OncBioMune Announces Former Puma Biotechnology Executive and Genentech Veteran Brian Barnett, M.D., as Chief Executive Officer

On January 9, 2019 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported that its Board of Directors has appointed Brian Barnett, M.D., as Chief Executive Officer (Press release, Oncbiomune, JAN 9, 2019, View Source [SID1234532611]).

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!

Prior to joining the Company, Dr. Barnett served at Puma Biotechnology, Inc. since August 2016 ("Puma") most recently as a Vice President and Head of Medical Affairs. Prior to his time with Puma, Dr. Barnett was with Genentech, Inc., a subsidiary of Roche, from October 2012 to August 2016 and served as Medical Director, Kadcyla (T-DM1), Global Product Development Oncology and U.S. Medical Affairs. Prior to his appointment as CEO, Dr. Barnett was a member of the Company’s Scientific Advisory Board. Dr. Barnett received his B.S. from Millsaps College, M.D. from the University of Mississippi Medical Center, and completed his Medical Oncology Fellowship at Tulane University in New Orleans.

Dr. Barnett succeeds Dr. Jonathan Head as Chief Executive Officer at OncBioMune. Dr. Head will continue to serve the Company as the Chairman of the Board of Directors and now as its Chief Scientific Officer.

"It has long been our strategy to advance ProscaVax into mid-stage clinical trials for prostate cancer and find my successor from big pharma to lead our continued growth and pipeline development," commented Dr. Head. "Dr. Barnett was a natural choice given his experience at Puma and Genentech and understanding of our pipeline through his time as an advisor to the Company. I am confident that the Company is going to benefit from Dr. Barnett’s passion for drug development, business savvy and industry connections and I am thrilled to introduce him as our new CEO."

"I am excited and honored to take this opportunity to lead OncBioMune and spearhead development of our pipeline of exceptional drug candidates," said Dr. Barnett. "As an oncologist and as I’ve gotten to know the company more intimately, I see the opportunities that are presented with ProscaVax, the platform vaccine technology and our patented targeted transferrin transport technology. As we move forward with the Phase 2 trials of ProscaVax, I intend to focus on and expedite development of the transferrin technology simultaneously. This is an underappreciated part of our pipeline that I believe can possibly help cancer patients by addressing an unmet need and will resonate potentially as a tumor-agnostic, biomarker-directed and targeted approach to cancer therapy."

As previously announced, OncBioMune intended to host a shareholder call in December. With change in leadership, the company is rescheduling the call for later this quarter to give Dr. Barnett some time to get acclimated to his new position.

Sign up for OncBioMune email alerts at: View Source

Cancer Genetics, Inc. Announces Pricing of Public Offering of Common Stock

On January 9, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the pricing of an underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $0.225 per share (Press release, BioServe Biotechnologies, JAN 9, 2019, View Source [SID1234532612]). Cancer Genetics also granted the underwriter a 45-day option to purchase up to an additional 2,000,000 shares of its common stock at the public offering price of $0.225 per share, less underwriting discounts and commissions. Cancer Genetics expects to receive aggregate gross proceeds of approximately $3.0 million from the offering, assuming no exercise of the underwriter’s option to purchase additional shares. The offering is expected to close on or about January 14, 2019, subject to customary closing conditions.

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!

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

Cancer Genetics intends to use the net proceeds from the offering to pay lender fees and other costs incurred in connection with the potential forbearance agreements it is negotiating with its banks, to pay certain costs previously incurred by it in connection with its terminated transaction with NovellusDx Ltd., and if any proceeds remain available, to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering was filed with the SEC on January 9, 2019, and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, 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, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

BerGenBio Announces Start of Phase I Trial Evaluating First-in-Class Anti-AXL Antibody BGB149

On January 9, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class drug candidates targeting AXL kinase to treat aggressive diseases including immune-evasive and therapy resistant cancers, reported that the first subject has been dosed in a Phase I clinical trial evaluating the anti-AXL therapeutic monoclonal antibody BGB149 in healthy volunteers (Press release, BerGenBio, JAN 9, 2019, View Source [SID1234532614]).

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!

BGB149 is the first functional blocking anti-AXL monoclonal antibody to enter clinical development and is BerGenBio’s second clinical stage drug development programme targeting AXL.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are delighted to initiate this Phase I study as planned. BGB149 has cleared all required regulatory pre-clinical evaluations. This AXL functional blocking antibody is BerGenBio’s second drug candidate to enter clinical trials: An important milestone in expanding our pipeline of first-in-class AXL targeting drug candidates positioned to treat aggressive diseases with severe unmet medical need. We are expecting results from this Phase I trial in 2019 and are looking forward to announcing BGB149’s further clinical development strategy in the coming months."

END

About BGB149 and the Phase I Healthy Volunteer Trial
BGB149 is a fully humanised anti-AXL functional blocking monoclonal antibody, developed and fully-owned by BerGenBio. A robust, high yielding manufacturing process has been established and preclinical studies have confirmed its mechanism of action as well as efficacy.

The Phase I healthy volunteer trial BGB149-101 will enrol up to 36 subjects andinvestigate the safety, tolerability and pharmacokinetics of BGB149 following single dose administration.The study is being sponsored by BerGenBio.

For more information, see ClinicalTrials.gov: NCT03795142

About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that Axl mediates other aggressive diseases

Genmab Achieves USD 75 Million Sales Milestone in DARZALEX® (daratumumab) Collaboration with Janssen

On January 8, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it has achieved a USD 75 million sales volume milestone in its DARZALEX (daratumumab) collaboration with Janssen Biotech, Inc (Press release, Genmab, JAN 8, 2019, View Source [SID1234532577]). The milestone was triggered by confirmation by Janssen that sales of DARZALEX reached USD 2 billion in the calendar year of 2018. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

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!

"We are very pleased that as the launch continues, DARZALEX has become available to so many more multiple myeloma patients in need, which is reflected in the achievement of this sales milestone. With the potential for further indications to be approved in the future, we look forward to even greater growth in the coming years," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The milestone payment was included in the financial guidance issued by Genmab originally on February 21, 2018 and then reiterated in subsequent quarterly financial reports, most recently on November 14, 2018, and as such there is no change to the company’s financial guidance for 2018.

Heat Biologics Principal Investigator Selected to Deliver Oral Presentation of New HS-110 Interim Phase 2 Data at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium

On January 8, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported that the Company’s principal investigator for its Phase 2 Lung Cancer Trial, Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, has been selected to deliver an oral presentation of his abstract summarizing new interim data from the Company’s Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) at the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium (Press release, Heat Biologics, JAN 8, 2019, View Source [SID1234532579]).

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!

The 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium will be held from February 28-March 2, 2019 at the San Francisco Marriott Marquis. The details for the oral presentation at the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium are as follows:

Title: Viagenpumatucel-L (HS-110) plus nivolumab in patients with advanced non-small cell lung cancer (NSCLC)

Date and time: February 28, 2019 at 1:00 PM to 2:15 PM PST

Session title: Oral Abstract Session A: Lung Cancer

Abstract number: 101