On June 16, 2020 Sanofi reported to increase its vaccines research and production capabilities (Press release, BioSpace, JUN 16, 2020, View Source [SID1234561165]). As part of the plan it will invest $679.4 million (€610 million) to create a new production site and a research center, both in France, both dedicated to vaccines.

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!

"Sanofi’s heart beats in France," said Sanofi’s chief executive officer Paul Hudson in a statement. "We have a long history and exceptional teams working throughout the country, embodying our strong values. By investing in a new industrial site and a R&D center, Sanofi positions France at the core of its strategy, aiming to make France a world-class center of excellence in vaccine research and production."

The company’s Evolutive Vaccine Facility (EVF) will be based in Neuville sur Saone. This industrial site will leverage the latest innovative vaccine production technologies. The company will invest €490 million over a five-year period, with plans to create 200 new jobs.

Sanofi Pasteur is Sanofi’s vaccine company and it will utilize the manufacturing site to handle any new pandemics. Sanofi indicates that EVF "is a new type of factory designed around a central unit housing several fully digital production modules that make it possible to produce three to four vaccines simultaneously, versus only one in current industrial sites. This modularity will make it possible to prioritize the production of a specific vaccine in a more timely manner based on public health issues."

Of the total funding, €120 million will go to form a new R&D center at the Sanofi Pasteur site in Marcy-l’Etoile to develop future vaccines. It too will be a state-of-the-art digital facility with specialized laboratories. Sanofi indicates it plans for the facility to become a world reference for preclinical research and pharmaceutical and clinical development.

Hudson added, "Sanofi is a major healthcare player in France, in Europe, and worldwide. It is our responsibility to focus our resources and expertise against the current pandemic, but also to invest in preparing for future ones. We welcome the ongoing collaboration and commitment of the French authorities who we have been working alongside with the last several months to achieve this."

Sanofi, in collaboration with GlaxoSmithKline, is approaching the development of two different COVID-19 vaccines with two different technological approaches. The first, with GSK, is using recombinant DNA technology, which would allow for manufacturing very large quantities of antigens, the proteins that are injected to stimulate the immune system. The second is messenger RNA technology in collaboration with TranslateBio. This is a new technology also being utilized by U.S.-based Moderna and Germany-based BioNTech, which is collaborating with Pfizer.

Sanofi says it is committed to making its vaccine accessible to "all and around the world."

On April 14, Sanofi and GSK signed a letter of intent to collaborate on the COVID-19 vaccine using technology from both companies. Sanofi is contributing its S-protein COVID-19 antigen, which utilizes recombinant DNA technology. This allows for an exact genetic match to proteins found on the virus surface. The DNA sequence that codes for the antigen has been combined into the DNA of the baculovirus expression program, which Sanofi uses for its recombinant influenza product in the U.S.

GSK is contributing its pandemic adjuvant technology, which can decrease the amount of vaccine protein required per dose, which allows for more manufacturing volume.

At the time, Emma Walmsley, chief executive officer of GSK, said, "This collaboration brings two of the world’s largest vaccines companies together. By combining our science and our technologies, we believe we can help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19."

The deal with TranslateBio was signed earlier, on March 27. That deal leverages an existing agreement from 2018 to develop mRNA vaccines for infectious diseases. The primary aspect of that agreement is TranslateBio is producing multiple mRNA constructs using its technology platform to discover, design, and manufacture several SARS-CoV-2 vaccine candidates. Sanofi will provide its vaccine expertise and its external research network to advance vaccine candidates.

On June 16, 2020 HALO Diagnostics reported interim 10-year results from its Phase II 20-year clinical trial for prostate laser focal therapy in patients with localized prostate cancer (Press release, HALO Diagnostics, JUN 16, 2020, View Source [SID1234561161]). Over 170 men, 45-years or older diagnosed with low-to-intermediate risk or recurrent prostate cancer, volunteered to participate in the study . The results are impressive: less than 1% infection, less than 1% erectile dysfunction and less than 1% incontinence – compared to conventional whole gland prostatectomy which has a risk of up to 50% erectile dysfunction and 25% urinary incontinence. These results, along with a 100% prostate cancer-specific survival rate, are an encouraging development for men looking for a prostate cancer therapy option with a lower risk of side effects.

