On February 4, 2019 Syntrix Pharmaceuticals reported that it has been awarded a three-year grant worth $3.4 million from the National Heart Lung and Blood Institute of the National Institutes of Health to assess its investigational CXCR1/2 inhibitor SX-682 in patients with low- and high-risk myelodysplastic syndrome (MDS) who had progression or were intolerant to prior therapy (Press release, Syntrix, FEB 4, 2019, View Source [SID1234553882]). The phase 1/2 clinical trial will be carried out in collaboration with researchers at the Moffitt Cancer Center led by Dr. Rami Kamrokji.

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"Patients with low-risk MDS have an expected median survival measured in years, but suffer from hematologic deficits and related symptoms that lead to transfusion dependence," said Syntrix’s President John Zebala. "Patients with high-risk MDS have debilitating cytopenias and borderline leukemia, and can have expected survival measured in months."

Only three drugs have received regulatory approval for MDS treatment, all with suboptimal response rates (<50%) and of limited durability (1-2 years). Once these agents fail in patients, there is no second-line treatment. Prognosis after failure is dismal, with median survival estimated at <6 months for higher-risk patients, and <18 months for lower-risk patients.

The Phase 1/2 clinical trial of SX-682 builds on groundbreaking discoveries by investigators at the Moffitt Cancer Center and the Albert Einstein College of Medicine who showed CXCR1/2 is pivotal in MDS and that its inhibition is a therapeutic strategy against the disease.

This Phase 1/2 trial in MDS patients will test the hypothesis that targeting CXCR1/2 with SX-682 will be efficacious in the disease by eliminating the MDS stem cells and bone marrow MDSCs. The FDA approved the protocol for the study in an IND sponsored by Syntrix.

ABOUT SX-682: SX-682 is a clinical-stage oral allosteric small-molecule inhibitor of CXCR1 and CXCR2 (CXCR1/2). Inhibiting both human receptors is believed essential. CXCR1/2 are a combined "master switch" of the immunosuppressive tumor microenvironment. Clinical studies in melanoma, breast, ovarian, prostate and colon cancer have shown a direct correlation between serum levels of CXCR1/2 ligands and disease progression. SX-682 has been validated in all major solid tumor models, where it exhibits mono-agent anti-tumor activity, blocks metastasis, depletes immunosuppressive myeloid cells, activates tumor killing by effector cells, reverses chemo-resistance, and potently synergizes with anti-CTLA-4 and anti-PD1. SX-682 is also being evaluated in solid tumors supported by the National Cancer Institute.

On February 4, 2019 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the retention of worldwide rights for its novel antibody, SRF388, targeting IL-27 (Press release, Surface Oncology, FEB 4, 2019, View Source [SID1234533066]). This program was previously subject to Surface’s collaboration with Novartis. IL-27 is a novel target in immuno-oncology, believed to play a significant and broad role in tumor-related immunosuppression via the regulation of checkpoint protein expression.

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"SRF388 is an ideal program for Surface Oncology. We have conducted significant preclinical and translational work to understand IL-27’s role in specific tumor types and have a focused translational strategy as we advance this program into clinical development," said Jeff Goater, chief executive officer of Surface Oncology. "We are pursuing an aggressive development timeline for SRF388, with an IND filing planned for the fourth quarter of this year."

Based on the terms of the 2016 agreement with Novartis, IL-27 was one of a set of predefined targets for which Novartis had a right to purchase an option, subject to certain financial conditions. Novartis has elected to not purchase an option for SRF388 and as a result full rights remain with Surface Oncology.

Currently, Surface Oncology is conducting IND-enabling studies for both SRF388 and its wholly owned CD39 program, SRF617, and anticipates submission of both INDs in Q4 of 2019.

ABOUT SRF388

SRF388 is a fully human anti-IL-27 antibody. In preclinical studies, treatment with SRF388 was observed to block IL-27 signaling and its downstream immunosuppressive effects. Preclinical combination with a PD-1 inhibitor increased the production of key inflammatory cytokines. SRF388 also demonstrates preclinical anti-metastatic tumor activity.

On February 4, 2019 Torque, an immuno-oncology company developing first-in-class Deep Primed T Cell Therapeutics to direct immune power deep within the tumor microenvironment, and Thermo Fisher Scientific Inc. (NYSE: TMO), reported a collaboration to build a dedicated Slipstream manufacturing facility for high-efficiency production of Torque’s Deep-Primed T cell immunotherapies (Press release, Torque Therapeutics, FEB 4, 2019, View Source [SID1234553883]).

