On March 25, 2019 Aprea Therapeutics, a clinical-stage biotechnology company developing novel anticancer therapies targeting the p53 tumor suppressor protein, reported the appointment of Dr. Eyal C. Attar as Senior Vice President and Chief Medical Officer (Press release, Aprea, MAR 25, 2019, View Source [SID1234534615]). A trained physician in medical hematology and oncology, Dr. Attar brings nearly 20 years of medical research and clinical development experience to Aprea.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Dr. Attar’s deep medical and biotech industry experiences will strengthen our clinical development efforts as we continue to advance our first-in-class p53 reactivating agents in late-stage clinical studies," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "His proven leadership and focus on improving outcomes for patients with limited therapeutic alternatives is an excellent fit with Aprea’s determined strategy to advance novel oncology therapies."

"I am thrilled to join the Aprea team at this exciting time in the company’s evolution," said Dr. Attar. "I believe Aprea’s leading scientific approach in reactivating the mutated tumor suppression gene, p53, represents a new paradigm in anti-cancer treatment and a promising novel therapeutic approach for patients for whom there is tremendous need."

Dr. Attar joins Aprea from Agios Pharmaceuticals, where he was Senior Medical Director and IDH Hematology Medical Lead. Having served at Agios since 2014, Dr. Attar played a leadership role in the clinical development and approval of IDHIFA and TIBSOVO for patients with relapsed/refractory AML. Prior to Agios, he served on the clinical staff at the Massachusetts General Hospital Cancer Center, where Dr. Attar was a member of the Center for Leukemia and Assistant Professor of Medicine at Harvard Medical School. He completed his residency in Internal Medicine at Brigham and Women’s Hospital and held fellowships in hematology and oncology in the Dana-Farber Partners Cancer Care Hematology/Oncology Fellowship Program. Dr. Attar received his medical degree from the University of North Carolina School of Medicine.

On March 25, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the closing of its previously announced underwritten public offering of 16,666,668 shares of common stock, short-term warrants to purchase up to 8,333,334 shares of common stock, and long-term warrants to purchase up to 8,333,334 shares of common stock, at a price to the public of $0.75 per share and accompanying warrants (Press release, Oragenics, MAR 25, 2019, View Source [SID1234534633]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oragenics expects to receive gross proceeds of approximately $12.5 million from the offering.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

Each short-term warrant has an exercise price of $0.75 per share of common stock, is immediately exercisable, and will expire on the earlier of (1) the eighteen-month anniversary of the date of issuance and (2) twenty-one trading days following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013. Each long-term warrant has an exercise price of $0.90 per share of common stock, is immediately exercisable and will expire five years following the date of issuance.

The Company has granted the underwriter a 30-day option to purchase up to 2,500,000 additional shares of common stock and/or short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock of the Company at the public offering price, less underwriting discounts and commissions. The underwriter exercised its option to purchase the short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock effective as of the closing.

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above were offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016, and additional registration statement filed pursuant to Rule 462(b) (File No. 333-230422). A final prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction

On March 25, 2019 Australian oncology-focused biotech company Kazia Therapeutics Ltd (ASX: KZA,NASDAQ: KZIA) reported that it has been selected to present data from the Phase I study of Cantrixil in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting (Press release, Kazia Therapeutics, MAR 25, 2019, View Source [SID1234534572]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AACR’s Annual Meeting is one of the top-tier academic conferences worldwide and brings together around 20,000 representatives from academia, industry, government and advocacy organisations from across the globe. The meeting is being held from 29 March to 3 April at the Georgia World Congress Center in Atlanta, Georgia, USA.

Clinical Program Director, Daniel Berg will be presenting on Kazia’s Cantrixil Phase I in ovarian cancer at the event on 1 April 2019. Mr Berg will present data from Part A of the study — the dose escalation component — which completed recruitment in October 2018.

TRX-E-002-1 (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells and is being developed to treat ovarian cancer. It was developed in Australia and initial preclinical studies were conducted at Yale University. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015.

The abstract presentation is entitled: Phase I Study of Intraperitoneal TRX-E-002-1 in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer: Results of Dose-Escalation Phase.

The abstract has been authored by the trial’s Principal Investigators (PIs) – led by the two primary PIs in Australia and the US: Associate Professor Jermaine Coward at the ICON Cancer Care in Brisbane, Queensland and Dr Don Dizon at the Lifespan Cancer Institute at Rhode Island Hospital. The trial is being conducted across six sites in the US and Australia as follows:

Country

State

Site

Principal Investigator

US

Rhode Island

Lifespan Cancer Institute, Providence

Dr. Don Dizon

US

Oklahoma

Stephenson Cancer Center, Oklahoma City

Assoc. Prof. Kathleen Moore

US

Texas

Mary Crowley Cancer Research Centre, Dallas

Dr. Minal Barve

Australia

Queensland

ICON Cancer Care, Brisbane

Assoc. Prof. Jermaine Coward

Australia

New South Wales

Westmead Hospital, Sydney

Prof. Paul Harnett

Australia

South Australia

Flinders Medical Centre, Adelaide

Dr. Ganessan Kichenadasse

"The key objective with Part A of the Phase I study was to assess the safety of the drug and find the right dose level to take the study to the next stage. We are delighted to be presenting our data at the AACR (Free AACR Whitepaper) meeting and we look forward to discussing our findings with clinicians and potential partners," said Cantrixil Program Director Daniel Berg.

