On June 1, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and GO Therapeutics, Inc. (Co-Founder and CEO: Constantine Theodoropulos, "GO") reported that Xyphos Biosciences, Inc., (a wholly owned subsidiary of Astellas, "Xyphos") and GO have entered into a strategic research collaboration and license agreement to develop novel Immuno-Oncology therapeutics (Press release, Astellas, JUN 1, 2022, View Source [SID1234615305]).

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GO is applying new advances in glycoproteomics to develop antibody-based cancer therapeutics that specifically target cancer cells. Xyphos holds a novel and proprietary ACCELTM technology platform that uses its convertibleCAR (convertible Chimeric Antigen Receptor) on immune cells.

Under the terms of the agreement, the two companies will collaborate exclusively to identify novel antibodies with high affinity to two different glycoprotein targets and apply these antibodies to a range of therapeutic modalities. GO will lead the collaboration to discover high-affinity antibodies against the two targets, and Astellas will be responsible for research activities, clinical development and commercialization of the therapeutics derived from the antibodies provided by GO.

Under the terms of the agreement, Xyphos will pay GO Therapeutics US$20.5 million in upfront cash. Milestone and contingency payments could total up to another US$763 million.

"We are excited to collaborate with Astellas to develop a new class of Immuno-Oncology therapeutics," said Constantine Theodoropulos, co-founder and CEO of GO Therapeutics. "The combination of GO’s targets and antibodies and Astellas’ ACCEL technology promises to create a new generation of cancer treatments that have a greater therapeutic index. This will enable oncologists to increase the efficacy of antibody-based immunotherapies for solid tumors with less damage to healthy tissues."

Naoki Okamura, Chief Strategy Officer at Astellas said, "At Astellas, we have positioned Immuno-Oncology as one of the Primary Focuses of our R&D strategy. We believe that this collaboration will bring synergies between the two companies’ cutting-edge research, and will ultimately lead to the development of new therapeutics for patients with great unmet medical needs."

On June 1, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that an abstract titled "A phase I/II study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in patients with advanced solid tumors (TORCH-2)" will be presented as a poster during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2022), taking place from June 3rd to 7th in Chicago, Illinois via in person or virtual attendance (Press release, Antengene, JUN 1, 2022, View Source [SID1234615296]).

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"Antengene is very pleased to share the clinical data from the TORCH-2 study with the oncology community. Based on the data outlined in the abstract, we are very enthusiastic to further explore the combination of ATG-008 and the PD-1 inhibitor, toripalimab, in the treatment of patients with advanced solid tumors, including cervical cancer. We hope to validate these encouraging early data and thereby help guide the next steps in our clinical development program with ATG-008." said Dr. Kevin Lynch, Antengene’s Chief Medical Officer.

As of the data cut-off on December 20, 2021, the overall response rate (ORR) was 28.6% (based on 6 patients with 5 confirmed responses) and the disease control rate (DCR) was 71.4%. These data are based on 21 efficacy evaluable patients of 28 patients with advanced solid tumors enrolled in the dose-escalation and dose-expansion phases of the Phase I/II TORCH-2 study (median of 2 prior lines of therapy). No dose-limiting toxicities were reported in the dose escalation phase. Most common adverse events (grade 3 or greater) included lymphocyte count decrease, rash and hyperglycemia etc.

Toripalimab was developed by Junshi Biosciences.

The abstract provided several observations regarding cohorts in the efficacy evaluable patients:

Efficacy Evaluable Cervical Cancer Cohort: Among the 5 efficacy evaluable patients in the cervical cancer cohort, 1 patient with negative PD-L1 expression experienced a complete response (CR) and 3 patients experienced a partial response (PR); all responses were confirmed.
Additional Responses in the Efficacy Evaluable Patients: the study reported two additional PRs (one nasopharyngeal carcinoma and one ovarian cancer).
Progression Free Survival (PFS) and Duration of Response: The median PFS for all 28 efficacy evaluable patients was 3.52 months and the 18-month PFS rate was 31.2% (as of December 20, 2021). Note that the patient who achieved CR in the cervical cancer cohort had remained on treatment for 580 days.
The Recommended Phase II Dose was determined.

