On December 8, 217 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the first subject has been treated in the APOLLO study of FATE-NK100 in women with ovarian cancer resistant to, or recurrent on, platinum-based treatment (Press release, Fate Therapeutics, DEC 8, 2017, View Source [SID1234522461]). The clinical trial is intended to evaluate the safety and determine the maximum dose of FATE-NK100, the Company’s first-in-class, donor-derived adaptive memory natural killer (NK) cell cancer therapy, as a monotherapy when administered intraperitoneally in the outpatient setting. A clinical assessment of patients with ovarian cancer has previously shown that endogenous NK cells within the peritoneal fluid exhibit an altered phenotype with reduced cytolytic function.

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"Women today often are treated with intraperitoneal chemotherapy, and the administration of FATE-NK100 directly within the peritoneal cavity is an exciting therapeutic strategy to restore NK cell function, promote persistence and inhibit tumor growth," said Melissa A. Geller, M.D., Associate Professor in the Department of Obstetrics, Gynecology and Women’s Health, Division of Gynecologic Oncology at the University of Minnesota and the lead investigator of the clinical trial at the Masonic Cancer Center. "Ovarian cancer is a disease of middle age women, and over 60% of women with ovarian cancer initially present with advanced disease. For these women, the rate of recurrence is around 70%, and there is an urgent need for novel therapeutic strategies since standard treatments in the recurrent setting provide dismal response rates especially in platinum resistant disease."

The APOLLO study is an open-label, accelerated dose-escalation, Phase 1 clinical trial of FATE-NK100 in subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer. Up to three dose levels of FATE-NK100 are intended to be assessed to evaluate safety and determine the maximum dose. Other endpoints to be evaluated include objective response rate at 28 days, and progression-free and overall survival at six months. Subjects with stable disease or better at Day 28 following infusion may be considered for retreatment with FATE-NK100.

Ovarian cancer is the fifth leading cause of cancer-related death among women, and is the deadliest of gynecologic cancers. The American Cancer Society estimates that in 2017, about 22,440 new cases of ovarian cancer will be diagnosed and 14,080 women will die of ovarian cancer in the United States. While a high proportion of women respond to initial platinum-based chemotherapy, around 70% of patients diagnosed with ovarian cancer will have a recurrence. While recurrent ovarian cancer is treatable, it is rarely curable and there is a significant need for more effective, better-tolerated therapies.

About FATE-NK100
FATE-NK100 is a first-in-class, donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In preclinical studies, FATE-NK100 has demonstrated enhanced anti-tumor activity across a broad range of hematologic and solid tumors, with augmented cytokine production, improved persistence and increased resistance to immune checkpoint pathways compared to other NK cell therapies that are being clinically administered today. FATE-NK100 is produced through a feeder-free, seven-day manufacturing process during which NK cells sourced from a healthy donor are activated ex vivo with pharmacologic modulators.

About APOLLO
APOLLO is an open-label, accelerated dose-escalation, Phase 1 clinical trial in subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer designed to evaluate the safety and determine the maximum dose of a single infusion of FATE-NK100 as a monotherapy when administered via intraperitoneal catheter after out-patient chemotherapy followed by sub-cutaneous IL-2 administration. Up to three dose levels of FATE-NK100 are intended to be assessed (1×107 cells/kg, >1×107 cells/kg to ≤3×107 cells/kg, and up to 1×108 cells/kg). In the event a dose limiting toxicity is observed, the clinical trial will convert to a 3+3 design. A ten-subject expansion cohort is expected to be enrolled at the maximum dose level. Other endpoints include objective response rate at 28 days, and progression-free and overall survival at six months, post-infusion of FATE-NK100. The clinical trial is being conducted at the Masonic Cancer Center, University of Minnesota as an investigator-initiated study.

On December 8, 2017 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that the company is scheduled to present at the 2017 BMO Capital Markets Prescriptions for Success Healthcare Conference at 11:30 AM ET on Thursday, December 14, 2017 in New York City (Press release, Pacira Pharmaceuticals, DEC 8, 2017, View Source;p=RssLanding&cat=news&id=2321829 [SID1234522467]).

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A live audio webcast of the Pacira presentation can be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the presentation date.

On December 8, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported new results from two studies with EndoPredict are being featured at the 2017 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas (Press release, Myriad Genetics, DEC 8, 2017, View Source [SID1234522466]). EndoPredict is a second-generation prognostic gene expression test for patients with breast cancer.

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"We are excited to present new data on our EndoPredict test which demonstrates our ongoing commitment to collaborate with leading academic research centers and advance personalized medicine for patients with breast cancer," said Ralf Kronenwett, M.D., Ph.D., director of International Medical Affairs, Myriad Genetics. "Importantly, these new studies add to the expanding body of evidence demonstrating how EndoPredict can be used to predict both disease recurrence as well as response to therapy."
The data are highlighted below and abstracts are available at: View Source Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS17.

