On January 27, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of NeoImmuneTech’s Hyleukin-7 (NT-I7) and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of patients with relapsed/refractory (R/R) advanced solid tumors (Press release, NeoImmuneTech, JAN 27, 2020, View Source [SID1234553590]). This IND clearance allows NeoImmuneTech to initiate a Phase 1b/2a basket study evaluating this combination in patients with both checkpoint inhibitor (CPI)-treated and CPI-naïve R/R advanced solid tumors.

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"As a company, we are striving to develop a safe and effective immunotherapy for patients with R/R advanced solid tumors, including those who have not been responsive to single-agent CPIs," said NgocDiep Le, MD, PhD, Chief Medical Officer and Executive Vice President of NeoImmuneTech. "This clearance marks the next step towards our goal of combining Hyleukin-7 with advanced cancer therapeutics such as pembrolizumab."

The goal of this study is to establish a recommended dosing regimen and explore the preliminary anti-tumor activity of the combination in patients with both CPI-treated and CPI-naïve R/R tumors. The results of this study will be used to further clinical development of this combination in select tumor types. The study will be led by Aung Naing, MD, FACP, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

"We are constantly looking for better and safer treatment options for our patients, as only a fraction of them can benefit from currently available immunotherapies," said Dr. Naing. "This agent has the potential to augment and broaden the reach of current treatments such as pembrolizumab, due to its T cell amplifying mechanism of action. We hope this study yields results helpful for our patients in dire need."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About Hyleukin-7

Hyleukin-7 (NT-I7), the only clinical-stage long-acting human IL-7, is uniquely positioned to address unmet medical needs in immuno-oncology. IL-7 is a fundamental cytokine for T-cell development and for sustaining immune response to chronic antigens (as in cancer). Hyleukin-7’s favorable PK/PD and safety profiles make it an ideal combination partner for immunotherapy standard of care (SOC) such as Checkpoint Inhibitor and CAR-T therapies. Hyleukin-7 is being studied in multiple clinical trials in solid tumors, and being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On January 27, 2020, INmune Bio, Inc. (the "Company") reported that it has entered into an agreement (the "Repurchase Agreement") to purchase 220,000 shares of its common stock, par value $0.001 per share (the "Shares") from Linda F. Powers. The purchase price is $4.60 per share, resulting in a total purchase price of $1,012,000 (the "Repurchase Transaction") which the company believes is an attractive price and will be accretive (Filing, 8-K, INmune Bio, JAN 27, 2020, View Source [SID1234553569]). Prior to consummating the Repurchase Transaction, Ms. Powers held approximately 10.4% of the Company’s outstanding common stock. Following the consummation of the Repurchase Transaction, Ms. Powers now holds approximately 8.6% of the Company’s outstanding common stock. The Repurchase Agreement and the transactions contemplated therein, were approved by the Company’s board of directors and audit committee.

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The foregoing is merely a brief description of the material terms of the Repurchase Agreement, which is attached hereto as Exhibit 10.1 and incorporated herein by reference. The foregoing does not purport to be a complete description of the rights and obligations of the parties thereunder and such description is qualified in its entirety by reference to such exhibit.

On January 27, 2020 GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for GammaTile Therapy (Press release, GT Medical Technologies, JAN 27, 2020, View Source [SID1234553566]). Patients with newly diagnosed malignant brain tumors are now eligible to receive the FDA-cleared surgically targeted radiation therapy (STaRT).

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"We are pleased to offer GammaTile Therapy to patients who are newly diagnosed with malignant brain tumors, in addition to patients with recurrent brain tumors," said Matthew Likens, president and CEO of GT Medical Technologies. "This is a significant step forward that expands our ability to improve the lives of patients with brain tumors. Patients receiving GammaTile Therapy immediately after the removal of a brain tumor will have the peace of mind that they are accelerating their radiation treatment and targeting residual tumor cells where treatment is most needed to help prevent recurrence."

