On June 29, 2022 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the second quarter ending June 30, 2022 on Wednesday, July 27, 2022 at 8:00 a.m. EDT (Press release, Boston Scientific, JUN 29, 2022, View Source [SID1234616388]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the second quarter on July 27 prior to the conference call.

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A live webcast and replay of the webcast will be accessible at investors.bostonscientific.com. The replay will be available approximately one hour following the completion of the event.

On June 29, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported a peer-reviewed publication highlighting the potential of its proprietary Cas-CLOVER Site-specific Gene Editing System as a high-efficiency platform for the production of allogeneic CAR-T cells (Press release, Poseida Therapeutics, JUN 29, 2022, View Source [SID1234616386]). The paper, titled "Cas-CLOVER is a novel high-fidelity nuclease for safe and robust generation of TSCM-enriched allogeneic CAR-T cells," was published online today in Molecular Therapy – Nucleic Acids. The paper will appear in print in the September 2022 issue of the journal.

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"We are excited to publish data from this very comprehensive study of our gene editing system in T cells," said Eric Ostertag, M.D., Ph.D., Executive Chairman of Poseida Therapeutics. "This publication validates the precision of our proprietary Cas-CLOVER system, which is utilized in the manufacture of our fully allogeneic product candidates currently in clinical trials, including P-BCMA-ALLO1 for relapsed/refractory multiple myeloma and P-MUC1C-ALLO1 for multiple solid tumor indications."

Cas-CLOVER is a novel, high-fidelity gene editing system that can be used for high-efficiency gene editing in T cells to create allogeneic CAR-T products. In these published studies, Cas-CLOVER was used for multiplexed gene editing in resting T cells, which resulted in allogeneic product candidates with a high percentage (45%-70%) of desirable T stem cell memory (Tscm) cells. Using next-generation sequencing, off-target activity was measured at a rate between 0.012% and 0.089%, which is significantly lower than many other gene editing platforms. In addition, off-target translocations, which are undesirable chromosomal abnormalities, approached the lower limit of detection at a frequency of less than 0.01%.

"Cas-CLOVER is a highly versatile and precise system that can be used to make site-specific deletions, insertions and knock-ins and works in multiple cell types," said Blair Madison, Ph.D., Vice President, Genetic Engineering at Poseida Therapeutics, first author of the publication. "We continue to innovate, including the enhancement of Cas-CLOVER, to create potentially transformative treatments for patients in oncology and rare diseases."

On June 29, 2022 CanariaBio Inc. (developing its biotechnology assets through its subsidiaries, MH C&C and OncoQuest Pharma US Inc.) reported that it has reached 50% of target enrollment of 602 patients for its pivotal Phase III clinical study of its lead product oregovomab, in combination with standard of care chemotherapy (carboplatin and paclitaxel) for the treatment of front-line advanced ovarian cancer patients (Press release, CanariaBio, JUN 29, 2022, View Source [SID1234616385]).

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This double blind and placebo controlled multinational trial (FLORA-5, GOG-3035, NCT04498117) is currently accruing patients at over 137 centers in Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Hungary, Italy, Korea, Mexico, Poland, Spain, Taiwan and US; with additional sites in India and Romania being activated. This study seeks to confirm the observations of Brewer et al (Gynecology Oncology 2020 156:523-529) that demonstrated oregovomab in combination with carboplatin and paclitaxel improved both progression free and overall survival relative to chemotherapy which was statistically significant and clinically meaningful in the absence of incremental toxicity.

For this ongoing Phase-III study, the last Independent Data Safety Monitoring Board (IDSMB) meeting held in March 2022 identified no safety concerns and IDSMB recommended to continue the study without modifications.

"We are excited about reaching this important milestone, which is a testament of the hard work that all our investigators, GOG leadership, team members and collaborators has put in, and are grateful to the patients that have participated in the study," said Dr. Sunil Gupta MBBS, FRCPC, Chief Medical Officer of OncoQuest Pharma US, Inc. (a subsidiary of CanariaBio Inc.) "We remain on track with our projected enrollment, and we are excited about the potential benefits that our drug may bring to patients with ovarian cancer."

