On August 30, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its CAR-T (Chimeric Antigen Receptor-T cell) therapy, which is being developed in partnership with Moffitt Cancer Center (Moffitt) (Press release, Anixa Biosciences, AUG 30, 2021, View Source [SID1234586994]).

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Dr. Robert Wenham, Chair of Gynecological Oncology at Moffitt will lead the clinical trial.
This CAR-T therapy was developed by Dr. Jose Conejo-Garcia and his research team, when he was at the Wistar Institute. Dr. Conejo-Garcia is currently the Chairman of Immunology at Moffitt.
Anixa Biosciences has an exclusive worldwide license to the technology.
This technology is an autologous cell therapy. The therapeutic product is 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. Amit Kumar, President and CEO of Anixa stated, "We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting therapy. Outcomes for women with late-stage ovarian cancer are poor, so if this approach demonstrates efficacy, it would have a dramatic impact on patients for whom there are no other options."

"This is a major milestone for our program. CAR-T therapy has had major successes in B-cell malignancies, but no clinical success in other types of tumors. We feel that our technology could be the first CAR-T approach that will demonstrate efficacy in a solid tumor indication, and we are looking forward to testing and verifying that assertion in human trials," said Dr. Wenham.

In addition to Drs. Wenham and Conejo-Garcia, other key members of the team at Moffitt include:

Dr. Marco Davila, Clinician and Director of the Cell Therapy Facility at Moffitt
Dr. Daniel Abate Daga, Assistant Director of the Cell Therapy Facility at Moffitt
Dr. Ana Marie Landin, Experimental Cell Therapy Manager at Moffitt
Dr. Theresa Boyle, Department of Pathology at Moffitt
Carrie Thomas, FDA Regulatory Liaison at Moffitt
Tam Jackson, Project Management Consultant
Scientists and Members of the Moffitt Cell Therapy Facility
Members of the Moffitt Alliance Relations Team

On August 30, 2021 Legend Biotech Corporation (NASDAQ: LEGN), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it will participate in the 19th Annual Morgan Stanley Virtual Global Healthcare Conference on Friday, September 10 (Press release, Legend Biotech, AUG 30, 2021, View Source [SID1234587010]). Ying Huang, Chief Executive Officer and Chief Financial Officer, will represent the Company in a session scheduled at 8:45 a.m. (Eastern Time).

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The webcast will be available to investors and other interested parties by accessing the Legend Biotech website at View Source

On August 30, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported CEO Jeff Wolf will host a conference call on Thursday, September 2nd at 11:00 A.M. Eastern Time to provide an update on the Company’s activities (Press release, Heat Biologics, AUG 30, 2021, View Source [SID1234587028]).

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The conference call may be accessed by dialing 844-602-0380 for U.S. callers or +1 862-298-0970 for international callers. A webcast of the call may be accessed at View Source or on the Company’s website at View Source

An audio replay of the call will be available through September 16, 2021, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and by entering the access code: 42602.

On August 30, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the Aptose management team will participate at the upcoming conferences in September 2021 (Press release, Aptose Biosciences, AUG 30, 2021, View Source [SID1234586995]):

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• H.C. Wainwright 23rd Annual Global Investment Conference

Date: Monday, September 13, 2021
Time: On demand starting 7:00 AM EDT
Format: Virtual
Webcast: Link

• Cantor Global Healthcare Conference

Date: Tuesday, September 28, 2021
Time: 11:20 AM EDT
Format: Virtual
Webcast: Link
The webcasts also can be accessed through the Aptose website at www.aptose.com and will be archived shortly after the live events.

On August 30, 2021 CivaTech Oncology reported that Physicians from four medical centers recently published data this month from an initial six patients implanted with CivaSheet to treat retroperitoneal sarcoma (Press release, CivaTech Oncology, AUG 30, 2021, View Source [SID1234587011]). The article, titled "Initial Clinical Experience With Novel Directional Low-dose Rate Brachytherapy for Retroperitoneal Sarcoma" was accepted for publication in the Journal of Surgical Research on June 28, 2021. With a mean follow up of 16 months, no local cancer recurrences, no toxicities, and no complications have been reported.

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Approximately 13,460 new soft tissue sarcomas will be diagnosed and 5,350 people are expected to die of soft tissue sarcomas in 2021. (American Cancer Society). And Retroperitoneal Sarcomas (RPS) make up approximately 15% of all patients with soft tissue sarcoma. Despite advances in cancer care, however, many of these patients endure multiple recurrences and their overall 5 year survival rate remains under 65%.

CivaSheet, a new bio-absorbable, internal radiation treatment, is implanted in approximately 30 minutes in the operating room at the time of sarcoma surgery. CivaSheet is designed to help prevent sarcoma recurrence by delivering a highly targeted dose of radiation directly to the surgical margin where residual cancer cells may remain. CivaSheet’s integrated shielding protects healthy surrounding organs, enabling a higher dose than can be administered using other treatment options.

"CivaSheet has been effective for our patients as it allows the clinician to personalize therapy to the patient’s anatomy at the time of surgery and to their previous course of treatment to minimize long term radiation side-effects," said Krisha Howell MD, Clinical Director of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.

Designed and manufactured by CivaTech Oncology, CivaSheet is a flexible, implantable intra-operative radiation therapy device (brachytherapy), which emits unidirectional radiation using integrated gold shielding. The unidirectional property makes the device active on one side to provide a homogenous radiation dose. This feature is entirely unique to CivaSheet, allowing physicians to safely deliver aggressive radiation doses immediately adjacent to healthy, sensitive tissue. No complications or radiation related side effects have been reported in nearly 150 patients treated with CivaSheet to date. Radiation is delivered over the course of several weeks as the isotope naturally decays, eliminating the need for repeat hospital visits, and no follow up procedure is necessary to remove the device.

CivaSheet has broad FDA clearance to include soft tissue sarcomas and many other malignancies. This sarcoma Registry will help to determine CivaSheet’s impact on local control and recurrence.