EndoPredict Podium Presentation
Title: The EndoPredict score predicts residual cancer burden to neoadjuvant chemotherapy and to neuroendocrine therapy in HR+/HER2- breast cancer patients from ABCSG34.
Presenter: Peter Dubsky, M.D., Medical University of Vienna, Austria and the Breast Center St. Anna Klinik, Lucerne.
Date: Friday, Dec. 8, 2017, 3:15—5:00 p.m.
Location: Podium, GS6-04

This study was designed to show the predictive value of the EndoPredict (EP) 12-gene molecular score for tumor response to neoadjuvant chemotherapy and neoendocrine therapy. The study included biopsies from 217 women with HR+ breast cancer. Of these, 134 patients were assigned to receive neoadjuvant chemotherapy according to aggressive clinico-pathologic tumor features. The remaining 83 patients were clinically identified as having luminal A types of breast cancer and were assigned to receive neoendocrine treatment. The primary endpoint was residual cancer burden RCB0/I (i.e., good tumor response) vs. RCB II/III (i.e., poor tumor response) at time of surgery.
In the neoadjuvant chemotherapy group, 125 patients had high EP scores and nine had a low EP score. The results show that 26.4 percent of those with a high score showed a good tumor response (RCB0/I) to neoadjuvant chemotherapy, while all patients with a low score showed only a poor tumor response (Table 1). In the "luminal A" group receiving neoendocrine therapy, 39 patients had a high EP score and 44 had a low EP score. The results show that 27.3 percent of those with a low EndoPredict score and 7.7 percent with a high score achieved excellent tumor response (RCB0/I) to neoendocrine therapy (Table 1).

Table. 1 EndoPredict
Low Score EndoPredict
High Score
p-Value
Response to
Neoadjuvant
Chemotherapy 0.0 % 26.4 % p=0.0001
Response to
Endocrine Therapy 27.3 % 7.7 % P=0.015

"This exciting study is evidence that women with a high EP score responded better to neoadjuvant chemotherapy than those with a low score, while those with a low EndoPredict score responded better to neoadjuvant endocrine therapy," said Peter Dubsky, M.D., principal investigator, speaking on behalf of the Austrian Breast and Colorectal Cancer Study Group (ABCSG). "These findings are relevant to better patient selection for biomarker driven studies in the neoadjuvant setting."

EndoPredict Poster Presentation
Title: The role of EndoPredict in invasive lobular carcinoma.
Presenter: Ivana Sestak, Ph.D., Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London.
Date: Thursday, Dec. 7, 2017, 5:00—7:00 p.m.
Location: Poster, P3-08-01

This study evaluated the role of EndoPredict molecular-clinical score (EPclin) for the prediction of distant recurrence in women diagnosed with invasive lobular carcinoma (ILC) compared to those with invasive ductal carcinoma (IDC). The study included 928 women with E R+/HER2- breast cancer: 141 had ILC, 710 had IDC and 77 were mixed type.
This result shows that EndoPredict provided significant power for predicting distant recurrence in patients with both ILC (EPclin: LR-X2=5.8) and IDC (EPclin: LR-X2=13.8). Women with ILC who had a high EPclin score were at seven times increased risk of 10-year distant recurrence with endocrine therapy only than patients with low EPclin score. In comparison, women with IDC who had a high EPclin score were at five times increased risk of 10-year recurrence than patients with low EPclin score. Importantly, there was a similar 10-year distant recurrence risk in patients with a low EPclin score (~6 percent), which suggests that chemotherapy is not indicated in these patients with a low risk score regardless of tumor type.
"Our results show that EndoPredict provided highly significant prognostic information and risk stratification in women with invasive lobular carcinoma," said Ivana Sestak, Ph.D., principal investigator, Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London. "Importantly, the 10-year risk of distant recurrence in the EndoPredict low-risk groups was similar between ILC and IDC, suggesting that chemotherapy is not indicated for these patients, irrespective of tumor type."

About EndoPredict
EndoPredict is a second-generation, multigene prognostic test for patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com.

On December 7, 2017 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it will webcast its Analyst Day on Wednesday, December 13, 2017 from 9:00 a.m. to 12:00 p.m. ET in New York, NY (Press release, Iovance Biotherapeutics, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321615 [SID1234522427]).

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The event will highlight Iovance’s lead clinical programs, LN-144 for the treatment of metastatic melanoma, LN-145 for recurrent and/or metastatic squamous cell carcinoma of the head and neck, and LN-145 for recurrent, metastatic or persistent cervical cancer. In addition, Iovance will discuss the expanding clinical pipeline, strategic collaborations and manufacturing plan for upcoming clinical trials.

A live webcast of the presentation can be accessed on the investor page of Iovance Biotherapeutics’ website at View Source A replay of the webcast will be archived on Iovance Biotherapeutics’ website for 30 days following the presentation.

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.