On December 7, 2017 bluebird bio, Inc. (Nasdaq: BLUE) and Scottish immunotherapy company TC BioPharm, Ltd. (TCB) reported a strategic collaboration and license agreement focused on gamma delta CAR T cells (Press release, bluebird bio, DEC 7, 2017, View Source [SID1234522423]). The companies will work together to advance TC BioPharm’s lead CAR-engineered gamma delta T cell program into clinical trials as well as on additional hematologic and solid tumor targets.

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"Emerging research suggests that gamma delta T cells may constitute a powerful platform for CAR T cell therapies," said Philip Gregory, D.Phil., chief scientific officer, bluebird bio. "TCB is a leader in the gamma delta T cell field, with extensive capabilities spanning early research, clinical development and manufacturing. The combination with our deep expertise in CAR T cell biology, translational and clinical experience with leading CAR T cell drug products, and powerful gene therapy toolbox, offers a high degree of synergy. This partnership aims to help realize the full potential of the gamma delta T cell platform to bring novel and transformative therapies to cancer patients with high unmet medical need."

Commenting on the partnership with bluebird bio, TCB’s chief executive – Michael Leek, PhD, said, "We are delighted to be working alongside bluebird bio to discover and develop next-generation CAR T cell therapies based on our innovative ImmuniCAR platform. Both companies share the same dynamic culture, passion and drive, spearheaded by an overwhelming desire to treat cancer patients – with the potential to dramatically improve each individual’s prognosis and quality of life."

"We believe our gamma delta T cell platform has broad therapeutic potential," added Artin Moussavi, PhD, chief business officer of TC BioPharm. "The collaboration with bluebird bio, a leader in cell and gene therapy, recognizes the enormous potential of ImmuniCAR to deliver life-changing medicines."
"bluebird bio is leveraging its industry-leading toolbox of advanced cell and gene therapy technologies to accelerate immuno-oncology targets from concept to clinic," said Joanne Smith-Farrell, bluebird’s senior vice president, corporate development and strategy. "The agreement with TCB complements bluebird bio’s growing immuno-oncology development program, which includes clinical and pre-clinical CAR T and T Cell Receptor programs that leverage bluebird bio’s leading translational research and deep vector technology expertise to rapidly accelerate from target identification to clinical development."

Under the terms of the agreement, bluebird bio and TCB will collaborate to discover and develop CAR-engineered gamma delta T cells for cancer targets and indications. TCB is responsible for development of all targets through Phase 1/2, at which point bluebird has the exclusive option to assume sole responsibility for further clinical development and commercialization on a global basis.

Financial terms of the agreement include a $16 million upfront payment and subsequent potential R&D and commercial milestone payments. The Company is also eligible to receive undisclosed tiered royalties on product sales.

On December 7, 2017 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or "the Company") reported that it has begun dosing subjects in its pivotal study for the Company’s fulvestrant formulation intended as a monotherapy treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy or as a combination therapy with palbociclib for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy (Press release, Eagle Pharmaceuticals, DEC 7, 2017, View Source [SID1234522424]).

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This pharmacokinetic and safety pivotal study is an open label trial in which healthy female volunteers across multiple U.S. sites will be randomized 1:1 to receive either the Company’s fulvestrant formulation or the reference drug Faslodex. The Company anticipates dosing its last subject during the first half of 2018, with study completion within twelve months, and an expected NDA filing in the fourth quarter of 2018.

"We began dosing the first cohort of subjects in our pivotal study fulvestrant trial on November 30th, following guidance from the U.S. Food and Drug Administration (FDA) regarding the study design. We believe our fulvestrant formulation holds the potential to be a best-in-class treatment option for thousands of patients," stated Scott Tarriff, Chief Executive Officer.

"Our innovative formulation, if approved, could offer multiple potential benefits compared to the current branded fulvestrant product, Faslodex. Our formulation allows the therapy to be administered at the recommended dose with one intramuscular injection instead of two high-viscosity intramuscular injections, and in far less time – seconds instead of minutes. In addition, it does not contain castor oil, and our formulation’s lower viscosity allows for administration with a 23-gauge needle, which is 25% thinner than the current needle required to administer Faslodex," added Tarriff.

Faslodex, manufactured by AstraZeneca, generated worldwide sales of $925 million in the twelve months ended September 30, 2017.

Enzo Biochem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Enzo Biochem, 2017, DEC 7, 2017, View Source [SID1234522436]).

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On December 7, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that it received written responses from the U.S. Food and Drug Administration (FDA) following its Type C meeting regarding its planned registrational HS-110 clinical trial design for the treatment of non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, DEC 7, 2017, View Source [SID1234522426]).

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The discussion focused on elements of proposed clinical trial designs, both single-arm and controlled, which the FDA agreed would be appropriate to support a registrational trial of HS-110. Clinical endpoints and post-marketing commitments were also discussed in the context of accelerated approval.

"We are very pleased with the outcome of our recent Type C guidance meeting with the FDA," said George Peoples, M.D., Chief Medical Officer for Heat. "The FDA clearly understands the significant unmet need for more effective second-line treatments for NSCLC. We look forward to incorporating their guidance as we prepare to advance HS-110 into registrational trials."

HS-110 is currently in Phase 2 as a treatment for NSCLC. Trial design details and next steps are expected to be announced following the read-out of the Phase 2 data, anticipated in 2H 2018.

On December 6, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported that its WP1066 drug will receive $2 million in private grant funding for its recently announced Investigational New Drug ("IND") clearance for a physician-sponsored Phase I trial of Moleculin’s drug WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma (Press release, Moleculin, DEC 6, 2017, View Source [SID1234522405]).

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"On the heels of our recent IND announcement, we are honored to now announce that a significant private grant has been awarded to help cover the costs of the upcoming brain tumor trial at MD Anderson," commented Walter Klemp, Chairman and CEO of Moleculin. "We should emphasize that this $2 million grant is in addition to two prestigious SPORE grants awarded by the National Cancer Institute ("NCI")."

Mr. Klemp added, "The Specialized Programs of Research Excellence ("SPORE") program was established by NCI to enable the rapid and efficient movement of basic scientific findings into clinical settings and it is now considered a highly prestigious award for promising anticancer technologies. Due to the highly competitive nature of such grants and their and external review processes, we believe they provide further validation of our program and the approach to the treatment of brain cancer and cancer metastasis to the brain. Overall, the combination of all of these funding sources not only allows this trial to begin to move forward, we believe it signals strong support for the development of this class of potential drugs and more specifically, significant enthusiasm for the potential of WP1066 to shut down unwanted cell signaling and to empower the immune system to fight cancer."

The grants described here do not flow through Moleculin’s financial statements, but instead are applied to the cost of preclinical and clinical activities at and conducted by MD Anderson.