Foresee Pharmaceuticals Enters Exclusive License Agreement with GenSci for the Commercialization of Camcevi(TM) in China

On November 17, 2020 Foresee Pharmaceuticals (6576.TWO) ("Foresee")reported that it has entered into an exclusive license agreement with GenScience Pharmaceuticals ("GenSci") – a wholly-owned subsidiary of Changchun High-Tech Industry (Group) Co., Ltd. (000661.SZ) – for the commercialization of Foresee’s novel FP-001 program, Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous 6-month and 3-month depot formulations ("Camcevi") (Press release, Foresee Pharmaceuticals, NOV 17, 2020, View Source [SID1234571308]). The license agreement will cover the China market.

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!

Under the terms of this partnership, Foresee, a Taiwan and US-based biopharmaceutical company, will receive 8 million US dollars upfront, and a combination of regulatory milestones, technology transfer milestones, and commercialization milestones payments totalling up to 123.85 million US dollars in addition to a share of the product revenue in the territory. GenSci will cover all costs of development, registration, and commercialisation in the territory.

"GenSci has an impressive record developing and commercializing hormonal therapeutics in the China market and possesses extensive experience, expertise and infrastructure in R&D, regulatory affairs, manufacturing and commercialization," said Dr. Ben Chien, Founder and Chairman of Foresee. "Camcevi 6-month depot is currently under review process by the FDA and EMA, and will soon be followed by Camcevi 3-month depot. This important collaboration with GenSci will allow us to aggressively move forward phase III registration studies, registration, and commercialization of Camcevi in China. We are highly confident in Camcevi’s potential in the China market, and see this as the foundation to a potentially broader partnership with GenSci in the future, related to Foresee’s SIF technology and related programs."

Dr. Lei Jin, CEO of GenSci said, "GenSci is very committed to bringing complex, added value products to the China market, improving the standard of care and ultimately the lives of patients. We are very pleased to have established a partnership with Foresee and look forward to a successful registration and launch of the FP-001 franchise in China. The products will provide meaningful advantages and benefits to patients and all medical practice stakeholders."

D3 Bio Launches with US$200 Million Investment to Develop Precision Medicines Addressing Unmet Patient Needs in Oncology & Immunology

On November 17, 2020 D3 Bio, a global biotechnology company focused on developing and commercializing precision medicines to improve or replace existing standard-of-care treatments that do not fully meet patient needs, reported that launched with US$200 million Series A financing by Boyu Capital, Matrix Partners China, Sequoia Capital China, Temasek, and WuXi AppTec’s Corporate Venture Fund, among others (Press release, D3 Bio, NOV 17, 2020, View Source [SID1234571303]). The funding will support the development of D3 Bio’s portfolio in oncology and immunology.

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!

"Our strong and agile team of scientific innovators and business executives are experienced in discovery, development and commercialization of important, world-class pharmaceuticals that have achieved blockbuster status on a global basis. We anticipate D3 Bio’s development program in China will be closely followed by ones in other major global markets."

"Our mission at D3 Bio is to build a global biotechnology company that develops innovative and more efficacious medicines for patients worldwide," said George Chen, MD, co-founder, Chairman and CEO of D3 Bio. "The financing and support of our approach by reputable institutional investors give us a great start as we begin our journey to transform drug development to accomplish our mission."

A Powerful Drug Development Approach

D3 Bio brings a unique approach to drug discovery and development. Rather than only following laboratory insights wherever they may lead, the Company surveys the clinical landscape to identify areas of major unmet need in which existing standard-of-care approaches yield unsatisfactory clinical outcomes.

Harnessing insights from clinical development, D3 Bio identifies new disease targets and delivery methods in immunology and oncology to match patients with optimal therapies to treat their diseases. D3 Bio anticipates that having a clear understanding during preclinical development both of relevant cancer biomarkers and the therapeutic improvement or replacement goals will make drug discovery and development as efficient and focused as possible.

