On September 26, 2022 CellOrigin Biotech (Hangzhou) Co., Ltd. reported it has made a global strategic collaboration agreement with Qilu Pharma to develop, manufacture and commercialize proprietary "off-the-shelf" induced pluripotent stem cell- (iPSC) derived Chimeric Antigen Receptor Macrophages (CAR-iMAC) for cancer immunotherapy (Press release, CellOrigin Biotech, SEP 26, 2022, View Source [SID1234621400]).

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The collaboration will take advantages of technologies and expertise from both parties, as well as integrate capabilities of R&D, manufacturing and marketing to develop CAR-iMAC clinical products aiming for solid tumors.

"Innovation and offering the best products that benefit patients are the core values that CellOrigin Biotech and Qilu Pharma both appreciate," said Dr. Jin Zhang, the Co-Founder of CellOrigin Biotech and a Principal Investigator of Zhejiang University, one of the top universities in China. "This is what brings us together."

"We are very excited to collaborate with Qilu Pharma because of its prestige in the field of Chinese pharmaceutical industry, as well as its tremendous track records on drug development," said Dr. Jiansong Tong, the Chief Executive Officer at CellOrigin Biotech. "Meanwhile, we will continue to seek other potential collaborators to jointly develop our innovative anti-tumor CAR-iMac cell products."

"CellOrigin Biotech is a startup company established by a group of outstanding scientists who have tremendous experiences both in R&D research and cGMP manufacture. It focused on developing innovative technologies in cell therapy and building valuable pipeline of products. It is an ideal strategic partner for novel cell therapy, and it is our pleasure to collaborate with such a great biotech company," said Qilu Pharma.

On September 23, 2022 Lacerta Therapeutics, a leader in the development of adeno-associated virus (AAV) technologies for the treatment of central nervous system (CNS) diseases, reported a new AAV capsid licensing and research collaboration agreement with Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company (Press release, Lacerta Therapeutics, SEP 23, 2022, View Source [SID1234622161]). The collaboration will focus on the discovery and development of novel AAV capsids for CNS diseases.

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"We are eager to initiate this exciting collaborative work with our new partners at Prevail. The goal is to broaden the AAV medicines cabinet by improving the safety, potency, and manufacturability of novel AAV capsid variants for CNS indications," said Edgardo Rodriguez-Lebron, Chief Executive Officer of Lacerta Therapeutics. "With this agreement, Lacerta gains its third clinical and commercial partner as we continue to push towards our shared goal of improving the life of patients with intractable neurodegenerative diseases."

As a part of the collaboration, Prevail will receive rights to utilize one of Lacerta’s novel AAV capsids for select undisclosed CNS targets. In addition, Lacerta’s proprietary AAV capsid platform will be utilized to discover and develop novel AAV capsids that are optimized to target desired CNS tissues and cell types. The collaboration will leverage Lacerta’s established expertise in AAV technologies and Prevail’s development and clinical capabilities, with the goal of accelerating development of gene therapies for patients with neurodegenerative disorders.

"We are excited to be collaborating with Lacerta on the discovery of novel AAV capsids with improved CNS delivery to advance the development of new medicines by Prevail and the Lilly Institute for Genetic Medicine," said Mansuo Shannon, Chief Scientific Officer of Prevail Therapeutics. "We believe this will allow us to move promising therapeutics more quickly to the clinic to study novel genetic medicines for diseases with high unmet need."

Lacerta will lead capsid discovery, screening, and validation, while Prevail will complete preclinical and Investigational New Drug-enabling studies with therapeutic payloads. Prevail will be responsible for all manufacturing, clinical development, and commercialization. Under the terms of the agreement, Lacerta will receive an upfront payment and will be eligible for development and commercial milestones, as well as tiered royalties on future net sales of products that incorporate capsids covered under the collaboration. Lilly will also provide Lacerta with new financing under the terms of a convertible promissory note agreement.

On September 23, 2022, Syndax Pharmaceuticals, Inc. (the "Company") reported made a prepayment of $21.5 million to satisfy in full all of the Company’s principal and interest obligations and related fees under that certain Loan and Security Agreement, dated February 7, 2020, by and among the Company and its subsidiaries, the several banks and other financial institutions or entities from time to time parties thereto, and Hercules Capital, Inc. ("Hercules"), in its capacity as administrative agent and collateral agent (collectively, the "Lender"), as amended (as amended, the "Loan Agreement") (Filing, 8-K, Syndax, SEP 23, 2022, View Source [SID1234621399]). The payoff amount paid by the Company in connection with the termination of the Loan Agreement was pursuant to a payoff letter with Hercules and included payment of (a) $1.0 million as an end-of-term fee and (b) $0.4 million pre-payment fee. Hercules released all security interests held on the assets of the Company and its subsidiaries.

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On September 23, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, will present at the Virtual Investor Innovations in Oncology – Ongoing Pivotal Global Study for Treatment of Glioblastoma Multiforme (GBM) Event on Wednesday, September 28, 2022 at 1:00 PM ET (Press release, CNS Pharmaceuticals, SEP 23, 2022, View Source;ongoing-pivotal-global-study-for-treatment-of-glioblastoma-multiforme-gbm-301631776.html [SID1234621398]).

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As part of the virtual event, the Company will discuss its ongoing potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV1) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival (OS), which is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

In addition to the moderated portion of the event, investors and interested parties will have the opportunity to submit questions. The Company will answer as many questions as possible during the event.

A live video webcast of the Virtual Investor Innovations in Oncology – Ongoing Pivotal Global Study for Treatment of Glioblastoma Multiforme (GBM) Event will be available on the Events page in the Investors section of the Company’s website (www.cnspharma.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On September 23, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that management will participate in a fireside chat at 1:30 p.m. ET on Friday, September 30, 2022 at the upcoming Jefferies Cell & Genetic Medicine Summit set to take place in New York City (Press release, Wugen, SEP 23, 2022, View Source [SID1234621397]).

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