On June 1, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reported that it has appointed an investment-services provider to purchase 125,000 Ipsen S.A. shares, or about 0.15% of the share capital, over a maximum period of three months (Press release, Ipsen, JUN 1, 2022, View Source [SID1234615290]). The shares purchased under this agreement will be allocated mainly to cover its employee free share-allocation plan.

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This program is made pursuant to the authorization granted by the Combined Shareholders’ meeting, held on May 24th, 2022.

On May 31, 2022, GlycoMimetics, Inc. (the "Company") reported that it received a notice from The Nasdaq Stock Market ("Nasdaq") that the Company is not in compliance with Nasdaq’s Listing Rule 5450(a)(1), as the minimum bid price of the Company’s common stock has been below $1.00 per share for 30 consecutive business days (Filing, 8-K, GlycoMimetics, MAY 31, 2022, View Source [SID1234615506]). The notification of noncompliance has no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Global Market.

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The Company has 180 calendar days, or until November 28, 2022, to regain compliance with the minimum bid price requirement. To regain compliance, the minimum bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the minimum bid price requirement by November 28, 2022, the Company may be eligible for an additional 180-calendar day compliance period if it elects to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period. The Company’s failure to regain compliance during this period could result in delisting.

The Company intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the listing requirements. There can be no assurance that the Company will be able to regain compliance with Nasdaq’s Listing Rule 5450(a)(1) or will otherwise be in compliance with other Nasdaq listing criteria.

On May 31, 2022 Greenfire Bio, LLC reported that its subsidiary, Green3Bio, and its collaborators at MD Anderson Cancer Center will present an update on the ongoing first-in-human clinical trial of GRN-300 at the upcoming ASCO (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Greenfire, MAY 31, 2022, View Source [SID1234615421]). GRN-300 is a first-in-class, orally bioavailable novel small molecule inhibitor of the Salt Inducible Kinases 2 and 3 (SIK2/SIK3) that is highly expressed in ovarian cancer and has been identified to play a pivotal role in several other cancers. The transition of this emerging biologic pathway and a novel agent into the clinic marks a successful step in the progress of the GRN-300 program. The goal of the clinical study is to determine the recommended Phase 2 Dose (RP2D), safety/tolerability and the tumor response of GRN-300 as a monotherapy or in combination with paclitaxel in subjects with ovarian cancer.

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This study is registered at ClinicalTrials.gov Identifier: NCT04711161.

Format: Poster Presentation
Abstract number: TPS5616
Session: Poster Session/Gynecologic Cancer
Time: Saturday, June 4, 2022, 1:15 PM-4:15 PM CDT
Presenter: Siqing Fu, PhD, MD (Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center)

Title: GRN300–001: Phase 1/1b evaluation of the safety, pharmacokinetics and efficacy of GRN-300, a salt-inducible kinase inhibitor, alone and in combination with paclitaxel, in recurrent ovarian, primary peritoneal, and fallopian tube cancers.

About Ovarian Cancer

According to the American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women. They estimate that in 2022 there will be about 19,880 new cases of ovarian cancer diagnosed in the United States and that about 12,810 will die of the disease. According to the World Cancer Research Fund International, there were about 313,000 new cases of ovarian cancer diagnosed worldwide in 2020. Ovarian cancer is difficult to detect at an early, more treatable stage; therefore, the current lack of salvage treatment for women, who experience a recurrence, results in a 5-year survival rate of less than 30%.

About GRN-300

GRN-300 (previously ARN3261) is an orally bioavailable first-in-class novel, small molecule, dual inhibitor of the salt-inducible kinases 2 and 3 (SIK2, SIK3). This agent has the potential to overcome chemoresistance based on its mechanism of action (MOA) and synergistic effects with standard of care including chemotherapy, PARP inhibitors, and immune checkpoint inhibitors (ICIs). SIK2 is overexpressed in 30% of ovarian cancer specimens suggesting a multifunctional role of SIK2/3 in tumorigenesis. SIK2 and SIK3 are known to play an oncogenic role in other tumor types, including prostate cancer, breast cancer, diffuse large B-cell lymphoma, and melanoma. Higher levels of expression of SIK2 have been shown to be significantly correlated with poor progression-free survival in patients with high-grade serous ovarian cancers. GRN-300 attenuated tumor growth in several preclinical xenograft ovarian cancer models as a single agent and in combination with paclitaxel. The compound completed the first dose escalation groups without DLT, and preliminary PK analysis indicate dose proportionality.