On June 23, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported that held its annual general meeting ("AGM") at which the following principal resolutions were passed (Press release, Isofol Medical, JUN 23, 2021, View Source [SID1234584272]).

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Adoption of income statement and balance sheet for the financial year 2020 and discharge from liability
The AGM resolved to adopt the income statements for the financial year 2020 as well as the balance sheets as of 31 December 2020, as set out in the annual report for the Company and the group. The members of the Board of Directors and the managing director were discharged from liability for the financial year 2020.

Allocation of profit or loss
The AGM resolved, in accordance with the Board of Directors’ proposal, that no dividend shall be paid for 2020 and that the results of the Company shall be carried forward.

Election of board members, auditors, fees to the Board of Directors and auditors
The AGM resolved, in accordance with the nomination committee’s proposal, that the number of members of the Board of Directors shall be eight without deputies and that the number of auditors shall be one registered accounting firm.

In accordance with the nomination committee’s proposal Lennart Jeansson was elected as new member of the Board of Directors and Alain Herrera, Anna Belfrage, Aram Mangasarian, Magnus Björsne, Paula Boultbee, Pär-Ola Mannefred and Robert Marchesani were re-elected as members of the Board of Directors, all for the period until the end of the next AGM. Pär-Ola Mannefred was re-elected as the chairman of the Board of Directors.

The audit firm KPMG AB was re-elected as auditor of the Company, with Jan Malm as auditor-in-charge, for the period until the end of the next AGM.

The AGM further resolved to, in accordance with the nomination committee’s proposal, that fees to the chairman of the board shall be paid with SEK 550,000, to members of the board who are not employed within the Company with SEK 250,000, to the chairman of the audit committee with SEK 75,000, to each of the other members of the audit committee with SEK 40,000, to the chairman of the remuneration committee with SEK 50,000 and to each of the other members of the remuneration committee with SEK 25,000.

The AGM further resolved, in accordance with the nomination committee’s proposal, that board members that board members (in addition to remuneration for expenses relating to travel and accommodation) domiciled in Europe, but outside the Nordic countries, shall receive a remuneration of SEK 7,500 per physical board meeting and board members domiciled in North America shall receive a remuneration of SEK 15,000 per physical board meeting.

The AGM further resolved, in accordance with the nomination committee’s proposal, that the remuneration to the auditor of the Company shall be paid in accordance with approved statement of costs.

Principles for the appointment of the nomination committee
The AGM resolved, in accordance with the nomination committee’s proposal, that the principles for appointment of a nomination committee as adopted at the annual general meeting 2020 and as presented in the convening notice would remain unchanged.

Approval of the Board of Directors’ remuneration report
The AGM resolved, in accordance with the proposal from the board of directors, to approve the remuneration report for the financial year 2020.

Amendment of the articles of association
The Board of Directors’ proposal to amend the articles of association did not achieve the required majority, hence, the proposal was not adopted by the AGM.

Authorisation for the Board of Directors to resolve on issues
The Board of Directors’ proposal regarding issue authorisation to the Board of Directors, did not achieve the required majority, hence, the proposal was not adopted by the AGM.

The information was submitted for publication, through the agency of the contact person set out above, at 18:10 CEST on June 23, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate that is developed to improve the efficiency of 5-FU based (folate-based) chemotherapy primary for advanced colorectal cancer. Arfolitixorin is currently being evaluated in a global phase III-study, AGENT. Arfolitixorin is the active end product of extensively used folate-based drugs and can potentially benefit all patients with advanced colorectal cancer, as arfolitixorin does not require metabolic activation to become effective.

On June 23, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the regulatory approval for HBI-8000 monotherapy of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) by the Japanese Pharmaceuticals and Medical Devices Agency (Press release, HUYA Bioscience, JUN 23, 2021, View Source [SID1234584271]).

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"Relapsed and/or refractory ATLL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 has demonstrated meaningful disease response despite the advanced stage of disease, and acceptable safety profile, to address an important unmet medical need in this patient population", said Dr. Atae Utsunomiya, honorary hospital director of Imamura General hospital in Japan.

The drug was approved based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients, having few effective treatment options, all had advanced disease either refractory to or relapsed after receiving mogamulizumab. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This first regulatory approval for our lead oncology drug, HBI-8000, is a major milestone for the Company. The durability and strong immuno- oncology properties of HBI-8000 set the stage for improved cancer treatment of both solid and liquid tumors. Synergy with PD-1/PD-L1 inhibitors hold particular promise for major solid tumor advances."

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting.

On June 23, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the U.S. Food and Drug Administration (FDA) has reviewed and confirmed all comments have been addressed regarding the Company’s clinical trial protocol for the Acclaim-1 clinical trial, an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with AstraZeneca’s Tagrisso in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso (Press release, Genprex, JUN 23, 2021, View Source [SID1234584270]). In January 2020, Genprex received FDA Fast Track Designation for the Acclaim-1 patient population.

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In addition, the Company has engaged its first clinical site for Acclaim-1, and Genprex is continuing to work with a number of other important cancer research centers and academic institutions to select optimal study sites.

"This feedback from the FDA on our Acclaim-1 clinical trial and the engagement of our first clinical site are key milestones for Genprex," said Rodney Varner, President and Chief Executive Officer of Genprex. "We are now looking forward to opening patient enrollment in this important study of this cutting-edge investigational gene therapy to evaluate the role it can play in the fight against lung cancer, the leading cause of cancer deaths worldwide."

