Torque and Thermo Fisher Scientific Announce Collaboration to Build State-of-the-Art Facility to Manufacture Torque’s Deep-Primed T Cell Immunotherapies

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

PharmaCyte Biotech Nearing Major Milestone—An Open IND with the FDA

On February 4, 2019 PharmaCyte Biotech (OTCQB: PMCB) is now closer than ever to reaching what would be a monumental milestone in the company’s history (Press release, PharmaCyte Biotech, FEB 4, 2019, View Source [SID1234533033]). Years of patience from PharmaCyte’s shareholders has now likely been whittled down to what should now be just months, and with the condensed timeline, the company is reported that this is approved Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for its development of a treatment for patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PharmaCyte is a California-based biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box. When the company recently announced that it had successfully encapsulated the live cells used in its therapy for patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC), and that those cells are now growing and dividing inside the Cell-in-a-Box capsules, the news seemed to suggest that all of the pieces necessary to complete and submit the long overdue IND application to the FDA are falling into place for the company’s upcoming clinical trial in the treatment of LAPC.

After enduring what has been a lengthy and time-consuming checklist of FDA-required tests, reports, documents and meetings, PharmaCyte’s shareholders should take comfort in knowing that the list of items they’re waiting on has now been trimmed to (1) the encapsulated live cells fully filling the Cell-in-a-Box capsules, (2) the fully-filled capsules being placed into syringes and frozen, (3) FDA-required testing of the capsules, and finally (4) the writing of the reports and submission of the IND application to the FDA.

Currently, PharmaCyte’s submission of an IND application is what has its shareholder’s attention, but it is what an FDA approval of that application would mean for PharmaCyte that will soon garner the most attention. Once the FDA has approved the company’s IND application for Cell-in-a-Box + low doses of ifosfamide to treat LAPC, the FDA’s approval will officially permit PharmaCyte to open clinical activities throughout the country.

After speaking with PharmaCyte’s Chief Operating Officer, Gerald W. Crabtree, we learned that an open IND is key to PharmaCyte realizing a number of benefits that include:

PharmaCyte can begin the formal arrangements required to conduct its clinical trial in LAPC.
PharmaCyte can begin working towards the major milestone of enrolling the first patient in its clinical trial.
PharmaCyte can publish that the technology behind its LAPC treatment has passed the incredibly difficult FDA screening process and met all of the FDA’s regulatory requirements.
An open IND gives PharmaCyte credibility in terms of delivering on an FDA clinical trial and persevering through a number of setbacks and delays.
Having an open IND with the FDA will offer global exposure of PharmaCyte’s Cell-in-a-Box technology.
PharmaCyte could begin to credibly seek a joint venture/partner in developing its therapy for LAPC if it should choose to go that route.
And because the therapy is the same, it would also allow PharmaCyte to credibly pitch the Cell-in-a-Box technology to joint venture/partners to develop its therapy for malignant ascites fluid.
PharmaCyte could also credibly pitch the Cell-in-a-Box technology to joint venture/partners to develop its therapy to treat cancer using the constituents of the Cannabis plant (cannabinoids).
An open IND also signals that many of the major hurdles PharmaCyte faced to get the FDA to approve the initiation of a clinical trial using its unique encapsulation material will not have to be replicated again—meaning that the FDA’s list of extensive requirements related to the capsules that contain live cells for the treatment of diseases will have been met—paving the way for the development of treatments for diabetes and a host of solid tumors.
The upcoming trial will be PharmaCyte’s first-ever clinical trial, and the company’s novel and complex therapy will address what world-renowned oncologist, Dr. Manuel Hidalgo, the trial’s Principal Investigator, says is a therapy to treat "an unmet medical need where there is no effective therapy after the first-line therapy no longer provides any further benefit to a patient."

Should PharmaCyte’s IND submission receive approval from the FDA, the clinical trial may proceed 30 calendar days from the submission date of the IND. And the good news for investors is as Dr. Hidalgo says, "If the results are very positive, these results may pave the way for an accelerated approval process through one or more avenues afforded by the FDA."

The Union For International Cancer Control And Pfizer Announce New Phase Of Global Grants Initiative Supporting Metastatic Breast Cancer Patients

On February 4, 2019 In conjunction with World Cancer Day, the Union for International Cancer Control (UICC) and Pfizer Inc. reported the third round of the Seeding Progress And Resources for the Cancer Community (SPARC): Metastatic Breast Cancer (MBC) Challenge: their pioneering grants initiative designed to support the implementation of projects worldwide that address the specific needs of women with metastatic breast cancer in local communities – many of which extend beyond treatment (Press release, Pfizer, FEB 4, 2019, View Source [SID1234533050]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A total of US$275,000 in funding will be awarded to 10 new organizations, bringing the SPARC awardees network to 50 cancer organizations from all across the globe with a total funding of US$1,565,000. As part of this new round, five grantees from Round 2 of the SPARC MBC Challenge will receive additional funding to continue their projects.

In addition to receiving the seed grant to support their projects, the new awardees will benefit from trainings, best-practice sharing workshops, and mentoring. They will also have the opportunity to participate in key global convening cancer events to network, share knowledge, and showcase their work.

