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Abpro Forms Strategic Partnership to Advance Two Bispecific Antibody Candidates in Asian Markets

On March 3, 2020 Abpro, a biotechnology company dedicated to developing next-generation antibody therapeutics to improve the lives of patients with severe and life-threatening diseases, reported the formation of a strategic partnership to advance two bispecific antibodies in key Asian markets including Greater China, Japan, and South Korea (Press release, Abpro Therapeutics, MAR 3, 2020, View Source [SID1234555113]).

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The strategic partnership was formed with Abpro Bio Co. Ltd ("Abpro Bio") (KOSDAQ: 195990), formerly known as Ugint Co. Ltd. Under this partnership agreement, Abpro has granted an exclusive license to Abpro Bio to develop and commercialize two of Abpro’s bispecific antibody candidates: ABP-100 and ABP-201. ABP-100 is in development for immuno-oncology with initial indications including gastric, breast and endometrial cancers. ABP-201 is in development for ophthalmology with initial indications inclusive of Wet AMD (age-related macular degeneration) and diabetic macular edema. The collaboration will also leverage Abpro’s proprietary DiversImmune antibody platform for generating novel molecules.

"We are delighted to form this important partnership and expand our geographical reach across Asia for two of our key programs. We plan to partner with Abpro Bio to propel the development of ABP-100 and ABP-201 in diseases that have large unmet patient needs across Asia," said Mr. Ian Chan, CEO of Abpro. "This strategic partnership provides resources to accelerate our pipeline based on our Diversimmune platform in immuno-oncology and ophthalmology indications. Together, we plan to conduct preclinical and clinical development programs in both geographies."

Pursuant to the agreement, Abpro will lead global clinical development of the bi-specific candidates and work closely with Abpro Bio. Key terms of the agreement include:

Abpro will receive from Abpro Bio up to $1.1 billion in total payments, including a $30 million upfront equity investment, and an additional $1.05 billion based on clinical milestones, post-approval payments, and royalties as ABP-100 and ABP-201 progress through the clinical development and regulatory approval processes in Greater China, Japan, and South Korea.
In addition, Abpro Corporation’s two co-founders, Ian Chan and Eugene Chan, as well as Robert S. Langer, PhD, Institute Professor at MIT, will join the Board of Abpro Bio Ltd.
"We are excited to form this alliance with Abpro to bring these much needed therapies to Asia to treat patients suffering from cancer and eye disease. There are very large populations of patients in this region for these therapies. We look forward to progressing these therapies through the clinic and ultimately to patients. Abpro’s immuno-oncology and ophthalmology therapies, as well as the Diversimmune platform, will become a cornerstone for us as we build a leading biotechnology company in Asia," said Mr. Yang, Co-CEO at Abpro Bio.

Outside the partnership, Abpro continues to make headway on a number of other programs in immuno-oncology and other major disease areas. The company has multiple programs in development, including some with partners across the globe, including Memorial Sloan Kettering, AstraZeneca, and Nanjing Chia Tai Tianqing Pharmaceutical Co.

About ABP 100 and ABP 201

ABP-100 and ABP-201, two of Abpro’s lead programs, are bispecific antibody therapies for the treatment of solid tumors, including breast, gastric and colorectal, and ophthalmology diseases, such as Wet AMD and diabetic macular edema, respectively. ABP-100 targets HER2 and CD3 for the treatment of Her2+ solid tumors. ABP-201 is designed to block blood vessel formation and normalize damaged vessels through co-targeting VEGF and ANG2. Abpro is developing ABP-201 to treat vascular diseases of the eye, focusing on diabetic macular edema and Wet AMD.

Cernostics Announces Groundbreaking Data Demonstrating TissueCypher® Performance for Predicting Risk of Progression to EAC in Patients with Non-Dysplastic BE

On March 3, 2020 Cernostics, a leader in the development of AI-driven image analysis technologies for precision medicine testing, reported the publication of positive data from a blinded, independent validation study of its breakthrough TissueCypher Barrett’s Esophagus Assay by the American Journal of Gastroenterology (Press release, Cernostics, MAR 3, 2020, View Source [SID1234555112]).

As the first and only precision medicine test for esophageal pinch biopsies, TissueCypher is designed, developed, and independently validated to identify patients with Barrett’s esophagus (BE) who are at higher risk of developing esophageal adenocarcinoma (EAC) and may require earlier therapeutic intervention or more frequent endoscopic surveillance. The test has now been validated in six independent clinical studies with leading clinical centers around the world including Cleveland Clinic, University of Pennsylvania Medical Center, Geisinger Health, and Academic Medical Center in Amsterdam.

"TissueCypher addresses one of the most pressing unmet needs in our field – the identification of which Barrett’s patients will progress to cancer. A diagnostic test that helps address this problem will be of great use clinically," says Nicholas J. Shaheen, M.D., MPH, Chief, Division of Gastroenterology and Hepatology, UNC HealthCare, Chapel Hill, NC; Bozymski-Heizer Distinguished Professor of Medicine, University of North Carolina School of Medicine, and current member of the Cernostics’ Medical Advisory Board.

"With its combination of morphology and molecular insights to assess progression risk, TissueCypher addresses a number of challenging issues for GI pathologists. Of most concern is differentiating non-dysplastic BE (NDBE) patients that are histologically identical but progress at significantly different rates to high-grade dysplasia (HGD) or EAC," says Jon M. Davison, MD, pathologist and co-author of the article and Associate Professor, Department of Pathology, University of Pittsburgh School of Medicine. Davison continues, "This test also adds further prognostic clarity to cases diagnosed as indefinite for dysplasia (IND)."

