment for COVID-19 caused by SARS-CoV-2 and its emerging variants, including the fast-spreading Delta variant that is becoming the dominant COVID-19 variant globally,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “The broad-spectrum activity against these SARS-CoV-2 variants is highly encouraging as CDI-45205 previously demonstrated excellent in vivo efficacy in a MERS-CoV-2 infected animal model.”

“CDI-45205 has now shown antiviral activity in preclinical testing against SARS-CoV-2 and all four major variants,” said James Martin, CFO and interim co-CEO, “Our next steps are to scale-up synthesis and manufacture active pharmaceutical ingredient (API) to support Investigational New Drug (IND)-enabling studies to advance CDI-45205 into clinical trials.”

The Company continues to develop SARS-CoV-2 oral protease inhibitors and replication inhibitors using its proprietary drug discovery platform technology. Cocrystal’s approach to drug discovery provides a unique path for designing broad-spectrum coronavirus antivirals against SARS-CoV-2 and emerging variants.

About CDI-45205
Cocrystal announced agreements in February and April 2020 with Kansas State University Research Foundation (KSURF) for certain proprietary broad-spectrum CL3 antiviral compounds for the treatment of norovirus and coronavirus infections. In December 2020 Cocrystal announced the selection of CDI-45205 as its lead coronavirus development candidate from a group of protease inhibitors obtained under the KSURF agreements. CDI-45205 showed good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and also no cytotoxicity against a variety of human cell lines. CDI-45205 has also demonstrated a strong synergistic effect with remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-infected mice. Cocrystal has obtained promising preliminary pharmacokinetic results and is continuing to evaluate CDI-45205.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our beliefs related to the effectiveness of CDI-45205 against SARS-CoV-2 and its major variants, and the anticipated clinical development of CDI-45205. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the impact of the COVID-19 pandemic on the national and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our coronavirus program, our ability to complete the preclinical and clinical trials of CDI-45205, the results of such future preclinical and clinical studies, and general risks arising from clinical trials and more generally, the development of investigational drugs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

PDS Biotechnology Announces Conference Call and Webcast to Present Second Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., July 28, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, announced today that its management team will present at several investor conferences listed below during the third quarter of 2021. 

At the recent American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, interim data was presented in an oral session on PDS Biotech’s lead asset, PDS0101, in combination with two investigational immune-modulating agents being studied in two groups of advanced cancer patients. In the first group of patients who had failed treatment with chemotherapy and radiation, tumor reduction (objective response) was seen in 83% (5 of 6) of patients. In the second group, patients who in addition had failed treatment with checkpoint inhibitors, tumor reduction was seen in 58% (7 of 12) patients.

PDS0101 (Versamune^®-HPV16) is an investigational immunotherapy candidate designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by activating the immune system to produce in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive. Analyses of immune responses and other immune correlates are ongoing. 

The upcoming investor conferences will offer leadership the opportunity to provide an update on both ongoing PDS0101 Phase 2 clinical trials, as well as preparations to move two other investigational compounds PDS0102 (Versamune^®-TARP) and PDS0103 (Versamune^®-MUC1) into human testing. The conference details are as follows:

BTIG Investor Conference
Date: Tuesday, August 10, 2021

HC Wainwright 23^rd Annual Global Investment Conference
Date: Tuesday, September 14, 2021

Cantor Healthcare Conference
Date: Monday, September 27, 2021

AGP Fall Virtual Biotech & Specialty Pharma Conference
Date: Wednesday, October 13, 2021

A separate press release will be issued once presentation times become available. 

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based 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 breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

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, 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.

Media & Investor Relations Contacts

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

How to Train the Body’s Own Cells to Combat Antibiotic Resistance

 

Drug-resistant superbugs have threatened human health for decades. The situation is getting worse because of the shortage of new antibiotics. But what if we changed the way we aim to treat them, and trained our cells to kill these invaders instead of relying on antibiotics to do the dirty work? This new strategy, called host-targeted defense, could help to solve antibiotic resistance problem.