Dr Cary Adams, Chief Executive Officer of the Union for International Cancer Control, said: "We are proud that, together with Pfizer, we will continue to improve the lives of people living with metastatic breast cancer cross the world through this unique programme that combines seed grants, mentoring and peer-to-peer
learning."

The impact of the SPARC MBC Challenge has been significant. Since the initiative launched in 2015, over 8,000 patients from 30 countries have been reached directly through SPARC projects, and more than 125,000 people have benefitted from SPARC advocacy campaigns and information materials. Organizations such as Project Pink Blue and Run for a Cure Africa have reached the next level receiving international awards and additional funds after receiving the SPARC grant. In particular, SPARC contributed to:
Supporting metastatic breast cancer patients through projects such as the creation of an online app to guide patients in finding financial resources to cover some of the expenses of the disease in Canada; a project for young women to better cope with MBC through integrative oncology techniques (occupational therapy, expressive creative techniques, mind body intervention, and acupuncture) in Mexico and training for patients on the importance of treatment adherence in Bulgaria
Strengthening advocates and supporting the development of a positive national policy environment for MBC. SPARC projects have delivered training on advocacy for metastatic breast cancer for individuals from 47 European countries, supported the recent inclusion of medicines for MBC in the National Essential Medicines list in Kyrgyzstan and contributed to the development of supportive national legislation on cancer in Brazil and Nigeria.
Reducing the information gap for patients, with information materials and advocacy campaigns created in 26 local languages. SPARC enabled the creation of the first navigational programs in Nigeria and Trinidad & Tobago.
Building local capacity. Nearly 2,000 health professionals were trained on how to manage the specific needs of MBC patients across all SPARC projects. In Australia, an e-learning training was deployed across the country to help nurses better attend to the needs of MBC patients.
"We’re proud of the far-reaching impact that the SPARC MBC Challenge has had over the past four years on metastatic breast cancer patients around the world, ranging from educational resources to tailored programming," said Andy Schmeltz, Global President, Pfizer Oncology, "With our ongoing partnership with UICC and this year’s renewal, we look forward to continuing to make a difference for breast cancer patients around the globe."

Applications to the new round of the SPARC grants will open at the end of February and new SPARC awardees will be announced in October 2019.

About the Seeding Progress and Resources for the Cancer Community (SPARC): Metastatic Breast Cancer (MBC) Challenge

The SPARC MBC Challenge aims to address critical issues for those at risk of, or living with metastatic breast cancer. The SPARC grants consist of seed-funding, capacity building and convening opportunities to launch and strengthen new projects addressing the needs of MBC patients. Awardees are integrated into the SPARC network where they can share best practices, learn from others and share resources between themselves. The awardees are selected by an independent, external steering committee, consisting of leading experts in the fields of cancer care and chaired by globally renowned oncologist and leading breast cancer advocate, Dr Fatima Cardoso.

Calithera Biosciences Completes Patient Enrollment in Randomized Phase 2 ENTRATA Trial of Telaglenastat (CB-839) and Everolimus in Renal Cell Carcinoma

On February 4, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that it has completed patient enrollment in the ongoing Phase 2 ENTRATA trial. ENTRATA is a randomized clinical study of the glutaminase inhibitor CB-839 combined with everolimus versus placebo with everolimus for the treatment of advanced renal cell carcinoma (RCC) (Press release, Calithera Biosciences, FEB 4, 2019, View Source [SID1234535231]). CB-839 now has the International Nonproprietary Name (INN) telaglenastat, as recommended by the World Health Organization.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The ENTRATA trial is the first randomized trial evaluating the glutaminase inhibitor telaglenastat. There is ample evidence demonstrating the potential of glutaminase inhibition to block growth and survival of cancer cells," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are pleased that patient enrollment is now complete and look forward to learning more from ENTRATA about how this promising mechanism could help heavily pre-treated patients with advanced renal cancer."

The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including a VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report efficacy and safety data from the trial in the second half of 2019.

Telaglenastat is an investigational, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. RCC tumors commonly exhibit metabolic alterations that increase their dependence on glutamine. In preclinical studies, telaglenastat produced synergistic antitumor effects when used in combination with standard-of-care RCC therapies.

Telaglenastat is also being investigated in the CANTATA trial, which will enroll approximately 400 patients and is designed with registrational intent. It is a global, randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced clear cell RCC who have been treated with one or two prior lines of systemic therapy. The primary endpoint is PFS by blinded independent review, and a key secondary endpoint is overall survival.

Curis, Inc. to Present at the 2019 BIO CEO & Investor Conference

On February 4, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that James Dentzer, President and Chief Executive Officer, will present at the 2019 BIO CEO & Investor Conference on Tuesday, February 12th, at 10:30 a.m. EST in the Hudson/Empire Room at the Marriott Marquis in New York City (Press release, Curis, FEB 4, 2019, View Source;investor-conference-300787029.html [SID1234533034]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available on the Company’s website: www.curis.com. The webcast will be archived for 90 days.