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Category: Therapeutics

Blue Cross Blue Shield of Massachusetts Expands Medicare Network to Include Iora Health

BOSTON, Nov. 19, 2018 /PRNewswire/ — Blue Cross Blue Shield of Massachusetts (Blue Cross) announced today an expansion of its Medicare provider network to include Iora Health.

Iora Primary Care, Iora Health’s consumer brand, began accepting Blue Cross Blue Shield Medicare Advantage plans on October 1, 2018. This means that Medicare beneficiaries with an Iora Primary Care provider now have the option to select Blue Cross as their Medicare carrier.

“We are thrilled to welcome Iora Health into our Medicare network,” said Stephanie Lovell, Blue Cross’ executive vice president of Medicare. “They are a wonderful addition to our Medicare network because their relationship-based care model complements our commitment to providing high-quality care that puts members first.”

“Iora Primary Care is a primary care doctor’s office for adults on Medicare. We know that when you invest in relationships with people, you can help them live happier and healthier,” said Iora Primary Care Northeast Medical Director Neil Patel. “We’re thrilled to partner with Blue Cross Blue Shield of Massachusetts to care for more Medicare patients in Massachusetts, the state where Iora got its start and is still headquartered.”

Iora Primary Care has practices in Hyde Park and Medford.

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TraceLink Achieves 55% Overall Revenue Growth for Q3 2018

NORTH READING, Mass., Nov. 19, 2018 /PRNewswire/ — TraceLink Inc., the world’s largest integrated digital supply network, providing real-time information sharing for better patient outcomes, today announced financial and company results for the third quarter of 2018.

Financial growth highlights for Q3 2018 include:

  • A 55 percent year-over-year increase in Q3 revenue, including growth in the following regions:
    • 165 percent revenue growth in EMEA;
    • 145 percent revenue growth in APAC; and,
    • 63 percent revenue growth in India.
  • A 53 percent year-over-year increase in all bookings for Q3, including a 120 percent increase in EMEA bookings for the quarter;
  • A two-year revenue compound annual growth rate (CAGR) of 71 percent;
  • A total of 1,016 customers by the end of Q3, representing a 46 percent year-over-year increase in total customers, located across 44 countries, including:
    • 63 percent representing pharmaceutical and contract manufacturers;
    • 5 percent representing wholesale distributors, 3PLs and repackagers; and
    • 32 percent representing pharmacies, hospitals, clinics and health systems

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Promentis Pharmaceuticals Announces Successful Completion of Phase 1 Studies for SXC-2023 Targeting Novel Glutamatergic Mechanism

MILWAUKEE,  /PRNewswire/ — Promentis Pharmaceuticals, Inc, a privately-held biopharmaceutical company developing innovative therapies for neuropsychiatric disorders, today announced it has completed Phase 1 single ascending dose and multiple ascending dose studies for its lead compound, SXC-2023.  SXC-2023 has demonstrated a compelling profile across a range of non-clinical studies. Promentis is developing SXC-2023 and other compounds that engage System xc-, a central nervous system (CNS) target addressing glutamatergic imbalance and oxidative stress, to treat impulse control disorders, obsessive-compulsive disorder and other neuropsychiatric diseases.

The aim of the Phase 1 studies was to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of SXC-2023.  In the first study, single ascending doses were evaluated in six cohorts, with a total of 48 subjects. In the second study, SXC-2023 was administered daily for 14 days within four different dose groups. SXC-2023 proved to be safe and well-tolerated over a wide dose range in healthy volunteers in both the SAD and MAD studies, and demonstrated a very consistent PK profile. There were no significant adverse events and no treatment-related discontinuations in either study.

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CareStack® Partners with Callpop to Expand Patient Communication Capabilities for Dental Practices Nationwide

CareStack to Integrate Callpop’s Phone Device and Software Application onto Enterprise Cloud-based Practice Management Platform to Enhance Patient Scheduling and Practice Operations

Celebration, FL and American Fork, UT – November 14, 2018 – CareStack®, a cloudbased technology platform for the dental industry and Callpop, a leading provider of solutions that integrate dental practice phone systems with existing practice management solutions, today announced they will partner to integrate Callpop’s communication platform into CareStack’s enterprise cloud-based practice management and clinical platform to help dental practices across the United States effectively communicate with patients and streamline administrative workflows. Since the launch of the platform in 2017, CareStack has rapidly grown to more than 100 dental groups which represents over 500 offices across the country.

