On January 18, 2023 Pluristyx and panCELLa today are excited to reported the granting of a patent used in their universal, off-the-shelf, induced pluripotent stem cells (iPSCs) (Press release, panCELLa, JAN 18, 2023, View Source [SID1234626300]). The Great Britain Patent Office on January 4, 2023 issued patent number GB2588249B extending panCELLa’s protection of its induced Allogeneic Cell Tolerance (iACT Stealth) technology (WO/2018/227286) to the United Kingdom.

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The iACT Stealth technology, exclusively licensed by panCELLa from Mount Sinai Hospital, allows clinical-grade cell therapy products and tissues to avoid rejection by the patient after transplant and reduces or eliminates the need for the immunosuppression currently required for tissue transplants. The iACT Stealth technology is available for evaluation under the ‘Try- before-you-buy’ research evaluation model as a stand-alone product or in combination with FailSafe and SafeHarbor platform technologies.

Mahendra Rao, Co-Chairman of the Board at panCELLa and Chief Scientific Officer at Pluristyx commented, "As we integrate Pluristyx and panCELLa into a single entity, we have continued to fund and protect the development of our industry-leading platform technologies for use in iPSCs. We are extremely pleased with the grant of claims by the Great Britain patent office to protect our iACT Stealth technology. iACT Stealth is immediately available in custom or catalog format for quick evaluation and adoption by our academic and industry partners."

Benjamin Fryer, Chief Executive Officer at Pluristyx, said: "At the new Pluristyx, we believe that the unique combination of iACT Stealth, FailSafe, and SafeHarbor technologies are the cornerstone of future cell therapies. With a single cell line and license, a sponsor can now develop, manufacture, and commercialize their universal cell or tissue therapy using our off-the-shelf technologies and gene-edited cells. This unique combination of proprietary gene edits simplifies manufacturing, reduces business and process costs, and offers a chance to revolutionize iPSC-based therapeutic development."

On January 17, 2023 Hengrui Medicine reported that recently, the company’s SHR2554 tablets were proposed to be included in the list of breakthrough therapeutic varieties by the Drug Evaluation Center of the State Drug Administration, and the publicity period will be 7 days (Press release, Hengrui Pharmaceuticals, JAN 17, 2023, View Source [SID1234633514]). SHR2554 tablet is a new, highly effective and selective oral EZH2 inhibitor developed by the company, which is intended for the treatment of malignant tumors. Up to now, about 89.38 million yuan has been invested in the research and development of SHR2554 related projects.

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On March 17, 2023 FivepHusion is developing Deflexifol, reported that it has optimised all-in-one formulation of the chemotherapeutic agent 5-FU and its biomodulator LV for the treatment of solid tumours (Press release, FivepHusion, JAN 17, 2023, View Source [SID1234629015]). The Deflexifol formulation addresses significant limitations with current treatment, offering a "best in class" therapy by optimising co-administration of 5-FU and LV at a physiological pH to enhance patient treatment via greater safety, tolerability and superior efficacy.

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In December 2022, FivepHusion, together with its global regulatory consultants PharmaLex, engaged with the US Food and Drug Administration (FDA) in a Type C meeting to seek feedback on the company’s proposed clinical development program, CMC and regulatory paths for Deflexifol. The FDA provided constructive feedback on the design of the planned next clinical trial, FP101B, a dose-ranging clinical study designed to confirm the appropriate Deflexifol dose to take forward into a pivotal phase III trial in mCRC patients. The Agency confirmed that Deflexifol can be developed in 1st line metastatic colorectal cancer patients, and that only one successfully conducted phase III trial should be sufficient for registration of Deflexifol. The FDA stated no concerns about the FivepHusion proposed CMC pathway and also confirmed that registration of Deflexifol should be pursued via the 505(b)(2) regulatory path.

FivepHusion Executive Director, Dr Bill Ketelbey said, "The FDA has provided very valuable feedback on the design elements for our future clinical studies. These insights allow FivepHusion to optimise the Deflexifol clinical development program to generate the data set necessary to achieve registration of Deflexifol as an enhanced 5-FU and LV formulation for the treatment of 1st line metastatic colorectal cancer patients."

FivepHusion CEO, Dr Christian Toouli commented, "This strategically important interaction with the FDA has confirmed our understanding of the clinical development, CMC and regulatory paths for Deflexifol. We are delighted that the Agency confirmed their requirement for one successfully conducted phase III trial and that FivepHusion can develop Deflexifol via the accelerated and de-risked 505(b)(2) regulatory path for our chosen patient population."

On January 17, 2023 Biocure Technology Inc. ("CURE" or the "Company") (CSE:CURE) BiocurePharm, Korea ("BPK"), a subsidiary of Biocure Technology Inc. ("CURE") reported that it has closed its non-brokered private placement through its Korean Subsidiary BiocurePharm, Korea ("BPK"), BPK has issued 12,500 shares at 4.328CAD per share for gross proceeds of $54,100 (Press release, Biocure Technology, JAN 17, 2023, View Source [SID1234628741]). All dollar values are based on the published Exchange Rate of CAD0.001082/KRW1 on January 13, 2023, Bank of Canada. After the issuance of new BPK shares, CURE holds now 93.42% interest in BPK.

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The net proceeds from the non-brokered private placement are intended to be used for general working capital.

On January 17, 2023 BioCentriq, Inc.—a New Jersey-based, cell and gene therapy contract development and manufacturing organization (CDMO)—reported that they have successfully completed tech transfer of AVB-001 from client Avenge Bio and initiated manufacturing of clinical grade material, which will support Avenge Bio’s ongoing phase 1/2 clinical trial (Press release, Avenge Bio, JAN 17, 2023, View Source [SID1234626316]).

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Additionally, Avenge Bio announced on the 9th of January that they successfully dosed the first patient in a First-in-Human Phase 1/2 clinical trial evaluating AVB-001 in relapsed refractory ovarian cancer. AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered allogeneic human cells.

"We’re very enthusiastic about the advances our client has made in the development of their novel allogeneic cell therapy. Our goal now is to continue offering strong support and process development and manufacturing expertise as Avenge advances through their program," said BioCentriq CEO Haro Hartounian, Ph.D.

Avenge Bio’s first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT05538624) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AVB-001 delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.

The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of native IL-2. The product initiates a robust and durable, local and systemic immune response while avoiding toxicities associated with systemic immunotherapies.

"This major milestone comes at a time when there are limited treatment options for those with relapsed refractory ovarian cancer," said Doug Carlson, Chief Operating and Financial Officer at Avenge Bio. Ovarian cancer is notoriously difficult to treat and ranks fifth in cancer deaths among women. "Our LOCOcyte platform addresses existing challenges and is a promising new potential treatment option for patients."