On October 31, 2022 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that it has voluntarily paused enrollment in its ongoing clinical trials of ITIL-168 and ITIL-306 and has notified regulatory authorities in the United States, Canada, and the UK (Press release, Instil Bio, OCT 31, 2022, View Source [SID1234622638]). No regulatory agencies, including the FDA, have notified the Company of a clinical hold in any of its clinical trials.

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The voluntary pause by the Company was instituted following a recent decrease in the rate of successful manufacturing of ITIL-168, resulting in the inability to dose some patients whose individual product of ITIL-168 was not successfully manufactured. A pre-specified safety analysis in the DELTA-1 trial has been conducted on patients who received ITIL-168 and did not identify any unexpected safety issues. The Company has commenced an end-to-end analysis of its manufacturing processes and upon completion of this analysis, plans to take corrective actions to improve the rate of manufacturing success and resume the study. Although no manufacturing failures have been observed to date in the ongoing Phase 1 trial of ITIL-306, the Company has also voluntarily paused enrollment in this trial as part of its overall manufacturing analysis.

"We are committed to advancing TIL therapy for the treatment of patients with cancer," said Bronson Crouch, Chief Executive Officer of Instil Bio. "This pause in enrollment provides us an opportunity to refine our processes and enable us to manufacture and deliver TIL therapies to patients with no other treatment options. We have assembled a world-class technical operations organization and leadership team to address the challenges associated with manufacturing these therapies."

"With the quality of our technical operations staff and our significant experience in developing cell therapies, I am confident in our ability to overcome obstacles in manufacturing," said Tim Moore, Chief Operating Officer of Instil Bio. "Our end-to-end manufacturing analysis is being carried out to expeditiously identify contributing causes, design solutions, and implement corrective actions in order to resume clinical manufacturing."

The Company intends to provide an update on the manufacturing analysis by early Q1 2023. The Company confirms its previously disclosed cash runway into 2025 upon the successful completion of a potential sale-leaseback transaction of its Tarzana manufacturing facility.

On October 31, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the inventor of its ovarian cancer CAR-T technology, Dr. Jose Conejo-Garcia, Senior Member of the Immunology Department at Moffitt Cancer Center, has been invited to be the keynote speaker at Duke Cancer Institute’s Immuno-Oncology Research Program Retreat on November 4, 2022 (Press release, Anixa Biosciences, OCT 31, 2022, View Source [SID1234622636]).

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During the presentation, Dr. Conejo-Garcia will discuss the CAR-T technology, which is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T. Dr. Conejo-Garcia will also discuss the ongoing Phase 1 clinical trial of this technology.

"I am excited to be presenting our novel FSHR-mediated CAR-T technology to the researchers at Duke’s Immuno-Oncology Research Program and to share work we’ve been doing in developing CAR-T treatments against solid tumors," stated Dr. Conejo-Garcia. "I am pleased by the strong interest from the scientific community in our unique CAR-T approach to treating ovarian cancer."

On October 31, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AU-007, a monoclonal antibody computationally designed by Biolojic Design (Press release, Aulos Bioscience, OCT 31, 2022, View Source [SID1234622635]). AU-007 leverages a unique approach to harnessing the power of interleukin-2 (IL-2) to eradicate solid tumors. This is the first time that a computationally designed human monoclonal antibody has been cleared for human trials in the United States.

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"We are thrilled to have received IND clearance to advance our AU-007 program and expand our Phase 1/2 clinical trial into the United States," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "Receiving IND clearance is a testament to the strength of the preclinical data and initial clinical data from Australia. AU-007’s mechanism of action is unique among all other IL-2 therapeutics in development, and we are excited to pursue the promise of AU-007 in solid tumor cancer care."

The company’s Phase 1/2 clinical trial (NCT05267626) is an open label, first-in-human study currently enrolling patients in Australia. The study is evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Initial safety results from the ongoing clinical trial will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held November 8-12, 2022, in Boston, Massachusetts.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On October 31, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported that the company will participate in the Sidoti November Virtual Micro-Cap Conference on November 9, 2022 (Press release, Akari Therapeutics, OCT 31, 2022, View Source [SID1234622634]). President and CEO Rachelle Jacques will present a company overview at 1:45 pmEastern time and the management team will attend scheduled 1:1 investor meetings. Investors registered for the conference may schedule 1:1 meetings with Akari through the Sidoti conference website.

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A recording will be available at akaritx.com following the company presentation.

On October 31, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that it will provide business updates and report financial results for the third quarter ended September 30, 2022 on Monday, November 7, 2022 and will host a conference call and webcast at 8:00 a.m. Eastern Time that morning (Press release, Mersana Therapeutics, OCT 31, 2022, View Source [SID1234622633]).

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To access the call, please dial 646-307-1963 (domestic) or 800-715-9871 (international) and provide the Conference ID 9941053. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.