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Intellia Therapeutics Announces Three Oral Presentations on In Vivo and Engineered Cell Therapy Data at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy

On April 15, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported three oral presentations at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), taking place April 29-May 2, 2019, in Washington, D.C (Press release, Intellia Therapeutics, APR 15, 2019, View Source [SID1234535128]).

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Intellia’s data includes important updates from the company’s programs and platform development activities:

"CRISPR/Cas9-Mediated Targeted Insertion of Human F9 Achieves Therapeutic Circulating Protein Levels in Mice and Non-Human Primates"

Intellia will present data showing that its targeted gene insertion platform achieved therapeutic levels of Factor IX protein in non-human primates (NHP). The company employs a proprietary hybrid delivery system, comprised of both lipid nanoparticles (LNPs) and adeno-associated virus (AAV), to insert the desired gene sequence. Factor 9 (F9) is a gene that encodes Factor IX (FIX), a blood-clotting protein that is missing or defective in hemophilia B patients.

The data showing therapeutic levels of FIX achieved in NHPs is from an ongoing research collaboration between Intellia and Regeneron Pharmaceuticals, Inc.

Presenter: Hon-Ren Huang, Ph.D., associate director, Vector Biology, Intellia
Abstract number: 11
Session: Advances in Genome Editing and Hemophilia Gene Therapies
Presentation date/time: Mon., April 29, 2019, 9-9:15 a.m. ET
Location: Heights Courtyard 2
"Exploiting Clonal Tracking of WT1-Specific T Cells to Generate a Library of Tumor-Specific T Cell Receptors (TCR) for TCR Gene Editing of Acute Leukemia"

This presentation will focus on Intellia’s ongoing research collaboration with IRCCS Ospedale San Raffaele in Italy to develop CRISPR-edited T cell therapies to address intractable cancers, such as acute myeloid leukemia (AML). Researchers generated and tested a library of TCRs with different epitope specificities and human leukocyte antigen (HLA) restrictions.

Presenter: Eliana Ruggiero, Ph.D., Experimental Hematology Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS Ospedale San Raffaele, Italy
Abstract number: 123
Session: Cancer Adoptive Immunotherapy
Presentation date/time: Mon., April 29, 2019, 5-5:15 p.m. ET
Location: Georgetown
"CRISPR/Cas9-Mediated Gene Knockout to Address Primary Hyperoxaluria"

Intellia will provide information demonstrating successful knockout of two targets of interest, lactate dehydrogenase A (LDHA) and hydroxyacid oxidase 1 (HAO1), to address primary hyperoxaluria type 1 (PH1) in a PH1 mouse model. The data shows the continued progression of the company’s modular platform capability using CRISPR to knock out liver gene targets. The data being presented includes results from an ongoing collaboration with researchers at the University of Alabama at Birmingham.

Presenter: Anette Hübner, Ph.D., associate director, Liver Biology, Intellia
Abstract number: 1000
Session: Use of New Technologies for Hepatic Therapy
Presentation date/time: Thur., May 2, 2019, 12-12:15 p.m. ET
Location: Heights Courtyard 3
"Delivering on the Therapeutic Promise of CRISPR/Cas9"

Intellia also will participate in the ASGCT (Free ASGCT Whitepaper) Gene Editing Workshop, which will provide an overview of current gene editing technologies and approaches, as well as emerging uses and applications.

Presenter: Sean Burns, M.D., senior director, Hematology and New Therapeutic Areas
Session: Corporate Review II
Session date/time: Sun., April 28, 2019, 5-6 p.m. ET
Location: Lincoln

Eagle Pharmaceuticals, Inc. Expands Licensing Agreement for BENDEKA™ with Teva Pharmaceuticals International GmbH

On April 15, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that it has expanded its existing BENDEKA (bendamustine hydrochloride) licensing agreement with Teva Pharmaceuticals International GmbH ("Teva") (Press release, Eagle Pharmaceuticals, APR 15, 2019, View Source [SID1234535127]). Under the terms of the revised licensing agreement, beginning on October 1, 2019, Eagle’s royalty payment will increase from 25% to 30% of BENDEKA net U.S. sales, provided that BENDEKA’s orphan drug exclusivity has not been rescinded, withdrawn or waived by such date. The royalty rate will increase by one percentage point on each anniversary of October 1, 2019 until it reaches 32%, and it will remain at 32% thereafter.

The revised agreement, effective April 13, 2019, also extends the U.S. BENDEKA royalty term until it is no longer sold in the United States. The previous U.S. royalty term was set to expire in 2025. The extended term recognizes the strength of the bendamustine patents with expiries through 2033, and the value of the product beyond the original ten-year period. As part of the agreement restructuring, Eagle will continue to manufacture BENDEKA for the U.S. market for so long as it is sold in the United States and has agreed to assume a portion of the BENDEKA-related patent litigation expenses.

"We are very pleased to deepen our relationship with Teva by extending and expanding our licensing agreement for BENDEKA. This agreement recognizes the long-term value of the product, which is supported by orphan drug exclusivity through December 7, 2022 and an extensive patent portfolio through 2033. Teva has been a strong commercial partner, and we look forward to exploring additional areas of cooperation," stated Scott Tarriff, Chief Executive Officer of Eagle.

BENDEKA was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

April 12,2019 IND approval by FDA

On April 12, 2019 Wayshine Biopharm reported that it has received IND approval from FDA about its innovative experimental medicine WSD0922, a First-in-Class CNS penetrable EGFR/EGFRvIII inhibitor for the treatment of Glioblastoma, Anaplastic Astrocytoma and cancers with CNS metastasis patients (Press release, Wayshine Biopharm, APR 12, 2019, View Source [SID1234537799]). The WSD0922 program is under the sponsorship of Wayshine and the clinical trial, entitled "A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU" will be performed at Minnesota, Arizona and Florida, the three campuses of Mayo Clinic. Glioblastoma is the most aggressive malignant primary brain tumor in adults and is nearly always fatal. Treatment options for GBM are scarce and recurrence is inevitable. After recurrence, no standard treatment has been established. WSD0922 could be a potential game-changing program in treating GBM and other brain cancers.

"We are very pleased that the FDA has approved the application of IND, which is a significant development milestone in advancing our Portfolio," said Wei Zhong, Ph.D., CEO and Founder of Wayshine Biopharm. "WSD0922 is the first and only BBB penetrable EGFR/EGFRvIII inhibitor under development. The discovery of WSD0922 truly reflects our innovation and commitments and the clinical potential has been recognized and endorsed by the FDA, for this substantial unmet medical need. "

"If only one target can be picked for brain cancer, it’s EGFR/EGFRvIII." Comments from KOLs in Neuro-Oncology field.

"We make difference! WSD0922 is discovered and developed by Chinese scientists and the IND approval in US is a very important progress in its development. With the help from FDA and Mayo Clinic, we can definitely move this program forward quickly to benefit patients who are suffering Glioblastoma and the data generated from the study in cancer patients will significantly contribute to the brain cancer field." commented by Jinqiang Zhang, Ph.D., VP and co-founder at Wayshine.

Kitov Announces Key Milestone in FameWave Acquisition

On April 12, 2019 Kitov Pharma Ltd.(NASDAQ/TASE: KTOV), an innovative pharmaceutical company developing first-in-class combination oncology therapies, reported a key milestone in the acquisition of FameWave Ltd., following signature of a clinical collaboration agreement between FameWave and Bristol Myers Squibb (BMY) for their planned Phase 1/2 clinical trials to evaluate the combination of CM-24, a monoclonal antibody targeting the novel immune checkpoint carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1) with nivolumab (Opdivo), a PD-1 inhibitor, in patients with non-small cell lung cancer (NSCLC) (Press release, Kitov Pharmaceuticals , APR 12, 2019, View Source [SID1234535142]).

"We look forward to completing the acquisition of FameWave and advancing CM-24 studies in the clinic," said Isaac Israel, chief executive officer of Kitov. "Our goal is to assess the innovative combination of CM-24 with Opdivo In NSCLC patients. Since we believe CM-24 has great potential as a novel checkpoint inhibitor to be used in combination therapies to provide new options to address the significant unmet medical need in hard-to-treat cancers."

