1stOncology™: Cancer Intelligence Service – Page 9105 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Midatech Pharma PLC (“Midatech” or the “Company”) UK Placing to Raise £10.0 million

On June 29, 2021 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, reported that it has raised £10.0 million (before expenses) by way of a placing to investors in the UK ("Placing") of 35,087,720 new ordinary shares of 0.1p each ("Placing Shares") at an issue price of £0.285 per Placing Share ("Issue Price"). The Placing brings new UK institutions into the Company’s shareholder base. Turner Pope Investments (TPI) Limited ("Turner Pope") acted as sole bookrunner for the Placing. Turner Pope participated in the Placing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

The Issue Price of the Placing Shares represents a discount of approximately 12.3% to the closing middle market price of £0.325 per existing ordinary share on 28 June 2021, being the last business day before this announcement. The Placing Shares represent approximately 35.6% of the issued share capital of the Company as enlarged by the Placing.

The allotment of the Placing Shares is being made pursuant to existing authorities to allot shares and other relevant securities and to disapply pre-emption rights under section 551 of the Companies Act 2006, which the Directors were given at the Company’s General Meeting held on 2 March 2020.

Background to the Placing

On 17 June 2021, the Company announced a series of updates to its R&D programmes including:

·data that demonstrate the Company has been able to encapsulate an exemplar monoclonal antibody ("mAb") using its Q-Sphera technology while preserving its functional integrity and antigen binding;
·delivery of proof of concept Q-Sphera formulations of MTX214 and MTX216 for the Company’s collaboration partner to initiate in vivo IND-enabling studies;
·in vivo data to support a three month dosing interval for MTD211, the Company’s formulation of long-acting brexpiprazole;
·start up activities for a Phase II study of MTX110 in Diffuse Intrinsic Pontine Glioma ("DIPG") following a positive pre-IND meeting with the FDA; and
·planning for a Phase I pilot study of MTX110 in Glioblastoma Multiforme ("GBM") following encouraging preclinical data which demonstrate the potency of MTX110 in multiple patient-derived GBM cell lines.

Use of Proceeds

The proceeds of the Placing, net of fees and expenses, are expected to be approximately £9.0 million ("Net Proceeds"). We expect the Net Proceeds will be used to:

·develop, to proof of concept stage, additional mAb formulations using the Company’s Q-Sphera technology following the success with the exemplar mAb disclosed as part of the Company’s R&D update on 17 June 2021;
·add new small molecule Q-Sphera programmes to the Company’s internal pipeline;
·initiate a Phase II clinical study of MTX110 in DIPG;
·initiate a pilot Phase I clinical study of MTX110 in GBM; and
·general corporate purposes.

Taking into account available cash resources and the expected Net Proceeds, the Company expects to have sufficient cash resources to fund operations into the first quarter of 2023.

Further Information on the Placing

The Company and Turner Pope entered into a placing agreement ("Placing Agreement"), pursuant to which Turner Pope agreed to use its reasonable endeavours to procure placees pursuant to the Placing. The Placing is not underwritten. Turner Pope has received binding commitments from placees to acquire the Placing Shares at the Issue Price.

The Placing Agreement contains certain warranties and indemnities by the Company in favour of Turner Pope. It also contains provisions entitling Turner Pope to terminate the Placing Agreement prior to Admission, as defined below, if, among other things, a breach of any of the warranties occurs or on the occurrence of an event fundamentally and adversely affecting the position of the Company.

The Placing is conditional upon, inter alia:

(a)the Placing Agreement becoming unconditional in all respects (save for Admission occurring) and not having been terminated in accordance with its terms; and
(b)Admission becoming effective by no later than 8.00 a.m. on 6 July 2021 (or such later time and/or date as the Company and Turner Pope may agree (being not later than 4.30 p.m. on 3 August 2021).

Application for Admission to trading on AIM

Subject to all conditions being met, application will be made for the 35,087,720 Placing Shares to be admitted to trading on AIM ("Admission"). It is expected that settlement of the Placing Shares and Admission will take place at 8.00 a.m. on or about 6 July 2021 and that dealings in the Placing Shares will commence at that time.

When issued, the Placing Shares will be fully paid and will rank pari passu in all respects with the existing ordinary shares.

Total Voting Rights

Upon Admission, the Company’s issued share capital will comprise 98,468,387 ordinary shares of 0.1p each with voting rights. The Company does not hold any shares in treasury. Upon Admission this figure of 98,468,387 may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change in their interest in, the share capital of the Company under the FCA’s Disclosure and Transparency Rules.

