On January 4, 2021, Kura Oncology, Inc., (the "Company"), reported that it entered into a Master Collaboration Agreement and a project schedule, collectively the Agreement, with Illumina, Inc. ("Illumina") (Filing, 8-K, Kura Oncology, JAN 4, 2021, View Source [SID1234573701]). Pursuant to the Agreement, Illumina has agreed to develop and commercialize an assay as a companion diagnostic test to identify head and neck squamous cell carcinoma patients with an HRAS mutation for use with tipifarnib, one of the Company’s lead drug candidates.

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Under the Agreement, Illumina is responsible for developing, and obtaining and maintaining regulatory approvals for, the companion diagnostic test in the United States, the United Kingdom and major European markets and such other countries as the parties may mutually agree. In addition, Illumina has agreed to use commercially reasonable efforts to manufacture the companion diagnostic test and to make the companion diagnostic test commercially available in the United States, the United Kingdom and major European markets and such other countries as the parties may mutually agree.

On January 4, 2021 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, reported the completion of its end-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) on AL102, a potent, selective, oral gamma secretase inhibitor (GSI), for the treatment of desmoid tumors (Press release, Ayala Pharmaceuticals, JAN 4, 2021, View Source [SID1234573635]). The FDA has agreed, based on data from AL101 and AL102 studies including durable responses observed in patients with Desmoid tumors, to proceed with a Phase 2/3 pivotal study, which can potentially be used as a registrational study. Ayala expects to initiate the pivotal Phase 2/3 RINGSIDE study in adult and adolescent patients with desmoid tumors in the first half of 2021.

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"This exciting news of entering into a potentially registration-enabling pivotal trial, earlier than expected, represents an important step for Ayala as we are able to accelerate the development of AL102 for the treatment of desmoid tumors based on positive and encouraging feedback from the FDA following our end-of-Phase 1 meeting," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Desmoid tumors are a rare, debilitating and often disfiguring class of soft-tissue tumors for which there are currently no approved therapies. We believe AL102 is well positioned to potentially provide effective systemic treatment based on the body of data conducted by BMS in patients with desmoid tumors implicating the role of Notch pathway in activating aberrant growth pathways contributing to desmoid tumor growth."

The pivotal Phase 2/3 RINGSIDE trial is designed to evaluate the efficacy, safety and tolerability of AL102 in adult and adolescent patients with desmoid tumors. Part 1 of the study will be open label and will enroll up to 36 patients with progressive desmoid tumors in three study arms across three doses of AL102: 1.2 mg daily (QD), 2 mg twice weekly (QIW), and 4mg twice weekly (QIW) with initial follow up of safety, tolerability and tumor volume by MRI after 16 weeks in order to determine the optimal dose. At the end of part 1, all patients will be eligible to enroll into an open label extension study at the selected dose where long-term efficacy and safety will be monitored.

Part 2 of the study will start immediately after dose selection from part 1 and will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized 2:1 between AL102 or placebo. The study’s primary endpoint will be progression free survival (PFS) with secondary endpoints including, objective response rate (ORR), duration of response (DOR) and patient reported Quality of Life (QOL) measures.

The study is expected to commence in the first half of 2021 with an initial interim data read-out from part 1 and dose selection expected by mid-2022 with part 2 of the study to commence immediately thereafter.

About AL102

AL102 is a potent, selective, oral gamma secretase inhibitor (GSI). AL102 is currently being developed for the treatment of desmoid tumors, as well as in combination with Novartis’ B-cell maturation antigen (BCMA)-targeting agents for the treatment of multiple myeloma (MM).

About Desmoid Tumors

Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

On January 4, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that Sanofi has made the decision to progress IPH6101/SAR443579 into investigational new drug (IND)-enabling studies (Press release, Innate Pharma, JAN 4, 2021, View Source [SID1234573454]). IPH6101/SAR443579 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. Cell 2019).

