On June 29, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that Andrew Robbins, Chief Executive Officer and President, will present at the Ladenburg Thalmann Virtual Healthcare Conference on Wednesday, July 14th, from 2:00-2:25pm ET (Press release, Cogent Biosciences, JUN 29, 2021, View Source [SID1234584458]).

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Access to the webcast of this event, as well as an archived recording, will be available under the "Events" tab on the investor relations section of the Cogent Biosciences website at: View Source

On June 29, 2021 AccessHope, LLC, a company that provides cancer expertise to employers and their health care partners, reported a new foundational partnership with Dana-Farber Cancer Institute, extending member access to specialized cancer expertise to more people living with complex cancers across the United States (Press release, Dana-Farber Cancer Institute, JUN 29, 2021, View Source [SID1234584477]). Dana-Farber joins two National Cancer Institute (NCI)-designated comprehensive cancer centers — City of Hope and Northwestern Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University — in a novel collaboration that delivers advanced, expert knowledge for employees with cancer and their local treating oncologists, as well as cancer support services .

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"The AccessHope program deploys the latest cancer care knowledge to the places and people who need it most, when it is most valuable, wherever they are located," said AccessHope CEO Mark Stadler. "By adding Dana-Farber as a new foundational partner alongside City of Hope and Northwestern Medicine, we expand our ability to connect plan members with world-renowned specialists who can review their cases and share insights with their local treating oncologists to help improve clinical outcomes, enhance quality of life, and optimize cancer treatment plans."

Cancer experts from Dana-Farber will provide expertise for AccessHope’s core services — Accountable Precision Oncology, Expert Advisory Review and Cancer Support Team — to employers and their plan members in Northeast states including Massachusetts, Maine, New Hampshire, Vermont, Connecticut, Rhode Island, New York and New Jersey, as well as patients from all across the United States. Through an employer benefit, employees of AccessHope clients have access to AccessHope’s network of oncology experts. The medical specialists are at the forefront of the latest cancer research and lifesaving discoveries, and they can guide individuals and their treating oncologists to the newest personalized treatments, such as clinical trials or breakthrough medications, and genetic/genomic testing and targeted therapies.

Dana-Farber Cancer Institute blends leading science and exceptional care into transformative medicine and is a principal teaching affiliate of Harvard Medical School. Dana-Farber cares for adults and children challenged with cancer, blood disorders and related diseases with world-renowned specialists, providing comprehensive and personalized care for each patient and support for their families.

Dana-Farber’s specialized treatment centers are staffed by teams of experts who work closely together to offer patients the latest therapies and strategies, including access to more than 1,100 therapeutic and non-therapeutic clinical trials.

"The extraordinary pace of innovations in cancer research and care can sometimes make it challenging for oncologists everywhere to keep up with rapidly evolving practices, especially if they are managing many types of cancer every day," said Eric Winer, M.D., chief clinical development officer and Thompson Chair in Breast Cancer Research, Dana-Farber. "Through our new collaboration with AccessHope, Dana-Farber specialists can be helpful resources to community oncologists, particularly when treating patients with complex cancers. Joining forces with AccessHope is a part of our commitment to sharing the very latest science, extraordinary care and exceptional expertise with those who need it."

The COVID-19 pandemic accelerated the rise in telehealth over the past year and a half, amplifying the need to rethink cancer care and the patient experience. Regardless of location, employees of AccessHope clients who are diagnosed with cancer, along with their local treating oncologist, can benefit from the expertise of specialists knowledgeable in the latest cancer discoveries for review of diagnosis, treatment plan and personalized precision medicine opportunities, as well as clinical trial information and support services. AccessHope’s cancer support services help employees navigate the complexity of a cancer diagnosis to improve quality of life and health outcomes, help people return to their work and lives, and reduce expenses.

Today, AccessHope serves approximately 2.3 million plan members who have its cancer support services through 43 employers including Adobe and Pitney Bowes, and through collaborative relationships with Health Transformation Alliance and Quantum Health.

Following AccessHope’s national launch as a wholly owned subsidiary of City of Hope, Northwestern Medicine, a nationally recognized health system in Chicago that includes the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, was the first organization to join AccessHope as a foundational partner in the fall of 2020. Northwestern Medicine has extended its subspecialists’ expertise to AccessHope’s services throughout the Midwest, enabling AccessHope’s employer plan members and their treating oncologists to be matched with Northwestern Medicine and Lurie Cancer Center cancer specialists for case review and treatment plan recommendations.

"When we first formed AccessHope, our vision was to continuously increase its reach and impact to patients across the U.S. through new partnerships. We are pleased that one of the world’s leading academic cancer institutes, Dana-Farber, has joined AccessHope. This partnership not only will deliver significant benefit to employers and cancer patients, but also further validates the value proposition of AccessHope’s unique approach," said Harlan Levine, M.D., president of strategy and business ventures, City of Hope, and chair of the board for AccessHope. "By leveraging remote delivery of cutting-edge insights and knowledge from clinical research, we are able to help people with cancer and their treating physicians benefit from the latest cancer care expertise, close to home."

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.

