Sosei Heptares Notes that its Partnered Adenosine A2a Antagonist Imaradenant (AZD4635) has been Removed from AstraZeneca’s Clinical Pipeline

On November 12, 2021 Sosei Group Corporation ("the Company") (TSE: 4565) reported that in AstraZeneca’s third quarter 2021 clinical trials appendix presentation (published today and available on www.astrazeneca.com), the oral, small molecule adenosine A2a receptor antagonist imaradenant (AZD4635) has been removed from its clinical development pipeline as part of its ongoing pipeline prioritization (Press release, Sosei Heptares, NOV 12, 2021, View Source [SID1234595499]). Imaradenant was discovered by Sosei Heptares and licensed to AstraZeneca in 2015.

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AstraZeneca has been evaluating imaradenant in Phase 1 and 2 clinical trials as a monotherapy and in combination with Imfinzi (durvalumab) in solid tumors. In these trials, imaradenant, with or without Imfinzi, was found to be safe and well tolerated and associated with clinical benefit in some immune checkpoint-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC). Imaradenant has been extensively tested in patients with a range of different solid tumor types and has been demonstrated to be safe and well tolerated at escalating doses.

Targeting the production or action of adenosine is a promising strategy for overcoming immune suppression in the tumor microenvironment, and several companies have now disclosed positive results from early clinical trials.

AstraZeneca has a diverse oncology pipeline that requires it to regularly make strategic prioritization decisions regarding projects in its portfolio. Following the removal of the imaradenant program from AstraZeneca’s clinical pipeline, Sosei Heptares will discuss with its partner AstraZeneca the next steps for the future of imaradenant, including the possibility of the Company regaining worldwide rights to the licensed program.

The event reported today has no material impact on the consolidated financial results for the fourth quarter and full year accounting period ending 31 December 2021. Should any impacts or other matters that require an announcement be identified, the Company will announce such matters promptly.

Shinichi Tamura, President and CEO of Sosei Heptares, commented: "The imaradenant clinical program has generated encouraging clinical results in cancer patients under AstraZeneca’s guidance. We respect their decision on imaradenant, as a result of a pipeline portfolio review, and we are keen to assess the possibility of regaining the worldwide rights in order to evaluate the future clinical development and/or re-licensing potential of the program, as we have successfully done so on multiple occasions. AstraZeneca is one of our longest serving partners, and we have enjoyed a highly productive collaboration with them. We look forward to the ongoing discussions about the future of imaradenant and will report the outcome in due course."

Curaleaf Expands its Presence in Three Key Growth Markets with Acquisition of Tryke Companies

On November 12, 2021 Curaleaf Holdings, Inc. (CSE: CURA / OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported that entered into a definitive agreement to acquire Tryke Companies ("Tryke") (dba as Reef Dispensaries), a privately held vertically integrated, multi-state cannabis operator, in a cash and stock transaction valued at approximately US$286 million (Press release, Curaleaf Holdings, NOV 12, 2021, View Source [SID1234595546]).1 The transaction is expected to close in the second half of 2022, subject to customary approvals and conditions.

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Under the terms of the agreement, Curaleaf will pay US$40 million in cash at closing, with a remaining US$75 million in cash to be paid in equal installments on the first, second and third anniversaries of the closing. The stock portion of the transaction, which consists of 17 million subordinate voting shares of Curaleaf ("Curaleaf Shares"), will also be paid in three equal installments on the first, second and third anniversaries of the closing. An incremental earnout of up to 1 million Curaleaf Shares may be paid in 2023 based on the business exceeding certain EBITDA targets for the year 2022.

Founded in Arizona in 2014, Tryke has focused on growing and producing the finest and most consistent cannabis products on the market. The company helped pioneer Nevada’s legal cannabis market from its inception in 2015, and continues to lead the industry in Utah where it has worked since 2019 to help establish the state’s medical cannabis program. Tryke has refined processes to craft an ever-evolving selection of products and brands at multiple price points. The company’s dispensaries have served more than 7.6 million customers, offering a wide variety of in-house and third-party flower, concentrates, vape cartridges, edibles, topicals and CBD products. Upon closing, Curaleaf will assume ownership of Tryke’s extensive portfolio of processing licenses and expects to significantly expand its cultivation capacity from 30,000 square feet to over 80,000 square feet over the next three years.

