CSI Laboratories Announces Equity Stake Acquisition by Synergy Capital Investments

On July 9, 2019 CSI Laboratories (CSI) and Synergy Capital Investments (Synergy) reported the transition of a convertible note to equity stake in CSI, a state of the art, specialized cancer diagnostic center (Press release, CSI Laboratories, JUL 9, 2019, View Source [SID1234537441]).

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 security purchase agreement, originally issued in 2017, supported a significant transformation around revenue cycle, sales and operational management that improved our profitability," said Chief Executive Officer and Chief Financial Officer, Chris Wicker. "The note positioned CSI to expand capabilities through the implementation of cutting-edge informatics and the addition of the second testing facility in Jupiter, FL that opened earlier in 2019. We are very pleased to continue our partnership with Synergy as a shareholder and build on CSI’s robust performance."

CSI executed a considerable financial turnaround in the past two years, and the financial outlook is positive for sustained planned growth.

Munir Karimi, Chief Executive Officer of Synergy, assumes a seat on the Board of Directors of CSI. Said Karimi, "We have been working closely with the CSI team for the past couple of years. This is an excellent time to participate on the equity side given their strong financial performance, outstanding executive guidance, and medical thought leadership. The investment reflects our excitement and optimism for CSI’s continued momentum and reinforces our support of CSI Laboratories."

PureTech Announces Issuance of U.S. Patent Covering Compositions of Matter for Immuno-Oncology Program Targeting Galectin-9

On July 9, 2019 PureTech Health plc (LSE: PRTC) ("PureTech"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,344,091 to support the Company’s internal immuno-oncology product candidate, LYT-200 (Press release, PureTech Health, JUL 9, 2019, View Source [SID1234537440]). The patent covers compositions of matter directed to fully human anti-galectin-9 antibodies, which PureTech intends to develop for historically difficult-to-treat cancers including pancreatic, colorectal, and cholangiocarcinoma, among other cancer types. PureTech intends to file an investigational new drug (IND) application for LYT-200 in the first half of 2020.

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!

"PureTech’s galectin-9 antibody has been designed to address the challenges encountered with current immuno-oncology treatments due to redundancies in the immunosuppressive tumor microenvironment. Our now patented antibody composition leverages a new mechanism of action to disrupt the immunosuppressive environment, potentially enabling the body’s immune system to attack cancers that have historically been hard to treat," said Joe Bolen, Ph.D., chief scientific officer of PureTech. "This patent provides important coverage for our immuno-oncology program, and we look forward to continuing the development of LYT-200 to address the tremendous patient need that exists."

Galectin-9 induces robust immunosuppression that allows tumors to evade immune system attack. It is a foundational immune modulator that is expressed in the tumor microenvironment, on tumor cells, and in the blood of cancer patients, globally inducing and maintaining immunosuppression in cancer. High galectin-9 expression has been demonstrated in a number of patient tumor samples, including those that do not respond well to current checkpoint inhibitors. By blocking galectin-9, PureTech’s potentially first-in-class, fully human, monoclonal antibody is designed to intercept the immunosuppressive pathways that galectin-9 stimulates, potentially enabling an immune-mediated response against tumors. While existing therapies have not been sufficiently effective in the treatment of aggressive tumors, PureTech’s approach has shown favorable drug properties and safety in pre-clinical models, and it is being explored as both a single-agent and in combination with other modalities for cancer treatment, including other immunotherapies and chemotherapies.

About LYT-200
PureTech’s immuno-oncology program, LYT-200, is a fully human, potentially first-in-class, IgG4 monoclonal antibody designed to target galectin-9, which is a fundamental immunosuppressive mechanism in hard-to-treat cancers such as pancreatic, colorectal, and cholangiocarcinoma, among other tumor types. LYT-200 has demonstrated proof-of-concept in both mouse and preclinical human cancer models, indicating that targeting galectin-9 activates T cells in tumors and reduces tumor growth, which could significantly extend survival. These data suggest that LYT-200 has strong potential to be used as both a monotherapy and in combination with existing immuno-oncology therapies. PureTech intends to file an investigational new drug (IND) application for LYT-200 in the first half of 2020.

