Blog

Category: Therapeutics

Buoy Health Partners With Boston Children’s Hospital To Improve The Way Parents Currently Assess Their Children’s Symptoms Online

BOSTON — Buoy Health (www.buoyhealth.com), a health technology company that develops digital tools to help people from the moment they get sick start their care on the right foot, today announced that it has named Boston Children’s Hospital, the leading children’s hospital in the United States, its first innovation partner. As part of the multi-pronged strategic partnership, Boston Children’s hospital will integrate Buoy’s advanced AI into its website and will work side-by-side with the health-tech startup to provide input on the product’s future enhancements and developments.

“Every day, we see thousands of parents come to Buoy who are unsure of where to go or what to do next when their kids are sick,” said Dr. Andrew Le, CEO of Buoy Health. “By combining our AI technology with the cutting edge pediatric knowledge of Boston Children’s hospital, we will improve our ability to deliver the best possible healthcare advice to parents and get their kids to the right care at the right time. We are proud to be working with this world-class institution to further our mission of building technology with heart for the health of every person.”

As Buoy’s first innovation partner, Boston Children’s hospital will aid Buoy in improving its pediatric capabilities. Currently, parents concerned about their children’s symptoms gain advice from Buoy by visiting its home page, www.buoyhealth.com. Yet, now, by being placed on the Boston Children hospital’s website, Buoy will now be able to naturally train its advanced machine learning on a more diverse set of parents.

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Denali Therapeutics Announces Positive Clinical Results From LRRK2 Inhibitor Program for Parkinson’s Disease

SOUTH SAN FRANCISCO, Calif. — Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today announced positive results from its Phase 1 clinical study with DNL201, a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2).

In a randomized, double blind, placebo-controlled, oral dose study in healthy subjects, DNL201 achieved its safety, pharmacokinetic, and pharmacodynamic objectives. DNL201 was generally well tolerated with no serious adverse events at doses that achieved high levels of cerebrospinal fluid (CSF) exposure, robust target engagement as measured by two blood-based biomarkers of LRRK2 activity, and effects on biomarkers of lysosomal function.

Mutations in the LRRK2 gene are the most frequent genetic cause of Parkinson’s disease and a major driver of lysosomal dysfunction, which contribute to the formation of Lewy body protein aggregates and neurodegeneration. LRRK2 regulates lysosomal genesis and function, which is impaired in Parkinson’s disease and may be restored by LRRK2 inhibition, thereby potentially positively modifying disease progression in patients with a genetic LRRK2 mutation as well as in patients with sporadic Parkinson’s disease.

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Innovent Receives IND Approval to Initiate Clinical Trials in China with its anti-OX40 Agonistic Antibody IBI101 and its anti-RANKL Antibody IBI307

SUZHOU, China — Innovent Biologics, a world-class China-based biopharmaceutical company that develops and intends to commercialize high quality innovative antibody-based therapeutics, today announced that it has received Investigational New Drug (IND) approval from the China Food and Drug Administration (CFDA) to initiate clinical trials in China with IBI101, an anti-OX40 agonistic antibody, and with IBI307, an anti-RANKL antibody.

Innovent’s IBI101, is the first OX40-targeted molecule to receive IND approval in China. OX40 is one of the most important targets in the field of immune-oncology. Innovent will be among one of a few companies pursuing the development of OX40 agonists in early stage clinical trials globally. IBI307 is an anti-RANKL antibody under development for the treatment of osteoporosis and lytic bone lesions associated with cancer metastasis. Currently there is no anti-RANKL inhibitors approved for marketing in China.

“The IND approvals for IBI101 and IBI307 by CFDA once again demonstrate Innovent’s capability and commitment to lead the rapid development of China’s biopharmaceutical market. As part of our 17 drug candidates under development, we will prepare to bring these two targeted therapeutic agents into clinical trials quickly,” said Michael Yu, Founder, Chief Executive Officer and Chairman. “Innovent will continue to discover and develop new biopharmaceutical drugs to expand our portfolio of products to treat patients. With today’s rapid improvements in cancer treatment modalities, we will utilize our well-established platform to discover, develop, manufacture and commercialize innovative high-quality biopharmaceutical drugs.”