Boris Jordan, Founder and Executive Chairman of Curaleaf, said, "On Behalf of the Board of Directors and management team, I look forward to welcoming Tryke to the Curaleaf family as we expand our offerings and operations and bolster our competitive position in three key growth markets. We believe that Tryke represents a unique opportunity to join forces with another industry leading pioneer that shares Curaleaf’s commitment to legalization and expansion. This strategically and financially compelling transaction will expand our US presence by bringing additional premium products to our consumers and retailers in Nevada, Arizona and Utah, all while yielding meaningful benefits for all of our stakeholders. We expect the acquisition to be immediately accretive to our EBITDA margins and free cash flow generation upon closing."

1 Based on the closing price of Curaleaf’s subordinate voting shares on the OTC market as of November 5, 2021.

"This is a tremendous opportunity for Tryke and, as a combined entity, we will continue to deliver significant value for our consumers and retailers in Arizona, Nevada and Utah," said Adam Ryan, Chief Executive Officer of Tryke Companies. "As a part of Curaleaf’s growing network of dispensaries, Tryke is excited to bring its full suite of multi-price point products to an expanded base of consumers across the country. We are excited to join forces with the industry leader at such a pivotal moment in the United States’ legalization efforts. We share Curaleaf’s optimism for the future and are excited to become investors alongside the Company’s talented leadership team."

Compelling Strategic and Financial Benefits

·Enhances Curaleaf’s operations in Arizona, Nevada and Utah: Tryke currently owns and operates six heavily trafficked dispensaries under the Reef brand, with two retail stores in Arizona and four in Nevada, including the Phoenix metropolitan area, Las Vegas strip and North Las Vegas. The company’s products are sold in over 50 additional locations across its footprint.

·Enriches Curaleaf’s product offerings: Tryke currently offers a wide variety of in-house and third-party flower, concentrates, vape cartridges, edibles, topicals and CBD products at a range of price points. Tryke’s product portfolio is highly complementary to Curaleaf’s, allowing the Company to offer consumers and retailers in Arizona, Nevada and Utah an even broader selection of premium cannabis products.

Improves Curaleaf’s margins and free cash flow generation: Tryke has a strong financial profile, with a history of delivering significant revenue growth and compelling EBITDA margins in excess of 35%. Tryke is expected to record nearly US$110 million in full year 2021 revenue. Curaleaf expects the acquisition will be immediately accretive to the Company’s EBITDA margins and free cash flow generation.

The closing of the transaction is expected to occur in the second half of 2022 subject to customary closing conditions, including the receipt of approval from the applicable state regulators, including the Nevada Cannabis Compliance Board.

Transaction Advisors

In a separate press release to be issued today after the market closes, Curaleaf will announce its financial results for the third quarter of 2021, and it will be available at View Source

Conference Call & Webcast

Curaleaf will hold a conference call today, November 8, at 5:00 p.m. Eastern Time to discuss this announcement, as well as its third quarter 2021 results. Investors who wish to participate in the call should dial 1-888-317-6003 (U.S.) or 1-866-284-3684 (Canada) or 1-412-317-6061 (International) approximately 15 minutes before the call begins and provide conference ID number 2599473.

Alligator Announces Poster Presentation on ATOR-1017 at SITC Virtual Annual Meeting 2021

On November 12, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported new preclinical data highlighting the 4-1BB (CD137) antibody ATOR-1017 including an update on the ongoing phase 1 study (Press release, Alligator Bioscience, NOV 12, 2021, View Source [SID1234595323]). ATOR-1017, a promising candidate for immunotherapy with enormous potential for combination with other immunomodulatory antibodies, will be presented at the Society for Immunotherapy Cancer’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-Conference Programs virtually on November 10th – 14th, 2021.

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"By combining ATOR-1017 with antibodies blocking PD-1, tumor infiltrating T cells, in particular exhausted tumor specific T cells, can be more effectively activated and potentially increase the response rate in multiple types of cancer," stated Karin Enell Smith, PhD, MS, Principal Scientist at Alligator Bioscience. "The functional activation profile of ATOR-1017 is expected to minimize the risk of systemic immune activation and toxicity, by directing a potent immune response to immune cells in tumor tissue and tumor draining lymph nodes. This is supported by early data from the ongoing first-in human phase I study where ATOR-1017 has been shown to be safe and tolerable. These results support further clinical development of ATOR-1017 in combination with PD-1 blocking antibodies"

In addition, the poster includes data from the 360 mg cohort of the ongoing ATOR-1017 phase 1 study.

