On April 27, 2022 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, primarily in genetically defined patient populations, reported that it will present a poster featuring data on AL101 in adenoid cystic carcinoma (ACC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to take place June 3-7, 2022 in Chicago, Illinois (Press release, Ayala Pharmaceuticals, APR 27, 2022, View Source [SID1234613027]).

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Details of the poster presentation are as follows:

Abstract Title: Results of ACCURACY: A phase 2 trial of AL101, a selective gamma
secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid
cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut)
Abstract Number: 6046
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
The ongoing Phase 2 ACCURACY clinical trial is an open-label, single-arm, multi-center study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. The company will present safety, efficacy, PK and PD data from the 4mg and 6mg AL101 cohorts in the trial.

About Adenoid Cystic Carcinoma (ACC)

ACC is a rare malignancy of the secretory glands including salivary glands, accounting for about 10% of all salivary gland tumors with an annual incidence of 3,400 in the U.S. There is currently no approved standard of care for patients with recurrent/metastatic ACC. Patients with locoregional disease undergo surgery and radiation therapy, with recurring disease treated by chemotherapy. ACC is an immunologically "cold" tumor that is refractory to chemotherapy, with a recurrence rate of about 60% after initial surgery. The Notch pathway has been determined to be an oncogenic driver of ACC and its dysregulation plays a key role in tumorigenesis and correlates with a distinct pattern of metastasis and a poor prognosis.

About AL101

AL101 is an investigational small molecule Gamma Secretase Inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2 ACCURACY clinical studies in patients with adenoid cystic carcinoma (ACC). AL101 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL101 from Bristol-Myers Squibb Company in November 2017. AL101 was granted U.S. FDA Fast Track Designation and Orphan Drug Designation for the treatment of ACC.

On April 27, 2022 Ashvattha Therapeutics ("Ashvattha"), a clinical stage company developing novel hydroxyl dendrimer therapeutics, reported it has secured $69 million in a Series B financing and in a separate agreement entered an exclusive licensing deal with Huadong Medicine (Press release, Ashvattha Therapeutics, APR 27, 2022, View Source [SID1234613043]). Proceeds will support the advancement of Ashvattha’s pipeline of hydroxyl dendrimer therapeutics (HDTs), including multiple clinical stage programs. Ashvattha launched a Phase 2 study in severe COVID-19 earlier this year and in 2022 plans to launch a Phase 2 study in wet AMD/DME and Phase 1/2 study in ALS.

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The Series B financing was led by Huadong Medicine Investment Holding Co., Ltd, with participation from existing investors, including Natural Capital, Plum Alley, Tribe Capital and several prominent technology and biotech angel investors bringing Ashvattha’s total funding to $69 million.

The exclusive licensing agreement with Huadong which includes up to $45 million advanced payments for product development, grants Huadong development and commercialization rights to its pipeline assets in China and parts of southeast Asia. Under the terms of the exclusive licensing agreement:

Huadong will advance up to $30 million to cover research and development costs for Ashvattha’s hydroxyl dendrimer clinical candidates, OP-101, D-4517.2 and OP-801, and $15 million for additional preclinical candidates
Huadong will gain exclusive licensing rights to develop, manufacture and commercialize these candidates in China, and southeast Asian countries such as Singapore and Malaysia.
Huadong will pay Ashvattha a royalty of 10% of net sales of licensed products
HDTs have been shown to selectively target reactive inflammatory cells in diseased tissue, with the ability to cross the blood-brain barrier and blood-retinal barrier to treat neurology, ophthalmology, and inflammatory diseases. Interim data from ongoing Phase 2 PRANA clinical study in severe COVID-19 patients demonstrated the ability of OP-101, an HDT, to cross the blood-brain barrier and reduce neuronal injury and systemic hyperinflammation, reinforcing the potential of the HD platform.

"We believe that hydroxyl dendrimer therapeutics are the future of precision medicine and look forward to demonstrating this with multiple clinical data catalysts in our ophthalmology, neurology and inflammatory programs this year," said Jeffrey Cleland, Ph.D., Chairman & CEO of Ashvattha Therapeutics. "This investment and partnership confirm confidence in our approach to precision medicine with disease-cell selective HDTs, as well as the broad potential of our platform, and the potential to dramatically increase the therapeutic index of drugs."