"Our R&D programs in oncology and immunology are designed to address current unmet clinical needs and to provide the structure, or ‘backbone,’ upon which future drugs can be developed. D3 Bio intends to create a robust portfolio comprised of internal core assets that can be leveraged for follow-on development as well as in-licensed early-stage clinical assets," explained Dr. Chen. "We expect our entire portfolio to enable discovery and development of additional indications and combination regimens. This cycle of drug development that allows for subsequent discovery and innovation is at the core of D3 Bio. In fact, it underlies our name: Development leading to Discovery that then leads back to more Development, or D3 Bio."

Experienced and Proven Drug Development Industry Leadership

D3 Bio is building a seasoned, agile drug development and business management team. Dr. Chen himself, an oncologist by training, has a successful track record in the multinational pharmaceutical industry. After receiving his medical degree from the Shanghai Medical College of Fudan University and his MBA from the Wharton School of Business at the University of Pennsylvania, he held senior research, management, business development, medical affairs and drug development positions at leading institutions and multi-national companies, including the National Institutes of Health, Eli Lilly, GlaxoSmithKline, Johnson & Johnson and AstraZeneca. Dr. Chen’s experience includes regulatory registrations and market introductions of blockbuster drugs in both the US and Chinese markets, including more than 70 Investigational New Drug (IND) and more than 30 New Drug Application (NDA) approvals.

D3 Bio takes advantage of the diverse, world-class resources of the second largest global pharmaceutical market, including academic research, hospitals and investigators, clinical research organizations, venture capital and broad development talent.

"Leveraging these resources, we expect to accelerate development and delivery of novel, life-transforming therapeutics to serve patients worldwide," Dr. Chen continued. "Our strong and agile team of scientific innovators and business executives are experienced in discovery, development and commercialization of important, world-class pharmaceuticals that have achieved blockbuster status on a global basis. We anticipate D3 Bio’s development program in China will be closely followed by ones in other major global markets."

"We believe that a tremendous amount of medical innovation will be created by D3 Bio coupling China’s talent pool with the global R&D ecosystem," said Yanling Cao, Partner, Boyu Capital. "We share D3 Bio’s vision of developing innovative drugs by integrating deep clinical insights with creative science and technology. D3 Bio’s founders and management team have already demonstrated strong track records and leadership in delivering many first-in-class and blockbuster medications into China from major international pharmaceutical companies."

Dr. Chen adds, "We want to thank the investors in this blue-chip syndicate for their support of our business model. We are now well-positioned to advance the clinical development of our robust pipeline of precision medicines."

VECT-HORUS and CERIMED Announce Collaboration to Support the Development of VECT-HORUS’ Theragnostic Agents

On November 17, 2020 VECT-HORUS, a biotechnology company that designs and develops vectors that facilitate the targeted delivery of therapeutic molecules and imaging agents, reported the signing of a collaboration agreement with CERIMED (European Centre for Research in Medical Imaging) to support the preclinical development of VECT-HORUS’ theragnostic agents (Press release, Vect-Horus, NOV 17, 2020, View Source [SID1234571301]).

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!

"CERIMED is very proud to announce the initiation of this collaboration with VECT-HORUS. The respective expertise of VECT-HORUS and CERIMED makes this consortium a major asset in the development of new theragnostic approaches to oncological pathology"

CERIMED, also based in the Timone Aix-Marseille University Campus, has expertise in medical imaging techniques (PET, SPECT, etc.) and provides a complete platform of in vivo preclinical and clinical imaging entirely dedicated to R&D of innovative clinical imaging tools.

VECT-HORUS is co-developing with RADIOMEDIX (Tx, USA) one agent which will enter clinical trials in 2021 for the diagnosis of glioblastoma. VECT-HORUS also pursues the investigations on its other theragnostic candidates targeting the Low-Density Lipoprotein Receptor, which has been shown to be expressed at high levels in some tumours, including pancreatic tumours.