Medical Research Council Funds Phase 2 Multi-Center Study of XBiotech’s Bermekimab in Advanced Cancer Patients

On July 9, 2019 XBiotech (NASDAQ: XBIT) reported that the Medical Research Council (MRC), part of UK Research and Innovation, has awarded funding to study bermekimab therapy in a Phase 2 multi-center study in advanced cancers (Press release, XBiotech, JUL 9, 2019, View Source [SID1234537437]). The MRC will provide funding for all clinical costs of the Phase 2 study to treat patients with advanced lung, pancreatic and ovarian cancers. The MRC uses leading medical researchers to evaluate and award grants based on the mission "to improve human health through world-class medical research." [View Source

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 2 study will be conducted at multiple cancer centers across the UK. Patients will receive eight weekly doses of bermekimab and be assessed for tumor-related wasting and other quality of life symptoms (using the EORTC QLQ-C30). The study was developed in conjunction with the National Institute for Health Research (NIHR) Cancer & Nutrition Collaboration and the National Cancer Research Institute (NCRI) Supportive and Palliative Care Group.

Barry J. A. Laird, M.D., Senior Lecturer in Palliative Medicine at the University of Edinburgh’s Cancer Research Centre, Institute of Genetics and Molecular Medicine, and Consultant in Palliative Medicine at St Columba’s Hospice in Edinburgh will head the study. Dr. Laird commented, "In patients with cancer, loss of weight, decreased activity and impaired quality of life are often regarded as inevitable with limited treatments available. Using immunotherapy to abrogate this disease process is a new approach. We are grateful to the MRC and to XBiotech for supporting this trial."

John Simard, President & CEO of XBiotech, commented, "We are pleased that the medical experts at the MRC have committed resources to the bermekimab program in oncology. We are grateful to Dr. Baird for his work in advancing a novel clinical protocol and for bringing this important immunotherapy to patients in the UK. Bermekimab has proven to significantly benefit patients with advanced cancer. We are eager to provide bermekimab in support of the planned clinical study and to help patients suffering from advanced cancer."

Bermekimab targets the inflammatory cytokine interleukin-1a and has been used in other innovative oncology studies. The Company previously met its primary endpoint in a randomized double-blind, placebo-controlled study with bermekimab for the treatment of advanced colorectal cancer. The primary endpoint in the study was a novel symptom cluster, which assessed a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—that are key measures of patient quality of life and predictors of survival. Patients treated with bermekimab were significantly more likely to achieve the primary endpoint compared to placebo (33% vs 17%, respectively); moreover, patients who achieved the primary endpoint had one-fifth as many serious adverse events, were twice as likely to have stable disease (according to RECIST criteria), showed significant and clinically relevant improvement in all life quality measures, and had almost three-fold increase in survival compared to failures.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

Quest Diagnostics To Release Second Quarter 2019 Financial Results On July 23

On July 9, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report second quarter 2019 results on Tuesday, July 23, 2019, before the market opens (Press release, Quest Diagnostics, JUL 9, 2019, View Source [SID1234537436]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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 conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-871-1320 for domestic callers or 402-280-1688 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 23, 2019 until midnight Eastern Time on August 6, 2019.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Nimbus Therapeutics and Celgene Expand Alliance to Immunotherapy in Oncology

On July 9, 2019 Nimbus Therapeutics, a biotechnology company applying deep computational expertise throughout drug discovery and development, reported the expansion of its long-term strategic alliance with Celgene Corporation to include Nimbus’ HPK1 inhibitor program (Press release, Nimbus Therapeutics, JUL 9, 2019, View Source [SID1234537435]).

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 the agreement, Celgene will receive an option to acquire the program up through a clinical inflection point. Nimbus will retain full control of research and development activities for the program prior to the program’s option point. Financial terms will remain undisclosed until Celgene exercises its option to acquire the program.

Hematopoietic Progenitor Kinase 1 (HPK1), a member of the MAP4K family, is an intracellular negative regulator of T cell proliferation and signaling and plays a key role in dendritic cell activation. The challenge with HPK1 thus far has been the ability of small molecules to achieve potency and selectivity profiles that do not inhibit other T cell kinases or MAP4K family members. Given its role in both T cells and dendritic cells, and an opportunity for working synergistically in upregulating immune system surveillance of cancer, HPK1 has been a highly prized target in immuno-oncology. Nimbus will continue to own and develop its potent small molecule HPK1 inhibitors that are highly selective against relevant off targets and possess robust cellular activity.

"We value the innovation that the Nimbus team can bring and we look forward to working together to bring powerful new immunotherapies to patients," said Robert Hershberg, M.D., Ph.D., Executive Vice President, Business Development & Global Alliances for Celgene Corporation.

"We are thrilled to expand our collaboration with Celgene and benefit from their capabilities in the development of immunotherapy approaches for cancer patients," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus.