On January 7, 2019 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that its partner Innovent Biologics has received BLA approval in China for an antibody against PD-1 to treat Hodgkin’s Lymphoma (Press release, Adimab, JAN 7, 2019, View Source [SID1234532543]).

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Adimab and Innovent initiated a partnership in 2013 to discover antibodies against multiple targets selected by Innovent. The partnership has been expanded multiple times to add additional programs and to access Adimab’s bispecifics capabilities. Innovent currently has 12 programs in development derived from the Adimab Platform. The PD-1 program, which Innovent has partnered with Lilly, was initiated in the spring of 2013.

On December 27th, 2018, Innovent and its co-development partner, Eli Lilly, announced that Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin’s lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL).

"Innovent has been an outstanding partner. Their ability to go from inception to an approved drug in five years is impressive by any standard. Innovent has a deep pipeline of quality programs and we expect them to be a major player in the Chinese pharmaceutical industry for years to come," said Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab.

"Adimab’s technology helped generate one of the most competitive PD-1 programs in the industry and the quality of the antibody allowed Innovent’s PD-1 program to go from initiating discovery to approval in China in less than six years," said Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent. "Adimab has been one of our most important partners. The quality of their work and professionalism are exceptional."

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug co-discovered by Innovent and Adimab, jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1 (Programmed Cell Death-1 Ligand-1, PD-L1 pathway) and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.

On January 7, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported expected milestones for 2019, which highlight the company’s progress advancing its clinical development candidates: NiCord, an investigational universal bone marrow donor source in late-stage development for patients with hematologic malignancies (blood cancers), and NAM-NK, an investigational, cell-based cancer immunotherapy in development in patients with non-Hodgkin lymphoma and multiple myeloma (Press release, Gamida Cell, JAN 7, 2019, View Source [SID1234532542]).

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Gamida Cell expects to complete patient enrollment in its Phase 3 clinical study of NiCord in the second half of this year. The international, randomized, multi-center study is designed to evaluate the safety and efficacy of NiCord compared to standard umbilical cord blood for allogeneic hematopoietic stem cell (bone marrow) transplant in approximately 120 patients with no available matched donor. The company also expects to report additional data from the ongoing Phase 1 study of NAM-NK at a medical meeting during the first half of 2019.

Today Gamida Cell also announced the appointment of Thomas Klima to the newly created role of chief commercial officer. Mr. Klima brings nearly 20 years of global experience in the pharmaceutical industry with expertise in cellular therapy, hematology, oncology and transplantation. During his career, he has played key roles in building commercial organizations and leading multiple successful product launches. Additionally, the company announced that Nurit Benjamini, an experienced financial executive, has been appointed to Gamida Cell’s board of directors and will chair the board’s audit committee.

"We are intently focused on advancing NiCord, which has potential to expand and improve bone marrow transplants, giving patients a chance for a cure. We are on track to complete enrollment by the end of this year, with topline data from the Phase 3 study anticipated in first half of 2020," stated Julian Adams, Ph.D., chief executive officer at Gamida Cell. "We are also continuing to build a pipeline based on our proprietary nicotinamide, or NAM, technology and plan to report additional data from the ongoing Phase 1 study of NAM-NK in the coming months."

"We have also augmented our team with two new experienced individuals. I’m pleased to welcome Tom Klima, who will join as chief commercial officer, and Nurit Benjamini, who will serve as an independent director on the company’s board. Their experience and contributions will be invaluable as we advance toward anticipated commercialization," Dr. Adams continued.

Mr. Klima most recently served as head of global commercial planning and operations at Atara Biotherapeutics, prior to which he played a key role as senior vice president and chief commercial officer at Navidea Biopharmaceuticals Ltd. Mr. Klima also served as head of sales and commercial operations at Algeta U.S. and led the successful commercial build-out and launch of Xofigo. Before Algeta, he held various commercial leadership positions at Dendreon. Mr. Klima began his pharmaceutical career at Eli Lilly where he held several positions of increasing responsibility and participated in the global launch of Cymbalta. Mr. Klima earned a B.A. in Business Administration and Marketing from Western State College.

Ms. Benjamini has served as chief financial officer of TabTale Ltd. since 2013. Previously, she held a number of chief financial officer positions, including at Wix.com Ltd., Sigma Designs Israel Ltd. and Compugen Ltd. She has served as a director at RedHill Biopharma Ltd., BioLine Rx and Allot Communications. Ms. Benjamini holds a BA in Economics and Business and an MBA in Finance from Bar Ilan University, Israel.

Expected 2019 Milestones

Gamida Cell expects to achieve the following milestones this year:

Present additional data from the Phase 1 study of NAM-NK in first half of 2019
Report early data from the Phase 1/2 study of NiCord in patients with severe aplastic anemia data in the first half of 2019
Complete patient enrollment in the Phase 3 study of NiCord in patients with high-risk hematologic malignancies in the second half of 2019
2019 Financial Outlook

Gamida Cell ended 2018 with cash, cash equivalents and available-for-sale securities of approximately $60 million (unaudited). The company expects that such funds will support the company’s capital needs through the data readout for the Phase 3 clinical study of NiCord, which is expected in the first half of 2020. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

Gamida Cell intends to provide additional financial guidance for 2019 when it reports its fourth quarter and full-year 2018 financial results in March 2019.

About NiCord

NiCord, the company’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. A Phase 3 clinical study evaluating NiCord in patients with leukemia and lymphoma is ongoing in the United States, Europe and Asia.1 For more information on clinical trials of NiCord, please visit www.clinicaltrials.gov.