“We are excited to partner with Callpop to bring more real-time patient communication to our enterprise cloud-based platform. Today’s busy patients and parents expect real-time communication capabilities, and we continue to equip practices with tools to provide an exceptional patient experience and streamline their operations,” said Ben Walling, Chief Product Officer of CareStack. “CareStack is continually increasing the breadth of the capabilities on our platform and introducing additional modules for finance, order management, and patient management. By incorporating Callpop’s technology onto our enterprise platform our dental practices will be able to better automate scheduling, more easily access patient health history, and optimize overall front office efficiency.”

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Precision BioSciences and MaxCyte Enter into Clinical and Commercial License Agreement

Precision BioSciences and MaxCyte Enter into Clinical and Commercial License Agreement 
Precision BioSciences gains rights to MaxCyte’s cell engineering technology to develop next-generation, oncology-focused, cell therapies with Precision’s ARCUS® genome-editing technology

DURHAM, NC, and GAITHERSBURG, MD, November 14, 2018 – Precision BioSciences (Precision) and MaxCyte today announced they have entered into a non-exclusive, clinical and commercial license agreement that will allow Precision to use MaxCyte’s Flow Electroporation® technologies to robustly deliver Precision’s proprietary ARCUS genome-editing technology for use in next-generation gene edited allogeneic T-cell immunotherapies designed to treat a broad range of cancers.

David Thomson, Chief Development Officer of Precision, expressed his support for the agreement, noting, “Precision’s therapeutic grade ARCUS editing platform is sufficiently compact and specific to use with a range of delivery systems. In considering these, we have found MaxCyte’s electroporation technology complements our approach to allogeneic T-cell manufacturing, which is focused on preserving cell quality throughout the process while maximizing overall yield.”

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Tempest Therapeutics Reports Proof of Mechanism Data for First-in-Class PPAR Alpha Antagonist

SAN FRANCISCO — Tempest Therapeutics Inc. presented a poster at the Society for Immunotherapy of Cancer annual meeting in Washington, D.C., describing lead compound TPST-1120’s two-pronged mechanism of directly targeting tumor cells dependent on fatty acid metabolism and driving a metabolic shift in the tumor microenvironment to glycolysis from fatty acid oxidation. The resulting significant reductions in tumor growth and stimulation of durable anti-tumor immunity support Tempest’s rationale to advance the first-in-class oral small molecule inhibitor of PPAR alpha into clinical studies in patients with advanced solid tumors in early 2019.

The poster titled “Antagonism of Peroxisome Proliferator Activated Receptor Alpha (PPARα) by TPST-1120 Suppresses Tumor Growth and Stimulates Anti-Tumor Immunity” describes studies that demonstrate significant anti-tumor efficacy of TPST-1120. As monotherapy, TPST-1120 prevented fatty acid oxidation and directly inhibited primary human tumor cells in culture and in human tumor xenografts in immune-deficient mice. In tumor-bearing immune-competent animals, TPST-1120 inhibited tumor growth as a single agent and in combination with chemotherapy or with anti-PD-1 antibodies.

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Modis Therapeutics Announces Prime Designation Granted by the European Medicines Agency to MT1621 for the Treatment of TK2 Deficiency

Oakland, Calif., November 13, 2018 – Modis Therapeutics announced today that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation to MT1621, Modis’ investigational treatment for patients with thymidine kinase 2 deficiency (TK2d).

The PRIME designation is awarded by the EMA to promising medicines that target an unmet medical need. Since the program was launched in March 2016, the EMA has granted PRIME designation to only 36 medicines (21% of 177 requests). Our application was supported by data from initial clinical studies in TK2d patients, some of which was presented by Dr. Michio Hirano at the International World Muscle Society (WMS) Congress last month.

“We are pleased that MT1621 has been granted PRIME designation by the EMA,” said Joshua Grass, Chief Executive Officer of Modis Therapeutics. “We believe this designation from a major health authority provides validation of our clinical data and therapeutic approach and recognition that TK2 deficiency represents a significant unmet medical need. We look forward to collaborating with the EMA to accelerate development of this important therapy for patients with TK2 deficiency.”

MT1621 has also been granted Orphan Drug designation by both the FDA and EMA.