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Buildout of the Torque/Thermo Fisher manufacturing facility has begun, and the companies anticipate processing patient cells by the end of 2019. The Slipstream platform will initially be used in the clinical development of Torque’s lead Deep-Primed T cell candidate, TRQ-1501, in solid and hematologic tumors; followed by TRQ-1201, also for solid and hematologic tumors.

"Torque’s cell manufacturing technology platform is critical to achieving our goal of developing and commercializing a new class of cellular immunotherapy for cancer patients with both early and advanced disease, particularly for the large population of solid tumor patients in need of new treatments," said Bart Henderson, CEO of Torque. "We are very excited about partnering with Thermo Fisher to build this state-of-the-art manufacturing facility because of their vision and exceptional track record in building high-efficiency, globally integrated operations. This is a pioneering manufacturing partnership with the goal of dramatically improving the efficiency and scalability of producing best-in-class cellular immunotherapy products that have the potential to benefit a significant number of cancer patients."

"Thermo Fisher is dedicated to advancing precision medicine, and our collaboration with Torque is a tangible example of the progress we are making to become a recognized leader in cell therapy manufacturing," said Michel Lagarde, President of Pharma Services for Thermo Fisher Scientific. "We are pleased to partner with Torque to build and launch this unique and advanced manufacturing facility utilizing the Slipstream technology, Torque’s innovative cellular immunotherapy product, which has the potential to transform cancer treatment and patients’ lives."

The Slipstream platform technology situated in Princeton is a revolutionary design that uses a fully closed, semi-automated system that surpasses conventional cell therapy manufacturing techniques. The Slipstream process leverages advanced logistics that enable a substantially smaller manufacturing footprint that is less capital- and labor-intensive. Production capacity can be expanded modularly by adding arrays in Lego-like fashion.

About Slipstream Cell Therapy Manufacturing Technology
Slipstream is a proprietary, high-efficiency T cell manufacturing platform engineered by Torque. Currently marketed immune cell therapies are produced using open, complex, labor- and cost-intensive processes that require a substantial manufacturing facility. In contrast, Slipstream production is semi-automated and fully closed, which eliminates contamination risk between transfers and can dramatically reduce staffing requirements and the factory footprint. The cell engineering process uses a modular design that enables both large-scale and decentralized manufacturing. Slipstream has the potential to improve manufacturing efficiency beyond what is possible with currently used cell therapy manufacturing processes and to move cell therapy production closer to the point of care.

About Torque’s Deep-Primed Immune Cell Therapy Platform
Torque’s Deep-Priming platform uses advanced cell process engineering to:

prime and activate T cells to target multiple tumor antigens and
tether immune-stimulatory drugs to the surface of these multi-target T cells to direct immune activation in the tumor microenvironment
using a proprietary technology platform, without genetic engineering, for a high margin of safety.
Deep-Primed T cells both target multiple tumor antigens and pharmacologically activate an immune response with anchored cytokines. This process does not require genetic engineering of the T cells and so preserves the natural T cell receptor for delivering a regulated immune response, with the potential for a high margin of safety. In addition to antigen priming, immunomodulators are tethered to the surface of Deep-Primed T cells—initially IL-15 and IL-12 cytokines, and TLR agonists—that activate both innate and adaptive immunity. Administering these immunomodulators systemically to a patient can cause lethal toxicity by activating immune cells throughout the body. By loading precise doses of cytokines onto the surface of T cells, Deep Priming focuses the immune response to target the tumor, without systemic exposure.

In hematologic cancers, this new class of immune cell therapeutics has the potential to improve on the initial success of single-target CAR T therapeutics with expanded efficacy and also move cell therapy treatment out of the hospital with a high margin of safety. For solid tumors, Deep-Primed T cells have the potential to enable efficacy against tumors with heterogeneous antigens protected by hostile microenvironments, which are not readily addressable with the first generation of immune cell therapies.

On February 4, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced today that Adelene Perkins, Infinity Pharmaceutical’s Chief Executive Officer, will present at the BIO CEO & Investor Conference on Monday, February 11, 2019, at 10:00 a.m. EST at The New York Marriott Marquis in New York, NY (Press release, Infinity Pharmaceuticals, FEB 4, 2019, View Source [SID1234533031]). A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event

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On February 4, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that management will present company overviews at the following conferences (Press release, Alnylam, FEB 4, 2019, View Source [SID1234533048]):

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21st Annual BIO CEO & Investor Conference on Monday, February 11, 2019 at 1:30 pm ET at the Marriott Marquis in New York City

8th Annual SVB Leerink Global Healthcare Conference onWednesday, February 27, 2019 at 10:30 am ET at the Lotte New York Palace Hotel in New York City

A live audio webcast of each presentation will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after each event.