On July 9, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates" or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported the dosing of the first subject in a Phase 1 study investigating MT-6402 in patients with PD-L1-positive solid tumors (Press release, Molecular Templates, JUL 9, 2021, View Source [SID1234584754]).

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"We are excited to have dosed the first subject in the Phase 1 study for MT-6402, a third generation ETB, which is being developed as a potential treatment for patients with PD-L1-positive cancers. MT-6402 utilizes both our proprietary de-immunized toxin scaffold and antigen seeding technology," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "The PD-1/PD-L1 axis is central to many tumors and targeting that axis with a new mechanism of action has an opportunity to provide meaningful benefit to patients. We look forward to providing an update on this study by year-end 2021."

The Phase 1 study for MT-6402 is planned as a multi-center, open-label, dose escalation and dose expansion trial in the United States and outside of the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment. The starting dose is 16 mcg/kg. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts. For more information on the Phase 1 study for MT-6402, refer to ClinicalTrials.gov identifier: NCT04795713.

About MT-6402

MT-6402 is an ETB consisting of a single chain variable fragment (scFv) with affinity for PD-L1, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA) and a class I antigen derived from the human cytomegalovirus (HCMV) pp65 protein. MT-6402 was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the existing PD-L1 antibody therapies. In MTEM’s preclinical studies, MT-6402 was found to specifically bind and kill both tumor and immune PD-L1 expressing cells in a manner consistent with SLTA mediated cellular cytotoxicity through ribosomal inactivation, independent of checkpoint inhibition. Additionally, MT-6402 alters the immunophenotype of targeted cells by delivering foreign class I antigen from CMV for presentation in complex with MHC class I, which may provoke a CMV-specific immune response against the targeted cells. MT-6402 may rehabilitate the tumor microenvironment (TME) and allow for immune recognition of tumors by destroying PD-L1-expressing immune cells in the TME.

On July 9, 2021 Vinings Holdings, Inc. (OTC PINK: NDYN), reported that it is changing its corporate name to "Coeptis Therapeutics, Inc." and updating its ticker symbol to "COEP" effective Monday, July 12, 2021 (Press release, Vinings Holdings, JUL 9, 2021, View Source [SID1234584755]). The name modification and ticker change will align the Company with its wholly-owned subsidiary, Coeptis Pharmaceuticals (together "Coeptis"), and its strategic focus on the development of innovative therapeutics and technologies that have the potential to disrupt conventional treatment paradigms and improve patient outcomes.

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"Our new corporate name, Coeptis Therapeutics, and updated ticker symbol reflect what has been and should continue to be a period of growth for the company and subsidiary, Coeptis Pharmaceuticals, that, we believe, will allow us to unlock numerous opportunities that offer the potential to translate into significant shareholder value," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Coeptis’ business model is designed around advancing the development and value potential of its current product portfolio, while actively targeting opportunities to expand its portfolio via partnerships with companies that have novel therapies in development or companies with technologies that improve the way that drugs are delivered to patients. Our previously announced option agreements with VyGen-Bio involving a cell therapy technology and an in vitro diagnostic targeting CD38-related cancers are emblematic of this business strategy and demonstrate our ability to identify and potentially cultivate such potentially transformative technologies."

On July 9, 2021 ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, reported the publication of pre-clinical data highlighting the safety and anti-tumor efficacy of ABL503/TJ-L14B in the Journal for ImmunoTherapy of Cancer(JITC) (Press release, ABL Bio, JUL 9, 2021, View Source [SID1234584756]).

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Jointly developed with I-Mab (NASDAQ: IMAB), ABL503 is a bispecific antibody combining PD-L1 checkpoint pathway with 4-1BB agonistic activity to overcome the current limitation of PD-(L)1 therapy and 4-1BB related toxicity. Using ABL’s Grabody-T bispecific antibody platform technology, ABL503 induces 4-1BB activation only in the presence of PD-L1 expressing tumors to minimize the risk of 4-1BB related peripheral toxicity. ABL503 is currently being evaluated in a Phase 1 study in the U.S. in patients with locally advanced or metastatic solid tumors (NCT04762641).

The paper, "Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade," was published in collaboration with Su-Hyung Park, PhD, Professor at the KAIST Graduate School of Medical Science and Engineering. The paper highlights key in vitro and in vivo research that demonstrate ABL503’s potential as a promising immunotherapeutic agent against cancer.

In the study, ABL503 induced complete tumor regression in humanized mice, which was superior to anti-PD-L1 or anti-4-1BB monotherapy. Moreover, no tumor growth was observed in these mice when they were rechallenged at 40 days after their first ABL503 treatment, demonstrating that ABL503 treatment yields a prolonged anti-tumor response despite a short-term administration schedule.

In addition, ABL503 was well-tolerated following a repeated high dose administration of ABL503 in monkeys. Monkeys treated with ABL503 exhibited overall good tolerance with normal liver functions.

"These published data validate our Grabody-T platform technology to achieve anti-tumor efficacy with a low risk of off-tumor liver toxicity and support the therapeutic value of ABL503 as a potential best-in-class treatment for cancer," said Sang Hoon Lee, PhD, CEO of ABL Bio. "We have great expectations for the program and look forward to further evaluating ABL503 in our Phase 1 study with I-Mab."

On July 9, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on July 9th 2021, that its Safety Monitoring Committee has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac (Press release, RhoVac, JUL 9, 2021, View Source [SID1234584757]). The safety profile of RV001 was excellent and the Safety Monitoring Committee concluded the trial can continue without modifications.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for RV001 in this cancer indication. RhoVac currently estimates finalizing the patient recruitment for the study no later than September this year, and after that the study will run to completion, which is estimated to take 9-12 months after the closing of the recruitment. The objective of the study is to show that RV001 can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. As planned, an interim safety review was conducted today by the Safety Monitoring Committee, and no unexpected adverse events have been identified, confirming excellent safety, in concurrence with the previous clinical phase I/II findings.

RhoVac CEO, Anders Månsson, comments: "We had never anticipated anything but a clean safety review. Nevertheless, it is great to get further confirmation that our drug has a safety profile that makes it suitable for treating symptomless cancer patients who have already undergone local curative intent therapy, with an aim to prevent cancer recurrence. Also, the fact that we have excellent patient compliance in the study in spite of the pandemic circumstances, is a sign of how motivated these patients are to receive the treatment. This will add to the interest we already experience in our drug candidate".

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-07-2021 14:20 CET.

On July 9, 2021 HAMLET Pharma reported that All required milestones and deliverables to date are without any significant deviations (Press release, HAMLET Pharma, JUL 9, 2021, View Source;utm_medium=rss&utm_campaign=hamlet-pharmas-achievements-are-emphasized-after-eu-evaluation-the-company-has-fully-achieved-its-milestones-and-secured-the-second-payment [SID1234584810]). This is particularly impressive in light of the global Corona virus pandemic.

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To date, the beneficiary has succeeded in manufacturing the Investigational Medicinal Product (IMP) Alpa1H. The company has demonstrated non-clinical improvement of therapeutic efficacy of other cancer drugs like Mitomycin C and Epirubicin, when combined with Alpa1H and successfully continued with the Phase I/II study of Alpha1H in bladder cancer patients.

There is evidence of good financial management in this project. The amount of financial resources utilized to date is proportionate to the achievements of the project to date".

Hamlet Pharma will now receive the second payment from the EIC Accelerator Horizon 2020 fund of approximately 6,7 million SEK. The third payment is expected at the end of the program.

This disclosure contains information that Hamlet is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-07-2021 09:47 CET.