Approximately 700,000 Americans are living with some type of brain tumor each year.1 Despite the efforts of the most skilled brain tumor specialists throughout the world, outcomes for patients with brain tumors have improved very little over the past 30 years. During this time, there have been only four FDA-approved drugs and two FDA-cleared devices available to patients and physicians for the treatment of brain tumors. GammaTile Therapy, which became available to patients with recurrent brain tumors in January 2019, is the most recent treatment cleared or approved by the FDA for the treatment of brain tumors.

GammaTile Therapy is the only radiation therapy specifically designed for use in the brain and offers advantages for patients undergoing surgery for brain tumors. GammaTile begins targeting residual tumor cells immediately at the time of tumor removal surgery, rather than waiting several weeks for surgical wound healing before beginning treatment. GammaTile protects healthy brain tissue while delivering a targeted dose to any remaining tumor cells. The unique design also limits side effects typically associated with radiation therapy, including hair loss. Additionally, the burden of radiation treatment is reduced for patients treated with GammaTile Therapy. These patients receive their course of radiation while going about their daily lives, requiring no additional trips to the hospital or clinic for radiation therapy.

In a clinical study, GammaTile Therapy gave the average patient approximately ten extra months without a local recurrence with extended overall survival.2 Clark C. Chen, M.D., Ph.D., head of the Department of Neurosurgery at the University of Minnesota Medical School, presented data from his first patients treated with GammaTile at the 2019 Society of Neuro-Oncology (SNO) Annual Meeting. Consistent with data published in a peer-reviewed article, Chen reported that local control was achieved in approximately 90% of patients who underwent gross total resection. This impressive result was achieved without an increase in wound complications or length of hospital stay. "GammaTile Therapy is an important addition to the armamentarium of treatments available against brain cancer," said Dr. Chen. "It has the potential to improve the quality of life as well as clinical outcome. I am encouraged by the FDA’s decision to expand the indications for this therapy."

GammaTile Therapy became available to patients in January 2019 and is being used in top cancer treatment centers across the United States. Dr. Vincent DiNapoli, neurosurgeon and director of the Brain Tumor Center at The Jewish Hospital in Cincinnati, Ohio, has been treating patients with GammaTile Therapy since August 2019. "Having been encouraged by the outcomes for recurrent brain tumor patients treated with GammaTile Therapy in my practice, I am excited by the FDA’s decision to expand this technology to the many patients who can benefit from the treatment during their initial diagnosis," Dr. DiNapoli said. "This could potentially create a more meaningful impact on patient outcomes, treatment compliance, and quality of life."

About GammaTile Therapy

GammaTile Therapy is an FDA-cleared, Surgically Targeted Radiation Therapy (STaRT) that is designed to delay tumor regrowth for patients with brain tumors. Roughly the size of a postage stamp, GammaTile Therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source, Cesium-131, provided by Isoray, Inc. (NYSE: ISR). GammaTile Therapy is placed at the end of excision surgery to immediately target residual tumor cells while limiting the impact of radiation on healthy brain tissue.

On January 27, 2020 PharmaMar (PHM:MSE) and Bionical Emas, a global specialist Clinical Research Organization (CRO) have reported the launch of an Expanded Access Program (EAP) for lurbinectedin to treat patients in the United States (U.S.) with relapsed Small Cell Lung Cancer (SCLC), who are unable to enter clinical trials and there are no appropriate alternative treatments (Press release, PharmaMar, JAN 27, 2020, View Source [SID1234553610]).

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Dr. Jack West, Associate Clinical Professor, City of Hope Cancer Center, Duarte, CA, said: "I welcome the availability of lurbinectedin through the EAP as an option for patients. This disease has few compelling alternatives in this setting, so this would be a very welcome option for physicians and patients alike."

SCLC is a very aggressive cancer that is usually diagnosed with advanced, often metastatic disease, thus limiting the role of traditional approaches and usually posing a worse prognosis when compared to other lung cancers1. In the U.S., approximately 10-15% of lung cancers are small cell1. Approximately 30,000 new cases of SCLC are recorded in the U.S. every year2. The treatment of relapsed SCLC has not changed substantially in more than two decades.

