On July 2, 2018 NewLink Genetics Corporation (NASDAQ:NLNK), reported that updated Phase 1 data evaluating indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) were presented Sunday, July 1, at the International Symposium of Pediatric Neuro-Oncology (ISPNO) 2018 Annual Meeting in Denver (Press release, NewLink Genetics, JUL 2, 2018, View Source [SID1234527547]).

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Data were presented on ten newly diagnosed DIPG patients, all of whom had initiated therapy at the time of this assessment. All (10/10) demonstrated initial symptomatic improvement. Eight of ten had completed radiation, with the remaining 2 of 10 patients continuing radiotherapy. While a subset of the patient cohort developed inflammatory and other adverse symptomology, a common occurrence in this patient population, these symptoms were actively managed. Currently, 9/10 patients remain on study, with the longest time on study of 8.5 months. These data include more mature follow-up on the 6 patients previously presented at AACR (Free AACR Whitepaper) 2018.
"These data continue to demonstrate the potential for indoximod plus radiochemotherapy as a combination treatment regimen which may improve disease related symptoms for these pediatric patients with an otherwise dire prognosis," said Dr. Theodore S. Johnson, M.D., Ph.D., Associate Professor of Pediatrics at Augusta University, lead investigator for the trial. "We remain encouraged and look forward to additional data as the study proceeds."
This DIPG cohort is a subset of NLG2105, a Phase 1 study evaluating indoximod, NewLink’s IDO pathway inhibitor, in combination with radiation and chemotherapy for pediatric patients with malignant brain tumors. The DIPG cohort has been expanded from an initial pilot study based on early safety and efficacy data and is currently enrolling with a target of 30 DIPG patients.
About Diffuse Intrinsic Pontine Glioma (DIPG)
Diffuse intrinsic pontine glioma, or DIPG, is a rare, aggressive brain tumor found in the brain stem that almost exclusively affects children. Every year in the United States, approximately 200-400 children, ages ranging from 4 to 11, are diagnosed with DIPG. As the tumor grows, it puts pressure on the nerves that control essential bodily functions. Children experience symptoms including, but not limited to: vision issues, arm and leg weakness and difficulty speaking, breathing and heartbeat resulting in death. The median survival time is 9 months, with only 1% of all children diagnosed with DIPG surviving more than 5 years.1
1 Defeat DIPG Foundation
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.

On July 2, 2018 NewLink Genetics Corporation (NASDAQ:NLNK), reported that updated Phase 1 data evaluating indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) were presented Sunday, July 1, at the International Symposium of Pediatric Neuro-Oncology (ISPNO) 2018 Annual Meeting in Denver (Press release, NewLink Genetics, JUL 2, 2018, View Source [SID1234527548]).

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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

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Data were presented on ten newly diagnosed DIPG patients, all of whom had initiated therapy at the time of this assessment. All (10/10) demonstrated initial symptomatic improvement. Eight of ten had completed radiation, with the remaining 2 of 10 patients continuing radiotherapy. While a subset of the patient cohort developed inflammatory and other adverse symptomology, a common occurrence in this patient population, these symptoms were actively managed. Currently, 9/10 patients remain on study, with the longest time on study of 8.5 months. These data include more mature follow-up on the 6 patients previously presented at AACR (Free AACR Whitepaper) 2018.

"These data continue to demonstrate the potential for indoximod plus radiochemotherapy as a combination treatment regimen which may improve disease related symptoms for these pediatric patients with an otherwise dire prognosis," said Dr. Theodore S. Johnson, M.D., Ph.D., Associate Professor of Pediatrics at Augusta University, lead investigator for the trial. "We remain encouraged and look forward to additional data as the study proceeds."
This DIPG cohort is a subset of NLG2105, a Phase 1 study evaluating indoximod, NewLink’s IDO pathway inhibitor, in combination with radiation and chemotherapy for pediatric patients with malignant brain tumors. The DIPG cohort has been expanded from an initial pilot study based on early safety and efficacy data and is currently enrolling with a target of 30 DIPG patients.

About Diffuse Intrinsic Pontine Glioma (DIPG)
Diffuse intrinsic pontine glioma, or DIPG, is a rare, aggressive brain tumor found in the brain stem that almost exclusively affects children. Every year in the United States, approximately 200-400 children, ages ranging from 4 to 11, are diagnosed with DIPG. As the tumor grows, it puts pressure on the nerves that control essential bodily functions. Children experience symptoms including, but not limited to: vision issues, arm and leg weakness and difficulty speaking, breathing and heartbeat resulting in death. The median survival time is 9 months, with only 1% of all children diagnosed with DIPG surviving more than 5 years.1
1 Defeat DIPG Foundation

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.

On July 2, 2018 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the second quarter ended June 30, 2018 on Wednesday, July 25, 2018 at 8:00 a.m. EDT (Press release, Boston Scientific, JUL 2, 2018, View Source [SID1234527600]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the second quarter on Wednesday, July 25, 2018, prior to the conference call.

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A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com under the Events heading.