The presentation session details are as follows:

Session Title: Phase I Clinical Trials: Part 3
Date and Time: Monday April 1, 2019 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16
Poster Board Number: 15
Permanent Abstract Number: CT091

Interested parties are encouraged to attend and can add the session to their itinerary here: View Source!/6812/session/1315

Meanwhile, the link to the abstract is here: View Source!/6812/presentation/9899

The content of the abstract and presentation is embargoed until the start of the conference when it will be available through the above link and on the Kazia website.

On March 25, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class of therapies that degrade disease-causing proteins, reported the initiation of patient dosing in its Phase 1 clinical trial of ARV-110, the company’s oral androgen receptor (AR)-targeted PROTAC protein degrader (Press release, Arvinas, MAR 25, 2019, View Source [SID1234534600]). The study will evaluate the safety, tolerability, and pharmacokinetics of ARV-110 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on standard of care therapies. Arvinas believes ARV-110 is the first in a new class of targeted protein degraders to enter human clinical trials and anticipates preliminary data from the study in the second half of 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With ARV-110 we are harnessing the body’s natural protein disposal system to degrade AR, a key contributor to the progression of prostate cancer," said John Houston, Ph.D., President and CEO of Arvinas. "Given the promising results seen in preclinical studies, it is our hope that ARV-110 will overcome known mechanisms of resistance to standard of care agents and offer a new treatment option for patients. We believe this is the first time a patient has been treated with this new class of targeted protein degraders and we look forward to furthering our understanding of ARV-110 as a potential treatment for men with mCRPC and the broader field of protein degradation."

The Phase 1 open-label, dose-escalation clinical trial will assess the safety, tolerability, and pharmacokinetics of ARV-110 and is expected to enroll approximately 28-36 patients with progressive mCRPC. In addition, the study will evaluate the biochemical and clinical activity of ARV-110, by assessing prostate specific antigen (PSA) levels, AR degradation, radiographic measurements of evaluable lesions, and other exploratory markers of disease burden. Additional information on this clinical trial can be found on www.clinicaltrials.gov.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
In the United States, prostate cancer is both the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society predicts that one in nine men will be diagnosed with prostate cancer in his lifetime. Metastatic castration-resistant prostate cancer (mCRPC) is defined by disease progression despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen (PSA).

Current AR-targeted standard of care treatments for mCRPC are less effective in patients whose disease has increased levels of androgen production, AR gene or gene enhancer amplification, or AR point mutations. Up to 25% of patients do not respond to second-generation hormone therapies like abiraterone and enzalutamide, and the vast majority of responsive patients will ultimately become resistant, resulting in poor prognoses for men diagnosed with this devastating condition.

About PROTAC (Proteolysis-Targeting Chimera) Protein Degraders
Arvinas’ PROTAC protein degraders harness the body’s own natural protein recycling system to degrade disease-causing proteins. PROTAC protein degraders recruit an E3 ligase to tag the target protein with ubiquitin, which directs its degradation through the proteasome, a large protein complex that breaks down the ubiquitinated target protein into small peptides and amino acids. As the target protein is degraded, the PROTAC protein degrader is released and acts iteratively to destroy additional target protein.

PROTAC protein degraders offer numerous potential advantages as a therapeutic, including broad tissue distribution, routes of administration that include oral delivery, and simpler manufacturing than other new modalities, such as cell-based therapies. Arvinas has developed and optimized a proprietary library of protein targeting ligands, E3 ligase ligands, and linkers, which allow the company to rapidly identify and optimize efficient protein degraders with favorable characteristics for successful drug development.

About ARV-110
ARV-110 is an orally bioavailable PROTAC protein degrader designed to selectively target and degrade the AR. ARV-110 is being developed as a potential treatment for men with mCRPC. ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies. Arvinas believes the differentiated pharmacology of ARV-110, including its iterative activity, has the potential to translate into improved clinical outcomes for patients.

On March 25, 2019 NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) reported that the English version of the Annual report for 2018 is now available on the company’s website www.neurovive.com (Press release, NeuroVive Pharmaceutical, MAR 25, 2019, View Source [SID1234534616]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, at 10:00 a.m. CET on 25 March 2019.