Wnt inhibitor XNW7201 in Evopoint obtained the ethical approval to conduct Phase IIa clinical trial

On October 18, 2021 Evopoint Biosciences reported XNW7201 approved by Beijing Cancer Hospital, the unit of the team leader, for the Phase IIa clinical trial on October 18, 2021 (Press release, Evopoint Biosciences, OCT 18, 2021, View Source [SID1234656283]).

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Variation of Wnt signaling pathway is common in gastrointestinal tumors (e.g., gastric cancer, colorectal cancer, esophageal cancer, pancreatic cancer, etc.). Inhibition of Porcupine protein can block the abnormally activated Wnt signaling pathway. Moreover, it has been confirmed that the use of Wnt inhibitor is expected to enhance the effect of tumor immunotherapy. In this regard, Evopoint will continue to make every effort to promote the Phase IIa clinical trial of XNW7201 and strive to accelerate product launch for the benefit of numerous sufferers.

Huahui Health Closed Series A+ Financing

On October 18, 2021 Huahui Health reported completion of its Series A+ financing round back in March 2021, raising approximately CNY 500 million (Press release, Huahui Health, OCT 18, 2021, View Source [SID1234642183]). The A+ round was led by GL Ventures and joined by existing investors including Hankang Capital and Matrix Partners China. Raised fund will be used to support clinical development of its pipeline products, establishing pilot scale manufacturing for biologics, and building research platform for small molecules.

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"This financing round will fuel and further expedite the growth and expansion of Huahui, " said Dr. Wenhui Li, founder of Huahui. "We are pleased with the recognition and support from our partners. We will continue building and advancing our internal competence and capabilities in order to meet the needs of patients across the globe."

Dragonfly Therapeutics Announces Sixth Dragonfly Drug to be Licensed by Bristol Myers Squibb and Receipt of Milestone Payments Following First Patient Dosing of Two TriNKET™ Immunotherapies Français

On October 18, 2021 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported that Bristol Myers Squibb has licensed a fifth TriNKET Immunotherapy drug candidate, bringing the total drug candidates licensed by Bristol Myers Squibb to six including Dragonfly’s novel IL-12 cytokine DF6002/BMS-986415 (Press release, Dragonfly Therapeutics, OCT 18, 2021, View Source [SID1234596017]). Since their original 2017 collaboration focusing on hematology malignancies, the companies have agreed to two additional collaborations which include oncology and neuroinflammation targets.

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Dragonfly also announced that the first patients have been dosed in Phase 1 clinical trials of both the CC-96191 and CC-92328 investigational immunotherapies, which are licensed to Bristol Myers Squibb. Following Dragonfly’s wholly-owned HER2-targeted NK cell engager therapy, DF1001, these are the second and third TriNKET drug candidates in the clinic, along with DF6002/BMS-986415 novel IL12-Fc fusion protein.

"We believe this recent opt-in decision by Bristol Myers Squibb further validates our drug discovery platform," said Bill Haney, Dragonfly’s CEO. "We are also delighted that Bristol Myers Squibb has brought our partnered targeted NK cell engager therapies to their first patients. The ongoing clinical trials of four Dragonfly-developed drugs, including our first cytokine, underscores the breadth of Dragonfly’s portfolio of innovative therapeutics, and the pace with which our team is bringing important new treatment options to patients with cancer and autoimmune disease."

The Phase 1 clinical trial for the CC-96191 TriNKET is a first-in-human study which will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of relapsed or refractory acute myeloid leukemia (R/R AML). Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04789655).

The Phase 1 clinical trial for the CC-92328 TriNKET is a first-in-human study which will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04975399).

bluebird bio Sets Record Date and Distribution Date for Planned Business Separation

On October 18, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported that October 19, 2021 has been set as the record date for the dividend of shares of common stock of 2seventy to be distributed to bluebird stockholders in order to effect the separation of bluebird bio and 2seventy bio, Inc. into two independent, publicly traded companies (Press release, 2seventy bio, OCT 18, 2021, View Source [SID1234594669]).

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Each bluebird bio stockholder of record as of the close of business on October 19, 2021 will receive, on the distribution date, one share of 2seventy common stock for every three shares of bluebird common stock held. The share dividend is expected to be distributed to bluebird stockholders on or about November 4, 2021. Following the separation, bluebird stockholders will also receive cash in lieu of any fractional shares of 2seventy common stock that those holders would have received after application of the 3:1 distribution ratio. No action is required by bluebird stockholders in order to receive the shares of 2seventy common stock in the dividend distribution.

Additionally, on October 18, 2021 the Securities and Exchange Commission declared 2seventy’s Registration Statement on Form 10 (the "Form 10") effective. This Form 10 contains further information regarding bluebird bio’s plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company, including the conditions to completion of the separation.

"When-issued" trading for 2seventy common stock and "ex-distribution" trading for bluebird common stock is expected to commence on October 18, 2021 under the stock ticker symbols "TSVTV" and "BLUEV", respectively. A description of these expected trading markets is included in the Form 10. After the separation, 2seventy common stock is expected to trade on the Nasdaq Global Select Market under the stock ticker symbol "TSVT" and bluebird will continue to trade on Nasdaq Global Select Market under the stock ticker symbol "BLUE."

