Midatech Pharma PLC (“Midatech” or the “Company”) MTX110 Programmes to be Presented at The International Symposium on Pediatric Neuro-Oncology, Karuizawa, Japan (ISPNO 2020)

On December 11, 2020 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 its University collaborators will be presenting three sets of research findings on MTX110 at The International Symposium on Pediatric Neuro‐Oncology on 13‐16 December 2020 in Karuizawa, Japan (to be held online this year) (Press release, Midatech Pharma, DEC 11, 2020, View Source [SID1234572861]). The first two presentations, by Columbia University Medical Center and University of Texas Health Center at Houston, are being presented for the first time. The third presentation, by the Pacific Pediatric Neuro‐Oncology Consortium, was also presented at last months’ Society of Neuro‐Oncology (SNO2020)
conference. Abstract details and links to the posters are provided below:

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A Phase I Study Examining the Feasibility of Intermittent Convection‐Enhanced Delivery (CED) of MTX110 for the Treatment of Children with Newly Diagnosed Diffuse Intrinsic Midline Gliomas (ABSTRACT DDEL‐07, Page iii284*) ‐ Lead Author: Dr Stergios Zacharoulis MD, Columbia University Medical Center, New York, USA. In the study:

Patients are receiving continuous CED infusions of MTX110 for 48 hours on two cycles separated by 5 to 7 days;
3 patients have been treated so far at 30 microM;
No Serious Adverse Events;
Toxicity: Grade II diplopia (1) Grade I sensation (n=1), headache Grade II (n=2); and
1 patient progressed 8 months post treatment

The presentation may be found at: View Source;phase‐i‐study‐examining‐the‐feasibility‐ofintermittent‐ convection‐enhanced‐delivery‐ced‐of‐mtx110‐for‐the‐treatment‐of‐childr/b4b8cf89e6‐ 1607680894/mtx110‐203_dipg_trial_‐dr_stergio_zacharoulis.pdf

High Dose MTX110 (Soluble Panobinostat) Safely Administered into the Fourth Ventricle in a Non‐Human Primate Model (ABSTRACT DDEL‐09, Page iii285*) ‐ Lead Author: Dr David Sandberg MD, McGovern Medical School, University of Texas Health Center at Houston, Houston, Texas, USA. Conclusions of the presentation are:

Fourth ventricle catheters were successfully instilled to enable locoregional infusion of MTX110;
MTX110 was well‐tolerated, with no evidence of toxicity;
Drug levels in the CNS reached a therapeutic range; and
The data support the safety of administration of MTX110 via the fourth ventricle
Clinical trial in recurrent medulloblastoma patients is ongoing (NCT04315064)

The presentation may be found at: View Source;dose‐mtx110‐soluble‐panobinostat‐safelyadministered‐ into‐the‐fourth‐ventricle‐in‐a‐non‐human‐primate‐model/df48e55757‐ 1607683538/mtx110_preclinical_safety_‐dr_david_sandberg.pdf

PNOC015: An Open Label Single Arm Phase I/II Study of MTX110 Delivered by Convection‐Enhanced Delivery (CED) in Patients with Diffuse Intrinsic Pontine Glioma (DIPG) Previously Treated with External Beam Radiation Therapy (ABSTRACT EPCT‐12, Page iii306*) Lead Author: Dr Sabine Mueller, Pacific Pediatric Neuro‐Oncology Consortium

The presentation may be found at: View Source;an‐open‐label‐single‐arm‐study‐of‐mtx110‐ delivered‐by‐convection‐enhanced‐delivery‐ced‐in‐patients‐with‐diffuse‐intrins/ee47f281a6‐1607683490/mtx110‐ 201_dipg_trial_‐dr_sabine_mueller.pdf

* Abstracts from the 19th International Symposium on Pediatric Neuro‐Oncology (ISPNO 2020), December 13‐16, 2020.
Neuro‐Oncology, Volume 22, Supplement 3 may be found at:
View Source

Commenting, Steve Damment, EVP R&D of Midatech, said: "These presentations by Midatech’s University collaborators
provide useful data points for our MTX110 programmes; the Columbia study in DIPG uses an implantable and
programmable pump to infuse drug without the need for repeated surgery, unlike the system deployed in the UCSF study
we recently reported; and, the Texas pre‐clinical safety study demonstrates the feasibility of fourth ventricle infusion, the
method of administration for our ongoing Phase I pilot study in recurrent medulloblastoma patients."

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 (panHDAC 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 anticance

V2ACT Therapeutics™, LLC Announces FDA Clearance of an IND Application to proceed with a Phase 1/2a Study of V2ACT for the Treatment of Pancreatic Cancer

On December 11, 2020 V2ACT Therapeutics, LLC reported that the Company has obtained permission from the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application and may proceed with the clinical investigation of V2ACT in a Phase 1/2a trial for the treatment of newly diagnosed surgically-resectable pancreatic cancer patients (Press release, V2ACT Therapeutics, DEC 11, 2020, View Source [SID1234572777]).

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"We are pleased the FDA cleared the IND for V2ACT for the treatment of pancreatic cancer within the initial 30-day review period," said Thomas Zindrick, J.D., President and CEO of V2ACT Therapeutics. "There is a serious unmet medical need for safer, more effective treatments to address this devastating disease and we believe that V2ACT has the potential to help patients in their fight."