Preclinical studies have shown a strong synergetic anti-cancer effect using CM-24 in combination with a PD-1 antibody. Based on Kitov’s review of the initial Phase I dose ranging study of CM24 as a single agent, performed by Merck Sharpe & Dohme, Kitov plans to explore higher doses in order to reach receptor saturation,.

Kitov isacquiring FameWave, pending completion of certain additional closing conditions, including approval by the shareholders of Kitov of the acquisition.

Conference Call and Webcast Information:

The Company will host a conference call Monday, April 15, 2019, at 8:30 a.m. EDT to discuss the FameWave acquisition deal and new asset CM-24.

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website. Please access the webcast and conference line dial-in at least 15 minutes ahead of the conference call to register. Conference ID: 13689863; U.S dial in: 877-705-6003; Israel dial in: 1 809 406 247; International dial in: 201-493-6725. Webcast: View Source

About CEACAM1 and CM-24

CM-24 is a humanized monoclonal antibody directed against carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1), an immune checkpoint protein belonging to the Human CEA (Carcino-Embryonic Antigen) protein family. Evidence has shown that CEACAM1 is expressed on tumor lymphocytes and is up-regulated in several cancer types. Preclinical studies have shown evidence that CM-24 enhances the cytotoxic activity of tumor-infiltrating lymphocytes (TILs) against various CEACAM1-positive tumor cell lines. CM-24 is being developed for multiple oncological indications according to the expression pattern of its target protein.

As part of the recently announced agreement for the acquisition of FameWave by Kitov, cCAM BioTherapeutics Ltd., a wholly owned subsidiary of Merck Sharp and Dohme Corp., known as "MSD" in Israel, has returned the rights to CM-24 to former cCAM shareholders and founders of FameWave, following an initial Phase 1 dose ranging study of CM-24 as single agent.

FameWave Announces Clinical Collaboration with Bristol Myers Squibb for the Planned Phase 1/2 Trial in Non-Small Cell Lung Cancer to Evaluate Immuno-Oncology Candidate CM-24 in Combination with Nivolumab (Opdivo®)

On April 12, 2019 FameWave Ltd. a privately held biopharmaceutical company developing CM-24, which is being acquired by Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), reported the signing of a clinical collaboration with Bristol Myers Squibb Company (NYSE:BMY) to evaluate the combination of CM-24, FameWave’s monoclonal antibody targeting the novel immune checkpoint carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1), with nivolumab (Opdivo), a PD-1 inhibitor, in patients with non-small cell lung cancer (NSCLC) (Press release, Kitov Pharmaceuticals , APR 12, 2019, View Source [SID1234535123]).

FameWave and Bristol Myers Squibb will coordinate on the protocol design for the Phase 1/2 clinical trial in a well-defined patient population with NSCLC. Under the terms of the agreement, FameWave will fund and sponsor the study and Bristol Myers Squibb will supply nivolumab.

"FameWave’s collaboration with Bristol-Myers Squibb, a global leader in immuno-oncology, is a crucial step to begin evaluation of CM-24 in combination with a PD-1 inhibitor," said Dr. Michael Schickler, chief executive officer of FameWave. "We look forward to evaluating CM-24 in NSCLC since we believe it has a great potential as a novel immune checkpoint to be used in combination therapies for a variety of hard-to-treat cancers."

About CEACAM1 and CM-24

As part of the recently announced agreement for the acquisition of FameWave by Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), cCAM BioTherapeutics Ltd., a wholly owned subsidiary of Merck Sharp and Dohme Corp., known as "MSD" in Israel, is returning the rights to CM-24 to former cCAM shareholders and founders of FameWave, following an initial Phase 1 dose ranging study of CM-24 as single agent. Kitov’s acquisition of FameWave is pending completion of certain closing conditions, including FameWave entering this collaboration agreement for CM-24 with Bristol Myers Squibb.