On March 4, 2020 Bioasis Technologies Inc. (OTCQB:BIOAF; TSX.V:BTI), (the "Company" or "Bioasis"), a biopharmaceutical company developing its proprietary xB3 platform technology for the delivery of therapeutics across the blood-brain barrier ("BBB") and the treatment of central nervous system ("CNS") disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, reported the appointment of Dr. May Orfali to the position of Consultant Chief Medical Officer, effective immediately (Press release, biOasis, MAR 4, 2020, View Source [SID1234555185]). In this position, Dr. Orfali replaces Dr. Jose Iglesias, who has recently accepted a full-time position at another company. We thank Dr. Iglesias for his contributions to Bioasis to date.

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Dr. May Orfali has a deep and extensive background in drug and clinical development programs that spans two decades in multiple therapeutic areas, with a focus on rare diseases, oncology, hematology, infectious disease and women’s health. Her most recent role was President at Oncology and Rare disease Consulting, LLC, she was the Chief Medical Officer at CANbridge Life Sciences where she led the clinical development and medical affairs group, focused on progressing phase 1 and phase II oncology assets in glioblastoma multiforme and esophageal cancer, filing NDA for neratinib in China in adjuvant and metastatic breast cancer therapy. Dr. Orfali has also spent several years at Pfizer as Global Medical Lead and Executive Director, Global Product Development across multiple rare disease assets in hematology, sickle cell disease, hemophilia, endocrinology, gene therapy and TTR-amyloidosis. Prior to her time at Pfizer, Dr. Orfali held several clinical leadership positions, at Wyeth, Artisan Pharma, Aeris Therapeutics, Cubist Pharmaceuticals and Boston Scientific Corporation.

Dr. Orfali holds a medical degree from the University of Baghdad, Baghdad, Iraq, and a Pharmaceutical Master of Business Administration from Cambridge University, Cambridge, England. She was a practicing physician, specialized in CNS Oncology Clinical Research at Dana-Farber Cancer Institute, in Boston, MA and completed her Fellowship in Pediatric Oncology/Hematology at Massachusetts General Hospital and Children’s Hospital, Boston, MA.

"We are very pleased that Dr. Orfali has joined the team at Bioasis. She has a unique experience in clinical development that is well suited to Bioasis’ deep pipeline across multiple therapeutic areas including neuro-oncology and rare diseases," said Deborah Rathjen, Bioasis’ CEO and Chair. "In particular Dr. Orfali will make a significant contribution to the progression of our lead program xB3-001 in development for the treatment of Her2+ breast cancer and brain metastases. We are very appreciative of the contribution Jose has made to this important program and we wish him all the best," Deborah Rathjen added.

"The promise offered by Bioasis’ technology platform has the potential to make a real difference in the life of Her2+ breast cancer patients with brain metastases. This condition is very hard to treat, and efficient solutions are needed for it. I am thrilled to be part of this exciting endeavor," said Dr. May Orfali.

On March 4, 2020 City of Hope reported that scientists have developed and tested the first chimeric antigen receptor (CAR) T cell therapy using chlorotoxin (CLTX), a component of scorpion venom, to direct T cells to target brain tumor cells, according to a preclinical study published in Science Translational Medicine. The institution has also opened the first in-human clinical trial to use the therapy.

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CARs commonly incorporate a monoclonal antibody sequence in their targeting domain, enabling CAR T cells to recognize antigens and kill tumor cells. In contrast, the CLTX-CAR uses a 36-amino acid peptide sequence first isolated from death stalker scorpion venom and now engineered to serve as the CAR recognition domain.

Glioblastoma (GBM), the most common type of brain tumor, is also among the most deadly of human cancers, according to the American Cancer Society. It is particularly difficult to treat because the tumors are disseminated throughout the brain. Efforts to develop immunotherapies, including CAR T cells, for GBM must also contend with a high degree of heterogeneity within these tumors.

For the study, City of Hope researchers used tumor cells in resection samples from a cohort of patients with GBM to compare CLTX binding with expression of antigens currently under investigation as CAR T cell targets, including IL13Rα2, HER2 and EGFR. They found that CLTX bound to a greater proportion of patient tumors and cells within these tumors.

CLTX binding included the GBM stem-like cells thought to seed tumor recurrence. Consistent with these observations, CLTX-CAR T cells recognized and killed broad populations of GBM cells while ignoring nontumor cells in the brain and other organs. The study team demonstrated that CLTX-directed CAR T cells are highly effective at selectively killing human GBM cells in cell-based assays and in animal models without off-tumor targeting and toxicity.