"It is generally accepted there is no effective monotherapy for the treatment of pancreatic cancer, a devastating disease," said Gary Wood, Chief Science Officer of V2ACT Therapeutics. "V2ACT provides complementary immunotherapies in a unique process designed to transform non-immunoreactive pancreatic cancer into an immunoreactive ‘hot spot’ with cancer neoantigen-specific T cell infiltration and cancer cell killing. Therefore, V2ACT has the potential to effectively treat any type of cancer, even those considered to be resistant to immunotherapy."

Medivir strengthens its business development possibilities through a renegotiated agreement with TetraLogic regarding birinapant

On December 11, 2020 Medivir AB (Nasdaq Stockholm: MVIR) announced today that Medivir AB ("Medivir" or "the Company") has renegotiated its agreement with TetraLogic Pharmaceuticals Corporation ("TetraLogic") regarding financial obligations for birinapant, a SMAC mimetic, for the treatment of solid cancer tumors (Press release, Medivir, DEC 11, 2020, View Source [SID1234572709]). The purpose of the new agreement is to create improved business development opportunities.

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Medivir acquired birinapant from TetraLogic in 2016. The original agreement between Medivir and TetraLogic included milestone payments with predetermined amounts as well as royalty obligations to TetraLogic if and when Medivir develops, markets or out-licenses birinapant further. The original agreement has been dissolved and renegotiated so that the compensation Medivir is obliged to pay in a potential future transaction is now based solely on the distribution of actual future revenues to Medivir.

"It is very satisfying that we have now dissolved the previous agreement and negotiated a new agreement which is entirely based on the distribution of potential future revenues. This aligns and benefits both parties as the new agreement creates significantly improved conditions for a potential out-licensing or sale in our continued business development efforts with birinapant," says Yilmaz Mahshid, CEO Medivir AB.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.40 CET on 11 December, 2020.

About birinapant
Birinapant is being developed to enhance responses, and extend survival, of patients with solid tumors where existing treatments do not provide sufficient survival benefit, or where patients no longer have treatment options. Based on its unique design and mechanism, birinapant has the potential to enhance patients’ responses in combination with other treatments.

PharmaBlock Enters Strategic Partnership with Ascentage Pharma

On December 11, 2020 PharmaBlock Sciences (Nanjing), Inc. (300725.SZ), a leading innovative chemistry product and service provider throughout the pharmaceutical R&D process, reported the signing of a strategic partnership agreement with Ascentage Pharma (6855.HK), a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases (Press release, PharmaBlock Sciences, DEC 11, 2020, View Source [SID1234572708]). The partnership aims to strengthen the strategic cooperation between the two companies in drug development and manufacturing.

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As a long-term CDMO partner of Ascentage Pharma, PharmaBlock has witnessed many of its development projects advancing quickly from discovery to preclinical and clinical manufacturing. Under the terms of the agreement, PharmaBlock becomes the preferred CDMO partner of Ascentage Pharma, and the two parties will continue to advance and expand CDMO cooperation for current and future projects. PharmaBlock will fully support Ascentage Pharma to accelerate its novel drug development pipeline with the most sufficient R&D input and manufacturing capacity, along with its innovative technological solutions.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to block apoptosis or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China. HQP1351, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US Food and Drug Administration (FDA), and an NDA for the drug has been submitted in China. To date, Ascentage Pharma has obtained a total of eight ODDs from the FDA for four of the company’s investigational drug candidates.

Dr. Ming GUO, Co-founder and CEO of Ascentage Pharma, said: "PharmaBlock is a reliable and trusted business partner of Ascentage. We appreciate the dedication and professionalism of the PharmaBlock team. I believe that the strategic partnership between the two companies will definitely help us accelerate the new drug development pipeline towards the commercial stage."

Led by an experienced management and core technical team, PharmaBlock has been providing top-standard development and manufacturing solutions of RSMs, intermediates, and APIs for both the drug development and commercial stages. Taking full advantage of its building block capabilities, along with its know-how in chemistry, process development, analytical development, manufacturing and engineering technologies etc., the team has distinguished itself by showing great skill in tackling challenging chemistry, securing reliable supply, controlling costs, and maintaining full compliance of quality and EHS, etc. To further realize safe, efficient and green process development and manufacturing, PharmaBlock has developed an advanced chemistry and engineering technology platform, featuring flow chemistry, micropacked bed hydrogenation, biocatalysis, heterogeneous catalysis, crystallization, solid state chemistry, etc. Their technology platform has enabled more innovative solutions, with shortened lead time and reduced overall costs for development and manufacturing projects.

"With a rich pipeline of assets with first- and best-in-class potentials, Ascentage Pharma is a leading innovative biotechnology company in China with a global footprint. We are so proud to support companies like Ascentage to discover and develop next generation of medicines much needed by the patients," commented Dr. Haijun Dong, CEO of PharmaBlock.

Cipla Announces Settlement of REVLIMID® (lenalidomide) Capsules Patent Litigation

On December 11, 2020 Cipla Limited (BSE: 500087) (NSE: CIPLA) ("Cipla") reported the settlement of its litigation with Celgene Corporation, and wholly owned subsidiary of Bristol Myers Squibb (NYSE: BMY) relating to patents for REVLIMID (lenalidomide) (Press release, Cipla, DEC 11, 2020, View Source [SID1234572707]). As part of the settlement, the Parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

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In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after the March 2022. For each consecutive twelve-month period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Cipla cannot exceed certain agreed-upon percentages. The specific volume-limited license date and percentages agreed-upon with Cipla are confidential.

In addition, Celgene has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026. Cipla’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.

Mr. Arunesh Verma, CEO, Cipla North America, said, "This is an important step forward for us and is in line with our pursuit of improving access to high quality life-saving treatments."