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TraceLink Adds More than 130 New Customers in Q2 2018 with 255 Companies Now Live in Production, Exchanging Serialized Product Data on the Life Sciences Cloud

NORTH READING, Mass. — TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced it added more than 130 new customers in the second quarter of 2018, up 124 percent annually in quarterly customer growth, for a total of 939 customers in 39 countries. Additionally during the second quarter, 42 new pharmaceutical companies and contract manufacturing organizations (CMO) were configured for data exchange on the TraceLink network, for a total of 255 manufacturers that are now live in production, delivering serialized prescription medicines to markets around the world.

“I am extremely proud of the entire team at TraceLink and our continued success to meet the serialization and track and trace needs of the industry. Every department is integral to our momentum, helping TraceLink to considerably widen its position as the global market share leader, and meeting the high standard of service excellence that our customers have come to expect,” said Shabbir Dahod, president and CEO, TraceLink. “Companies we’re engaged with are telling us that most serialization projects with other solution providers are taking more than a year to implement and are over budget – whereas TraceLink’s average implementation time for serialization is less than eight months and comes with no hidden costs. Our unique network-tenant approach enables TraceLink to implement the fastest and most comprehensive integration with trade partners, ensuring that business can achieve their serialization goals on time and on budget.”

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Centivo, a New Type of Health Plan, Raises $34 Million in Series A Funding

Next Generation Self-Funded Health Plan Launched to Help Employers Deliver Affordable, Sustainable Healthcare for Their Employees

NEW YORK, July 18, 2018 /PRNewswire/ — Centivo, a new type of self-funded health plan, has raised $34 million in Series A funding.  The capital will be deployed to build the company’s technology and infrastructure, develop local partnerships, and support market launch.  Bain Capital Ventures led the financing round, with additional investments from F-Prime Capital Partners, Maverick Ventures, Bessemer Venture Partners, Ingleside Investors, Rand Capital (NASDAQ: RAND), Grand Central Tech Ventures, Oxeon Investments, and several individual investors, including industry veterans Jim Foreman, Ken Goulet, and Kevin Hill.

Centivo was founded to bring cost sustainability to employers and affordable, high-quality healthcare to the millions of Americans who struggle to pay their healthcare bills.  “After nearly 20 years of ‘consumerism,’ healthcare remains as unaffordable and inefficient as ever,” noted Centivo CEO and co-founder Ashok Subramanian.  “Employers are tired of apologizing to their employees for rising costs and diminishing benefits.  It is time to turn the page on the failed era of high deductibles and implement a new solution that produces better results for individuals, employers, and providers.”

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Compass Therapeutics Closes on Series A Financing Totaling $132 Million

Cambridge, Massachusetts-based Compass Therapeutics closed on the final $49 million of its $132 million Series A financing. The round was led by OrbiMed Advisors and included F-Prime Capital, Cowen Healthcare Investments, Thiel Capital, Biomatics Capital, Ulysses Holdings, Borealis Ventures, Alexandria Venture Investments and Biomed Realty Ventures.

Compass Therapeutics focuses on identifying antibody drug candidates, with an initial focus on T cells, NK cells and macrophages. It has antibody discovery and bispecific engineering platforms, including StitchMabs, its proprietary high-throughput bispecific screening platform that allows for rapid identification of synergistic bispecific activity.

The company’s lead product is CTX-471, which is currently in late IND-enabling studies. Compass plans to take the compound into the clinic in the first half of 2019. The company states, “It has been tested across multiple in vitro and in vivo models and has consistently shown potent and durable curative activity as a single agent, in combination with other immune-modulatory agents and with tumor-targeting therapies. In addition, in stringent high tumor burden therapeutic models, CTX-471 has led to complete tumor rejections and the generation of long-term, protective immunological memory.”