"Our chlorotoxin-incorporating CAR expands the populations of solid tumors potentially targeted by CAR T cell therapy, which is particularly needed for patients with cancers that are difficult to treat such as glioblastoma," said Christine Brown, Ph.D., City of Hope’s Heritage Provider Network Professor in Immunotherapy and deputy director of T Cell Therapeutics Research Laboratory. "This is a completely new targeting strategy for CAR T therapy with CARs incorporating a recognition structure different from other CARs."

Michael Barish, Ph.D., City of Hope professor and chair of the Department of Developmental and Stem Cell Biology, initiated the development of a CAR using chlorotoxin to target GBM cells. The peptide has been used as an imaging agent to guide GBM resection surgery, and to carry radioisotopes and other therapeutics to GBM tumors.

"Much like a scorpion uses toxin components of its venom to target and kill its prey, we’re using chlorotoxin to direct the T cells to target the tumor cells with the added advantage that the CLTX-CAR T cells are mobile and actively surveilling the brain looking for appropriate targets," Barish said. "We are not actually injecting a toxin, but exploiting CLTX’s binding properties in the design of the CAR. The idea was to develop a CAR that would target T cells to a wider variety of GBM tumor cells than the other antibody-based CARs."

"The notion is that the higher the proportion of tumor cells that one can kill at the beginning of treatment, the greater the probability of slowing down or stopping GBM growth and recurrence," Barish added.

Dongrui Wang, a doctoral candidate in City of Hope’s Irell & Manella Graduate School of Biological Sciences, was the lead scientist to establish and optimize the CLTX-CAR T cell platform and to determine that cell surface protein matrix metalloprotease 2 is required for CLTX-CAR T cell activation. He added that "while people might think the chlorotoxin is what kills the GBM cells, what actually eradicates them is the tumor-specific binding and activation of the CAR T cells."

Based on the promising findings of this study, the study team intends to bring this therapy to patients diagnosed with GBM with the hope of improving outcomes against this thus far intractable cancer. With recently granted Food and Drug Administration approval to proceed, the first-in-human clinical trial using the CLTX-CAR T cells is now screening potential patients.

This work was supported by the Ben & Catherine Ivy Foundation of Scottsdale, Arizona, and the clinical trial will be supported by The Marcus Foundation of Atlanta.

City of Hope, a recognized leader in CAR T cell therapies for glioblastoma and other cancers, has treated nearly 500 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world — it currently has 29 ongoing CAR T clinical trials, including CAR T trials for HER-2 positive breast cancer that has spread to the brain, and PSCA-positive bone metastatic prostate cancer. It was the first and only cancer center to treat GBM patients with CAR T cells targeting IL13Rα2, and the first to administer CAR T cell therapy locally in the brain, either by direct injection at the tumor site, through intraventricular infusion into the cerebrospinal fluid, or both. In late 2019, City of Hope opened a first-in-human clinical trial for patients with recurrent glioblastoma combining IL13Rα2-CAR T cells with checkpoint inhibitors nivolumab, an anti-PD1 antibody, and ipilimumab, blocking the CTLA-4 protein.

On March 4, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that Kenneth A. Berlin, President and Chief Executive Officer of Advaxis will present at the third annual LD Micro Virtual Conference on March 4, 2020 (Press release, Advaxis, MAR 4, 2020, View Source [SID1234555183]).

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Presentation Information:
Date: Wednesday, March 4, 2020
Time: 2:00 PM ET / 11:00 AM PT
Webcast: View Source

On March 4, 2020 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the commercialization and development of proprietary drugs for the treatment of gastrointestinal diseases, reported its full-year 2019 financial results and operational highlights (Press release, RedHill Biopharma, MAR 4, 2020, View Source [SID1234555181]).

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"With the planned U.S. launch of Talicia, the ongoing promotion of Aemcolo, the recent acquisition of Movantik and the expansion of our sales force, we expect 2020 to be a year of transformational growth as we work to become a leader in the gastrointestinal field," said Micha Ben Chorin, RedHill’s Chief Financial Officer. "The $36.3 million strategic investment by Cosmo Pharmaceuticals and the non-dilutive royalty-backed term loan facility of up to $115 million from HealthCare Royalty Partners allow us to continue to execute our plans."

Full Year 2019 Results1

Net Revenues for the year ended December 31, 2019 were $6.3 million, compared to $8.4 million for the year ended December 31, 2018. The decrease was attributed mainly to the competitive landscape surrounding Donnatal and EnteraGam.

