On June 1, 2022 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), an R&D biotechnology company focused on improving the bio-delivery and biodistribution of medicines, reported that upon submitting an application to the U.S. Food and Drug Administration ("FDA"), its development programme of MTX110 for the treatment of recurrent glioblastoma ("rGBM") has been granted Fast Track designation by the agency (Press release, Midatech Pharma, JUN 1, 2022, View Source [SID1234615608]).

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Fast Track is a process designed to facilitate the development and expedite the review of treatments for serious conditions and that potentially address unmet medical needs. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.

Commenting, Dmitry Zamoryakhin, CSO of Midatech, said: "GBM is a devastating cancer marked by short survival rate and universal recurrence. Receiving Fast Track designation for MTX110 is an important milestone for the development of the drug as it demonstrates the need for novel and effective treatment options for this currently universally fatal disease. MTX110, our water-soluble formulation of Panobinostat, will soon start recruitment into a company-sponsored Phase I study in patients with recurrent GBM".

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014, as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 (as amended).

About MTX110

MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-β-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of glioblastoma (SNO 2020 Abstract TMOD-27). MTX110 is delivered directly into and around the patient’s tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).

On June 1, 2022 (the "Effective Date"), Akoya Biosciences, Inc. (the "Company") reported that entered into an Amendment No. 2 (the "Amendment") to Credit and Security Agreement, with the lenders party thereto and MidCap Financial Trust, as agent, in order to provide the Company an additional tranche of non-dilutive funding and allow the Company to draw the second tranche (Filing, 8-K, Akoya Biosciences, JUN 1, 2022, View Source [SID1234615484]). The Amendment provides that the second tranche of $10,000,000 will be drawn on June 1, 2022. Additionally, the Amendment provides the Company with a third tranche pursuant to which the Company may draw $10,000,000 any time after September 30, 2022 until September 30, 2023. The Amendment also delays the amortization start dates for the outstanding loan amounts from November 1, 2023 until April 1, 2025, at which point the Company will repay the principal amounts in seven equal monthly installments until the maturity date. Finally, the Amendment amended the interest rate payable on the term loan to apply an interest rate equal to the SOFR rate (with a floor of 1.61448%) plus 6.35%. Substantially all other terms and conditions, and covenants of the credit agreement remain unchanged. In connection with the Amendment, the Company agreed to pay the lenders a $75,000 commitment fee as well as a 0.25% fee upon the funding of each of the second tranche and third tranche amounts.

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On June 1, 2022 AccuGenomics Inc reported that it has joined the FNIH Biomarkers Consortium focused on Measurable residual disease in acute myeloid leukemia (MRD in AML) (Press release, Accugenomics, JUN 1, 2022, View Source [SID1234615483]). We look forward to our participation in advancing the accuracy of targeted NGS testing of liquid biopsy samples.

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As a disruptive precision diagnostics technology company, AccuGenomics’s mission is to improve the accuracy and performance of clinical sequencing testing for better patient outcomes. The rapid pace of innovation in NGS diagnostics continues to push the limits of detection for low abundance biomarkers, increasing the need to demonstrate the analytical performance of Companion Diagnostic (CDx) tests for patients and healthcare providers. We create internal standards for targeted NGS assays that reduce uncertainty and give clinicians and patients the accuracy in data to make confident medical decisions by eliminating false positive and false negative results, allowing the true underlying biology to be seen. We design and manufacture internal spike in standards that enable accurate detection of low abundance biomarkers from liquid biopsy or other sample types (can be any target, any platform, and any sample type). We improve the true limit of detection (LOD) for NGS assays so even rare variants can be identified so that the molecular markers of cancer can be detected earlier, even from liquid biopsy samples.

The Foundation for the National Institutes of Health (FNIH) is a not-for-profit charitable organization chartered by Congress to create and manage alliances with public and private institutions in support of the mission of the NIH, the world’s premier medical research agency. The Biomarkers Consortium at FNIH is the preeminent public-private partnership focused on identifying, developing, and qualifying biomarkers that accelerate therapeutics and improve clinical care.

On June 1, 2022 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will be participating in the following investor conferences (Press release, Sangamo Therapeutics, JUN 1, 2022, View Source [SID1234615447]):

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Jefferies Healthcare Conference
Date: Thursday, June 9 at 9:00 a.m. Eastern Time
Guggenheim I&I Spotlight Series – Treg-based Therapies
Date: Tuesday, July 12 at 2:45 p.m. Eastern Time
Access links for presentations, panels and fireside chats will be available on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will also be available on the Sangamo Therapeutics website after the event.

On June 1, 2022 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported that its management team will present at the Jefferies Healthcare Conference on June 8, 2022 at 1:00 pm ET in New York City (Press release, Savara, JUN 1, 2022, View Source [SID1234615446]). A live webcast of the presentation will be available on Savara’s website at www.savarapharma.com/investors/events-presentations/ and will be archived for 90 days.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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