On July 3, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical stage oncology drug development company reported that it has granted to Y-mAbs Therapeutics, Inc., a privately held clinical stage biopharmaceutical company, an exclusive sublicense to a bi-valent ganglioside based vaccine intended to treat neuroblastoma, a rare pediatric cancer (Press release, MabVax, JUL 3, 2018, View Source [SID1234527551]). A third of neuroblastoma patients are diagnosed as infants; and ninety percent are younger than five years of age at time of diagnosis. Neuroblastoma is responsible for twelve percent of all cancer deaths in children less than 15 years of age.

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The neuroblastoma vaccine was originally developed by Dr. Philip Livingston and colleagues at Memorial Sloan Kettering Cancer Center (MSK) and licensed as part of a broader portfolio of anti-cancer vaccines to MabVax. MabVax filed for and was granted an Orphan Drug Designation for the neuroblastoma vaccine and has manufactured Phase II clinical supplies for a planned but not initiated clinical trial to be conducted with the consortium New Advances in Neuroblastoma Therapy (NANT). NANT is the only consortium of academic medical centers in the world solely dedicated to developing novel treatments and biomarkers for children with Neuroblastoma. Over the last several years MabVax has shifted its focus and resources to the Company’s human antibody discovery and development programs that are currently in early stage clinical trials and have attracted partner interest.

Y-mAbs Therapeutics, Inc ("Y-mAbs") is a clinical-stage biopharmaceutical company developing novel antibody therapeutics for oncology targets based on a range of technologies licensed from MSK under an exclusive worldwide license and research collaboration agreement. The Company has two antibody based products in advanced clinical trials for the treatment of neuroblastoma and other cancers.

Total value of the transaction to MabVax is $1.3 million plus a share of a Pediatric Disease Voucher if granted by the U.S. Food and Drug Administration ("FDA") to Y-mAbs on approval of the vaccine and the Pediatric Disease Voucher is subsequently sold. Additionally, Y-mAbs will be responsible for all further development of the product as well as any downstream payment obligations related to this specific vaccine to MSK that were specified in the original MabVax-MSK license agreement. If Y-mAbs successfully develops and receives FDA approval for the Neuroblastoma vaccine, it is obligated to file with the FDA for a Pediatric Disease Voucher. If the voucher is granted to Y-mAbs and subsequently sold, then MabVax will receive a percentage of the proceeds from the sale of the voucher by Y-mAbs.

David Hansen, President and CEO of MabVax Therapeutics, explained, "Y-mAbs is ideally positioned to continue the development of the Neuroblastoma vaccine because of their experience in immunotherapy generally and neuroblastoma specifically. If Y-mAbs is successful in development of this product, MabVax will see a greater financial benefit through participation in the sale of the Pediatric Disease Voucher."

On July 3, 2018 Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) ("Eagle" or "the Company") reported that an additional patent has been issued related to BENDEKA by the United States Patent and Trademark Office (USPTO) (Press release, Eagle Pharmaceuticals, JUL 3, 2018, View Source [SID1234527546]). Patent number 10,010,533 will expire January 2031. The USPTO has now issued or allowed a total of 15 patents in the BENDEKA family of patents expiring from 2026 to 2033.

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The newly issued patent will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) bringing Eagle’s total Orange Book listed patents for BENDEKA to thirteen1. Furthermore, as a result of a Court decision issued on June 8, 2018, BENDEKA now has Orphan Drug Exclusivity (ODE). The FDA will not be able to approve any drug applications referencing BENDEKA until the ODE expires in December 2022. Moreover, the Company now does not expect generic TREANDA entrants into the market until December 2022, rather than November 2019.

"We believe that with the recent positive ODE decision and the strength of our intellectual property portfolio, BENDEKA has longevity well beyond 2022," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Under a February 2015 exclusive license agreement for BENDEKA, Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution.

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.