On April 26, 2022 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, reported its audited preliminary results for the year ended 31 December 2021 (Press release, Midatech Pharma, APR 26, 2022, View Source [SID1234613004]).

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2021 HIGHLIGHTS

Operational

·In June 2021, in an R&D update we announced:

oBreakthrough data on the successful encapsulation of a biologic using Q-Sphera technology. We believe no other commercial or academic organisation has been able to successfully deliver therapeutic proteins over extended periods using methods capable of commercial scale up.

oDelivery of proof of concept formulations of MTX214 and MTX216 to our collaboration partner Janssen for them to undertake in vivo studies.

oSuccessful development of a long-acting formulation of MTD211 (Q-brexpiprazole) which, in in vivo studies, demonstrated that a single injectable dose could deliver therapeutic blood levels of brexpiprazole over a period of three months.

·In July 2021, we closed a Placing of 35.1m new ordinary shares with investors in the UK to raise gross proceeds of £10m (£9m net of expenses).

·In August 2021, we announced that the Company had moved its headquarters, including offices and custom built laboratories to new facilities at Caspian Point in Cardiff. The new premises were officially opened by Vaughn Gething MS, Welsh Government Minister for the Economy.

·In December 2021, we announced the successful completion of the 30-day FDA review period of our Investigational New Drug Application for a planned Phase I study of MTX110 in recurrent Glioblastoma Multiforme.

Post period end

·In January 2022, we announced an extension of our R&D collaboration with Janssen. Under the extended collaboration we will focus on maximizing drug loading and optimizing in vitro duration of release for Janssen’s undisclosed experimental molecule using our Q-Sphera technology.

·In February 2022, we announced Janssen had added a second molecule to the collaboration with the same objectives of maximizing drug loading and optimizing in vitro duration of release.

Financial

·Total gross revenue(1) for the year of £0.58m (2020: £0.34m).

·Customer revenue(2) for 2021 of £0.58m (2020: £0.18m).

·UK Placing in July 2021 raised £9.0m, net of expenses.

·Cash and deposits at 31 December 2021 of £10.06m (2020: £7.55m).

·Net loss from continuing operations of £5.46m (2020: £22.19m loss).

·Net cash inflow in the year of £2.52m (2020: £3.64m outflow).

·Tax credit receivable of £0.67m (2020: £1.16m).

1.Total gross revenue represents collaboration income from continuing operations plus grant revenue.

2.Customer revenue represents total gross revenue, excluding grant revenue.

On April 26, 2022 Novartis reported its first quarter financial results 2022 (Presentation, Novartis, APR 26, 2022, View Source [SID1234613001]).

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On April 26, 2022 GT Medical Technologies, Inc. reported that new data on the company’s innovative GammaTile Therapy for patients with operable brain tumors will be presented via an oral, live presentation at the 2022 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Philadelphia, PA (Press release, GT Medical Technologies, APR 26, 2022, View Source [SID1234613000]). The abstract will provide the first report of clinical outcomes for recurrent glioblastoma patients treated with FDA-cleared GammaTile Therapy. Impressive clinical outcomes were reported, with a Median Local Control of 81% at 12 months and Median Overall Survival reaching 37 months in MGMT methylated patients. The safety profile was comparable to patients undergoing repeat surgery without GammaTile treatment.

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GammaTile Therapy is a bioresorbable 3D-collagen tile embedded with Cesium-131 sources that is implanted in the last five minutes of brain tumor removal surgery. The sustained, controlled, and therapeutic dose of radiation immediately begins targeting remaining tumor cells, sparing healthy tissue. "There is no established standard of care today for patients with recurrent glioblastoma. This abstract, along with other studies and clinical publications, supports that GammaTile Therapy should be considered for all patients with operable recurrent glioblastomas," says Matthew Likens, President and CEO of GT Medical Technologies. "Patients receiving GammaTile Therapy have the benefit of prolonged survival without sacrificing quality of life. Our company purpose is to improve the lives of patients with brain tumors, and Dr. Chen’s early clinical experience at University of Minnesota advances this purpose."

The abstract will provide a report of clinical outcomes for recurrent GBM patients treated with FDA-cleared GammaTile.