Commenting, Stephen Stamp, Midatech CEO and CFO, said: "It has been a busy 13 months since we announced our Strategic Review and restructuring. On 17 June 2021 we announced progress in our R&D pipeline across multiple programmes and breakthrough data on the successful encapsulation of a large molecule protein with Q-Sphera – a world’s first. Today’s announcement of the Placing gives us the runway to initiate Phase II and Phase I clinical studies of MTX110 in DIPG and GBM, respectively. Our focus now turns to lining up partners for these programmes."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

The person responsible for arranging the release of this announcement on behalf of the Company is Stephen Stamp, Chief Executive Officer and Chief Financial Officer

eTheRNA immunotherapies and Quantoom Biosciences Announce a Strategic Collaboration for the Development of a Novel RNA Production System

On June 29, 2021 eTheRNA immunotherapies NV (‘eTheRNA’), a clinical-stage company developing mRNA-based immunotherapies with in-house GMP certified production and process development capabilities, and Quantoom Biosciences S.A. ("Quantoom"), a biotech company aiming to improve access to essential medicines through innovative bioproduction methods, reported that they are to collaborate on the development of a revolutionary RNA production system (RPS) for both research and GMP-grade material (Press release, eTheRNA, JUN 29, 2021, View Source [SID1234584493]).

Quantoom and eTheRNA will work together to build an advanced, small footprint technology platform for the production of affordable RNA-based therapies, that can be used either within existing facilities or rapidly deployed to areas of urgent need. Unlike large and costly existing RNA production plants, the RPS will manufacture RNA small modular units, which can be shipped easily across multiple geographic regions. The RPS is intended to be scaled seamlessly from small scale preclinical batches to mass production of GMP-grade RNA. The only requirement will be for the RPS to be located inside a suitable clean room with an uninterrupted utility supply.

Under the terms of the agreement, eTheRNA will transfer manufacturing technology to Quantoom with all materials and data necessary for the development of the novel RPS. Following completion of the RPS, Quantoom will be responsible for commercialization of the system on a worldwide basis, with sales-related royalties payable to eTheRNA. International sales and distribution are expected to commence in 2023 following RPS production in Belgium.

Bernard Sagaert, SVP Manufacturing and COO of eTheRNA, commented: "This cooperation aligns with our goals for RNA production; namely cost reduction, process scalability from small to large scale, portability and process automation. Currently, the global supply of RNA is hampered by the lack of dedicated production facilities and by the cost of constructing new plants. The RPS will revolutionize the way RNA is produced and distributed globally and we are excited to be able to work with a leading developer and manufacturer like Quantoom to bring this vision to the market."

José Castillo, CEO of Quantoom Biosciences, commented: "We are delighted to enter into this collaboration agreement with eTheRNA, which has extensive experience in the field of RNA and like Quantoom, has a mission to change the RNA world. Through our combined knowhow, I am confident that Quantoom will be able to develop an open, integrated RNA platform that will enable manufacture of RNA-based vaccines and therapeutics at scale, resulting in affordable development and production of RNA-based drugs. "

Ixaka and SomaLogic Enter Research Collaboration to Develop Bispecific Agents for Oncology

On June 29, 2021 Ixaka Ltd and SomaLogic reported a research collaboration to support the development of aptamer-based bispecific therapeutics (Press release, Ixaka, JUN 29, 2021, View Source [SID1234584492]).

The collaboration will evaluate the safety and efficacy of antigen-specific SOMAmer reagents (modified aptamers that bind tightly and specifically to protein targets) previously identified and screened by SomaLogic as potential candidates for combination with Ixaka’s anti-CD3 aptamers.

Ixaka is currently developing in vivo CAR-T therapies using its in vivo gene delivery technology, which facilitates in vivo targeting and transduction of patient T cells. The universal in vivo gene modification approach relies on proprietary anti-CD3 aptamers selected by Ixaka as targeting agents, which have been applied to engineer aptamer-based BiTEs (Bi-specific T-cell engagers).

SomaLogic’s antigen-specific SOMAmer reagents will now be evaluated with the intention of improving both the safety and efficacy of antibody-based bispecifics. This follows a recent in vitro proof-of-concept study that successfully highlighted the potential of Ixaka’s cancer specific antigenxCD3 bispecific aptamers as new anticancer agents that can recruit cytotoxic T cells and induce killing of tumor cells.