The peer-reviewed article, written by researchers from the University of Pittsburgh School of Medicine, Cleveland Clinic, and Cernostics, Inc., presents a blinded, independent validation of the TissueCypher Assay for predicting future development of EAC in patients with BE.

In the study that was funded by the NIH/NCI, patients with BE who progressed to HGD or EAC after at least one year following endoscopy (n=58) were matched to patients with BE without disease progression after a median of seven years’ surveillance (n=210). Baseline biopsies with expert GI pathologist diagnoses of NDBE, IND or LGD were blindly tested and classified by the TissueCypher Assay into high-risk and low-risk for future progression. Results demonstrated that patients classified as high-risk by TissueCypher were at 4.7-fold increased risk for HGD/EAC compared to those classified as low-risk group (p<0.0001). In addition, patients with no sign whatsoever of dysplasia, based on expert pathologist review, who scored high-risk by TissueCypher progressed at a higher rate (26%) than patients with expert pathologist confirmed LGD (21.8%). This is a crucial finding as these are the "at-risk" group who are missed by the current standard of care. A high-risk score with TissueCypher in patients with non-dysplastic BE may support early use of endoscopic eradication therapy or increased surveillance to prevent development of HGD/EAC.

"This independent validation of TissueCypher adds to the robust body of clinical evidence supporting this test as an important tool for managing patients with BE," said Mike Hoerres, CEO, Cernostics.

"TissueCypher is unique and powerful in that it objectively extracts highly meaningful cellular, molecular and morphologic features from standard pinch biopsies. It fits seamlessly into current clinical care, and no special brushes or alternative esophageal biopsy collection devices are required. So, physicians get an individualized risk score from the biopsies removed during an upper GI endoscopy, which supports clinical decision-making," said Hoerres.

"The Cernostics product, TissueCypher, fits seamlessly into a physician’s current clinical practice. No extra steps are needed in the endoscopy suite, as some systems today require," said Anthony Infantolino, M.D., AGAF, FACG, FACP, gastroenterologist, Professor of Medicine at the Sidney Kimmel Jefferson Medical College and Associate Chairman of the Division of Gi/Hepatology and Director of The Jefferson Barrett’s Center and long-time user of TissueCypher. "The test evaluates pinch biopsies taken during endoscopy and gives me the adjunctive information I need to determine my patient treatment plan."

TissueCypher is commercially available as a laboratory developed test (LDT) through Cernostics’ clinical reference lab located in Pittsburgh, Pennsylvania.

About Barrett’s Esophagus

BE affects more than three million Americans, occurring when chronic exposure to stomach acid causes the esophageal cell lining to deteriorate and undergo changes that can create an environment for cancer. Without treatment, Barrett’s can lead to EC, with a poor 5-year survival of less than 20%. Today, Barrett’s is commonly managed by surveillance, involving regular endoscopic procedures with biopsy, monitoring disease progression, and GERD-related drug therapy to control symptoms and prevent esophageal injury.

About TissueCypher Barrett’s Esophagus Assay

TissueCypher is a laboratory developed test (LDT) provided as a testing service by Cernostics clinical reference laboratory in Pittsburgh, PA. The test is indicated for evaluation of esophageal pinch biopsies (or Endoscopic Mucosal Resection [EMR] specimens) from patients confirmed to have Barrett’s esophagus with histology of no dysplasia (ND), indefinite for dysplasia (IND) or low- grade dysplasia (LGD). The TissueCypher platform utilizes a multiplexed fluorescence imaging platform that rapidly extracts high dimensional, quantitative data on multiple epithelial, stromal and morphometric biomarkers in biopsies and assess multiple pathways associate with malignant progression.

Experience TissueCypher for yourself by visiting www.ExperienceTissueCypher.com and choosing one of several charts to find a patient comparable to one in your own Barrett’s pool and see how TissueCypher provides adjunctive information to support your clinical decisions.

Voluntis and Bristol-Myers Squibb to Co-Develop Digital Therapeutics For Oncology

On March 3, 2020 Voluntis (Euronext Paris, Ticker: VTX – ISIN: FR0004183960), a leader in digital therapeutics, and Bristol-Myers Squibb Company (NYSE:BMY) reported a collaboration agreement to create and investigate digital therapeutic solutions that will support cancer patients (Press release, Bristol-Myers Squibb, MAR 3, 2020, View Source [SID1234555111]). Leveraging Theraxium Oncology, Voluntis’ core platform for digital therapeutics in oncology, the collaboration will evaluate potential solutions that will support management of patient symptoms and remote monitoring by healthcare providers.

The goal is that the digital therapeutic, once researched and developed, would provide patients access to a mobile app that would support treatment and track symptoms. The app will be developed to embed evidence-based algorithms intended to provide patients with real-time recommendations for self-management of symptoms related to their therapy. The parties will also investigate how the solution could enable patients to more effectively communicate with their health care providers, capture and track symptoms, and receive a personalized supportive care plan.

Avid Bioservices to Report Financial Results for Third Quarter of Fiscal Year 2020 After Market Close on March 10, 2020

On March 3, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the third quarter of fiscal year 2020 on March 10, 2020 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, MAR 3, 2020, View Source [SID1234555109]). Members of Avid’s senior management will discuss financial results for the third quarter and review recent corporate developments.

To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.

Aurinia Pharmaceuticals to Release Fourth Quarter and Full Year 2019 Financial Results on March 5, 2020

On March 3, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that it will release its fourth quarter and full year 2019 financial results on Thursday, March 5, 2020, after the markets close (Press release, Aurinia Pharmaceuticals, MAR 3, 2020, View Source [SID1234555108]). Aurinia’s management team will host a conference call to discuss the Company’s financial results and to provide a general business update.

The conference call and webcast is scheduled for March 5, 2020 at 4:30 p.m. ET / 1:30 p.m. PT. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.