Presage Announces New, Multi-Project Collaboration with Takeda for Phase 0 Studies of Novel Cancer Agents with CIVO® Technology

On September 9, 2020 Presage Biosciences, a biotechnology company pioneering a new cancer drug development approach using its Comparative In Vivo Oncology (CIVO) intratumoral microdosing platform, reported a new research collaboration with Takeda Pharmaceutical Company Limited (Takeda) that will utilize CIVO to evaluate multiple investigational oncology agents and combinations in Phase 0 trials (Press release, Presage Biosciences, SEP 9, 2020, https://www.prnewswire.com/news-releases/presage-announces-new-multi-project-collaboration-with-takeda-for-phase-0-studies-of-novel-cancer-agents-with-civo-technology-301126141.html [SID1234612195]).

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 agreement includes evaluation of a specified new investigational agent, as well as options for additional future projects over the next several years. All projects will involve the use of CIVO to evaluate patients’ unique responses to microdoses of cancer drugs. The agreement includes undisclosed upfront and milestone payments to Presage.

"Takeda’s partnership with Presage has yielded valuable learnings across our early immuno-oncology pipeline and this expansion of our collaboration represents a natural evolution of our fruitful efforts," said Chris Arendt, Head, Oncology Therapeutic Area Unit at Takeda. "The ability to gain critical mechanistic insights earlier in the development process is invaluable in clinical translation and can ultimately help us to accelerate advancing innovative oncology medicines to patients who may benefit."

"We are pleased to enter into this new, expanded alliance with Takeda – our longstanding collaborator with a deep oncology pipeline – that will further the company’s investigational efforts to rapidly advance anticancer agents and combinations with the most potential," said Rich Klinghoffer, PhD, Presage CEO. "For far too long, early cancer drug development has been reliant on laboratory models of cancer that serve as poor proxies of human tumors. It’s time to change that paradigm and employ platforms like CIVO to safely and more accurately evaluate novel therapies in cancer patients."

Research recently published in Clinical Cancer Research highlights the feasibility and safety of CIVO to evaluate multiple antitumor agents simultaneously in patients with solid tumors. (K. Gundle et al, Clinical Cancer Research, April 2020, Doi: 10.1158/1078-0432). These data support how multidrug assessments with CIVO may help define specific responses within the intact native tumor microenvironment providing better understanding of drug activity as well as potential mechanisms of tumor resistance. "Patients need and deserve the best cancer treatments. As described in our recent peer reviewed publication, the use of CIVO can bridge the gap between preclinical and clinical research, providing a frontline drug development tool to identify the most promising anti-cancer therapies that can truly impact human health," said Klinghoffer.

Takeda has previously partnered with Presage on preclinical mechanism of action and combination studies, including work highlighted by both companies at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting and an ongoing Phase 0 trial. Presage also has ongoing collaborations with Celgene and BMS for Phase 0 trials with CIVO.

About CIVO and Phase 0 Trials
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables intratumoral microdosing and analysis of multiple cancer agents. Phase 0 trials, or Exploratory Investigational New Drug studies, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. Presage is advancing the use of CIVO in Phase 0 trials in order to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. A recently completed clinical trial demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.

CorMedix Inc. to Present at the H.C. Wainwright 22nd Annual Global Investment Conference

On September 9, 2020 CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that CorMedix management will present a corporate overview at the virtual H.C. Wainwright 22nd Annual Global Investment Conference taking place on September 14 – 16, 2020 (Press release, CorMedix, SEP 9, 2020, http://www.cormedix.com/cormedix-inc-present-h-c-wainwright-22nd-annual-global-investment-conference/ [SID1234569343]).

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 22nd Annual Global Investment Conference (virtual)

Date: Monday, September 14
Time: 11:00am Eastern Time
Webcast: Link

AMAG Pharmaceuticals to Participate in H.C. Wainwright 22nd Annual Global Investment Conference

On September 9, 2020 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported that Scott Myers, Chief Executive Officer, and Brian Piekos, Chief Financial Officer, will participate in a fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 10:30 a.m. Eastern Time (Press release, AMAG Pharmaceuticals, SEP 9, 2020, View Source [SID1234565143]).

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!