A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

On July 2, 2018 TRIGR Therapeutics, a US-based Biopharmaceutical company, and ABL Bio Corporation, a South Korean biotechnology company, jointly reported that it had entered into a binding agreement for TRIGR to license the global commercial rights to ABL Bio’s pipeline of novel therapeutic antibodies to treat cancer (Press release, TRIGR Therapeutics, JUL 2, 2018, View Source [SID1234527550]). These therapeutic antibodies include ‘blood-brain barrier (BBB)’ penetrating bispecific antibodies (BsAb) (VEGF/undisclosed BBB target BsAb, undisclosed target/undisclosed BBB target BsAb); immune cell engaging bispecific antibodies (4-1BB/undisclosed target BsAb, 4-1BB/ undisclosed target BsAb); and a monoclonal antibody against undisclosed target.

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Under the terms of the agreement, TRIGR will pay a total upfront fee of USD $4.3 million to license global rights (except for South Korea) to 5 antibodies currently under development by ABL Bio. ABL Bio will also receive research, regulatory and sales-based milestones of more than USD $550 million in total plus royalties. In addition, TRIGR shall share the licensing revenue with ABL Bio in the event of out-licenses to a 3rd party. The deal is expected to close before the end of July.

George Uy, TRIGR founder and CEO, commented that "we are honored to be chosen as the partner of ABL Bio for their oncology pipeline. These assets include: a) BsAbs designed to cross the blood brain barrier more efficiently combating brain tumors and b) immuno-modulating BsAbs engineered for dual engagement of the body’s immune cells (T cells and NK cells) against tumor-associated antigens in the tumor microenvironment. The antibodies truly represent the next wave in cancer immunotherapy. It is TRIGR’s mission to identify and develop novel and paradigm-shifting immunotherapies. The delivery of antibodies into the brain, a privileged tissue in the human body and one of the last frontiers of drug delivery, to treat malignant gliomas and other brain cancers might enable TRIGR to bring new desperately-needed therapies to patients and their caregivers. Our new portfolio of unique immuno-modulatory BsAbs designed to activate patient T cells as well as NK cells in the tumor will allow TRIGR to establish itself as a leading biotechnology company. The BsAbs should also be valuable agents for combination therapies with cellular immunotherapies, such as CAR-T cell therapies and NK cell therapies."

Dr. Sang Hoon Lee, CEO of ABL Bio added, "ABL Bio is at the cutting-edge discovery of novel therapeutic antibodies with unique therapeutic applications. Our blood-brain barrier penetrating antibodies are potentially best-in-class in the industry globally. With a staff of over 40 scientists and years of global research and development experience-based working with the world’s foremost pharmaceutical companies and academic institutions, ABL Bio will accelerate the development of these oncology candidates to IND filing in the US beginning next year while working closely with the TRIGR team. In our discussion with George and his team, we were impressed by their commitment to identifying and developing innovative immunotherapies as well as their vast experience in and passion for drug development of therapies addressing unmet medical needs. We look forward to a productive and successful partnership."

On July 2, 2018 Compugen Ltd. (CGEN) (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the U.S. Food and Drug Administration (FDA) has cleared Bayer AG’s investigational new drug (IND) application for BAY 1905254, a first-in-class immuno-oncology therapeutic antibody targeting the ILDR2 protein in patients with advanced solid tumors (Press release, Compugen, JUL 2, 2018, View Source [SID1234527601]). ILDR2 is a novel immune checkpoint discovered by Compugen through its predictive computational capabilities, which enable the discovery of new drug targets and biological pathways. Under a collaboration and license agreement, Compugen and Bayer jointly pursued preclinical research advancing BAY 1905254 while Bayer is now responsible for conducting clinical development of this candidate.

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"Clearance of a second IND for a therapeutic antibody against a novel Compugen-discovered target provides substantial validation of our powerful computational platform," stated Anat Cohen-Dayag, PhD, President and CEO of Compugen. "Bayer has been an excellent partner for us, and we are delighted to see their commitment to advance this promising program. Together with COM701, our anti-PVRIG therapeutic antibody, there are now two new first-in-class programs, discovered by our unique computational platform, in the clinic."

In accordance with the agreement signed between Compugen and Bayer, Compugen is entitled to receive a milestone payment upon the first patient dosing with BAY 1905254 in the Phase 1 clinical trial expected in 2018.

About ILDR2 and BAY 1905254

ILDR2 is a novel B7/CD28-like immune checkpoint target candidate discovered computationally by Compugen. Studies testing the immune function of ILDR2, demonstrated inhibitory effects on T cells consistent with it being an immune checkpoint ligand. Additional expression and functional studies suggest that ILDR2 acts as an inhibitor of the priming step of T cell activation, thereby muting T cell response to cancer.

BAY 1905254 is a novel immune checkpoint inhibitor for cancer immunotherapy targeting ILDR2. BAY 1905254 is a human/mouse cross-reactive antibody blocking the immunosuppressive activity of ILDR2. BAY 1905254 has exhibited anti-tumor activity as a monotherapy in various mouse models, and was also shown to have additive anti-tumor effects in combination with other cancer therapy approaches in those models, indicating the possibility for multiple combination uses in cancer immunotherapy.