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Cytek Biosciences Continues Momentum by Strengthening Executive Team, Adding Board Members

Company’s Advanced Flow Cytometry Systems Being Embraced by Scientists, Clinicians Around the World

FREMONT, Calif., Nov. 13, 2018 (GLOBE NEWSWIRE) — Cytek Biosciences Inc., the preeminent provider of innovative flow cytometry solutions, today announced that Steve Ziganti and Patrik S. Jeanmonod have joined the company’s leadership team in the roles of vice president of worldwide sales and chief financial officer, respectively. Additionally, Jack Ball and Dr. Allen Poirson have been added to Cytek’s board of directors.

From pharmaceutical and biotech companies to contract research organizations, the scientific community is embracing Cytek’s Aurora and Northern Lights flow cytometry systems with open arms – and this success is driving the expansion of the company. Cytek is focused on making the advanced instrumentation that was once available to very few scientists accessible to more researchers. With Cytek’s systems, more labs will have the ability to obtain deeper biological insights from a single sample – and accelerate their fields of research.

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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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Threat Stack Announces Acquisition of Runtime Application Security Vendor, Bluefyre

Addition of Runtime Application Security Gives Threat Stack Customers Full Stack Security Observability for Cloud Infrastructure

BOSTON, Mass. — November 8, 2018 — Threat Stack, the leader in cloud infrastructure security, today announced it has acquired application security vendor Bluefyre, to deliver full stack security observability from the control plane to the application layer. With the addition of Bluefyre, Threat Stack will empower developers to build secure, cloud-native applications that can detect and prevent threats at runtime, including applications running on Kubernetes.

Combining Bluefyre’s powerful application security capabilities with Threat Stack’s industry-leading cloud optimized intrusion detectionwill provide customers with complete, full stack security observability including the control plane, host, containers, orchestration, and application layer. By adding the application layer to its existing cloud infrastructure security capabilities, Threat Stack will enable its customers to truly integrate development, security, and operations into a completely unified DevSecOps program.

“We’re thrilled to welcome the Bluefyre team to Threat Stack. Observability of the application layer has been a key part of Threat Stack’s strategic vision, and Bluefyre’s capabilities provide the ideal complement to Threat Stack’s industry-leading cloud-optimized intrusion detection system,” said Brian M. Ahern, CEO, Threat Stack. “They have built an extremely powerful runtime application security product that will drastically increase the ability of Threat Stack customers to reduce risk within cloud infrastructure.”

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Orchard Therapeutics Strengthens Global Commercial Leadership Team with Appointments of Heads of US and EMEA Region Commercial Operations

Commercial team preparing for potential gene therapy launches

Boston, Mass., USA and London, UK, November 08, 2018 / B3C newswire / — Orchard Therapeutics (Nasdaq: ORTX), a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today announced two additions to its global commercial leadership team, appointing Robin Kenselaar as senior vice president and general manager, EMEA commercial operations, and Brad Mathis as vice president, U.S. commercial operations. These two key appointments serve to build Orchard’s initial commercial infrastructure across North America and EMEA prior to the Company’s first three potential product launches. Mr. Kenselaar and Mr. Mathis will report to Jason Meyenburg, chief commercial officer.

“We are thrilled to welcome Robin and Brad to the Orchard team, with their decades of experience and proven success leading international and domestic commercial operations for companies targeting rare diseases,” said Jason Meyenburg. “With three submissions for product approvals anticipated over the next three years and several additional therapies in development, the recent expansion of our commercial leadership team marks an important milestone as we prepare for the potential launches of these late-stage gene therapies, focusing especially on market access preparations and further development of patient diagnosis pathways.”

Robin Kenselaar joins Orchard after almost 15 years at Sanofi Genzyme, where he built and led commercial operations throughout Europe for therapies addressing unmet needs such as rare genetic diseases, oncology and immunology. During his tenure at Genzyme, Mr. Kenselaar served in various commercial leadership roles, most recently as head of Europe, and previously held positions as head of the EMEA region, vice president of commercial operations and business unit director, rare diseases. He has demonstrated consistent success working with key stakeholders to secure registration and expedited access to therapy and led the launches for a number of important therapies throughout Europe. Mr. Kenselaar holds a master’s of business administration from Nyenrode Business University (Netherlands).

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Maine’s Northern Light Beacon Health Partners with PatientPing to Coordinate Care for Patients Throughout the State — and Beyond

BOSTON, Nov. 6, 2018 /PRNewswire/ — PatientPing, a health technology company that connects providers to seamlessly coordinate patient care, today announced it has launched in the state of Maine through its new partnership with Northern Light Beacon Health, the population health and accountable care member of Northern Light Health, formerly known as Eastern Maine Healthcare Systems (EMHS). This partnership will help the statewide healthcare system enhance care coordination for providers, care teams and patients throughout Maine.

Northern Light Health’s system includes nine hospitals with locations throughout the state, as well as ambulatory care centers, long-term care facilities, and home care and hospice agencies. With the PatientPing platform, Beacon Health’s specialized nurse care managers are able to access and share patient information, both inside and outside Northern Light Health’s system, through Pings—real-time notifications when a patient receives care—and Stories—important patient context at the point of care.

Beacon Health, one of Medicare’s original Pioneer Accountable Care Organizations (ACOs), continues to lead the transformation of healthcare throughout the state. A current participant in the Medicare Shared Savings Program, the ACO will benefit from PatientPing’s ability to share ADT (admit-discharge-transfer) alerts from hospitals in real-time and to share critical patient information during transitions of care.

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Unum Therapeutics to Present Preclinical Data on a New, Emerging Platform Technology for Solid Tumors at the SITC Annual Meeting

CAMBRIDGE, Mass., Nov. 06, 2018 (GLOBE NEWSWIRE) — Unum Therapeutics Inc. (NASDAQ: UMRX), today announced that the Company will present preclinical data on a new proprietary technology platform called Bolt-On Chimeric Receptor, or BOXR, designed to improve the effectiveness of T cells in solid tumor cancers, at the upcoming Society for Immunotherapy of Cancer (SITC) meeting taking place November 7-11, 2018 in Washington, D.C.

Unum has generated a large panel of novel bolt-on transgenes, evaluated using a unique screening strategy, and has identified lead candidates most likely to enhance T cell functions in the solid tumor microenvironment. The bolt-on transgenes enhanced immunometabolism or costimulation of both ACTR- and CAR-expressing T cells and significantly improved their function under stringent in vitro and in vivo conditions.

“We are excited by this new platform, which we believe has the potential to further bolster our ACTR technology pipeline, and highlights our innovative approaches to overcome immunosuppressive challenges in solid tumors,” said Seth Ettenberg, Unum’s Chief Scientific Officer. “We look forward to continuing to explore the potential of this novel technology by selecting a lead development candidate to bring to patients in need in the clinical setting.”

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