Uncategorized – Page 15252 – 1stOncology™: Cancer Intelligence Service

Recombinetics announces new CEO

On February 11, 2019 Recombinetics reported that named Mark Platt the organization’s Chief Executive Officer (Press release, Recombinetics, FEB 11, 2019, View Source [SID1234533249]).

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"Recombinetics is at the forefront of innovative research and development to address issues of global significance, like feeding the hungry, improving population health and the humane treatment of animals," Platt says. "I’m joining at this transformational time to ensure the organization and its strategic investors thrive, with all aligned to positively impact people, places and animals at home and abroad."

"Our organization will benefit greatly from Mark’s leadership experience," says Peter Hajas, chairman of the Board, Recombinetics. "Mark brings an excitement for the possibilities of our innovative work and is the right person to guide our corporate culture and nurture relationships with key stakeholders to achieve goals of improving human lives, feeding the world’s growing population, and reducing animal suffering."

Platt’s experience includes his time as President and CEO of Multistack, LLC, in Sparta, Wis., where he provided strategic long-term direction of the company and was directly involved in emerging technology, research and development. From 2002 to 2012, Mark led the company through its highest period of growth, with total revenue increasing by more than 1,000 percent.

Most recently Executive Sales Leader at the Trane, Inc. Midwest sales office, Platt played a role in doubling the organization’s market share in less than two years. He was also Senior Vice President of Business Services for Gundersen Health System from November 2013 to April 2017. In this role, Platt oversaw business development and marketing, government relations, supply chain, facility operations and community wellness initiatives. He has also served on the Gundersen Board of Trustees.

Platt received his bachelor’s degree in electrical engineering from Vanderbilt University, Nashville, Tenn. He was also a commissioned officer in the U.S. Air Force with 17 years of service and held the rank of captain in the U.S. Air Force Reserve.

Tammy Lee, who served as President and CEO of Recombinetics since August 2017, is taking a leave of absence from the company. Recombinetics thanks Lee for her leadership, which included securing $34 million for the company’s Series A financing round.

NeoTX Therapeutics Announces Immuno-Oncology Clinical Trial Collaboration with AstraZeneca

On February 11, 2019 NeoTX Therapeutics, Ltd reported that it has entered into a clinical collaboration with AstraZeneca Group Plc (NYSE: AZN) global biologics research and development arm, MedImmune, to support Phase 1b/2 studies investigating NeoTX’s naptumomab estafenatox ("naptumomab") in combination with IMFINZI (durvalumab) (Press release, NeoTX, FEB 11, 2019, View Source [SID1234640360]). These studies are expected to begin in 2019. Naptumomab is the lead drug in NeoTX’s novel Selective T cell Redirection ("STR") platform.

Naptumomab’s dual mechanism of action coats the tumor with a target that can be easily identified by T cells and then primes and redirects specific activated T cells that can identify that target, to the tumor.

Durvalumab is a human monoclonal antibody that blocks the immune checkpoint protein, programmed death-ligand (PD-L1), and allows activated T cells to attack tumor cells.

The Phase 1b/2 studies will determine the maximum tolerated dose (MTD) of naptumomab in combination with durvalumab, evaluate the clinical response, safety and tolerability of the combination, as well as test for multiple pharmacodynamic parameters.

Under terms of the agreement, NeoTX and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in solid tumors. NeoTX will sponsor the study, while AstraZeneca will supply durvalumab. Up to 195 patients are planned to be enrolled in this multicenter, open-label study.

"We are pleased to work with AstraZeneca addressing the high unmet medical need of patients with tumors for which checkpoint inhibitor therapy has had little success," said Asher Nathan, NeoTX Therapeutics’ Chief Executive Officer. "The safety profile of naptumomab alone and in combination with interferon has been demonstrated in clinical studies in hundreds of patients with solid tumors. Naptumomab can enhance T cell activation and infiltration in tumors and can remodel the immunosuppressive tumor microenvironment. In preclinical models, naptumomab has a synergistic effect with checkpoint inhibitors which could translate into durable responses in patients."

ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT

On February 11, 2019 Enzo Biochem, Inc. (the "Company"), along with its subsidiary Enzo Life Sciences, Inc. reported that it has entered into a Settlement Agreement as of February 5, 2019 (the "Agreement") with Roche Diagnostics GmbH and Roche Molecular Systems, Inc. (together, "Roche") with respect to an action between the Company and Roche before the U.S. District Court, Southern District of New York, Case No 04-CV-4046. Roche has agreed to pay $21,000,000 in settlement pursuant to the Agreement (Press release, Enzo Biochem, FEB 11, 2019, View Source [SID1234533206]). This settlement does not affect Enzo’s civil action for patent infringement against Roche in the U.S. District Court for the State of Delaware, Enzo Life Sciences Inc. v. Roche Molecular Systems Inc., et al., civil action no. 12-cv-00106, which remains pending on appeal. The Agreement is filed with this current report as Exhibit 10.1 and incorporated herein by reference.

Precigen Announces Clearance of IND to Initiate Phase 1 Study for First-in-Class PRGN-3005 UltraCAR-T™ to Treat Advanced Stage Platinum Resistant Ovarian Cancer Patients

On February 11, 2019 Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, reported that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Precigen’s PRGN-3005, a first-in-class investigational therapy using autologous chimeric antigen receptor T (CAR-T) cells to treat advanced-stage platinum-resistant ovarian cancer patients (Press release, Intrexon, FEB 11, 2019, View Source [SID1234533229]).

