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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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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• 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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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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SUZHOU, China, Oct. 31, 2018 /PRNewswire/ — Adagene, Inc., an innovative antibody engineering and discovery company, today announced the dosing of its first patient in its Phase I trial in American for its lead product ADG-106, a fully human agonistic monoclonal antibody (mAb) targeting a novel epitope of CD137. Adagene is also announcing a record speed of review and acceptance of their IND in China for ADG-106. 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 the Phase I clinical study.

“I have worked on this target previously and believe 4-1BB agonists have tremendous therapeutic potential in immunotherapy by targeting the costimulatory pathway,” said Anthony W. Tolcher, M.D., FRCPC, Founder, CEO and Director of Clinical Research at NEXT Oncology (San Antonio, Texas) and an investigator on the trial. “Our team is eager to evaluate ADG-106 because it has shown both excellent safety and efficacy in numerous native preclinical models, and we look forward to assessing the clinical benefit of ADG-106 via its novel mechanism of action that would potentially expand the opportunity for patients to benefit from a novel IO target in both single and combinational therapy.”

“The initiation of a Phase I clinical study of ADG-106 is a pivotal milestone for Adagene and our novel approach to improving cancer care,” said Peter Luo, CEO of Adagene. “Also, we are honored to receive the IND approval from the NMPA (National Medical Products Administration) in an expedited time. We believe it shows their commitment to support drugs with novel biology and mechanism of action. The preclinical evidence shows we are targeting a novel epitope and the antibody behaves very differently compared with the other two monoclonal antibodies previously in the clinic.”

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BOSTON and LONDON, Oct. 30, 2018 (GLOBE 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 pricing of its initial public offering in the United States of 14,285,715 American Depositary Shares (“ADSs”) representing 14,285,715 ordinary shares at an initial public offering price of $14.00 per ADS, before underwriting discounts and commissions. In addition, Orchard has granted the underwriters a 30-day option to purchase up to an additional 2,142,857 ADSs at the initial public offering price, less the underwriting discounts and commissions. Orchard’s ADSs are expected to begin trading on The Nasdaq Global Select Market on October 31, 2018, under the ticker symbol “ORTX.” Each of the ADSs are being offered by Orchard. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Orchard, are expected to be $200.00 million, excluding any exercise of the underwriters’ option to purchase additional ADSs. The offering is expected to close on November 2, 2018, subject to the satisfaction of customary closing conditions.

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