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NMPA Accepts Biosimilar New Drug Application for IBI303, a Biosimilar Candidate to Humira(R) (adalimumab)

SUZHOU, China, Nov. 12, 2018 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that National Medical Products Administration (NMPA, successor to CFDA) has accepted its new drug application (NDA) for adalimumab biosimilar candidate (IBI303). IBI303 is a recombinant human anti-TNF-α monoclonal antibody independently developed by Innovent for the treatment of ankylosing spondylitis (AS), rheumatoid arthritis (RA) and psoriasis.

This is Innovent’s second NDA accepted by the NMPA.

Branded adalimumab (Humira) has been globally recognized for its high efficacy and acceptable safety profile. Its adoption rate in China is relatively low despite the clinical demand for TNF-α antagonists is huge with high unmet medical needs in China. Innovent’s adalimumab biosimilar candidate (IBI303) offers a high-quality and affordable alternative to Chinese patients.

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Unum Therapeutics to Present Preclinical Data on Applications of ACTR Proprietary Technology Platform in Solid Tumors at the San Antonio Breast Cancer Symposium

Initiating Phase 1 ATTCK-34-01 Trial in HER2+ Advanced Cancers by Year-End

CAMBRIDGE, Mass., Nov. 09, 2018 (GLOBE NEWSWIRE) — Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of novel cellular immunotherapies, today announced that the Company will present preclinical data on the potential of its proprietary ACTR technology in HER2+ solid tumors and details on the design of its planned Phase 1 clinical trial to test ACTR707 in combination with trastuzumab at the upcoming San Antonio Breast Cancer Symposium taking place December 4-8, 2018 in San Antonio, Texas.

In preclinical testing, Unum has demonstrated robust activity of its proprietary ACTR T cells in combination with trastuzumab. Importantly, preclinical data demonstrate that, unlike certain CAR-T cells that target HER2, ACTR T cells are highly selective for HER2-overexpressing tumor cells and discriminate against cells from normal tissues that express low levels of HER2. Additionally, the activity of ACTR T cell has been shown to be dose-dependent, demonstrating control of ACTR activity by modulation of trastuzumab concentration. Together these data suggest that ACTR cells in combination with trastuzumab may exhibit an improved clinical therapeutic index.

“We are encouraged by these preclinical data, which further highlight our novel ACTR technology pipeline and demonstrate our innovative approach to overcoming current challenges in the solid tumor setting,” said Seth Ettenberg, Chief Scientific Officer of Unum.

“We have an active IND to evaluate ACTR707 in combination with trastuzumab as a potential treatment for HER2+ solid tumor cancers in a Phase I trial called ATTCK-34-01, and we remain on track to initiate this study before the end of 2018,” said Michael Vasconcelles, Chief Medical Officer of Unum. “We look forward to continuing our work in the solid tumor setting and reporting initial data in 2019.”

ATTCK-34-01 is a multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further study. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence and trastuzumab pharmacokinetics.

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Innovent Highlights Clinical Data of Anti-PD-1 Antibody Sintilimab in Patients with First-line Squamous NSCLC

Innovent Biologics, Inc. (Innovent) a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, today presented clinical research data on cohort E from a Phase Ib clinical trial at the International Association for the Study of Lung Cancer (IASLC) Asia Conference on Lung Cancer 2018 (#ACLC18). In this cohort of the Phase Ib clinical trial (NCT02937116), patients with first-line squamous non-small cell lung cancer (sNSCLC) were treated with sintilimab, a fully human anti-programmed cell death 1 (PD-1) monoclonal antibody, in combination with gemcitabine and cisplatin.

The combination demonstrated an objective response rate (ORR) of 64.7% and disease control rate (DCR) of 100.0%, based on data from 17 patients with at least one radiological assessment among a total of 20 patients in this cohort. As of the data analysis cutoff on September 1, 2018, after median follow up of 6.6 months, the data of median duration of response (DOR) and median progression free survival (PFS) were not yet mature, the preliminary results of which were 6.0 months and 6.8 months, respectively. Twelve-month overall survival (OS) was 87.0%. The study shows evidence of anti-tumor efficacy and an acceptable safety profile.

Based on the efficacy and safety profile from this early phase clinical trial, we have initiated ORIENT-12, a randomized, double-blinded, multicenter, phase III study of sintilimab versus placebo, both in combination with gemcitabine and platinum-based chemotherapy as first-line treatment for advanced or recurrent sNSCLC in China. Patient recruitment for this study is currently under way and Innovent plans to enroll 348 patients. The first patient dosing has been accomplished recently.

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