The funds raised will be used to push CTX-471 into the clinic as well as to identify two more clinical candidates by the end of this year. They hope to take the second and third compounds into the clinic by early 2020.

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TraceLink Unveils Product Information Manager, a Standards-Based Network Application for Its Industry-Leading Digital Information Sharing Platform

NORTH READING, Mass. — TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced Product Information Manager, a standards-based network application built on TraceLink’s end-to-end information-sharing platform. Designed to leverage serialized product information and address a range of business use cases such as rich media product education, patient engagement, and digital recalls, Product Information Manager will first deliver capabilities for master data sharing, verification routing and verification responses, in order to help companies meet the 2019 U.S. Drug Supply Chain and Security Act (DSCSA) saleable returns verification requirement.

As a notable contributor to 15 industry standards workgroups, including the Healthcare Distribution Alliance (HDA) Verification Router Service Task Force, and co-chair positions on two GS1 workgroups, TraceLink has leveraged interoperable standards defined in partnership with these organizations to ensure that Product Information Manager meets the interoperability requirements for saleable returns mandated by the DSCSA. More than 195 TraceLink customers from 93 companies spanning pharmaceutical manufacturers to healthcare organizations have also participated in a Product Information Manager solution innovation group to provide input into the application development process and ensure that their critical challenges associated with saleable returns verification and master data sharing are being addressed.

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US FDA Approves Adagene IO program IND for Solid Tumor and Non-Hodgkin Lympoma Ph1 trial

SUZHOU, China — Adagene, Inc., an innovative antibody engineering and discovery company, has received notification from the FDA to proceed on its Investigational New Drug (IND) application to study its lead product (ADG-106) in patients with advanced solid tumors and non-Hodgkin lymphoma.

CD137 or 4-1BB, a member of the tumor necrosis factor (TNF) receptor superfamily is a promising immune-oncology target. Ligation of CD137 induces a co-stimulatory signal on activated CD8+ T cells and natural killer (NK) cells, resulting in proliferation, increased pro-inflammatory cytokine secretion and, cytolytic function. CD137 is also thought of as an attractive target for autoimmune disease as T regulatory cells (Tregs) also express 4-1BB. ADG-106 is a fully human agonistic mAb targeting a novel epitope of CD137. Adagene will investigate the safety and efficacy of ADG-106 therapy as a single agent across a range of solid tumor and non-Hodgkin lymphoma patients in a Phase I clinical study expected to commence in the second half of 2018.

“ADG-106 is targeting a different epitope of CD137 compared with the other two therapeutic antibodies against this target in early clinical trials”, said Peter Luo, CEO and Co-Founder of Adagene. “Our proprietary Dynamic Precision Library was able to generate an antibody that targets a unique epitope with cross-reactivity, enabling robust translational studies in both efficacy and safety. ADG-106 is the only monoclonal antibody against this target that has demonstrated potent single agent efficacy in multiple tumor models with intact immune system and work in synergy with other therapeutics, while maintaining an excellent safety profile at extremely high dose. We look forward to starting our clinical trial in the United States soon.”

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UMMC Selects Kyruus’ ProviderMatch for Access Centers to Improve Call Center Operations

Kyruus, a patient-provider matching health ITcompany, announced that the University of Mississippi Medical Center (UMMC) has selected the company’s ProviderMatch for Access Centers solution to improve call center operations and enhance patient access to UMMC’s network of 800+ providers in 170 locations across the state of Mississippi.

ProviderMatch for Access Centers will make it easier for call center agents to identify the right provider for patients’ needs, enabling more precise patient-provider matching to support both patient and provider satisfaction.With its network of providers delivering care to over 600,000 patients a year across 82 counties, UMMC first needed a modern solution that would enable it to gain a single point of access to provider information and a deeper level of insight into providers’ areas of expertise.

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