Antibiotic resistance is a growing concern for global health. A recent report commissioned by the British government shows that every year globally around 700,000 people died due to infections caused by drug-resistant bacteria. The report also warned that, without action, the death toll could rise to 10 million globally and cost US$80 trillion to the global economy.

Drug resistance is a serious problem in the United States too. More than 23,000 people die every year due to multidrug-resistant pathogens and cost the country around $55 billion per year. The main culprits threatening the U.S. are methicillin-resistant Staphylococcus aureus (MRSA), carbapenem-resistant Enterobacteriaceae (CRE) and Clostridium difficile.

The CDC estimates that antibiotic-resistant pathogens cause more than 23,000 deaths annually in the United States. Source: Centers for Disease Control and Prevention. CDC webpage

The shortage of new antibacterial drugs in development to tackle the growing threat is a disturbing trend. A pathogen that is resistant to a drug reserved to treat infections when all others have failed is a particular concern. This is the case with carbapenem-resistant pathogen.

The decline in antibacterial drugs coupled with emergence of drug-resistant pathogens demands alternative approaches.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and opinions of Zahidul Alam, Postdoctoral Fellow, University of Pennsylvania

 

In Malay Haldar’s lab, along with other projects, my colleagues and I are studying how factors in an animal host play a role in response to infections. To test the approach, we are doing this work using a mouse model of infections. Our aim is to find novel traits or factors of the host that can be targeted to boost an individual’s immune response high enough to kill the offending microbes. The host factor we are investigating is called Spi-C, a gene found in every cell of the human body.

Targeting Host Factors

My interest in host factors arose during my graduate studies. While working on my Ph.D. research project, I learned that host factors, a variety of traits intrinsic to humans, play a significant role in bacterial infections. This inspired me to investigate how the host’s immune system fights bacteria.

New insights into the host’s defense against pathogens have led researchers to explore a new strategy called host-directed therapy (HDT), a relatively recent idea that has only been around for about a decade.

The goal of HDT is to enhance and amplify the host’s immune response to kill pathogens, rather than relying exclusively on antibacterial drugs. By targeting host factors as well as delivering antibiotic treatment, HDTs deliver a double whammy.

 

Virtual Roadshow with Avivagen CEO Kym Anthony This Virtual Road Show Replay features a formal corporate presentation from Avivagen CEO Kym Anthony. Afterwards, he is joined by Noble Capital Markets Senior Research Analyst Joe Gomes for a Q & A session featuring questions asked by the live audience throughout the event. Watch the replay, and get Noble’s research on VIVXF, as well as news and advanced market data at the link below. View All Upcoming Road Shows

 

The body naturally responds to infections with inflammation, a process in which specific populations of immune cells attack and kill the invading bacteria by either eating them or zapping them with protein weapons. However, uncontrolled inflammation triggers the production of proteins that can cause multi-organ failure and can even kill the host. Therefore, controlling inflammation is crucial to combat pathogens as well as to protect the body from hyperinflammation.

HDTs include a suite of treatments that boost the host response to pathogens and also protect the host from exaggerated immune response. HDTs include cellular therapy, in which a specific population of bone marrow cells are injected into the host body to prevent excessive immune response and tissue injury. Another HDT involves commonly used drugs for noninfectious diseases. Statins and ibuprofen, for example, calm the host response to infections. Biologics, the complex molecule drugs produced by recombinant DNA technology, do this too by neutralizing small-sized proteins and reducing tissue damage. Nutritional products, such as vitamin D3, have also been shown to cause a host’s immune cells to release antibacterial substances that enhance pathogen killing.

HDTs in conjunction to antibacterial drugs show great promise in treating various multidrug-resistant pathogens, notably against Mycobacterium tuberculosis, the pathogen which causes tuberculosis, one of the top 10 causes of death worldwide.

 

Personalizing Treatments for Infections

In the last decade, researchers have made much progress in host factor research, leading to new therapeutic strategies.

One of them is personalized medicine, in which a genomic blueprint can determine an individual’s unique susceptibilities to diseases and choose appropriate therapies.

