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.

On July 2, 2018 DNAtrix, a leader in oncolytic virus immunotherapies for cancer, reported that Sonia Tejada, MD, PhD, neurosurgeon and investigator at Clínica Universidad de Navarra, will present updated clinical data from an ongoing trial of its oncolytic virus DNX-2401 (tasadenoturev) for pediatric diffuse midline gliomas (Press release, DNAtrix, JUL 2, 2018, View Source [SID1234527602]). The data were selected for oral presentation at the Biennial International Symposium for Pediatric Neuro-Oncology taking place June 29 – July 3, 2018 in Denver, CO.

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Diffuse intrinsic pontine glioma (DIPG), also known as diffuse midline glioma, is a rare and highly aggressive infiltrative tumor of the brainstem with the worst prognosis of any pediatric cancer. No effective treatments are available and novel treatment approaches are needed. The evaluation of oncolytic adenovirus, DNX-2401, in DIPG is based on data from clinical studies of DNX-2401 in adults with recurrent glioblastoma that demonstrate prolonged survival while maintaining a favorable safety profile compared to approved therapies.

Dr. Tejada will report that DNX-2401 can be administered safely to the pons in pediatric patients prior to radiotherapy, with minimal side effects. Safety and clinical activity will be reported to date. The presentation will also report results from preclinical studies demonstrating the synergistic antitumor activity of DNX-2401 and radiation in animal models of high grade glioma and DIPG.

"We have treated six pediatric DIPG patients with DNX-2401 and observed no grade 3 or 4 adverse events, indicating that this a safe therapy for pediatric patients with brain tumors. Based on these updated results, we intend to test DNX-2401 in a range of brain tumors that affect children," said Sonia Tejada, MD, PhD.

"DNX-2401 can be delivered safely via cannula directly into the pontine glioma, which circumvents the challenge of drugs failing to reach the target," said Frank Tufaro, PhD, CEO of DNAtrix. "Early results are encouraging."

Details of the presentation are as follows:

Oncolytic virus pHGG and DIPGs: from the bench to the bedside

Abstract Session: DIPG/Diffuse Midline Glioma

Abstract Number: DIPG-17

Presenter: Sonia Tejada, MD, PhD

Date: Monday, July 2, 2018

To access the paper describing the Phase 1 study protocol, visit the Neurosurgery website: View Source

For more information about ongoing DNAtrix clinical studies, visit the ClinicalTrials.gov website: NCT03178032 (DNX-2401 for newly diagnosed pediatric diffuse intrinsic pontine glioma) and NCT02798406 (DNX-2401 + pembrolizumab for recurrent glioblastoma).

About DNX-2401 (Tasadenoturev)
DNX-2401 is an investigational oncolytic immunotherapy designed to treat cancer. DNX-2401 sets off a chain reaction of tumor cell killing by selectively replicating within cancer cells (but not normal cells), causing tumor destruction and further spread of the oncolytic virus to adjacent tumor cells. This process then triggers an immune response directed against the tumor. DNX-2401 has been well tolerated in patients with glioblastoma and survival has been prolonged compared to other therapies.

On July 2, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpassion130 study met its co-primary endpoint of progression-free survival (PFS) (Press release, Hoffmann-La Roche, JUL 2, 2018, View Source [SID1234527524]). Results demonstrated that the combination of Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]), as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in the intention-to treat and PD-L1 positive population with metastatic or unresectable locally advanced triple negative breast cancer (TNBC). Overall survival (OS) is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis.

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Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Results will be presented at an upcoming medical meeting and will be submitted to health authorities globally, including the U.S. Food and Drug Administration FDA) and European Medicines Agency (EMA).

"IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Highly encouraged by these results, we plan to submit to health authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible."

This is the third positive Phase III study that includes Tecentriq and nab-paclitaxel as part of a treatment regimen. Currently, Roche has seven ongoing phase III studies investigating Tecentriq in TNBC.

About the IMpassion130 study
IMpassion130 study is a phase III multicentre, randomised, double-blind study evaluating the efficacy, safety, and pharmacokinetics of Tecentriq and nab-paclitaxel compared with placebo in combination with nab-paclitaxel in patients with locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer (mBC). The study enrolled 902 patients who were randomised equally (1:1).

The co-primary endpoints were progression-free survival (PFS) per investigator assessment (RECIST 1.1) and overall survival (OS). PFS and OS were assessed in all randomized participants [intention-to-treat (ITT)] and in those whose disease expressed the PD-L1 protein. Secondary endpoints included objective response rate, duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.

During the treatment duration, patients in:
ARM A received Tecentriq at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle and nab-paclitaxel at a dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-paclitaxel was administered for a target of at least 6 cycles, with no maximum. Patients received both agents until unacceptable toxicity or disease progression.
ARM B received nab-paclitaxel at a dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-paclitaxel was administered for a target of at least 6 cycles, with no maximum and placebo was administered via IV infusion on Days 1 and 15 of each 28-day cycle. Participants received both agents until unacceptable toxicity or disease progression
About triple negative breast cancer
Breast cancer is the most common cancer among women with more than 1.67 million diagnosed worldwide each year. 1 Triple negative breast cancer represents 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer. 2;3 It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification. 4;5 Patients with metastatic triple negative breast cancer generally experience rapid progression and shorter overall survival compared to other subtypes of breast cancer. 6

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Tecentriq is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

On July 2, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") is reported that it has submitted its Investigational New Drug ("IND") application to the United States Food and Drug Administration ("FDA") for eftilagimod alpha ("efti" or "IMP321") in June 2018 (Press release, Immutep, JUL 2, 2018, View Source [SID1234527552]).

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If granted by the FDA, the IND application will allow Immutep to ship efti across U.S. State borders to U.S. clinical investigators participating in the Company’s planned TACTI-002 Phase II clinical study, making it an important step in the clinical trial preparations. This is the first IND application for efti in the U.S. following the encouraging pre-IND meeting in November last year.

The IND application incorporates information pertaining to completed pharmacology and toxicology studies for efti, along with manufacturing information and proposed clinical protocol for the TACTI-002 trial.

The Company continues to progress its preparations for the TACTI-002 clinical trial in the United States, Europe and Australia. Immutep expects to commence the TACTI-002 trial in the second half of 2018 and to report the first data from the trial in 2019.

About the TACTI-002 clinical trial

Up to 120 patients will be recruited for the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 15 study centres in the U.S., Europe and Australia. The trial is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It will evaluate the safety and efficacy of the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in patients with two different types of cancers, non-small cell lung cancer and head and neck cancer. It will be a Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment for 12 months using a 30 mg s.c. efti dosing every 2 or 3 weeks.