About Oregovomab.
Oregovomab is a murine IgG against CA 125. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefit as observed in a phase 2 trial. In a randomized Phase 2 clinical trial of 97 patients, treatment with Oregovomab in combination with chemotherapy had demonstrated a highly statistically significant and clinically meaningful outcome for both progression-free and overall survival compared to standard of care chemotherapy (carboplatin and paclitaxel). The risk of progression and of death was reduced by more than 50% when compared to control arm, and safety data showed that oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecology Oncology 2020 156:523-529) and Cancer Immunology and Immunotherapy 2020 69: 383-397, respectively. To learn more, visit www.FLORA-5.com.

On June 29, 2022 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that its novel inhibitor of the embryonic ectoderm development (EED) protein, APG-5918, has been cleared by the US Food and Drug Administration (FDA) to enter a first-in-human (FIH) study that will assess the safety, pharmacokinetics, and preliminary efficacy of APG-5918 in patients with solid tumors or hematologic malignancies (Press release, Ascentage Pharma, JUN 29, 2022, View Source [SID1234616384]).

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This multicenter, open-label Phase I study is designed to assess the safety and tolerability, and determine the dose-limiting toxicity, maximum tolerated dose, and recommended Phase II dose (RP2D) of orally administered APG-5918. Prof. Joseph Paul Eder, Clinical Director of the Early Drug Development Program at Yale Cancer Center will be the Principal Investigator of this multicentric clinical trial.

EZH2, which is highly expressed in multiple tumors in humans, was found to promote the development and progression of tumors, and the targeted inhibition of EZH2’s methyltransferase activity has already been proven as an effective mechanistic approach for cancer treatment. However, the secondary mutation of EZH2 may lead to acquired drug resistances, while the homologous EZH1 also has methyltransferase activity that could limit the effects of EZH2 inhibitors. Furthermore, EED protein can stimulate the methyltransferase activity of EZH2, thus making the allosteric targeting of EED an effective approach. EED inhibitors have shown good therapeutic potential in many kinds of solid tumors and hematologic malignancies.

Discovered and developed by Ascentage Pharma, APG-5918 is an orally active, potent, selective, small-molecule EED inhibitor with high binding affinity. As an allosteric inhibitor, APG-5918 selectively binds to the EED protein. By regulating tumor epigenetics and microenvironment, APG-5918 can potentially overcome tumor resistance and deliver complete and durable tumor regression.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, "I am excited that we are poised to initiate the FIH study of APG-5918 under the leadership of Prof Paul Eder. In preclinical studies, APG-5918 showed potent binding activity with the EED protein, in vitro antiproliferative activity, and in vivo antitumor activity."

"We look forward to advancing the clinical development of APG-5918 to hopefully bring clinically meaningful benefits to patients as early as possible", added Prof Paul Eder.

On June 29, 2022 TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported in vivo and in vitro boron delivery data using the company’s novel compounds at the 60th Particle Therapy Co-Operative Group (PTCOG) Conference, occurring June 27 – July 2, 2022 (Press release, TAE Life Sciences, JUN 29, 2022, View Source [SID1234616383]).

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"The identification of these targeted drugs as alternatives to boron phenylalanine (BPA) coupled with the development of a modern neutron source have the potential to provide a paradigm shift in cancer treatment," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "We are committed to developing BNCT as a treatment modality for difficult to treat tumors and bringing new hope to patients."

Title: Development of a novel accelerator system and new targeted drugs for BNCT
Abstract Number: PTC60-0255
Session Title: Boron Neutron Capture Therapy
Presenter(s): Michael Sandhu, Vice President of Business Development, EMEA, TAE Life Sciences
Date: Wednesday, June 29, 2022
Time: 17:51 – 17:59

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.