Radionetics Oncology Emerges from Crinetics Pharmaceuticals with a Platform and Deep Pipeline of Nonpeptide Targeted Radiopharmaceutical Drug Candidates for Precision Oncology

On October 18, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel nonpeptide therapeutics for rare endocrine diseases and endocrine-related tumors, together with 5AM Ventures and Frazier Healthcare Partners, reported the formation of an independently operated new company, Radionetics Oncology. Radionetics aims to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications (Press release, Crinetics Pharmaceuticals, OCT 18, 2021, View Source [SID1234591581]).

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Radionetics’ pipeline is based on a broadly enabling platform and intellectual property that will leverage more than a decade of discovery experience within Crinetics. The platform uses nonpeptides as targeting agents designed to deliver therapeutically active radiopharmaceuticals to tumors expressing unique peptide receptors. Radionetics’ initial drug development efforts will center on advancing a collection of 10 potent nonpeptide-targeted radiopharmaceutical candidates and leads, discovered at Crinetics, into clinical imaging and efficacy studies. Radionetics will work independently and with Crinetics to identify additional novel radiopharmaceutical targets and drug candidates for a range of cancer indications.

David Allison, Ph.D., a partner at 5AM Ventures and member of the Radionetics board of directors commented, "Radiopharmaceuticals have emerged as an important class of oncology therapeutics demonstrating survival benefits for patients in multiple tumor settings including prostate cancer and neuroendocrine tumors. We are launching Radionetics with what we believe to be a promising pipeline to expand the utility of radiopharmaceuticals to novel targets. We look forward to building on Crinetics’ world-class expertise in discovery and development of small molecule therapeutics targeting peptide receptors for the benefit of cancer patients."

In conjunction with formation of the company, Radionetics will receive an exclusive world-wide license to the radiotherapeutics technology platform and associated intellectual property from Crinetics for use in developing radiotherapeutics and related radio-imaging agents in exchange for equity, milestones in excess of $1 billion and single-digit royalties on net sales. Radionetics launches with a $30 million private financing with 5AM Ventures and Frazier Healthcare Partners as the sole investors. Radionetics and Crinetics will also engage in a research collaboration to identify drug candidates for multiple additional targets.

"Peptide receptors are a uniquely attractive family of drug targets for precision radiotherapeutics, with more than 120 different family members, many of which are over-expressed in hard-to-treat solid tumors. We are very excited to expand Crinetics’ nonpeptide therapeutics platform into the realm of radiopharmaceuticals with the formation of Radionetics," said Scott Struthers, Ph.D., founder and CEO of Crinetics. "With the launch of Radionetics, Crinetics shareholders will continue to participate in the value of these assets through Crinetics’ equity ownership in the new company as well as through potential milestones and future royalty streams, while at the same time giving the platform the dedicated attention and financing it deserves to fully realize its potential to help the many people around the world in need of new options to treat their cancers." Dr. Struthers has spent his entire scientific and business career seeking to better understand peptide hormone receptors and how to target them with novel therapeutics. As the founder and CEO of Crinetics, he has successfully led and grown the company from a four-person boot-strapped startup to a publicly traded company with multiple clinical stage programs. Dr. Struthers will serve as chairman of the Radionetics board of directors.

Radionetics Leadership
Radionetics launches with a seasoned R&D leadership team, including Crinetics co-founders, Yun-Fei (Frank) Zhu, Ph.D. and Ana K. Kusnetzow, Ph.D., who are assuming roles as chief research officer and vice president of biology, respectively. While at Crinetics Dr. Zhu was vice president of chemistry and a co-inventor of Crinetics’ nonpeptide drug candidates, three of which have now demonstrated clinical proof of concept. Dr. Kusnetzow was most recently the senior director of biology and co-leader of the Crinetics discovery project that gave rise to the nonpeptide targeted radiotherapeutics platform that now forms the basis of the Radionetics pipeline.

In addition, Deborah Slee, Ph.D. will join Radionetics as chief development officer. Dr. Slee was previously senior vice president of nonclinical development and operations at Gossamer Bio and has an extensive track record of advancing multiple drug candidates from discovery into clinical development in oncology and other indications. Brett Ewald, Ph.D. joins as senior vice president & head of strategy and corporate development. Dr. Ewald has extensive experience in early- and late-stage clinical development as well as alliance and portfolio management for oncology products in small and large pharmaceutical companies. Most recently, he was senior vice president of development and corporate strategy at DNAtrix, before which he was a senior member of the clinical operations team at Novartis Oncology.

Additionally, Zachary Hornby, an experienced oncology company leader, entrepreneur and currently CEO of Boundless Bio, will serve as a board member. Prior to joining Boundless Bio, Mr. Hornby was chief financial offer and subsequently chief operating officer at Ignyta, where he took the company public and oversaw development of the company’s portfolio of four clinical stage precision therapeutics for oncology and led the business development process that resulted in Ignyta’s acquisition by Roche for $1.7 billion. Stephen Betz, Ph.D., co-founder and chief scientific officer at Crinetics, will join the Radionetics scientific advisory board.

"Having such an experienced team, Radionetics is well positioned to move expeditiously towards the clinic and full realization of the potential of this platform technology. This is amplified by our collaboration with Crinetics and the direct commitment and participation of key members of the Crinetics founding team who built the underlying technology platform," said Daniel Estes, Ph.D., general partner at Frazier Healthcare Partners, and member of the Radionetics board of directors. "We look forward to building Radionetics into a world-class oncology company focused on radiopharmaceuticals."