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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

On June 29, 2021 Bioneer reported that has initiated two very exciting and ambitious R&D programs that during the next four years will strengthen our capabilities and service solutions that we offer to life science companies (Press release, Bioneer, JUN 29, 2021, View Source [SID1234584838]). We look forward to seeing our R&D organization move these programs forward and be able to assist a broad range of companies with the best services that can contribute to new therapies and medicines.
The first program within "In Vitro Modelling" aims at developing a new generation of in vitro models within CNS, immunology, cancer and the gastro-intestinal system. Our ambition is to develop the best-in-class in vitro models matching the industry needs where especially the CNS track will take us into the area of screening and automation. We are also excited to enter the fast-moving field of Artificial Intelligence that we will couple to our new generation of in vitro models.

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The other R&D program within "Early Stage Development of Drug Candidates" will further strengthen our ambition to assist companies from "gene to protein" and with peptide and small molecule development. This ambitious program will move our capabilities in the field of recombinant protein manufacturing to a new level both in terms of production efficiency and the ability to complete CMO transfers. We also look into the exciting world of peptides, where we will use our strong formulation competences to strengthen the service offering.

Bioneer encourages companies, universities and hospitals to contact us. If you would like to know more about the R&D programs, learn how you could benefit from the development activities, or would like to collaborate on one of the topics, feel free to contact CSO Christian Clausen (e-mail).

On June 29, 2021 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon) a clinical-stage biotechnology company focused on developing innovative small molecule-based medicines and Simcere Pharmaceutical Group Ltd (HKEX: 2096) (Simcere) reported that they have entered into a strategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat Alzheimer’s disease (AD) in Greater China (Press release, Vivoryon Therapeutics, JUN 29, 2021, View Source [SID1234584410]).

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The agreement grants Simcere a regional license to develop and commercialize varoglutamstat (PQ912), Vivoryon’s Phase 2b-stage N3pE amyloid-targeting oral small molecule glutaminyl cyclase (QPCT) inhibitor with disease-modifying potential for AD, as well as the Company’s preclinical monoclonal N3pE-antibody PBD-C06 in the Greater China region.

QPCT is an enzyme responsible for the formation of N3pE amyloid, a neurotoxic molecule that is not found in healthy individuals and has been identified as a driver of AD pathology. N3pE amyloid is not only implicated in Abeta peptides aggregating into plaques which are widely observed in AD patients, but also has a negative impact on other pathologies that underly the disease, including tau pathology, neuroinflammation, and impairment of synaptic function. By inhibiting QPCT and thus preventing the formation of toxic N3pE amyloid, varoglutamstat acts very early in disease pathogenesis and thereby has the potential to prevent neuronal damage.

Vivoryon’s monoclonal N3pE-antibody PBD-C06 is specifically designed to bind to and remove neurotoxic N3pE amyloid from the brain and has been optimized with respect to low immunogenicity and low potency to induce amyloid-related imaging abnormalities (ARIAs), a major side effect in antibody-based AD therapies.

Under the terms of the agreement, Vivoryon will receive an undisclosed upfront payment and will also be eligible for payments upon achievement of certain development and sales milestones, with all components amounting to a total of over US$565 M. In addition, Vivoryon will receive double-digit royalties on sales. Further financial details were not disclosed.

Pursuant to the agreement, Simcere will be responsible for clinical development of varoglutamstat in patients with early AD in China. The clinical development program in Greater China is intended to be complementary to Vivoryon’s efforts in Europe and the US including Vivoryon’s ongoing European VIVIAD Phase 2b trial as well as the Company’s planned Phase 2a/b study in the US, which is anticipated to start in the second half of this year. Simcere has also acquired an option to advance PBD-C06, an antibody that specifically targets N3pE amyloid, towards clinical development.

"This regional partnership represents an important milestone on our journey to bringing novel therapeutic options to as many patients suffering from Alzheimer’s disease as possible," commented Michael Schaeffer, PhD, Vivoryon’s Chief Business Officer. "With prevalence rising in China, AD is already a heavy burden on patients, families and the country’s healthcare system. In partnering with Simcere, who is continuously recognized as one of the top innovative pharmaceutical and manufacturing enterprises in China, we hope to be able to make an impact beyond our own focus of developing varoglutamstat towards the markets in Europe and the US."

"We are extremely pleased to have entered into this agreement with Vivoryon to leverage the potential of innovative N3pE amyloid-targeting agents to treat Alzheimer’s disease in Greater China," added Kevin Oliver, PhD, Senior Vice President and Head of Global Business Development at Simcere. "Both partners are clearly committed to delivering meaningful therapies to AD patients in need, in line with Simcere’s mission of providing today’s patients with medicines of the future."

About varoglutamstat (PQ912)

Varoglutamstat is an orally administered small molecule inhibitor of glutaminyl cyclase (QPCT), an enzyme which catalyzes the formation of N3pE amyloid, a particularly neurotoxic molecule not found in healthy individuals that has been identified as a driver of Alzheimer’s disease (AD). N3pE amyloid triggers a number of pathological processes in AD, including the formation of toxic soluble Abeta oligomers, tau pathology, neuroinflammation, and impairment of synaptic function. By preventing formation of this toxic molecule, varoglutamstat acts very early in disease pathogenesis and thus has the potential to prevent neuronal damage. Varoglutamstat is currently in Phase 2 clinical development.

About PBD-C06

PBD-C06 is a preclinical stage humanized and de-immunized IgG1 antibody specifically designed to bind to and remove neurotoxic N3pE amyloid from the brain. The antibody is optimized with respect to low immunogenicity and low potency to induce amyloid-related imaging abnormalities (ARIAs), which represent the major severe side effects of antibody-based AD therapies.