On August 4, 2021 Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin"), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, and Synaffix B.V. (CEO: Peter van de Sande, "Synaffix"), a biotechnology company with a clinical-stage platform technology enabling best-in-class antibody-drug conjugates (ADCs), reported the signing of a license and option agreement (Press release, Kyowa Hakko Kirin, AUG 4, 2021, View Source [SID1234585649]).

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In exchange for the license signature fee, Synaffix will initially provide target-specific rights to its proprietary ADC technologies, enabling Kyowa Kirin to evaluate two of its antibodies as proprietary ADC therapeutic candidates within its pipeline. Kyowa Kirin may expand the deal with additional ADC targets at a later point in time. Under the terms of the agreement, upon exercise of an option by Kyowa Kirin for further development and commercialisation of such selected ADC target, Synaffix is eligible to receive a license issuance fee for each additional target and milestone payments plus royalties on potential future commercial sales of ADCs developed against each licensed target. The agreement is the culmination of a successful initial research period between the companies.

The technologies licensed from Synaffix include GlycoConnect, HydraSpace, and multiple toxSYN linker-payloads, which allow for the drug-to-antibody ratio (DAR) to be tailored to 1, 2 or 4 to optimize the therapeutic index of the ADC.

Yoshifumi Torii, Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin said:

"Kyowa Kirin is committed to realizing the successful creation and delivery of life-changing value that ultimately makes people smile. We believe that Synaffix’s cutting-edge ADC technologies will enable us to rapidly generate multiple potential ADC pharmaceutical candidates, spanning different mechanisms of action and optimal structures, under a single, simple technology access license and result in providing new therapeutic options for people living with disease."

Peter van de Sande, CEO of Synaffix said:

"This collaboration is our sixth announced out-licensing deal, expanding the geographic footprint of and validation of our ADC technologies. At the same time, this brings the number of ADCs in development based on Synaffix’ technologies beyond 10, with three of those partnered programs already in clinical trials."

"We look forward to building on our already close collaboration with the Kyowa Kirin team over the coming years to successfully address areas of high unmet medical need."

On August 3, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will participate in a fireside chat at the BTIG Virtual Biotechnology Conference being held August 9-10 2021 (Press release, Cue Biopharma, AUG 3, 2021, https://cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-present-corporate-update-upcoming-btig-virtual [SID1234608275]).

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During the fireside chat, Cue Biopharma will provide a corporate update highlighting clinical progress on CUE-101, the lead Immuno-STAT (Selective Targeting and Alteration of T cells) IL-2 based therapeutic, in clinical trials for the treatment of second line and beyond patients with HPV+ recurrent/metastatic head and neck cancer. The presentation will also focus on the Company’s platform developments and pipeline progress including its next clinical candidate CUE-102, targeting the Wilms’ tumor 1 (WT1) antigen, which will be evaluated in a Phase 1 clinical trial expected to commence in 1H22.

Presentation Details

BTIG Virtual Biotechnology Conference
Date and Time: Tuesday, August 10, 2021 at 3:00 p.m. EDT

The webcasted fireside chat will be hosted on the conference website and available only to conference participants. Please visit www.BTIG.com for more information.

About BTIG
BTIG is a global financial services firm specializing in institutional trading, investment banking, research and related brokerage services. With an extensive global footprint and more than 650 employees, BTIG, LLC and its affiliates operate out of 19 cities throughout the U.S., and in Europe, Asia and Australia. BTIG offers execution, expertise and insights for equities, equity derivatives, ETFs and fixed income, currency and commodities (futures, interest rates, credit, and convertible and preferred securities). The firm’s core capabilities include global execution, portfolio, electronic and outsource trading, transition management, investment banking, prime brokerage, capital introduction, corporate access, research and strategy, commission management and more.

On August 3, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the Company will be evaluating mirdametinib, an investigational MEK inhibitor, in a platform study sponsored by Memorial Sloan Kettering Cancer Center (MSK) and supported by SpringWorks exploring the compound both as a monotherapy and as a combination therapy in advanced solid tumors harboring MAPK-activating mutations (Press release, SpringWorks Therapeutics, AUG 3, 2021, View Source [SID1234591664]). The trial, which is expected to begin recruiting patients during the third quarter of 2021, will initially explore mirdametinib in two patient cohorts: the first in combination with fulvestrant, a selective estrogen receptor degrader (SERD) in patients with estrogen receptor positive (ER+) metastatic breast cancer (mBC) with MAPK alterations (particularly inactivating mutations in NF1), and as a monotherapy in advanced solid tumors harboring oncogenic MEK1 or MEK2 mutations.