SCLC is one of PharmaMar’s priority research areas. In December 2019, the Company announced the filing of lurbinectedin’s New Drug Application (NDA) for the treatment of relapsed SCLC with the FDA under the "accelerated approval" program.

"SCLC is a devastating disease for patients and their families, having limited effective treatment options. We are excited to be able to provide access to lurbinectedin to eligible patients across the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.

"I am happy to see the launch of the lurbinectedin EAP in the U.S. today. Relapsed SCLC is a very aggressive disease with existing second line treatments showing only limited effectiveness. As oncology physicians, we are constantly looking for new treatment options for our patients. There is only one approved drug for the second line treatment which has modest benefit and significant side effects, and there are currently no other open EAPs. Providing access to this new option for patients requires time and investment from the Company and it is greatly appreciated by physicians in the clinic," said Dr. William Jeffrey Petty, Professor, Hematology and Oncology, Wake Forest Baptist Health, Winston-Salem, North Carolina.

Healthcare professionals wishing to request access to lurbinectedin under the EAP or who would like to find out more should do so by emailing [email protected].

On January 25, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, reported new real-world data on treatment patterns for patients with advanced colorectal cancer (CRC) during a poster session at the 2020 Gastrointestinal Cancer Symposium sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, NantHealth, JAN 25, 2020, View Source [SID1234553530]).

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The Symposium, held at the Moscone West Building in San Francisco, CA from January 23-25, provides evidence-based teaching methods and cutting-edge learning science to a diverse audience of leaders in oncology education, doctors and care teams.

NantHealth’s presentation examined therapeutic preferences and treatment patterns among advanced CRC patients using data from NantHealth’s Eviti Connect, an evidence-based treatment intelligence and web-based oncology decision support platform. Detailed information from 6,325 treatment plans was analyzed to identify treatment patterns using regorafenib and trifluridine + tipiracil for advanced CRC patients as third-line of therapy. National Comprehensive Cancer Network (NCCN) guidelines state that regorafenib and trifluridine+tipiracil are both treatment options for patients who have progressed through all available regimens.

Across all 6,325 treatment plans submitted for this patient population, regorafenib (n=217) or trifluridine+tipiracil (n=144) was the submitted treatment in 361 (5.5%) of the treatment plans, making them the 9th and 13th most frequently requested drugs (excluding growth factors, anti-emetics, and leucovorin) in this setting. While the total number of treatment plans for regorafenib was higher than that for trifluridine+tipiracil, the submission of trifluridine+tipiracil has increased over time, consistent with the latter drug’s more recent introduction into the market.

"Our analysis shows that recycling of chemotherapy and biologics in the late line setting is common and occurs more frequently than switching to a drug regimen with an alternative mechanism of action," said William A. Flood, MD, MS, Chief Medical Officer for Eviti, NantHealth. "As results cannot be fully explained by clinical trial outcome differences, NCCN guidelines preferences, or HEOR measures, we must delve deeper into why these therapeutic patterns exist to further our mission of optimizing patient outcomes and enabling value-based care in oncology. The uncertainty of what constitutes the ‘best’ treatment for this patient population provides an excellent opportunity to employ available data to guide patient-centered decision making and value-based care initiatives."

Title: "Real world data on treatment patterns of advanced CRC in 3rd line and beyond"

Authors: William A. Flood MD MS, Neil Margolis Ph.D., Vlad Kozlovsky, Sandeep K. Reddy MD

Abstract #56, Poster Session and Number: C – Anal and Colorectal Cancer

Location: Moscone West Building, Level 1, West Hall

Date and Time: January 25, 2020, 6:30-7:55 AM PT and 12:15-1:45 PM PT

"Our Eviti platform enables access to near-real time data on physician behavior which can provide unique and critical information to pharma, payers, and provider networks to optimize treatment strategies," said Sandeep "Bobby" Reddy, MD, Chief Medical Officer, NantHealth.