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In the first research program of the collaboration, IPH6101/SAR443579 has shown anti-tumor activity in pre-clinical models, including encouraging pharmacokinetic (PK), pharmacodynamic (PD) and safety data in preliminary non-human primate studies, as well as positive manufacturability properties, leading to its selection as a drug candidate for development.

The decision triggered a €7M milestone payment from Sanofi to Innate. Sanofi will be responsible for all future development, manufacturing and commercialization of IPH6101/SAR443579.

This milestone is part of the previously announced research collaboration with Sanofi, under which the companies collaborate on the generation and evaluation of up to two bispecific NKCEs, using technology from Innate and Sanofi’s proprietary bispecific antibody formats as well as tumor targets. The companies are also currently working on the second research program.

"We are very pleased that Sanofi will work to bring IPH6101/SAR443579 towards the clinic, as it highlights the potential of engaging NK cells through NKp46, as well as the robustness of Innate’s proprietary multi-specific antibody format," said Pr. Eric Vivier, PhD, Chief Scientific Officer at Innate Pharma. "We believe IPH6101/SAR443579 is the first NKp46-based NK cell engager to start development, demonstrating the next wave of scientific innovation at Innate. This successful validation will also be valuable for our second ongoing research program with Sanofi, and ultimately, the overall Innate NK cell engager platform."

Innate’s multifunctional NKCE technology is comprised of novel antibody formats that simultaneously target two activating receptors, NKp46 and CD16, on NK cells as well as a tumor antigen on cancer cells.

Such trifunctional NKCEs have proven more effective in pre-clinical models than classical antibodies directed against the same tumor target, as co-engagement of multiple surface receptors on NK cells is required for their full activation.

NKCEs may show improved therapeutic window for cancer treatment as compared to bispecific T lymphocyte-engaging formats.

About NKp46-based NKCE:
NKp46 is an activating receptor expressed on all NK cells. It is the most specific marker of human NK cells and plays a major role in their tumor cell recognition.

Innate’s NKp46 multi-specific NK cell engagers bind with one arm to an antigen at the surface of tumor cells, and with another arm to the NKp46 receptor on NK cells. This leads to activation and specific tumor-killing and cytokine secretion by NK cells, an immune cell population representing a significant proportion of all cytotoxic lymphocytes in the body.

About the Innate-Sanofi agreement:
The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multispecific antibody formats engaging natural killer (NK) cells to kill tumor cells and secrete cytokines through the activating receptor NKp46.

Under the terms of the licence agreement, Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

On January 4, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported its participation at the following upcoming investor relations events and scientific conferences (Press release, Ideaya Biosciences, JAN 4, 2021, View Source [SID1234573453]).

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Investor Relations Events

JP Morgan 39th Annual Healthcare Conference 2021 (Virtual)
Company Presentation
Wednesday, January 13th, 2021 at 5:20 pm ET
HC Wainwright Bioconnect (Virtual)
Company Presentation
Thursday, January 14th, 2021, at 6:00 am ET
A live audio webcast of each presentation will be available by visiting the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of the webcasts will be available for 30 days following the live event.

Scientific Conferences

PARP & DDR Inhibitors Summit 2021 (Digital)
Presentation Session – Next Generation Synthetic Lethal Interactions
"Pharmacological inhibition of DNA polymerase theta (Polq) activity shows promise as novel treatment for homologous recombination deficient tumors"
Thursday, January 28th, 2021 at 2:15 pm ET
The PARP & DDR Inhibitors Summit will be held January 26th-28th, 2021. See http://parp-ddr-inhibitors-summit.com/about/the-summit/.

On January 4, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will present at the 39th Annual J.P. Morgan Healthcare Conference (Press release, Karyopharm, JAN 4, 2021, View Source [SID1234573452]). The conference is being conducted in a virtual format and the presentation will take place on Monday, January 11 at 4:30 p.m. ET, followed by a question and answer breakout session at 4:50 p.m. ET.

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A live webcast of the presentation and breakout session can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be archived on the Company’s website for 30 days following the presentation.