This concept is applied in noninfectious diseases like cancer. However, the application of the concept in infectious disease is very recent. Nonetheless, personalized medicine leads us to speculate why some individuals are more prone to infections than others. My colleagues and I believe that such differences may be caused by subtle differences in the DNA of the host factor genes. By connecting these differences, called polymorphisms, to the level of individuals’ vulnerability to infections, we hope that our research will contribute to the precision medicine of bacterial infections.

Our Quest for a Novel Host Factor

My colleagues in the Haldar lab and I are exploring the role of Spi-C in bacterial infection. Spi-C is essential for the development of a specific type of population of cells in the spleen that regulate the iron  storage in the body. Iron is essential for transporting oxygen in red blood cells.

But, during infections, bacteria also require iron. They need it for growth, and they compete with the host to get it. Hence, if we could alter the activity of the Spi-C gene, we might be able to deprive bacteria of this vital nutrient and thus stop the infections without harming the host.

In a recent paper, we summarized the effect of iron in host cells and its interactions with host factors in the presence or absence of infections.

In mice, we tested the role of host factor, Spi-C, as a way to defend the host. In this study we injected a chemical that is a component of the bacteria into the mice. We wanted to trigger changes that occur in the animal during a real bacterial infection.

Our preliminary results showed that the host factor is active in various organs of the mice treated with the chemical. We believe this activation plays a role in host-defense. And, indeed, we found that losing Spi-C activity increased the release of small-sized proteins that facilitate the host defense against pathogens compared to the cells that have normal Spi-C activity. We believe this change in small-sized proteins might protect the host from hyperinflammation in response to infection.

We believe that shifting of our thinking from pathogen-targeted therapy to host-directed therapy ushers in a new avenue of precision medicine, which could help to end the drug resistance crisis.

 

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PDS Biotechnology Announces Conference Call and Webcast to Present Second Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., July 28, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, announced today that its management team will present at several investor conferences listed below during the third quarter of 2021. 

At the recent American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, interim data was presented in an oral session on PDS Biotech’s lead asset, PDS0101, in combination with two investigational immune-modulating agents being studied in two groups of advanced cancer patients. In the first group of patients who had failed treatment with chemotherapy and radiation, tumor reduction (objective response) was seen in 83% (5 of 6) of patients. In the second group, patients who in addition had failed treatment with checkpoint inhibitors, tumor reduction was seen in 58% (7 of 12) patients.

PDS0101 (Versamune^®-HPV16) is an investigational immunotherapy candidate designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by activating the immune system to produce in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive. Analyses of immune responses and other immune correlates are ongoing. 

The upcoming investor conferences will offer leadership the opportunity to provide an update on both ongoing PDS0101 Phase 2 clinical trials, as well as preparations to move two other investigational compounds PDS0102 (Versamune^®-TARP) and PDS0103 (Versamune^®-MUC1) into human testing. The conference details are as follows:

BTIG Investor Conference
Date: Tuesday, August 10, 2021

HC Wainwright 23^rd Annual Global Investment Conference
Date: Tuesday, September 14, 2021

Cantor Healthcare Conference
Date: Monday, September 27, 2021

AGP Fall Virtual Biotech & Specialty Pharma Conference
Date: Wednesday, October 13, 2021

A separate press release will be issued once presentation times become available. 

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based 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 breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

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, 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.

Media & Investor Relations Contacts

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

Avivagen CEO Kym Anthony makes a formal corporate presentation. Afterwards, he is joined by Noble Capital Markets Senior Research Analyst Joe Gomes for a Q & A session featuring questions asked by the live audience throughout the event. Research, News, and Advanced Market Data on VIVXF Information on upcoming live virtual roadshows About Avivagen Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

electroCore Announces Issuance of New Patent for Migraine Treatment using Smartphones

 

ROCKAWAY, NJ, July 27, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office (USPTO) has issued 
U.S. Patent No. 11,065,444 to electroCore, relating to the use of a mobile phone for stimulating the trigeminal nerve to treat disorders.