Cost of Revenues for the year ended December 31, 2019 was $2.3 million, compared to $2.8 million for the year ended December 31, 2018. The decrease was in line with the decrease in revenues from our commercial products.

Gross Profit for the year ended December 31, 2019 was $4.0 million, with gross margin of 64.1%, compared to $5.5 million and 66.1%, respectively, for the year ended December 31, 2018.

Research and Development Expenses for the year ended December 31, 2019, were $17.4 million, compared to $24.9 million for the year ended December 31, 2018. The decrease was mainly due to the completion of the Phase 3 study with Talicia and the finalization of the Phase 3 studies with
RHB-104.

Selling, Marketing and Business Development Expenses for the year ended December 31, 2019, were $18.3 million, compared to $12.5 million for the year ended December 31, 2018. The increase was mainly due to the expansion of our commercial operations to support the preparations for the launch of Talicia and Aemcolo.

General and Administrative Expenses for the year ended December 31, 2019 were $11.5 million, compared to $7.5 million for the year ended December 31, 2018. The increase was mainly due to the expansion of our U.S. commercial operations as well as an increase in professional services expenses to support the preparations for the launch of Talicia and Aemcolo.

Operating Loss for the year ended December 31, 2019 was $43.2 million, compared to $39.3 million for the year ended December 31, 2018. The increase was mainly due to the increase in commercial operating expenses, as described above.

Net Cash Used in Operating Activities for the year ended December 31, 2019 was $40.7 million, compared to $34.5 million for the year ended December 31, 2018. The increase in Net Cash Used in Operating Activities was a direct result of the increase in Operating Loss as described above.

Net Cash Provided by Financing Activities for the year ended December 31, 2019 was $35.5 million, compared to $41.8 million for the year ended December 31, 2018, resulting from a private placement transaction in 2019 compared to two underwritten public offerings in 2018.

Cash Balance2 as of December 31, 2019 was $47.9 million, compared to $53.2 million as of December 31, 2018.

Commercial Highlights:

Talicia (omeprazole magnesium, amoxicillin and rifabutin)3
In November 2019, the U.S. Food and Drug Administration (FDA) approved Talicia for the treatment of H. pylori infection in adults. RedHill expects to launch Talicia in the U.S. by mid-March 2020.

Aemcolo (rifamycin)4 and Strategic Investment by Cosmo Pharmaceuticals
In October 2019, RedHill entered into a strategic collaboration with Cosmo Pharmaceuticals N.V. (SIX: COPN), which included an exclusive license agreement for the U.S. rights to Aemcolo and a simultaneous private investment by Cosmo Pharmaceuticals of $36.3 million in RedHill. In December 2019, RedHill initiated the U.S. promotion of Aemcolo for the treatment of travelers’ diarrhea caused by non-invasive strains of Escherichia coli (E. coli) in adults.

Acquisition of Movantik (naloxegol)5
In February 2020, RedHill announced that it is acquiring the global rights to Movantik, excluding Europe, Canada and Israel, from AstraZeneca (LSE/STO/NYSE: AZN). The acquisition is expected to close in the first quarter of 2020, subject to certain closing conditions and regulatory clearances. Movantik is a peripherally acting mu-opioid receptor antagonist (PAMORA) indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent opioid dosage escalation. Movantik generated U.S. net sales of $96 million in 2019. Under the terms of the license agreement, RedHill will make an upfront payment of $52.5 million to AstraZeneca upon closing and a further non-contingent payment of $15 million 18 months post-closing. RedHill will also assume financial responsibility for sales-based royalty and potential milestone payments that AstraZeneca is required to pay to Nektar Therapeutics, the originator of Movantik. AstraZeneca will continue to manufacture and supply Movantik to RedHill during a transition period. In 2015, AstraZeneca entered into a co-commercialization agreement with Daiichi Sankyo, Inc. ("Daiichi Sankyo") for Movantik in the U.S., which will be transferred to RedHill upon closing of the transaction. Following such transfer, RedHill expects to lead all U.S. commercialization activities for Movantik and will continue to share costs and pay sales-related commissions to Daiichi Sankyo under that agreement.

