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Category: Therapeutics

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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Health First Selects Kyruus Solutions to Enable Digital Patient Access Initiatives

BOSTON–(BUSINESS WIRE)–Kyruus, a leader in provider search and scheduling solutions for health systems, today announced that Health First, a not-for-profit integrated delivery network in Florida, has selected the company’s patient access and provider data management solutions to modernize the access experience for patients while improving operational efficiency. The health system will implement the Kyruus ProviderMatch™ solutions both on its website and in its call center to enable an integrated, multi-channel approach to patient access.

Central Florida’s only fully integrated health system, Health First sought a solution that would make it easier for consumers to find and book appointments with the right providers across the system. Recognizing that this starts with complete, accurate provider information, Health First sought an access solution built on a strong provider data management foundation. With its KyruusOne™ platform powering each of the ProviderMatch solutions, Kyruus stood out for its ability to help Health First transform both data management and enterprise-wide patient access.

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Health First Selects Kyruus Solutions to Enable Digital Patient Access Initiatives

Florida-Based Health System to Enhance Patient-Provider Matching and Scheduling Across Multiple Access Points

BOSTON–(BUSINESS WIRE)–Kyruus, a leader in provider search and scheduling solutions for health systems, today announced that Health First, a not-for-profit integrated delivery network in Florida, has selected the company’s patient access and provider data management solutions to modernize the access experience for patients while improving operational efficiency. The health system will implement the Kyruus ProviderMatch™ solutions both on its website and in its call center to enable an integrated, multi-channel approach to patient access.

Central Florida’s only fully integrated health system, Health First sought a solution that would make it easier for consumers to find and book appointments with the right providers across the system. Recognizing that this starts with complete, accurate provider information, Health First sought an access solution built on a strong provider data management foundation. With its KyruusOne™ platform powering each of the ProviderMatch solutions, Kyruus stood out for its ability to help Health First transform both data management and enterprise-wide patient access.

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Compass Therapeutics Announces Preclinical Data on Lead Antibody Program and NK Cell Engager Platform to be Presented at the Society for Immunotherapy of Cancer Annual Meeting

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Compass Therapeutics, a biotechnology company committed to the ambitious goal of comprehensively drugging the human immune system, today announced that preclinical data on CTX-471, a fully human monoclonal antibody that potently induces immune-mediated destruction of solid tumors, will be presented at the Society for Immunotherapy of Cancer (SITC) 2018 Annual Meeting, which is being held this week in Washington, D.C. Preclinical data from the company’s novel NK cell engager platform will also be presented.

“To our knowledge, CTX-471’s preclinical efficacy as a monotherapy in a very large tumor model is unprecedented for an immuno-oncology antibody. These data support our plans to advance our lead therapeutic candidate into the clinic in the first quarter of 2019,” said Thomas Schuetz, M.D., Ph.D., the company’s co-founder and chief executive officer. “In addition, the data on our NK cell engager platform are very exciting. Our preclinical results underscore the power of our StitchMabs™ technology and our empirical approach to identifying novel combinations of therapeutic candidates that can engage the innate and adaptive immune system in unique and novel ways to eradicate tumors.”

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Orchard Therapeutics Announces Closing of $225 Million Initial Public Offering, Including the Partial Exercise of Underwriters’ Option

Boston, Mass., USA and London, UK, November 05, 2018 / B3C newswire / — Orchard Therapeutics plc (Nasdaq: ORTX), a biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through autologous ex vivo gene therapies, today announced the closing of its initial public offering of 16,103,572 American Depositary Shares (“ADSs”), each representing an ordinary share at an initial public offering price of $14.00 per share. The gross proceeds from the offering were $225.5 million before deducting underwriting commissions and estimated offering expenses. This includes the partial exercise by the underwriters of their option to purchase up to 1,817,857 additional ADSs from Orchard at the initial public offering price, less underwriting discounts and commissions. Each of the ADSs in the offering were offered by Orchard Therapeutics. The ADSs commenced trading on The Nasdaq Global Select Market on October 31, 2018 under the ticker symbol “ORTX.”

J.P. Morgan, Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the offering, and Wedbush PacGrow is acting as co-manager.

The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing prospectus-eq_fi@jpmchase.com; Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: prospectus-ny@ny.email.gs.com or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attention: Prospectus Department, or by email at PostSaleManualRequest@broadridge.com.