The newly issued patent includes descriptions of devices and methods that allow a patient to self-treat a medical condition, such as migraine headache, by non-invasive electrical stimulation of nerves of the head, particularly supraorbital, supratrochlear, infraorbital, and mental nerves in the vicinity of their foramen or notch. The system comprises a handheld mobile device, such as a smartphone, that is applied to the surface of the patient’s head. One or more electrodes apply electrical impulses through the patient’s skin modulating a targeted nerve to treat the medical condition. The system is designed to address problems that arise particularly during self-treatment, when a medical professional is not present.

This newly allowed patent is owned by electroCore and is the latest 
U.S. patent to issue in connection with the company’s non-invasive development program for pain.

“We are pleased with the continued advancement of electroCore’s non-invasive approaches to treating patients,” commented JP Errico, a founder, board member and investor of electroCore, who was also an inventor of the new patent. “These new developments expand the breadth and ease of use by which electroCore’s therapy may be deployed, enabling even more patients worldwide to receive much needed relief at home.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM
gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  
  

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

electroCore Announces Issuance of New Patent for Migraine Treatment using Smartphones

 

ROCKAWAY, NJ, July 27, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office (USPTO) has issued 
U.S. Patent No. 11,065,444 to electroCore, relating to the use of a mobile phone for stimulating the trigeminal nerve to treat disorders.

The newly issued patent includes descriptions of devices and methods that allow a patient to self-treat a medical condition, such as migraine headache, by non-invasive electrical stimulation of nerves of the head, particularly supraorbital, supratrochlear, infraorbital, and mental nerves in the vicinity of their foramen or notch. The system comprises a handheld mobile device, such as a smartphone, that is applied to the surface of the patient’s head. One or more electrodes apply electrical impulses through the patient’s skin modulating a targeted nerve to treat the medical condition. The system is designed to address problems that arise particularly during self-treatment, when a medical professional is not present.

This newly allowed patent is owned by electroCore and is the latest 
U.S. patent to issue in connection with the company’s non-invasive development program for pain.

“We are pleased with the continued advancement of electroCore’s non-invasive approaches to treating patients,” commented JP Errico, a founder, board member and investor of electroCore, who was also an inventor of the new patent. “These new developments expand the breadth and ease of use by which electroCore’s therapy may be deployed, enabling even more patients worldwide to receive much needed relief at home.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM
gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  
  

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

PDS Biotechnology Announces Conference Call and Webcast to Present Second Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., July 26, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, will release financial results for the second quarter of 2021 on Thursday, August 12, 2021, before the market opens. Following the release, management will host a conference call to review the company’s financial results and provide a business update.

The conference call is scheduled to begin at 8:00 am ET on Thursday, August 12, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13721612.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based 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 capable of targeting and killing tumors. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in three (3) Phase 2 clinical studies in HPV-associated cancers. Interim data for the company’s most advanced Phase 2 trial was reported in an oral presentation at the recent American Society of Clinical Oncology (ASCO) on June 7, 2021. The interim results demonstrated strong efficacy in treating the cancer in patients with advanced, treatment-resistant HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers. 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 breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

CONTACT: Media & Investor Relations Contact:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

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

PDS Biotechnology Announces Conference Call and Webcast to Present Second Quarter 2021 Financial Results

 

FLORHAM PARK, N.J., July 26, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, will release financial results for the second quarter of 2021 on Thursday, August 12, 2021, before the market opens. Following the release, management will host a conference call to review the company’s financial results and provide a business update.

The conference call is scheduled to begin at 8:00 am ET on Thursday, August 12, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13721612.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based 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 capable of targeting and killing tumors. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in three (3) Phase 2 clinical studies in HPV-associated cancers. Interim data for the company’s most advanced Phase 2 trial was reported in an oral presentation at the recent American Society of Clinical Oncology (ASCO) on June 7, 2021. The interim results demonstrated strong efficacy in treating the cancer in patients with advanced, treatment-resistant HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers. 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 breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

CONTACT: Media & Investor Relations Contact:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

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