PRGN-3005 is the second candidate to clear IND utilizing Precigen’s transformative UltraCAR‑T platform that reduces manufacturing time to less than two days following non-viral gene transfer. PRGN-3005 UltraCAR-T is a multigenic CAR-T cell treatment utilizing Precigen’s clinically-validated Sleeping Beauty system to co-express a chimeric antigen receptor, membrane-bound interleukin‐15 (mbIL15), and a kill switch for better precision and control in targeting advanced ovarian cancer. This is an open-label, first-in-human Phase 1 dose escalation study to evaluate the safety and maximal tolerated dose of PRGN‐3005 UltraCAR-T.

"This patient population has limited treatment options and ovarian cancer remains one of the most challenging with minimal advances in long-term survival for patients with advanced disease," said Mary L. (Nora) Disis, MD, professor of medicine at the University of Washington and lead investigator for the PRGN-3005 study. "Clinical advancements and new research, including the PRGN-3005 UltraCAR-T study, are needed to make progress in fighting this intractable disease."

Precigen’s UltraCAR-T platform has the potential to disrupt the CAR-T treatment landscape by increasing patient access through shortening manufacturing time, decreasing manufacturing-related costs, and improving outcomes using advanced approaches for precise tumor targeting and control of the immune system. The platform brings several key advancements:

Non-viral gene transfer using multigenic vectors for expression of multiple effector genes leads to better precision and control of tumor targeting and eliminates the need for virus;
Sustained persistence and desired phenotype of infused UltraCAR-T helps address T-cell exhaustion, a common issue with current CAR-T therapies;
T-cell control by incorporation of kill switch technology to potentially improve the safety profile; and
Rapid manufacturing of UltraCAR-T cells using our proprietary non-viral gene transfer process, eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to less than two days.
"We are pleased our PRGN-3005 UltraCAR-T investigational therapy received clearance from the FDA to advance into the clinic. This is an exciting milestone as it represents the first UltraCAR-T to enter the clinic targeting solid tumors," said Helen Sabzevari, PhD, President of Precigen. "This is an important step for patients and our dedicated employees who continue to work with urgency to execute our important mission of creating innovative medicines with meaningful benefit for patients."

About Ovarian Cancer
Worldwide, nearly 300,000 women are diagnosed with ovarian cancer every year1 and around 22,000 are diagnosed in the US2. Five-year survival rates depend on stage and type of ovarian cancer; however, stage IV survival can drop to as low as 20 percent.3.

Precigen : Advancing Medicine with Precision
Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cellular therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. Precigen also follows the science opportunistically in pursuit of promising programs in emerging therapeutics. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. Precigen was founded as a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and leverages Intrexon’s proprietary technology platforms to advance human health. For more information about Precigen, visit www.precigen.com.

1World Health Organization, International Agency for Research on Cancer, Global Cancer Observatory. Cancer Today, Estimated number of new cases in 2018, worldwide, both sexes, all ages. Accessed December 2018 via WHO IARC GCO website.
2American Cancer Society Ovarian Cancer Special Section. Access December 2018 via ACS website.
3American Cancer Society. Survival Rates for Ovarian Cancer, by Stage. Accessed December 2018 via ACS website.

Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to plans, objectives and expectations for the development of our business, including the timing and progress of preclinical and clinical trials and discovery programs. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.

IMMUNOMEDICS ANNOUNCES ORAL PRESENTATION AT THE 2019 GENITOURINARY CANCERS SYMPOSIUM

On February 11, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that updated data with longer follow-up on sacituzumab govitecan, its lead investigational ADC, in patients with metastatic urothelial cancer (mUC) who have relapsed or are refractory to chemotherapies and immune checkpoint inhibitors (CPIs), have been accepted for an oral presentation at this year’s Genitourinary Cancers Symposium (ASCO-GU) (Press release, Immunomedics, FEB 11, 2019, View Source [SID1234533208]).

As reported in the abstract released online, sacituzumab govitecan produced an overall response rate (ORR) of 31 percent in 45 heavily-pretreated mUC patients, with an encouraging median duration of response of 12.6 months and median progression-free survival of 7.3 months. Consistent with prior reports, the updated safety profile demonstrates that sacituzumab govitecan is generally well tolerated and manageable relative to other available therapies. Further data on subgroups will be presented at the meeting.

"Despite the late-stage setting, sacituzumab govitecan continues to show promising activity in patients who failed current standard of care for mUC," said Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics. "We believe these results support further investigation in a pivotal Phase 2 TROPHY U-01 study.

The trial design of TROPHY U-01 is the subject of the second presentation at ASCO (Free ASCO Whitepaper)-GU. Details of the two presentations are listed below (all times are in Pacific Time):

Friday, February 15, 2019

Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a Phase I/II study (Tagawa, et al.)

Oral Abstract Session B: Urothelial Carcinoma & Penile, Urethral, Testicular, & Adrenal Cancer

Abstract # 354

1:45 pm – 1:55 pm

Level 3 – Ballroom

Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, Testicular, and Adrenal Cancers

Board B5

12:15 pm -1:45 pm and 5:15 pm – 6:15 pm

Level 1 – West Hall

TROPHY U-01: A Phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy (Tagawa, et al.)

Trials in Progress Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, Testicular, and Adrenal

Abstract TPS495

Board N5