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."

Recruitment on C-BOBCAT pilot cancer trial closed for Clarity’s SAR-Bombesin product

On October 18, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, reported that the C-BOBCAT study led by Prof Louise Emmett has closed for recruitment at St Vincent’s Hospital, Sydney (Press release, Clarity Pharmaceuticals, OCT 18, 2021, View Source [SID1234591502]).

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C-BOBCAT is a pilot trial assessment of the diagnostic value of 64Cu SAR-Bombesin PET/CT imaging for staging of ER/PR + HER2- breast cancer patients with metastatic disease in comparison with conventional imaging (CT, bone scan and 18F FDG PET/CT). SAR-Bombesin has been used to image 7 patients with ER/PR positive metastatic breast cancer under the C-BOBCAT trial and a number of patients via the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) in both breast and prostate cancer patients.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with the imaging and safety data acquired during the trial and under the TGA SAS and have made a decision to close the trial early to enable the human clinical data to be used for regulatory submissions, including the upcoming Investigational New Drug (IND) Application filings with the US Food and Drug Administration (FDA) for SAR-Bombesin. As per our recent announcement, Evergreen Theragnostics, Inc. will be one of the US manufacturing groups to supply the Targeted Copper Theranostics for the US-based SAR-Bombesin clinical trial. We anticipate this trial to commence in 2022."

Prof Louise Emmett, Principal Investigator in the C-BOBCAT trial at St Vincent’s Hospital Sydney, commented, "Our collaboration with Clarity on the C-BOBCAT trial has been a very exciting one as the diagnostic program with 64Cu SAR-Bombesin generated evidence of the utility and superiority compared to conventional imaging in some patient subgroups (e.g. 99mTc bone scan, 18F FDG). In addition to these benefits for some breast cancer patients, we also found SAR-Bombesin advantageous for prostate cancer patients who are prostate specific membrane antigen (PSMA) negative, thus validating the product’s pan-cancer application. I look forward to finalising and publishing the results from the C-BOBCAT trial and wish Clarity every success in progressing this asset through clinical development."

Dr Taylor said: "SAR-Bombesin is a promising asset that can be developed for a number of cancer indications. The high uptake and strong product retention visualised by PET imaging of patients at 1, 3 and 24 hours after product administration suggest significant potential for therapy applications with 67Cu SAR-Bombesin. We are excited to further advance its clinical development with a strong focus on regulatory approvals in the US and leverage the results generated in collaboration with some of the leading Australian scientific organisations and hospitals to reach our ultimate goal of improving treatment outcomes for children and adults with cancer."

Isofol Medical AB (publ) publishes prospectus and new financial information in connection with listing on Nasdaq Stockholm

On October 18, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol" or the "Company"), reported that the prospectus prepared by the Company in connection with the listing on Nasdaq Stockholm has been approved and registered by the Swedish Financial Supervisory Authority (Finansinspektionen) (Press release, Isofol Medical, OCT 18, 2021, View Source [SID1234591501]). The prospectus contains updated financial information, due to regulatory requirements, attributable to the Company’s equity and liabilities as well as net indebtedness as of July 31, 2021. The prospectus is available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

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Prospectus and new financial information
On October 15, 2021 Isofol announced that Nasdaq Stockholm’s listing committee made the assessment that Isofol fulfills the applicable listing requirements and will approve an application for admission to trading of the Company’s shares on Nasdaq Stockholm, provided that certain customary conditions are fulfilled, including approval and registration of a prospectus by the Swedish Financial Supervisory Authority. The prospectus that has been prepared in connection with the listing was approved and registered today by the Swedish Financial Supervisory Authority and is now available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

The prospectus contains previously unpublished financial information attributable to Isofol’s equity and liabilities and net indebtedness as of July 31, 2021. The financial information, which is also outlined below, is presented due to regulatory requirements, according to which financial information regarding the capital structure must not be older than 90 days at the time of the prospectus’ publication. Note that only interest-bearing liabilities are reported in the tables below. The information has not been reviewed by the Company’s auditor.

Equity and liabilities as of July 31, 2021
KSEK Unaudited
Total current liabilities 1 613
For which guarantees have been issued –
Against other security –
Without secutity 1 613
Total long-term liabilities 687
Guaranteed –
With security –
Without guarantee/security 687
Equity 413 972
Share capital 4 945
Other contributed capital 1 217 607
Retained earnings -809 581
Total 416 272
Net indebtedness as of July 31, 2021
KSEK Unaudited
(A) Cash and cash equivalents 483 906
(B) Other cash and cash equivalents –
(C) Other financial fixed assets –
(D) Liquidity (A) + (B) + (C) 483 906
(E) Current financial liabilities (including debt instruments, but excluding the current portion of long-term financial liabilities) 1 613
(F) Current portion of long-term financial liabilities –
(G) Current financial indebtedness (E + F) 1 613
(H) Net current financial indebtedness (G – D) -482 293
(I) Long-term financial liabilities (excluding current portion and debt instruments) 687
(J) Debt instruments –
(K) Long-term accounts payable and other liabilities –
(L) Long-term financial debt (I + J + K) 687
(M) Total financial indebtedness (H + L) -481 606
Additional information about the listing
The first day of trading on Nasdaq Stockholm’s Main Market is planned to take place on Thursday, October 21, 2021 and the final day of trading on Nasdaq First North Premier Growth Market is expected to be Wednesday, October 20, 2021.

The Company’s shares will be traded with unchanged ticker ISOFOL and ISIN-code (SE0009581051). No new shares will be issued in connection with the shares being admitted to trading on Nasdaq Stockholm and the Company’s shareholders do not need to take any action in connection with the listing.

Advisors
Isofol has engaged Advokatfirman Vinge KB as legal advisor and Carnegie Investment Bank AB (publ) as financial advisor in connection with the listing on Nasdaq Stockholm.

The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CEST on October 18, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.