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!

Prostate cancer is the second leading cause of cancer death in men in the United States. It is estimated that over 191,000 men will be diagnosed with prostate cancer this year and more than 33,000 are expected to die.
Prostate cancer is the second leading cause of cancer death in men in the United States. It is estimated that over 191,000 men will be diagnosed with prostate cancer this year and more than 33,000 are expected to die.
Why is this study important to prostate cancer patients? "Magnetic resonance image (MRI)-guided laser focal therapy enables doctors to contour their approach to the areas of the prostate that needs to be treated, while creating safety boundaries around the areas that need to remain untouched," said Bernadette M. Greenwood, chief research officer of HALO Diagnostics. "This level of precision compared to other approaches, such as radical prostatectomy, radiation therapy and even other focal or targeted approaches like high-intensity focused ultrasound (HIFU), substantially lowers the risk of side effects, including urinary incontinence, impotence and decreased bowel function. Unlike other treatments, laser focal therapy does not limit the option to treat with radiation therapy or surgery if needed later."

The procedure is as follows: the laser focal therapy (also called LITT or FLA) is designed to destroy prostate tissue under MRI guidance using laser energy. The laser device is FDA 510(k) cleared for clinical use for soft tissue necrotization. The planning system is FDA 510(k) cleared for MRI-guided prostate biopsy. HALO Diagnostics is the first company in the world to combine these devices under IRB approved clinical trial NCT 02243033. The procedure is minimally invasive and ambulatory outpatient – no general anesthesia required.

"The purpose of this research, which began on May 24, 2010, is to investigate the safety and effectiveness of using MRI-guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years," said Dr. John Feller, chief medical officer of HALO Diagnostics. "The interim Phase II results indicate a paradigm shift in the treatment of men with intermediate risk prostate cancer and those with biochemical recurrence. These results are not only an exciting development in the advancement of laser focal therapy for prostate cancer, but speak to the strength of our clinical team and our commitment to developing life changing patient experiences and outcomes."

Recruitment for the "Phase II Study to Evaluate Outpatient Magnetic Resonance Image-Guided Laser Focal Therapy for Prostate Cancer, a 20-Year Survival Study" will continue through the HALO Diagnostics’ Center of Innovation in Indian Wells and conclude once the study goal of 200 men has been achieved and evaluated for oncological control for a 20 year period. The trial details are listed on clinicaltrial.gov and the 10-year interim results were published in Journal of Urology on May 15, 2020.

On June 16, 2020 Centene Corporation (NYSE: CNC) reported it will participate in the one-day, virtual-only BMO Capital 2020 Prescriptions for Success Healthcare Conference (Press release, Centene , JUN 16, 2020, View Source [SID1234561160]).

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!

Centene will participate in a virtual format on Tuesday, June 23, 2020, at 8:30 a.m. Eastern Daylight Time (EDT). A simultaneous live audio webcast is available at: View Source

A webcast replay will be available afterwards via the Company’s website at www.centene.com under the Investors section.

On June 16, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on unmet needs in global health, reported that it will issue financial results for its fourth quarter fiscal year 2020, ended March 31, 2020, at 4:15pm Eastern time on Thursday, June 25, 2020 (Press release, Aethlon Medical, JUN 16, 2020, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-fourth-quarter-financial-results-and-host-conference-call-on-june-25-2020-301077496.html [SID1234561159]).

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!

Management will host a conference call on Thursday, June 25, 2020 at 4:30pm eastern time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442
All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through July 2, 2020. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10145174.

On June 16, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported the closing of its initial public offering of 16,560,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 2,160,000 additional shares, at a public offering price of $18.00 per share (Press release, Avidity Biosciences, JUN 16, 2020, View Source [SID1234561158]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Avidity, were approximately $298.1 million. Avidity’s common stock is listed on the Nasdaq Global Market under the ticker symbol "RNA".

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!

Cowen, SVB Leerink, Credit Suisse and Wells Fargo Securities acted as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission (SEC) and became effective on June 11, 2020. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from Cowen and Company LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected]; or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd Floor, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected]; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, or by telephone at (800) 326-5897, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or 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 jurisdiction.