Strand Therapeutics and BeiGene Enter into Agreement to Develop Solid Tumor Immuno-Oncology Therapeutics Based on Strand’s Next-Generation, Multi-Functional mRNA Technology

On January 11, 2021 Strand Therapeutics, a privately held developer of next-generation, programmable mRNA therapeutics for cancer and other diseases, and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) reported that they have entered into an option and license agreement aimed at developing and commercializing Strand’s innovative, multi-functional mRNA treatments for solid tumors (Press release, Strand Therapeutics, JAN 11, 2021, View Source [SID1234573832]). BeiGene has secured an option to an exclusive license to develop and commercialize in Asia (excluding Japan), Australia, and New Zealand up to two immuno-oncology programs using Strand’s intratumoral or systemic delivery mechanism, which is designed to deliver a tumor microenvironment-modifying mRNA directly to the tumor site.

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Strand has developed the first platform for the creation of programmable, long-acting mRNA therapeutics capable of delivering multi-functional treatments for deadly diseases, with an initial aim of developing potentially curative treatments for solid tumor cancers. The company’s self-replicating mRNAs are bioengineered to enable precise control of the location, timing, intensity, and duration of therapeutic protein expression for improved efficacy and lower toxicity.

"BeiGene is a recognized global leader in the development and commercialization of innovative, high-quality cancer therapeutics," said Jacob Becraft, Ph.D., Co-founder and Chief Executive Officer of Strand. "This collaboration between our two companies provides strong validation of Strand’s next-generation mRNA platform and our work to advance mRNA-based medicines beyond vaccines into potentially curative therapies."

"We look forward to working closely with BeiGene’s unsurpassed clinical team to accelerate the development of our solid tumor immuno-oncology therapies," said Tasuku Kitada, Ph.D., Co-founder, President, and Head of R&D of Strand. "The aim of both our companies is to increase patient access to cutting-edge therapeutics by providing safe and effective treatments that are more easily administered, cost-effective, and scalable."

"Strand’s programmable mRNA technology is incredibly exciting as a cutting-edge therapeutic platform and is expected to help us build novel mRNA-based immuno-oncology therapeutics for the treatment of cancer. We look forward to exploring this technology further and to collaborating with Strand as we advance up to two development programs with this new approach," said Lusong Luo, Ph.D., Senior Vice President of External Innovation at BeiGene.

Under the terms of the agreement, Strand will receive an upfront cash payment of $5 million and will also be eligible to receive additional near-term payments totaling up to $28 million, inclusive of BeiGene’s exercise of its options to the two programs following initial proof-of-concept studies. Additionally, Strand is eligible to receive payments from BeiGene based upon the achievement of certain development, regulatory, and sales milestones for a total deal value of up to $277 million, together with tiered royalties on any product sales in the licensed territory. In connection with the agreement, Strand also received investments of $10 million, including $5 million from BeiGene.

Affimed to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 11, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that its Chief Executive Officer, Dr. Adi Hoess, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 7:30 a.m. Eastern Standard Time (Press release, Affimed, JAN 11, 2021, View Source [SID1234573831]).

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A live webcast of the presentation may be accessed on Affimed’s website at View Source and will be available for 30 days following the event. For more information or to schedule a one-on-one meeting with Affimed management, please contact Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.

Syros Announces Strategic Priorities and Expected Milestones

On January 11, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported its strategic priorities and expected upcoming milestones (Press release, Syros Pharmaceuticals, JAN 11, 2021, View Source [SID1234573830]).

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"Syros is rapidly accelerating toward becoming a commercial-stage company through three strategic priorities: advancing franchises in targeted hematology and selective CDK inhibition, as well as leveraging a robust gene control discovery engine to fuel our long-term growth," said Nancy Simonian, M.D., Syros’ Chief Executive Officer. "As we enter the new year, we are well-positioned to execute against each of these strategic priorities. We plan to launch three clinical trials across our portfolio of targeted hematology therapies in patients with higher-risk MDS, AML and APL, indications where we have the opportunity to set new standards of care."

"In parallel, we continue to build on our leadership in selective CDK inhibition, where we believe we can deliver highly selective product candidates with transformative potential for difficult-to-treat cancers. We are on track to report additional dose-escalation data, including clinical activity, from our Phase 1 trial of SY-5609 in the third quarter and move into the expansion phase of the trial in the second half of the year. These milestones bring us closer to our ultimate goal of bringing targeted therapies to market that provide profound benefits for patients with diseases that have eluded other approaches."

Expected Milestones

SY-1425: Oral RARα agonist

Initiate Phase 3 trial of SY-1425 in combination with azacitidine in the first quarter of 2021 in RARA-positive patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).
Initiate randomized Phase 2 trial of SY-1425 in combination with venetoclax and azacitidine in the second half of 2021 in RARA-positive newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy.
SY-2101: Oral arsenic trioxide (ATO)

Initiate dose confirmation study of SY-2101 in the second half of 2021.
Initiate Phase 3 trial in patients with newly diagnosed acute promyelocytic leukemia (APL) in 2022.
SY-5609: Oral CDK7 inhibitor

Report additional dose-escalation data, including clinical activity data, in the third quarter of 2021 from the ongoing Phase 1 trial of SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.
Initiate expansion portion of Phase 1 trial in the second half of 2021.
Gene control discovery engine

Expect to nominate next development candidate in 2022.
Financial Guidance
Syros ended the year with approximately $174 million in cash, cash equivalents and marketable securities1, which the company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2022.

J.P. Morgan Healthcare Conference Presentation – January 11, 2021

On January 11, 2021 Mirati Presented the Corporate Presentation (Presentation, Mirati, JAN 11, 2021, View Source [SID1234573829]).

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Investor Presentation dated January 2021

On January 11, 2021, Moleculin Biotech, Inc. (the "Company") presented the corporate presentations (Press release, Moleculin, JAN 11, 2021, View Source [SID1234573828]).

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