On September 8, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported that Oren Gilad Ph.D, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12, 2022 at 12:30 p.m. ET (Press release, Aprea, SEP 8, 2022, View Source [SID1234619241]).

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The presentation will discuss Aprea’s discovery program and development pipeline in synthetic lethality and DDR, including:

ATRN-119, the Company’s Phase 1-ready small molecule ATR inhibitor
ATRN-W1051, the Company’s WEE1 inhibitor in preclinical development
Repli-Biom, the Company’s discovery platform to identify both new precision oncology targets and patient populations most likely to benefit from treatment
Eprenetapopt, the Company’s clinical-stage small molecule p53 reactivator
A copy of the presentation will be accessible from the "Events Calendar" in the News and Events section of the Aprea website.

On September 8, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (‘Applied DNA’ or the "Company"), a leader in polymerase chain reaction ("PCR")-based technologies, and the Cornell University College of Veterinary Medicine ("CUCVM") reported the signing of a research agreement (the "Agreement") to advance LinearDNA-based vaccine research and discovery for animal diseases with agricultural biosecurity implications (Press release, Applied DNA Sciences, SEP 8, 2022, View Source [SID1234619240]). Primarily, the Agreement seeks to combine LinearDNA as a platform for rapid drug development with CUCVM’s expertise in viral vector design to advance a differentiated approach to animal vaccine development for infectious diseases.

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The Agreement builds on the strong, existing collaboration between Applied DNA’s biotherapeutics subsidiary, LineaRx, and Dr. Diego Diel, D.V.M, M.S., PhD., Associate Professor of Virology at the Cornell University College of Veterinary Medicine’s Department of Population Medicine and Diagnostics. Dr. Diel is the lead investigator for veterinary clinical trials sponsored by the Company for the LinearDNA-based COVID-19 vaccine candidate and other therapeutic candidates in the Company’s pipeline.

Recently, Applied DNA announced the successful administration and expression of a lipid nanoparticle-encapsulated (LNP) LinearDNA construct in mice via routine intramuscular (IM) injection. Based on this positive data, the Company is currently advancing several LNP LinearDNA vaccine designs that will be utilized in upcoming preclinical animal studies. Data generated by these preclinical animal studies will advance the LinearDNA platform toward the commercialization of LNP-LinearDNA vaccines for both prophylactic and therapeutic applications and will inform the final design of the Company’s LNP-LinearDNA canine cancer vaccine candidate that is currently slated to begin an initial clinical trial during 1H calendar 2023.

"The Agreement is an opportunity to expand our work with Dr. Diel and his talented team to accelerate the application of the LinearDNA platform to the animal health market," stated Dr. James A Hayward, president and CEO of Applied DNA and LineaRx. "Veterinary DNA vaccines present an attractive opportunity for us, and these animal studies should generate additional key validation data for our platform relevant to veterinary health. There is a continuing need for better veterinary therapies and we believe an LNP-LinearDNA product has the strong potential to offer enhanced ease of administration and improved clinical outcomes."

Dr. Diel said, "Vaccinology research and clinical trials are crucial to developing new prevention strategies that could have transformative applications in animal health. This partnership will help to advance research and development of novel vaccine candidates for emerging infectious diseases in ways that can benefit us all, including human and animal patients."

On September 8, 2022 Amgen (NASDAQ:AMGN) reported that it will present at Morgan Stanley’s 2022 Global Healthcare Conference at 9:10 a.m. ET on Tuesday, Sept. 13, 2022 (Press release, Amgen, SEP 8, 2022, View Source [SID1234619239]). Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On September 8, 2022 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that Ron Cohen, M.D., Acorda’s President and Chief Executive Officer, will be presenting at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12 at 3 p.m. ET (Press release, Acorda Therapeutics, SEP 8, 2022, View Source [SID1234619238]).

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The conference will be conducted in a hybrid format, with both in-person and virtual attendees. Acorda’s presentation will be streamed only to registered conference attendees, who will be able to view the presentation live, virtually, and on-demand for 30 days through the H.C. Wainwright Conference Platform.

To register for the in-person or virtual conference, please use the following link: View Source

On September 8, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (Valneva) and VBI Vaccines Inc. (Nasdaq: VBIV) (VBI) reported a partnership in select European markets for the marketing and distribution of PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)], the only 3-antigen hepatitis B vaccine approved in Europe (Press release, VBI Vaccines, SEP 8, 2022, View Source [SID1234619236]).

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Under the terms of the agreement, specialty vaccine company Valneva will promote and distribute PreHevbri throughout select European countries, which initially include the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands. Valneva and VBI expect PreHevbri to be available in these countries in early 2023.

Thomas Lingelbach, President and CEO of Valneva, commented: "We welcome this partnership with VBI which underlines Valneva’s expertise in vaccine commercialization. Among the past years, we have continued to develop our third-party vaccine marketing and distribution activities further, notably with the signing of a distribution agreement with Bavarian Nordic in 2020, and we are extremely pleased to add VBI’s Hepatitis B vaccine to this portfolio today. Our objective is to continue leveraging our commercial infrastructure to combat as many infectious diseases as we can."

Jeff Baxter, President and CEO of VBI, commented: "This partnership is a significant milestone for PreHevbri, enabling us to hit the ground running in Europe. Valneva has substantial local knowledge, experience, and relationships in each of these European countries where we expect to launch, which will be of critical value as we work, collectively, to provide broad access to this differentiated 3-antigen HBV vaccine in Europe. Strategically, VBI and Valneva are two companies aligned by a shared mission to reduce the burden of infectious disease, and this new collaboration will build upon that meaningful synergy."

PreHevbri was approved by the European Commission (EC) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) in the second quarter of 2022 for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.

About Hepatitis B

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

About PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)]

PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, the United Kingdom, the United States, and Israel. The brand names for this vaccine are: PreHevbri (EU/EEA/UK), PreHevbrio (US), and Sci-B-Vac (Israel).

Full European Summary of Product Characteristics for PreHevbri are available from the EMA website at www.ema.europa.eu.

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).