On June 1, 2022 Hangzhou DAC Biotechnology Co., Ltd. ("DAC Biotechnology") reported a collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson ("Janssen") (Press release, Hangzhou DAC Biotech, JUN 1, 2022, View Source [SID1234618939]). Under the terms of the agreement, DAC Biotechnology will apply its innovative and proprietary antibody drug conjugate (ADC) platform to Janssen’s proprietary antibodies with the aim to develop novel ADC products against up to five targets. The negotiation and finalization of the agreement was facilitated by Johnson & Johnson Innovation. DAC Biotechnology has also received an equity investment from Johnson & Johnson Innovation – JJDC, Inc.

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"We are very proud to mark this important collaboration with Janssen," said Dr. Robert Yongxin Zhao, President and Chief Executive Officer of DAC Biotechnology. "After years of dedicated research and development, DAC technology has become a key player in the field of ADC innovation. Our advanced ADC platform, with abundant reserve of payload/linker pairs, conjugation technologies and CMC capabilities, enables us to build a deep pipeline of products, many of them being first-in-class ADCs. We are committed to bringing safe and efficacious medicines not only to patients in China, but also those around the world."

"The collaboration with Janssen is the very first collaboration milestone in our global roadmap. The combination of the license agreement and equity investment creates an exciting approach to progressing novel therapeutic innovations in overseas markets," Dr. Zhao continues.

With the aim to discover novel ADC products via license collaboration, DAC Biotechnology will fully leverage its intellectual properties and proprietary ADC platform, while Janssen will provide its expertise in proprietary antibodies, clinical development and global commercialization. Through the collaboration agreement, DAC Biotechnology is eligible to receive an upfront payment, cost reimbursement and milestone payments, plus royalties on worldwide sales for each selected product.

On June 1, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported that Lonnel Coats, Lexicon’s chief executive officer, will present at the Jefferies 2022 Healthcare Conference on Wednesday, June 8, 2022 at 10:00 a.m. ET (Press release, Lexicon Pharmaceuticals, JUN 1, 2022, View Source [SID1234616372]).

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A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

On June 1, 2022 Manhattan BioSolutions, Inc., an emerging biotechnology company developing new classes of therapeutic biologics for the treatment of advanced and metastatic cancers, reported a multitarget research and development collaboration and license option agreement with Binghamton University (Press release, Manhattan BioSolutions, JUN 1, 2022, View Source [SID1234616177]). The collaboration will utilize novel immune-stimulatory linker-payload technology invented at Binghamton University to develop novel antibody-drug conjugates (ADCs) for oncology applications.

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The lead investigator is Dr. L. Nathan Tumey, an Assistant Professor in the School of Pharmacy and Pharmaceutical Sciences. Dr. Tumey is a world-class expert in linker-payload chemistry and ADC design, who joined Binghamton University following a long career as a medicinal chemist in the pharmaceutical industry, most recently at Pfizer. Manhattan BioSolutions will have an exclusive option to license global rights for selected linker-payload – antibody combinations targeting distinct tumor-associated antigens.

In addition to the collaboration, Dr Tumey has joined Manhattan BioSolutions’s Scientific Advisory Board.

Dr. Borys Shor, Chief Executive Officer, Manhattan BioSolutions commented: "This agreement comes as we continue to build out our preclinical pipeline of novel biologics. It enables us to combine our proprietary antibodies with non-cytotoxic payloads designed to specifically activate innate immune pathways in hematological or in solid tumors. Due to his expertise in medicinal chemistry, Dr Tumey’s laboratory will be a key partner to bringing innovative linker-payload technology into our development pipeline."

Dr. Tumey added: "We are excited to be partnering with Manhattan BioSolutions in order to advance a number of innovative preclinical immune-stimulating ADC programs. We believe that the combination of our proprietary ADC technology and Manhattan Biosolution’s novel tumor targeting antibodies will produce candidate medicines with unique biological properties. We are particularly excited about developing non-cytotoxic ADCs that may have an improved safety profile as compared to traditional ADC technology."

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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