UCL Spin-out Engitix Closes £5m Financing to Progress Liver Disease and Pancreatic Cancer Drug Discovery Platform and Pipeline

On November 27, 2018 Engitix Ltd, a company pioneering the development of both tissue-specific and disease-specific human extracellular matrix (ECM) for accelerating and improving the drug discovery process, reported it has closed a £5 million Series A financing, led by a private investor (Press release, Engitix, NOV 27, 2018, View Source [SID1234531649]).

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!

Engitix has validated its proprietary tissue-specific and disease-specific human ECM platform in determining drug efficacy in liver fibrosis through successful collaborations with a number of biotech and big pharma companies. With this new investment, the Company is now evolving its business model to in-house drug discovery, to develop a pipeline of candidate drugs targeting liver fibrosis and liver and pancreatic cancers.

Engitix was spun-out of the Institute for Liver and Digestive Health (ILDH), Division of Medicine, University College London (UCL) in 2016 by Dr Giuseppe Mazza, an inventor of decellularization protocols for human liver and other tissues, and Professor Massimo Pinzani, Director of ILDH and a world-renowned expert in the field of liver fibrosis. The Company acquired an exclusive license in 2017 from UCLB, UCL’s commercialisation company, to enabling ECM patents and other intellectual property.

The Company’s mission is to increase the efficacy and to the reduce cost of later stage drug failure by establishing more advanced platforms for drug target identification and validation in which healthy and diseased cells can be tested with potential therapeutic agents within their natural physiological and pathological microenvironment.

A key current limitation in developing more effective treatments in fibrosis and various solid cancers has been the failure to include human ECM in experimental models, with the majority of compounds failing in late stage clinical trials because of lack of efficacy.

The Company plans to double the size of its R&D team, recruiting at least an additional 10 scientists in London in the fields of drug discovery, bioinformatics and immune oncology, as well as establishing a presence in Boston, Massachusetts, USA.

Giuseppe Mazza, PhD, Co-Founder and Chief Executive Officer, said: "The traditional drug discovery process in fibrosis and solid tumours relies on artificial in vitro substrates and animal models. So far, these models have been shown to have limitations in providing efficient therapies for patients affected by these devastating diseases. The Engitix platform technology has already shown we can revolutionise our current understanding of human diseases while discovering more realistic targets for future drug development."

Steve Arlington, PhD, a Fellow of the Royal Society of Medicine, former Lead Global Partner, Life Sciences and Pharmaceuticals at PWC and recently appointed Chairman, said: "Engitix is developing a unique platform with many research applications, which allows the study of human pathophysiology leading to the discovery of novel targets and therapeutics that will benefit patients through the acceleration of drug discovery in liver disease and cancer."

Bellicum Pharmaceuticals to Host Analyst and Investor Event and Webcast on Monday, December 3

On November 27, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that it will host an analyst and investor luncheon event and webcast on Monday, December 3, 2018 at 12:00 p.m. – 1:30 p.m. PST in San Diego, California (Press release, Bellicum Pharmaceuticals, NOV 27, 2018, View Source [SID1234531652]).

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 event will follow the Company’s key data presentations at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including interim analyses of the overall results from the BP-004 trial in children with acute leukemias and nonmalignant blood diseases, as well as the comparator C-004 trial, a multicenter, observational study of similar pediatric patients receiving a matched unrelated donor (MUD) transplant. Featured speakers include Dr. Alice Bertaina, Associate Professor of Pediatrics (Stem Cell Transplantation), Lucile Packard Children’s Hospital at the Stanford School of Medicine, as well as Bellicum senior management.

A webcast replay of the event will be available on the News & Events section of the Bellicum website. An archived version of the webcast will be available for replay for at least two weeks following the event.

Forbius’ AVID200, a novel TGF-beta 1 & 3 Inhibitor, Cleared by the FDA to Commence Phase 1 Clinical Trial in Solid Tumors

On November 26, 2018 Forbius, a clinical-stage company developing biologics for the treatment of cancer and fibrosis, reported that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application to conduct a Phase 1 clinical trial in solid tumors with immuno-oncology candidate AVID200, a rationally designed inhibitor of TGF-beta 1 & 3 (Press release, Forbius, NOV 26, 2018, View Source [SID1234531617]).

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 Phase 1 trial will evaluate safety, pharmacokinetics, pharmacodynamics, and antitumor effects of escalating doses of AVID200. This agent is the Company’s second innovative biologic to enter clinical development.

AVID200 is designed to selectively neutralize TGF-beta 1 & 3 with best-in-class pM potency, thus neutralizing the principal immunosuppressive TGF-beta isoforms. AVID200’s optimal selectivity is also designed to circumvent cardiac and other safety issues which have limited the applicability of older generation, non-selective TGF-beta inhibitors.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

AVID200’s immuno-oncology mode of action centers on reversal of both immunosuppression and fibrosis in the tumor stroma. In syngeneic mouse tumor models, AVID200 treatment led to T-cell activation, increased immune tumor infiltration, and increased efficacy of immune checkpoint agents.

"TGF-beta signaling has emerged as a key target to overcome tumor immunosuppression and resistance to immunotherapies, a major unmet medical need. AVID200 has the potential to significantly expand the number of cancer patients that benefit from checkpoint blockade and other immunotherapies. I am keen to evaluate the effects of AVID200 in this clinical trial," commented Dr. Lillian Siu, a senior medical oncologist and Director of the Phase I Program at Princess Margaret Cancer Centre in Toronto. Dr. Siu is one of the investigators leading the AVID200 Phase 1 study in solid tumors.

About AVID200

AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings being rationally designed to selectively neutralize TGF-beta 1 & 3 with pM potency, thus avoiding TGF-beta 2 related cardiac and hematopoietic toxicity. Overexpression of TGF-beta isoforms 1 & 3 is closely associated with the progression of fibrosis and cancer.

AVID200’s immuno-oncology mode of action centers on reversal of immunosuppression as well as a strong anti-fibrotic effect in the tumor stroma. Its development in this setting is supported by the previously announced peer-reviewed BioCanRx grant with a total project value of CAD$1,655,297.

AVID200 is undergoing Phase 1 clinical testing for the treatment of fibrotic diseases and immune oncology.

Entry a Material Definitive Agreement

On November 20, 2018, Generex reported the Company’s wholly owned subsidiary, Antigen Express, Inc. ("Antigen") entered into a Clinical Trial Agreement with NSABP Foundation, Inc. ("NSABP") (Press release, Generex, NOV 26, 2018, View Source [SID1234531634]). Pursuant to the Clinical Trial Agreement, NSABP will conduct a Phase II Study to evaluate efficacy of administering Merck Sharpe & Dhome’s (‘Merck") Keytruda (pembrolizumab) in combination with Antigen’s AE37 cancer vaccine for the treatment of metastatic triple negative breast cancer. While Merck is not a party to the Clinical Trail Agreement, Merck is expected to provide Keytruda for the study pursuant to the Clinical Trial Collaboration and Supply Agreement between Antigen and Merck.

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!

Quanterix to Present at the Evercore ISI HealthCONx Conference

On November 26, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that Kevin Hrusovsky, Chief Executive Officer, President and Chairman of Quanterix, will present at the Evercore ISI HealthCONx Conference on Thursday, Nov. 29, 2018 at 11:45 a.m., EST at the Boston Harbor Hotel in Boston (Press release, Quanterix, NOV 26, 2018, View Source [SID1234531618]).

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!

To access the live webcast of Quanterix’ presentation, please visit the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. Replays of the webcast will be available for seven days following each conference.