A live audio webcast of the virtual event will be accessible through the Investors section of the company’s website at www.amagpharma.com. A replay of the webcast will be archived on the company’s website for 30 days.

Catalent Invests $130 Million to Add Additional Manufacturing Capacity at its Gene Therapy Campus in Harmans, Maryland

On September 9, 2020 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, reported that it is investing $130 million to add five additional Phase 3 through commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland to support a growing customer pipeline and market demand (Press release, Catalent, SEP 9, 2020, https://www.catalent.com/catalent-news/catalent-invests-130-million-to-add-additional-manufacturing-capacity-at-its-gene-therapy-campus-in-harmans-maryland/ [SID1234565136]).

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 Catalent Gene Therapy campus in Harmans, near the Baltimore Washington International (BWI) airport, comprises two state-of-the-art facilities that, when completed, will house a total of 15 gene therapy suites each designed to accommodate multiple bioreactors for commercial supply. The first Harmans/BWI facility on the campus was recently approved by the FDA for commercial manufacturing and is expected to have all 10 cGMP suites qualified and operational by the first quarter of 2021. The five new cGMP suites will be located in an adjacent building on the Harmans campus and are anticipated to be operational in the first half of 2022. The second Harmans building will also offer cold storage warehousing and additional office space.

"It is critical that we stay connected to the needs of our customers as they progress through the clinical pipeline. By increasing our late-stage manufacturing capacity at the Harmans campus, we will be able to meet demand through the medium term and take advantage of our shared resources, including the technical and manufacturing expertise that helped us reach the milestone of becoming an FDA-approved commercial partner," commented Manja Boerman, Ph.D., President, Cell & Gene Therapy at Catalent. "Catalent is committed to this journey with our customers as they bring life-changing therapies to their patients."

Catalent’s state-of-the-art Harmans/BWI commercial manufacturing campus is equipped with single-use manufacturing technology, and currently includes over 200,000 square feet (18,600 square meters) of late-stage clinical and commercial-stage gene therapy production. Upon outfitting of the second building, the large-scale Harmans/BWI production campus will encompass a total footprint of approximately 350,000 square feet. The campus is one of Catalent’s five gene therapy locations in Maryland and houses multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms, together with fill/finish, testing, warehousing, supply chain, and central services capabilities.

ABOUT CATALENT CELL & GENE THERAPY
With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.

Huadong Medicine and Exscientia enter co-development partnership to accelerate oncology drug discovery through artificial intelligence

On September 9, 2020 Exscientia, the world-leading, clinical-stage Artificial Intelligence (AI) drug discovery company and Huadong Medicine, the leading Chinese pharmaceutical company, reported that the companies have entered into a co-development partnership to accelerate the discovery of breakthrough small-molecule therapeutics targeted at innovative approach to oncology (Press release, Exscientia, SEP 9, 2020, View Source [SID1234565052]). The first project selected in partnership is focused on transcription control of DNA damage response genes, to treat patients with defective DNA damage repair mechanism, leading to high mutation frequency, as seen is in patients with ovarian cancer and breast cancer.

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 this collaboration, the pharmatech Exscientia and Huadong will share responsibilities, with Exscientia applying its advanced Centaur Chemist(TM) AI platform to design new molecules against project specific objectives and Huadong Medicine applying its China based experimental and managerial capabilities to generate data and progress Exscientia’s AI design in a rapid closed-loop cycle.

Huadong Medicine Co., Ltd (SZSE 000963), ranked in the top 10 Chinese pharmaceutical companies by Forbes 2020, with more than 10,000 employees and over US $4 Billion annual revenue. The co- development partnership will support both Huadong’s strategy to introduce new medicines in key markets and Exscientia’s aims to advance AI-designed innovative medicines globally.

"This collaboration marks a key step for Huadong on its journey to become an innovation-based pharmaceutical company. We are pleased to work with Exscientia and are fully committed to make this collaboration a success.", said Lyu Liang, Chairman of Huadong.

Professor Andrew Hopkins, CEO of Exscientia, said, "We are very excited to enter the partnership with Huadong Medicine. This innovative partnership provides strategic benefits to Huadong Medicine and Exscientia. We see this as the start of a long-term productive relationship to accelerate novel drug discovery and bring benefits to patients around the globe."