Mr. Lv Liang, Chairman of Huadong Medicine, added, "We believe Ashvattha’s hydroxyl dendrimer platform has the potential to produce highly selective drugs. This collaboration will enable us to build an R&D ecosystem, further enriching our pipeline in the fields of tumor, immunity and endocrinology. This allows us to accelerate scientific research innovation and internationalization. We look forward to working with Ashvattha to advance a new class of therapeutics that may hold the potential to enhance the treatment landscape for a broad range of patient populations."

About OP-101
OP-101 is an HDT with N-acetyl cysteine (NAC) that selectively targets reactive macrophages and microglia, which are responsible for hyperinflammation, lung injury and multi-organ failure caused by viral or bacterial infections, including COVID-19.

About D-4517.2
D-4517.2 is an HDT with potent anti-angiogenic activity inhibiting VEGFR/PDGFR that selectively targets reactive inflammatory cells and crosses the blood-retinal barrier.

About OP-801
OP-801 is an HD imaging agent that provides information on uptake of HDs across tissue barriers including the blood brain barrier. 18F-OP-801 selectively targets reactive microglia in regions of neuroinflammation in neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease.

On April 27, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that it will release financial results for the first quarter ended March 31, 2022 before the open of trading on Wednesday, May 11 (Press release, Biodesix, APR 27, 2022, View Source [SID1234613060]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. Eastern Time on the same day. Dial-in and call details are as follows:

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On April 27, 2022 Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company reported the presentation of new clinical research showcasing the potential of its investigational KRASG12C inhibitor, adagrasib, in a study of patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3 to 7, 2022 in Chicago, IL (Press release, Mirati, APR 27, 2022, View Source [SID1234613076]).

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"Mirati continues to develop adagrasib with the goal of having a meaningful impact on patients with lung cancer," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Our data at this year’s ASCO (Free ASCO Whitepaper) congress includes important insights into adagrasib’s clinical profile in patients with NSCLC who harbor a KRASG12C mutation, including those with active and untreated CNS metastases, which is a serious and potentially fatal complication for these patients. We believe adagrasib has the potential to transform the lives of those with KRAS-mutated cancers including lung, colorectal, pancreatic and other tumors that carry the KRASG12C mutation."

The adagrasib New Drug Application (NDA) is currently being reviewed by the U.S. Food and Drug Administration (FDA) for Accelerated Approval (Subpart H) as a treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. The application is being reviewed under the FDA Real Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.

Mirati presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Presentation Title: KRYSTAL-1: Activity and Safety of Adagrasib (MRTX849) in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring a KRASG12C Mutation
Author: Alexander I. Spira
Abstract Number: 9002
Session: Lung Cancer—Non-Small Cell Metastatic
Presentation Date/Time: Friday, June 3, 2022 at 2:24 to 2:36 PM ET/1:24 to 1:36 PM CT

Presentation Title: Activity of Adagrasib (MRTX849) in Patients with KRASG12C-Mutated NSCLC and Active, Untreated CNS Metastases in the KRYSTAL-1 Trial
Author: Joshua K Sabari
Abstract Number: LBA9009
Session: Clinical Science Symposium/Including the Excluded: Advancing Care for All Patients With Lung Cancer
Presentation Date/Time: June 6, 2022 at 5:30 to 5:42 PM ET/4:30 to 4:42 PM CT

Mirati will also host an exhibit at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting at booth number 2097.

Virtual Investor Event

Mirati Therapeutics will host an Investor Event on Monday, June 6, 2022 at 8:00 PM ET / 7:00 PM CT.

Investors and the general public are invited to register and listen to a live webcast of the event through the "Investors and Media" section on Mirati.com. A replay of the event will be available shortly after the conclusion of the event.

About Adagrasib (MRTX849)

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.

On April 27, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that the company’s annual report and corporate governance report for the financial year 2021 are now available on the company’s website, www.isofolmedical.com (View Source) (Press release, Isofol Medical, APR 27, 2022, View Source [SID1234613009]).

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This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CEST on April 27, 2022.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.