Registration statements relating to the ADSs being sold in this offering have been filed with the Securities and Exchange Commission and became effective on October 30, 2018. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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Denali Therapeutics Announces Broad Collaboration with Sanofi to Develop RIPK1 Inhibitors for the Treatment of Neurological and Inflammatory Diseases

  • Candidate RIPK1 inhibitor molecules have the potential to treat Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and systemic inflammatory diseases
  • Denali to receive $125 million upfront payment and future milestone payments that could exceed $1 billion
  • Denali and Sanofi plan to jointly develop and commercialize programs for neurological indications, and Sanofi will develop and commercialize programs for systemic inflammatory indications

SOUTH SAN FRANCISCO, Calif., Nov. 01, 2018 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced that it will collaborate with Sanofi on the development of multiple RIPK1 inhibitor molecules with the potential to treat a range of neurological and systemic inflammatory diseases.

The two lead molecules DNL747 and DNL758 target a critical signaling protein known as the receptor-interacting serine/threonine-protein kinase 1 (RIPK1) in the TNF receptor pathway, which regulates inflammation and cell death in tissues throughout the body. The companies plan to study DNL747 in Alzheimer’s disease, amyotrophic lateral sclerosis and multiple sclerosis, and DNL758 in systemic inflammatory diseases such as rheumatoid arthritis and psoriasis.

Under the terms of the agreement, Sanofi will make an upfront cash payment to Denali of $125 million, with future development and commercial milestone payments that could exceed $1 billion. Sanofi and Denali will share commercial profits and losses from DNL747 in the U.S. and China equally, while Denali will receive a royalty from Sanofi for other territories for DNL747 and worldwide for DNL758.

Phase 1b and 2 clinical development costs for DNL747 will be fully funded by Sanofi for MS, ALS, and other neurological indications, except in Alzheimer’s disease, which will be funded by Denali. Phase 3 trials for all neurological indications will be jointly funded by Sanofi (70%) and Denali (30%). Sanofi will fully fund the clinical development costs for DNL758 in systemic inflammatory diseases.

“This collaboration with Denali is yet another example of Sanofi’s commitment to accelerate the development of transformative and best-in-class treatments for patients living with serious illnesses,” said Rita Balice-Gordon, Ph.D., Global Head of Rare and Neurologic Diseases Research at Sanofi. “We look forward to working with Denali on the RIPK1 program as we explore the potential of this mechanism in neurologic and inflammatory diseases.”

“RIPK1 is a promising target with the potential to bring disease modifying medicines to patients suffering from neurodegenerative diseases as well as systemic inflammatory diseases. We are very excited to partner with Sanofi and expand our RIPK1 program into new indications,” said Ryan Watts, Ph.D., CEO of Denali. “With its considerable infrastructure and experience in both clinical development and commercial functions, Sanofi is an ideal partner for Denali to maximize the clinical and commercial success of our RIPK1 program.”

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PatientPing Expands Care Coordination Offering to Help Organizations Succeed Under BPCI Advanced

BOSTON, Nov. 1 , 2018 /PRNewswire/ — PatientPing, a health technology company that connects providers to seamlessly coordinate patient care, today announced enhancements to its product suite to help healthcare organizations throughout the nation improve outcomes under bundled payment arrangements. This product, which will “tag” patients in real time who belong to bundled programs, can help organizations improve quality of care and reduce episode expenditures under the Bundled Payments for Care Improvement Advanced (BPCI Advanced) initiative, which was launched by the Centers for Medicare & Medicaid Services’ (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) on Oct. 1, as well as other bundled payment models such as the Comprehensive Care for Joint Replacement (CJR) model.

“Post-acute care costs after discharge often take hospitals who enter these payment models by surprise,” said Jay Desai, founder and CEO of PatientPing. “Our solution activates the acute and post-acute network for hospitals that are taking on financial risks for these episodes and helps them reduce avoidable utilization. This is a win-win for the health system and for patients, since it enables continuity of care post-discharge and leads to lower episodic cost for health systems and for payers.”

How PatientPing Improves Outcomes Under Bundled Payment Programs
Using a pre-defined and customizable set of criteria, PatientPing “tags” patients belonging to a bundled-payment cohort in real time. For instance, hospitals participating in BPCI Advanced for patients who have received coronary artery bypass graft (CABG) surgery will receive notifications through PatientPing, enabling visibility into the continuum of care.

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China’s Innovent Biologics Makes 5 Percent Gain in Hong Kong Debut

HONG KONG, Oct 31 (Reuters) – Innovent Biologics climbed 5 percent in a Hong Kong debut closely watched as a test of investor appetite for Chinese biotechs after three rivals saw their shares slide post-listing.

The Chinese biotech – backed by mutual fund giant Fidelity and Singapore state investor Temasek Holdings – was trading at HK$14.7 on Wednesday morning, above its IPO price of HK$13.98.

Shanghai and Suzhou-based Innovent raised $421 million in its IPO, making it the largest Hong Kong biotech offering this year.

Hong Kong implemented the new rules allowing biotech firms with no revenue or profit to list in the city in April, hoping to woo new-economy firms away from centres such as New York.

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