Financial Highlights:

In February 2020 RedHill entered into a non-dilutive royalty-backed term loan agreement with HealthCare Royalty Partners (HCR) pursuant to which HCR committed up to $115 million to support RedHill’s U.S. commercial operations. Under the terms of the agreement, RedHill will receive $30 million following closing to support RedHill’s commercial operations. Subject to satisfaction of certain conditions, RedHill will receive an additional $50 million to fund the acquisition of rights to Movantik. Two additional tranches, the second of which is at the mutual agreement of RedHill and HCR, totaling $35 million will be available upon satisfaction of certain conditions to further support RedHill’s growing commercial operations. HCR will receive royalties in the low-single digits based on RedHill’s worldwide net revenues, subject to a cap, as well as interest on the outstanding term loan to be computed as the 3-month LIBOR rate plus a single-digit interest rate, depending on revenues generated. The term loan matures in six years with no principal payments required in the first three years. The loan can be prepaid at RedHill’s discretion, subject to customary prepayment fees, certain of which decrease over time.

R&D Highlights:

RHB-204 – Pulmonary Nontuberculous Mycobacteria (NTM) Infections
In light of positive data from an ongoing supportive non-clinical program, RedHill plans to initiate in mid-2020 a single, pivotal Phase 3 study evaluating RHB-204 as a first-line, stand-alone treatment for pulmonary NTM infections caused by Mycobacterium avium complex (MAC), subject to further input from the FDA.

RHB-104 – Crohn’s Disease
RedHill announced in October 2019 the full Week 52 results for all subjects in the previously announced positive Phase 3 randomized, controlled study of RHB-104 in Crohn’s disease (MAP US study) and supportive top-line results from the open-label extension Phase 3 study (MAP US2 study). The full Week 52 results of blinded treatment in the MAP US Phase 3 study with RHB-104 were consistent with the previously reported positive outcomes of the study.

The results from the MAP US study were presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting in October. RedHill continues to evaluate the path toward potential approval of RHB-104 in the U.S.

ABC294640 (opaganib, Yeliva) – Cholangiocarcinoma and Additional Indications
RedHill has completed the enrollment of the full cohort of 39 patients evaluable for efficacy in the Phase 2a study evaluating the activity of orally-administered ABC294640 in advanced cholangiocarcinoma. Preliminary data from the open-label Phase 2a study has indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma. RedHill plans to submit this data for presentation at an upcoming scientific meeting. In light of this, and in light of positive data from a pre-clinical program evaluating ABC294640 in combination with additional actives, RedHill has added a second arm to the study, evaluating ABC294640 in combination with hydroxychloroquine, an anti-autophagy agent. Enrollment of patients to the second arm of the Phase 1/2a study is planned to be initiated in the first quarter of 2020. RedHill also plans to add a third arm to the study, evaluating ABC294640 in combination with RHB-107 (upamostat).

An investigator-sponsored study with ABC294640 in prostate cancer is planned to be initiated at the Medical University of South Carolina (MUSC) in the coming weeks. The study is supported by a National Cancer Institute (NCI) grant awarded to MUSC.

RHB-106 – Encapsulated Bowel Preparation
RedHill has regained the exclusive worldwide rights to RHB-106, a proprietary encapsulated formulation intended for the preparation and cleansing of the gastrointestinal tract prior to abdominal procedures and diagnostic tests. RedHill terminated its 2014 license agreement with Salix Pharmaceuticals Ltd. in January 2020 and is now planning the development path toward potential approval of RHB-106 in the U.S.

RHB-102 (Bekinda) – Gastroenteritis and Gastritis
RedHill concluded a positive FDA meeting on the pediatric study plans required to potentially obtain pediatric labeling for RHB-102, in addition to the intended adult labeling. RedHill is currently working toward a confirmatory Phase 3 study to support a potential New Drug Application (NDA) for RHB-102 for acute gastroenteritis and gastritis, subject to FDA guidance. The confirmatory Phase 3 study will follow the successful completion of a first Phase 3 study for acute gastroenteritis and gastritis with RHB-102, the findings of which were published in JAMA Open Networks in November 2019.

Conference Call and Webcast Information:

The Company will host a conference call today, Wednesday, March 4, 2020 at 8:30 a.m. EST to review the financial results and operational highlights.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-866-966-1396; International: +1-631-510-7495; and Israel: +972-3-721-7998; The access code for the call is: 4753535.

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, View Source

On March 4, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Wednesday, March 11, 2020 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the fourth quarter and full year ended December 31, 2019 (Press release, Navidea Biopharmaceuticals, MAR 4, 2020, View Source [SID1234555180]).

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Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Director of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

Event:

Q4 2019 Earnings and Business Update Conference Call

Date:

Wednesday, March 11, 2020

Time:

5:00 p.m. (EDT)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13699935

Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.