Cecile Bauche, Vice President and Chief Scientific Officer at Ixaka, commented: "We have made great progress with our anti-CD3 aptamer candidate, with recent positive data demonstrating in vitro proof of concept when combined with a cancer-specific antigenic aptamer. SOMAmer molecules are a promising new class of drug entities with the potential to accelerate development of our aptamer-based BiTEs as anti-cancer agents and help us in our mission to offer new and effective treatments for cancer."

Renaud Vaillant, Vice President, Business Development at Ixaka, commented: "We have been working with aptamers as potential immunotherapies since the inception of the company. We first engaged in discussion with SomaLogic 4 years ago, when the project was just an idea as part of a presentation. I am proud and excited to finally start this collaboration, which is a result of the tremendous work achieved by our team."

In the collaboration, SomaLogic will provide SOMAmers for screening and subsequent evaluation of in vitro cytotoxic properties. Ixaka will lead the experiments to identify and evaluate SOMAmer candidates with high affinity and specificity. Further work will determine functional in vitro properties of bispecific aptamers in human cell cultures and evaluate in vivo anticancer efficacy in murine models.

Nebojsa Janjic, Chief Science Officer of SomaLogic, commented: "The ability of SOMAmer reagents to bind with high specificity and affinity to any target protein makes them ideal for the development of novel therapies for oncology. We hope to expand this collaboration with Ixaka in the future to support new treatments for other therapeutic areas."

SomaLogic’s anti-tumoral SOMAmers demonstrate potential utility as the chemical addition of ‘protein-like’ side chains to the nucleic acid bases that comprise a SOMAmer can be used to develop molecules with high specificity and affinity for any targeted protein, making SOMAmer candidates attractive for novel therapeutic development.

The first application of Ixaka’s TNP technology is the generation of CAR T-cell therapies for haematological malignancies. However, modification of the components offers the potential to target a broad range of therapeutic cells for the treatment of many serious diseases, including cancers, genetic disorders, neurological and ocular diseases.

Foundation Medicine and Flatiron Health Announce First-of-its-Kind Integration of Genomic Profiling Into OncoEMR®

On June 29, 2021 Foundation Medicine, Inc. reported it’s comprehensive genomic profiling (CGP) tests for their patients without leaving Flatiron Health’s OncoEMR platform (Press release, Foundation Medicine, JUN 29, 2021, View Source [SID1234584491]).

This integration, the first of a series planned by Flatiron, will support more efficient clinical decision making by allowing electronic ordering, order tracking and receipt of Foundation Medicine’s CGP test results all within the OncoEMR platform. Almost all oncology practices use an electronic medical record (EMR) system to input, view and manage the full patient medical record in a single location, replacing a traditional paper chart with a digital one.1 EMR platforms also support clinical teams by enabling them to more efficiently order and track tests, view results, communicate treatment plans to patients and enable the completion of charting, documentation, and billing.

"With the number of targeted treatments growing exponentially, the opportunity for cancer care transformation has never been greater. Clinicians increasingly rely on genomic insights to guide clinical decision-making, and Foundation Medicine is committed to implementing new solutions that enable widespread access to CGP," said Kathleen Kaa, Interim Chief Commercial Officer at Foundation Medicine. "The integration of Foundation Medicine tests into OncoEMR, and other leading EMR systems to follow, is just one way we’re improving our offerings to fuel precision medicine for cancer patients. The integrations will create efficiencies for oncology healthcare teams to deliver precision treatment plans based on individual genomic insights to their patients."

"We are excited to welcome Foundation Medicine in the first of our planned CGP integrations with OncoEMR," said James Hamrick, MD, MPH, Vice President, Clinical Oncology at Flatiron Health. "This kind of integration marks an important milestone in advancing precision medicine, helping oncologists have access to the information they need to select therapies."

The two companies are planning similar integrations with other CGP platforms and EMRs, respectively, in the oncology space, with the goal of helping every patient to realize the benefit of precision cancer care. These workflow-streamlining integrations are being designed by clinical and product experts in partnership with oncology practices.

I-Mab Announces Upcoming Participation at July Conference

On June 29, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported its participation in the following conference in July. Details of the conference are as follow:

CMBI Healthcare Corporate Day (Virtual)

Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Mr. Tianyi Zhang, Executive Director Investor Relations

One-on-one and small group meetings: July 7-9, 2021

For more information, please contact your CMBI representative.