"CERIMED offers a wide range of services in medical imaging, and we are tremendously pleased to work with them. This partnership is fully aligned with our strategy to collaborate with Regional Centers and to expand the use of our VECTrans technology in the theragnostic field," said Jamal Temsamani, Ph.D., Director of Drug Development of VECT-HORUS.

"CERIMED is very proud to announce the initiation of this collaboration with VECT-HORUS. The respective expertise of VECT-HORUS and CERIMED makes this consortium a major asset in the development of new theragnostic approaches to oncological pathology" said Pr Benjamin Guillet, director of CERIMED, head of radiopharmaceutical department of Marseille University Hospital and of Drug Department of Pharmacy faculty of Aix-Marseille University.

Abzyme Files Patent Application for pH-dependent anti-CD3 Antibodies

On November 17, 2020 Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic applications, reported that it has filed a patent application entitled "Antibodies Binding to Human CD3 at Acidic pH", USPTO number 63/109,005 (Press release, Abzyme Therapeutics, NOV 17, 2020, View Source [SID1234571300]). This patent application is an important step forward for Abzyme Therapeutics solidifying its intellectual property position in the field of therapeutic antibody development.

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!

Monoclonal antibodies are widely used for treatment of various cancers. On-target off-tumor binding to normal tissues is an obvious toxicity concern as many tumor-associated antigens are expressed in both tumor and normal tissues. Optimization of specific tumor targeting could be achieved by taking advantage of the extracellular acidity of solid tumors relative to normal tissues. Due to poor vascular perfusion, regional hypoxia, and fermentative glycolysis, the extracellular pH in most solid tumors is in the 6.0–6.8 range. In contrast, non-cancerous cells maintain their extracellular pH at physiological levels (7.3–7.4). Thus, an antibody with high binding affinity at acidic pH (pH 6.0 – pH 6.8), but with none or reduced binding affinity at normal pH will significantly minimize the on-target off-tumor toxicity. Tumor-microenvironment or TME-specific antibodies with reduced or no on-target off-tumor binding would find potential application in various forms of antibody-mediated and cell-mediated therapies including antibody monotherapies, antibody-drug conjugate or ADC therapy, T cell-engaging immunotherapy and CAR-T. TME-specific antibodies will reduce on-target off-tumor adverse effects while allowing dose-escalation

The invention provides for new anti-hCD3 antibodies that, in contrast to prior art anti-CD3 antibodies, bind specifically to human CD3 at acidic pH, but do not significantly bind to human CD3 at neutral or physiological pH, methods to produce these antibodies and therapeutic uses of these antibodies. These antibodies are able to activate T cells at acidic pH while having significantly reduced activity at neutral or physiological pH.

"We successfully created anti-CD3 antibodies that bind and activate human T cells at acidic pH that will be an important foundation for engineering bispecific T-cell engaging antibodies for solid tumors. As we pride ourselves as innovators, we are extremely pleased to achieve this milestone filing this application" said Dr. Tran, CEO and co-founder of Abzyme. "In addition, using the same approach, we were able to develop other pH-dependent antibodies targeting the acidic tumor microenvironment".

Theravance Biopharma to Present at the 3rd Annual Evercore ISI HEALTHCONx Conference

On November 17, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported that it will webcast a presentation as follows (Press release, Theravance, NOV 17, 2020, https://www.prnewswire.com/news-releases/theravance-biopharma-to-present-at-the-3rd-annual-evercore-isi-healthconx-conference-301174097.html [SID1234571297]):

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!

Evercore ISI 3rd Annual HEALTHCONx Conference on Tuesday, December 1 at 2:40 p.m. ET (11:40 a.m. PT/7:40 p.m. GMT)
Webcast of the presentation may be accessed by visiting the "Investors" section of Theravance Biopharma’s website at www.theravance.com under the "Presentations and Events" tab. Replay of the webcast will be archived on the Company’s website for at least 30 days.