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Chi-Med, Innovent Enter Global Cancer Partnership

Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) and Innovent Biologics Inc. (HKSE:1801) will take advantage of China’s new foreign data guidelines and enter into a global partnership to develop fruquintinib in combination with sintilimab to treat advanced solid tumors.

The companies said the new foreign data guidelines, which allow companies to submit foreign clinical data to support Chinese regulatory submissions, could expedite the path to a China launch (see “China Accelerates Drug Review Timelines for Rare, Life-Threatening Diseases”).

Innovent’s sintilimab, an anti-PD-1 mAb, is under review in China to treat relapsed or refractory classical Hodgkin lymphoma.

Elunate fruquintinib is approved in China to treat metastatic colorectal cancer (mCRC). According to Chi-Med, the inhibitor of VEGF receptors 1, 2 and 3 is the first China-discovered and developed product for an oncology indication to receive unconditional approval based on a randomized clinical trial (see “Chi-Med Scores a China First with Approval of Fruquintinib”).

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Innovent Announces Global Collaboration with Hutchison MediPharma to Evaluate Combination of Sintilimab and Fruquintinib in Solid Tumors

Global collaboration will initially evaluate Innovent’s anti-PD-1 monoclonal antibody sintilimab in combination with Hutchison MediPharma’s VEGFR inhibitor fruquintinib for solid tumors –

SUZHOU, China, Nov. 29, 2018 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 1801),  a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, today announces that it, through its wholly-owned subsidiary, Innovent Biologics (Suzhou) Co., Ltd, has entered into a global collaboration agreement with Hutchison China MediTech Limited (Chi-Med), through its Innovation Platform subsidiary Hutchison MediPharma Limited (“Hutchison MediPharma”), to evaluate the safety and tolerability of Innovent’s sintilimab in combination with Hutchison MediPharma’s fruquintinib in patients with advanced solid tumors.

Under the terms of the agreement, Innovent and Hutchison MediPharma will jointly explore potential application of this combination in solid tumors with global unmet medical needs through development efforts both in the US and in China.

“We are two leading China-based biopharmaceutical companies, one specialized in small molecules and another in large molecules; and we share the same vision of bringing China-originated mainstream anti-cancer therapies to global patients by combining our expertise and resources,” said Dr. Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. “There is strong scientific evidence supporting synergistic effects of PD-1 therapy when used in combination with VEGFR inhibitor. In addition, we hope to benefit from recent regulatory changes in China that allow for the recognition of foreign clinical trial data to possibly expedite the path to a China launch. We are very pleased to partner with Chi-Med to co-develop this novel combination therapy for global patients”.

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Precision BioSciences Receives FDA Authorization to Initiate Clinical Study of Gene Edited Cancer Immunotherapy

DURHAM, N.C.–(BUSINESS WIRE)–Nov 27, 2018–Precision BioSciences and Servier today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for PBCAR0191, an allogeneic anti-CD19 CAR T therapy for B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL). Upon trial initiation, PBCAR0191 will be Precision’s first clinical-stage product candidate.

“Our allogeneic CAR T program has exceeded all expectations, moving from concept to IND acceptance in under three years,” said Matt Kane, Chief Executive Officer of Precision. “We are thrilled to have received authorization to initiate clinical studies for a therapy that we believe could be transformative for patients suffering with NHL and B-ALL.”

Precision’s PBCAR0191 is positioned to be the first gene-edited allogeneic CAR T product candidate in human clinical trials for NHL. Data provided to the FDA in connection with the IND submission included the results of in depth off target cutting analyses and evidence to support the elimination of graft versus host interactions. Manufacturing data were provided to the FDA in support of the scalability and reproducibility of the T cell genome editing production process. Precision is currently producing clinical trial material at full scale with its manufacturing partner.

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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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Flywire Introduces Payment Plan Management for UK Educational Institutions

Improved collection rates, shorter payment cycles, and accelerated cash flows for universities, private schools and language schools

LONDON, Nov. 15, 2018 (GLOBE NEWSWIRE) — Flywire, a company that solves complex payment problems for businesses and institutions, today announced the availability of Flywire Payment Plan Management in the UK. The solution enables schools and universities of all types to offer students and their families custom tuition payment plans to fit their specific needs while streamlining the administrative requirements involved.

Payment Plan Management empowers school and university staff to manage personalised repayment terms with students and their families based on pre-defined rules. Payers can use a variety of vehicles; e.g., recurring card payments, installment payments, bank transfers, to pay their tuition on a schedule that fits both their needs and the institution’s. The offering is available to both domestic and international payers, and designed to meet GDPR and PCI DSS standards.

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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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Zeel Partners With Stride Health To Bridge Insurance Gap For Massage Therapists

NEW YORK, Nov. 14, 2018 /PRNewswire/ — Zeel, the Massage On Demand® company and national wellness provider, today announced it has partnered with Stride Health, the leading benefits platform for gig and independent workers, to offer the 11,000+ massage therapists on the Zeel platform access to simple, affordable health, dental, and vision insurance.

“We are committed to providing every massage therapist on our platform access to the best insurance for individuals and their families,” says Eva Carey, National Community Director for Zeel. “Through our partnership with Stride, each massage therapist will be able to find the best available insurance plan for them. As a wellness company, we’re not only focused on the health of our customers, but also in delivering access to the best wellness options to therapists.”

Specifically, Stride Health’s growing suite of offerings includes access to all major medical plans and personalized recommendations and customized dental and vision insurance.

“We’re excited to offer comprehensive benefits and guidance to the massage therapists on Zeel’s platform,” said Noah Lang, co-founder and CEO of Stride Health. “Massage therapists are healers who need access to benefits, security, and financial stability that are traditionally available only to full-time employees. Our partnership with Zeel will ensure that these independent workers receive the essential support they need to thrive.”

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