The abstract, titled GammaTile Brachytherapy in the Treatment of Recurrent Glioblastomas, earned lead author Clark C. Chen, MD, PhD, M Health Fairview neurosurgeon and the head of the University of Minnesota Medical School Department of Neurosurgery, the prestigious Brainlab Neurosurgery Award. This award is presented at both the annual meetings of AANS and the Congress of Neurological Surgeons (CNS) and is given to a neurosurgeon with a high-scoring abstract relating to central nervous system tumors.

"The treatment of recurrent glioblastoma remains a major challenge in our field, without consensus for a standard of care. Our published results suggest clinical benefit from GammaTile treatment and warrant consideration in this setting, especially given the highly favorable safety profile," said Dr. Chen. "Recapitulation of our results in a larger, multi-institution cohort has the potential to redefine the standard of care for recurrent glioblastoma patients."

The abstract will be presented on Monday, May 2nd at 4:16 PM in the Tumor Abstract Session in Philadelphia. This will be the first in-person AANS meeting since 2019. Read the abstract here.

On April 26, 2022 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the dosing of the first patient in a Phase I/II clinical trial of JBI-802 in patients with advanced solid tumors (Press release, Jubilant Therapeutics, APR 26, 2022, View Source [SID1234612999]). JBI-802 is a first-in-class, small-molecule, orally administered dual inhibitor of LSD1 and HDAC6 that has demonstrated synergistic anti-tumor activity in animal models.

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The Phase I/II trial is an open label, two-part dose escalation and expansion study designed to define the safety and tolerability, explore predictive biomarkers and assess preliminary activity of JBI-802 in more than 100 study participants with advanced solid tumors. More information on the clinical trial can be found at NCT05268666.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, "We have come a long way from drug discovery to first-in-human dosing. We look forward to making a difference in patients’ lives. Our expertise in structure-based drug design and medicinal chemistry enables us to create differentiated precision therapeutics with truly innovative properties."

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, "JBI-802, effectively modulates two validated oncology targets with similar affinity and quick on/off exposure kinetics, leading to synergistic anti-tumour activity with a reduced risk of thrombocytopenia. This is our first internally developed product candidate to enter clinical development. Other advancing programs include an oral brain penetrant inhibitor of PRMT5, JBI 778, and an oral brain penetrant PDL1 inhibitor, JBI 2174, for neurological cancers among others."

About JBI-802

JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone and a favorable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumors, such as small cell lung cancer and neuroendocrine prostate cancer and hematological cancers such as acute myelogenous leukemia, myelodysplastic syndrome, and other myeloproliferative cancers.

On April 26, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported that the company will be participating in several upcoming conferences (Press release, TC Biopharm, APR 26, 2022, View Source [SID1234612998]).

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TC BioPharm Co-founder and Executive Chariman, Michael Leek will participate in the Allogeneic Cell Therapies Summit, at the Hilton Boston Northshore between 9-11 May, 2022. Michael is scheduled to co-present the workshop on Supply Chain Management for Multicentered Clinical Trial Set-up (May 9) and chair sessions on Supply/Storage and Manufacturing (May 10 and 11 respectively).

He will also be speaking at the Advanced Therapies Conference at ExCel in London, May 24-25. The conference will explore the hottest topics in the advanced therapy medicinal products (ATMP) space alongside a faculty of industry leading speakers, whilst showcasing the latest technologies and advancements in the industry.

This June, Dr. Leek will be featured at the Next Generation CAR & T Cell Therapies 2022. The event takes place June 14-16, 2022 at the Mark Hopkins Hotel in San Francisco, California. Dr. Leek is scheduled to present and co-chair a workshop on on June 14th at 2:15 pm in a session entitled; TC Biopharm Case Study: Phase 3 Studies of Our Lead Product in Blood Cancers.

Additionally, Dr. Leek and Co-founder and Chief Operating Officer, Angela Scott will be speaking at the Onco Cell Therapy Summit. This seminar will be held June 29-30 at the Hynes Convention Center in Boston, Massachusetts. Michael Leek’s seminar is entitled: Using banked unmodified allogeneic gamma-delta T cells to treat cancer, while Angela Scott will speak to; Manufacture of GMP-grade frozen allogeneic cell therapies for phase 2/3 clinical studies’. The Onco Cell Therapy Summit (OCTS) is the only industry-led meeting covering the full range of autologous and allogeneic cell product advancements.