The Company expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients at three clinical sites and for the Phase 2 portion to enroll approximately 74 patients (a 1:1 ratio of REQORSA and Tagrisso combination therapy versus Tagrisso monotherapy) at up to 15 clinical sites. The first part of the Phase 1/2 clinical trial will be a dose escalation study. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization after first progression on Tagrisso, to first event (second progression) or death. An interim analysis will be performed at 51 events.

Genprex recently announced the Centralized Institutional Review Board (IRB) approval for the Acclaim-1 clinical trial in NSCLC. Additional information about the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

On June 23, 2021 Genomic Testing Cooperative, LCA (GTC) reported that the New York State Clinical Evaluation Program (CLEP) has completed their evaluation and approved all GTC’s Next Generation Sequencing (NGS) profiling tests for hematologic neoplasms and solid tumors (Press release, Genomic Testing Cooperative, JUN 23, 2021, View Source [SID1234584269]). This includes:

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-GTC Hematology Profile (177 genes)
-GTC Hematology Fusion/Expression (1408 genes)
-GTC Hematology PLUS (177 DNA + 1408 RNA)
-GTC Liquid Biopsy, Hematology Profile (177 genes)
-GTC Solid Tumor Profile (434 genes)
-GTC Solid Tumor Profile Fusion/Expression (1408 genes)
-GTC Solid Tumor PLUS (434 DNS + 1408 RNA)

These tests are also covered by Medicare Administrative Contractor Palmetto GBA (MolDx). The tests are carefully designed to provide cost-effective comprehensive evaluation of clinically relevant molecular abnormalities and biomarkers.

"At GTC, we believe that all patients with cancer have the right to have their cancer fully molecularly profiled and for their physicians to be able to discuss their treatment options prior to initiating therapy. Medicare coverage combined with NY state approval make this testing easily accessible for cancer patients living in NY. Our cooperative (Co-Op) business model enables other laboratories and large oncology practice groups to obtain similar coverage and approval when they internalize our tests" said Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer. "Our goal is to improve lives of cancer patients by democratizing NGS-based cancer profiling. We continue to collaborate with other Co-Op members to develop and validate new tests to address minimal residual disease, early diagnosis and other specific clinical indications" added Dr. Albitar.

GTC is first-in-class diagnostic company based on a cooperative business model. Using the most recent advances in NGS technology, GTC tests can be performed on minute samples including needle aspiration samples. Analysis of sequencing runs, curating data and interpretation of results is performed using proprietary algorithms/artificial intelligence (AI) software’s specially designed and developed for GTC’s technology. Cancer profiling combining DNA and RNA data is the most thorough approach not only for selecting therapeutic approaches and targeted therapy but also to help in establishing the diagnosis and classification of tumors, prognosis, and determining early relapse risk. GTC Hematology liquid biopsy is especially designed to be comprehensive and to replace the need for performing a bone marrow biopsy, which is a painful procedure and can be associated with complications.

On June 23, 2021 Strand Therapeutics, a privately held developer of next-generation, programmable mRNA therapeutics for cancer immunotherapy and other diseases, reported that the company raised $52 million in an oversubscribed Series A financing round syndicated by Redmile Group, BeiGene, Ltd., and Camford Capital, as well as existing investors Playground Global and ANRI. Strand has raised a total of $66 million to date (Press release, Strand Therapeutics, JUN 23, 2021, View Source [SID1234584268]).

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Founded by leaders in mRNA-based synthetic biology, Strand is creating the first platform for programmable, long-acting mRNA therapeutics that are bioengineered to enable precise control of the location, timing, intensity, and duration of their therapeutic activities. With the company’s self-replicating mRNAs, Strand’s goal is to develop improved treatment options for cancer and other life-threatening diseases.

"As shown with the COVID-19 vaccines, mRNA technology has revolutionized the way we can address diseases. At Strand, we have developed the next generation mRNA drug platform that can transform cancer treatment, cell therapy, and beyond," said Jake Becraft, PhD, co-founder and CEO of Strand. "We’re excited to work with this world-class syndicate of investors to continue our development of novel mRNA therapies and bringing patients more efficacious, accessible, and cost-effective treatments."

The company’s mRNA therapies combine genes for self-replication with genetically programmed logic circuits. By sensing and classifying unique expression signatures of cell types, the breakthrough technology enables precise and controlled delivery of multiple disease treatments in a single mRNA drug.

"While mRNA technologies allow drug development pipelines to move faster, existing platforms are limited due to lack of lasting therapeutic expression and control," said Jory Bell, General Partner at Playground Global and a member of Strand’s Board of Directors. "With the groundbreaking technology of programmable mRNA therapeutics, Strand is set to bring potentially better treatment options to patients that are more effective and less toxic than current standards. We look forward to continuing our work with the incredible team at Strand."

Strand’s initial focus is to develop its self-replicating programmable mRNA therapeutics to treat cancer, with plans to begin clinical trials of its first candidate in 2022. The company is also collaborating with the global biotechnology company BeiGene under a licensing agreement aimed at developing and commercializing Strand’s multi-functional mRNA technology to develop solid tumor immuno-oncology therapeutics.

"With this newest financing, we are well equipped to enable systemic delivery of mRNA to tumor cells and immune cells to tackle solid tumors as well as hematological malignancies," said Tasuku Kitada, PhD, co-founder, President, and Head of R&D at Strand. "The next generation of mRNA therapeutics will require new technology to move beyond vaccines and into cancer and other diseases. Our rapid growth will now accelerate both deeper into cancer immunotherapies, as well as beyond into further areas of high unmet medical need."