About NAM-NK

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.2

NiCord and NAM-NK are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On January 7, 2019 bluebird bio, Inc. (Nasdaq: BLUE) and Inhibrx, Inc. (Inhibrx) reported that they have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using Inhibrx’s proprietary single domain antibody (sdAb) platform to multiple cancer targets (Press release, bluebird bio, JAN 7, 2019, View Source [SID1234532541]). The small size of sdAbs may enable the generation of more complex CAR T cell products such as those designed to combine additional functions into a single CAR molecule or recognize multiple tumor antigens simultaneously.

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"Access to the Inhibrx sdAb binder technology will allow us to combine the advancements we’ve made with our T cell therapy platform with their sdAb binder technology to generate novel cellular therapies with the potential to help patients in their fight against cancer," said Philip Gregory, D. Phil., chief scientific officer, bluebird bio. "The technology from Inhibrx adds to our growing portfolio of tools and technologies that we can combine with our internal lentiviral vector, CAR and T cell expertise to discover potential new product candidates designed to recognize tumor-specific proteins expressed by cancer cells and kill them upon engagement."

"We are pleased to have formalized our relationship with bluebird bio, allowing us to couple our proprietary sdAb platform with a leading cell therapy platform," said Brendan Eckelman, Chief Scientific Officer and Executive Vice President of Corporate Strategy of Inhibrx. "Together with bluebird bio, we have generated compelling proof of concept preclinical data on the utility of incorporating our sdAbs into bluebird bio’s constructs for CAR-T cell generation."

Under the terms of the license agreement, Inhibrx will provide bluebird bio the exclusive worldwide rights to develop, manufacture and commercialize certain cell therapy products containing sdAbs directed to various cancer targets. bluebird bio will be responsible for the clinical development and commercialization of the cancer-targeting CAR-T products. Inhibrx received a $7.0 million upfront payment and is also entitled to receive specified developmental milestone payments as well as percentage tiered royalties on future product sales.

On January 7, 2019 Generex Biotechnology Corporation (OTCQB:GNBT) is reported that Joe Moscato, the company’s CEO is attending the annual J.P. Morgan Healthcare Conference from January 7 to 9, 2019 (Press release, Generex, JAN 7, 2019, View Source [SID1234532540]). Mr. Moscato is meeting with leading healthcare investors to present the corporate vision for Generex Biotechnology as an integrated healthcare holding company with a unique strategy to provide end-to-end, patient centric solutions to enhance the doctor patient relationship.

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With 9,000 attendees and representation from over 450 companies, the annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community.

"We are pleased to unveil the "New" Generex to the biotech and healthcare investment community," stated Joe Moscato, CEO of Generex. "After two-plus years of reorganizing the operations, capital structure, and strategic vision for the company, Generex is poised to deliver on our corporate mission to provide physicians, hospitals, and healthcare providers an end-to-end solution for patient centric care from rapid diagnosis through delivery of personalized therapies, streamlining care processes, minimizing expenses, and delivering transparency for payers. Entering 2019, we are building value in Generex by executing on our strategic plan with our newly acquired MSO and pharmacy network, the advancement of our clinical stage assets in immune-oncology, and through acquisitions in cutting-edge areas like regenerative medicine."

On January 7, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported that its targeted antibody vofatamab has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treatment of patients with advanced or metastatic urothelial cell carcinoma (bladder cancer) that is positive for FGFR3 mutation and/or fusion (Press release, Rainier Therapeutics, JAN 7, 2019, View Source [SID1234532539]).

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"This Fast Track designation underscores the great unmet medical need that exists for the treatment of bladder cancer," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "As the only antibody specifically targeted to FGFR3 we know to be in clinical development, we believe vofatamab offers a promising therapeutic option. We look forward to further data from our ongoing trials and working to advance our development efforts."

The FDA’s Fast Track designation is a process to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Through the Fast Track program, more frequent meetings may be scheduled with the FDA to discuss the drug’s development plan and to ensure the collection of appropriate data needed to support approval. Additionally, the drug may qualify for accelerated approval and priority review and, at the time of a biologics license application (BLA) filing, the drug candidate’s sponsor may be eligible to submit completed sections of the BLA on a rolling basis before the complete application is submitted.

"Fast Track designation offers the potential to reduce development time and cost associated with bringing a drug to patients," said Valerie Fauvelle, Vice President, Regulatory Affairs at Rainier Therapeutics. "We look forward to working with the FDA to rapidly advance vofatamab through the clinical development and regulatory processes."

Vofatamab (B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and other cancers. Vofatamab is the most advanced targeted biologic specific for FGFR3 known by Rainier to be in clinical development.

Rainier Therapeutics has ongoing Phase 1b and Phase 2 clinical studies of vofatamab in metastatic bladder cancer – the Fierce 21 and Fierce 22 studies. In addition, Rainier Therapeutics plans to study vofatamab in early stage bladder cancer – the Fierce 23 trial.

The Fierce 21 trial is evaluating vofatamab alone and in combination with docetaxel versus docetaxel alone to determine safety and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer with FGFR3 mutant/fusion who have relapsed after, or are refractory to, at least one prior line of chemotherapy. For more on this trial, visit www.clinicaltrials.gov (NCT0240542).

The Fierce 22 trial is evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy. For more on this trial, visit www.clinicaltrials.gov (NCT03123055).

The Fierce 23 trial will evaluate vofatamab monotherapy in non-muscle invasive bladder cancer (NMIBC). This trial is planned to start in 2019.