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"Emerging evidence points to alterations in the MAPK pathway playing a key role in mediating resistance to hormone therapy in ER+ mBC, which represents a significant unmet medical need," explained Ezra Rosen, M.D., Ph.D., Medical Oncologist, Assistant Member of MSK’s Early Drug Development Service, and the study’s principal investigator. "Based on emerging preclinical data, combinations of MAPK pathway inhibitors with ER-targeted therapy could potentially address this resistance mechanism and we look forward to studying mirdametinib to evaluate whether this MEK inhibitor can provide a clinical benefit. Separately, given the preclinical evidence that activating mutations in MEK1 and MEK2 can also act as oncogenic drivers in cancer, we’re looking to explore a potential role for mirdametinib monotherapy in solid tumors harboring these driver mutations."

Approximately 70% of breast cancers are ER+. Hormonal therapies targeting ER, such as SERDs, can be effective in treating ER+ mBC, but over 90% of patients eventually develop resistance to ER-targeted therapy. Loss of NF1 function has been shown to be responsible for enhanced ER transcriptional activity and reduced sensitivity to fulvestrant in preclinical models, with up to 6% of ER+ mBC patients harboring a detectable NF1 mutation.1 Combinations of MAPK pathway inhibitors and ER-targeted therapy could potentially address this resistance, as demonstrated by a combination of a MEK inhibitor and fulvestrant showing anti-tumor activity in fulvestrant-refractory NF1-deficient ER+ mBC preclinical models.1,2

In addition, MEK1 and MEK2 mutations are present in up to 2% of solid tumors and have been validated as oncogenic drivers. Recent publications demonstrate the activity of MEK inhibitors, including mirdametinib, in preclinical models driven by a subset of these MEK mutations.3,4

"This biomarker-driven platform study will enable us to evaluate mirdametinib’s ability to address subsets of patients with solid tumors that harbor specific MAPK pathway mutations," said Mike Burgess, M.B.Ch.B., Ph.D., Head of Research and Development at SpringWorks. "We are committed to exploring the full potential of mirdametinib on behalf of patients with devastating cancers and look forward to collaborating with Dr. Rosen and his colleagues at MSK on this important trial."

About the MSK-Sponsored Phase 1b/2a Trial

The open-label Phase 1b/2a parallel design, platform study will evaluate the safety and tolerability, efficacy, and pharmacokinetics of mirdametinib in two study arms: (1) in combination with fulvestrant in postmenopausal patients with ER+ mBC harboring NF1 loss of function or other alterations of the MAPK pathway and (2) as a monotherapy in adult patients with advanced solid cancers driven by the alterations of the MAPK pathway, including MEK1 or MEK2 mutations.

The primary objectives of the trial will be to evaluate the safety and tolerability and anti-tumor efficacy of mirdametinib in combination with fulvestrant and as a single agent. The efficacy endpoints will include best objective response by RECIST 1.1, disease control rate, duration of response, progression-free survival, and pharmacokinetic endpoints. Biomarker analyses will also be conducted to evaluate the changes from baseline in the biomarkers of tumor biology and anti-tumor activity and characterize potential mechanisms of resistance.

About Mirdametinib

Mirdametinib is an oral, potent, allosteric, brain-penetrant small molecule designed to inhibit MEK1 and MEK2, which are proteins that occupy pivotal positions in the MAPK pathway and that play a central role in multiple oncology and rare disease indications. To date, over 250 subjects have been exposed to treatment with mirdametinib across clinical trials, with preliminary evidence of clinical activity against tumors driven by over-activated MAPK signaling.5

Mirdametinib is being evaluated as a monotherapy in a Phase 2b trial for pediatric and adult patients with NF1-associated plexiform neurofibromas (NF1-PN), and in a Phase 1/2 trial for patients with pediatric low-grade gliomas. In addition, mirdametinib is being evaluated in a Phase 1b/2 trial in combination with BeiGene’s RAF dimer inhibitor, lifirafenib, in patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations, and other MAPK pathway aberrations.

On August 3, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in a Fireside Chat at the 12th Annual Wedbush PacGrow Healthcare Conference on Wednesday, August 11th at 9:45AM ET (Press release, SpringWorks Therapeutics, AUG 3, 2021, View Source [SID1234591663]).

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To access the live webcast please visit the "Events & Presentations" page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On August 3, 2021 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will be virtually participating in the Canaccord 41st Annual Growth Conference (Press release, Akoya Biosciences, AUG 3, 2021, View Source [SID1234590279]).

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Brian McKelligon, CEO is scheduled to present on Wednesday, August 11th, 2021 at 2:00 p.m. ET. Interested parties may request more information by contacting their sales representative at Canaccord.