Title: ATOR-1017, a second generation 4-1BB antibody with potential to

enhance efficacy of PD-1 therapies

Presenter: Karin Enell Smith, PhD, MS

Virtual Meeting: E-Posters Session: Poster

The above poster presentations will be available online at www. View Source on Saturday, November 13, 2021.

OncoMyx Presents New Data at SITC 2021 Demonstrating the Potential of a Multi-Armed Myxoma Virus as a Novel Oncolytic Immunotherapy for Solid Tumors and Heme Malignancies

On November 12, 2021 OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, reported the presentation of new preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-Conference Programs (SITC 2021) being held November 10-14, 2021, both virtually and in Washington, D.C (Press release, OncoMyx Therapeutics, NOV 12, 2021, View Source [SID1234595341]). The data demonstrate the potential of a multi-armed myxoma virotherapy for the treatment of solid tumors and heme malignancies. In addition to direct oncolytic effects on cancer cells, OncoMyx’s multi-armed myxoma platform show additional anti-tumor activity through immune activation and tumor microenvironment modulation. Furthermore, OncoMyx has previously established in a preclinical model of cancer that myxoma virus has anti-tumor efficacy following intravenous (IV) or intratumoral (IT) dosing (data presented at AACR (Free AACR Whitepaper) 2021).

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"Myxoma is a unique virus in that it naturally infects and kills cancer cells, but it is a nonhuman pathogen, so there’s no preexisting immunity, which allows for systemic dosing, a longer dosing window, and multi-dosing," said Steve Potts, Ph.D., MBA, cofounder and CEO of OncoMyx. "Furthermore, the large size of the myxoma genome allows for the insertion of multiple genes to arm the virus with immune modulators that can orchestrate the cancer-immunity cycle for optimal viral-mediated cancer-killing activity. These data show the unmatched potential of our myxoma platform to be effective across a broad range of cancers, from hematological malignancies to solid tumors. The data, along with previously published studies, support the advancement of these therapies into clinical development as a monotherapy and in combination with many cancer therapeutics and immunotherapies, including checkpoint inhibitors and chemotherapies."

Immune modulation is a key component of the anti-tumor activity of multi-armed myxoma virus in vivo. The data presented show myxoma multi-armed with decorin and IL-12 infects and kills primary human multiple myeloma cells in vitro and demonstrates efficacy in a mouse model of multiple myeloma. Additional data presented show multi-armed myxoma virus demonstrates efficacy in syngeneic and xenograft tumor models following IT or IV delivery and combinatorial efficacy with immune checkpoint inhibitors.

Titles of the presentations are as follows:

(742) Multi-armed myxoma virus induces potent anti-tumor responses in vitro and in vivo
(744) Multi-armed myxoma virus has therapeutic potential for treatment of multiple myeloma
Onsite posters will be presented in the Poster Hall at the Walter E. Washington Convention Center. The posters will be available for onsite viewing November 12-14 from 7am to 5pm EST. Even numbered posters will be presented Saturday, November 13. ePosters will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7am EST on Friday, November 12 until the virtual meeting platform is closed on January 9, 2022.

Posters for both presentations are available to view and download here (under publications).

About Oncolytic Immunotherapy and Myxoma Virus

Oncolytic viruses (OV) selectively replicate in and lyse tumor cells and provide stimulation to the immune system, representing a promising therapeutic option in development to treat cancers that do not respond well to treatment with immune checkpoint inhibitors. Myxoma virus (MYXV) is a member of the Pox family of double-stranded DNA viruses. The natural host of MYXV is a subset of rabbits and hares, but MYXV is able to infect cancer cell lines of humans and other species. The genome of MYXV is relatively large and is amenable to engineering for expression of transgenic proteins, making it an excellent oncolytic virus for introduction of immunomodulatory proteins.

BeyondSpring Pharmaceuticals to Present at the 2021 Jefferies London Healthcare Conference

On November 12, 2021 BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported that management will present at and host one-on-one investor meetings during the virtual portion of the Jefferies London Healthcare Conference, taking place November 18-19, 2021 (Press release, BeyondSpring Pharmaceuticals, NOV 12, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-to-present-at-the-2021-jefferies-london-healthcare-conference [SID1234595381]).

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The presentation will be available on-demand for attendees during the virtual conference beginning on November 18, 2021. Investors who would like to view the presentation or request a meeting with management may do so by clicking on the link and registering for the event HERE.

A replay of the presentation will also be available on BeyondSpring’s website on the Events & Presentations page for 30 days following the conclusion of the conference.