On September 30, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it and partner Moffitt Cancer Center ("Moffitt") have submitted an amendment to the current protocol that governs its ongoing clinical trial utilizing a CAR-T therapy to treat ovarian cancer (NCT05316129) (Press release, Anixa Biosciences, SEP 30, 2024, https://ir.anixa.com/news/detail/1052/anixa-biosciences-announces-submission-of-protocol-amendment-for-car-t-trial [SID1234646922]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A key change in the protocol provides a second dose of the therapy to patients who might benefit from an additional dose. Previously, Anixa and Moffitt sought and received approval of a single patient IND application to enable a second dose for a single patient who, upon examination of tumor obtained from a biopsy, exhibited cellular infiltration and necrosis, indicating biologic activity of the CAR-T. This amendment will permit all potential patients to receive another leukapheresis and a second dose of CAR-T, without submitting individual INDs for each patient.

Dr. Robert Wenham, Chair of the Gynecologic Oncology Department at Moffitt, and the principal investigator of the trial, stated, "In initial Phase 1 clinical trials, it is customary to begin with low, often subtherapeutic cell doses to verify safety, before increasing the dose levels. In our study, the patient approved for a second dose by the individual IND received the starting, lowest dose. While initially meeting the criteria for progression due to size of her predominate tumor, her cancer has since remained relatively stable and she has not received additional therapy since her first infusion. We are hoping a second, higher dose may improve her overall response and outcome. In general, we anticipate that higher cell doses will lead to efficacy, but for solid tumors, a second dose may be needed in a subset of patients to improve the rate and durability of responses."

"We hope to get approval from regulatory agencies shortly, to enable second doses for the appropriate patients. We are clearly enthusiastic about the progress of this trial and are looking forward to treating additional patients," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.

On September 30, 2024 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will participate in panel focused on innovations in the allogeneic cell therapy landscape during the Goldman Sachs Cell Therapy Day on October 1, 2024 in New York (Press release, Allogene, SEP 30, 2024, View Source [SID1234646921]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Goldman Sachs Cell Therapy Day
Tuesday, October 1, 2024
Panel Discussion: 10:00AM PT/1:00PM ET

A webcast of this panel discussion will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

On September 30, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that it has entered into a securities purchase agreement with a single institutional investor to purchase 4,653,036 shares of common stock in a registered direct offering at a purchase price of $0.27 per share (Press release, AIM ImmunoTech, SEP 30, 2024, View Source [SID1234646920]). In a concurrent private placement, the Company also agreed to issue unregistered Class C warrants to purchase up to an aggregate of 4,653,036 shares of common stock and, unregistered Class D warrants to purchase up to an aggregate of 4,653,036 shares of common stock. The Class C and Class D warrants will each have an exercise price of $0.28, will be exercisable six months from the date of issuance and, in the case of the Class C warrants, will expire on the eighteen-month anniversary from the initial exercise date, and in the case of the Class D warrants, will expire on the five-year anniversary from the initial exercise date.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The gross proceeds to the Company from the registered direct offering and concurrent private placement are estimated to be approximately $1.26 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on February 4, 2022. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement relating to the shares of common stock will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, at (212) 895-3745.

The warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and the shares of common stock underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 29, 2024 IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, reported a poster presentation of the comparative clinical outcomes of patients from FUMANBA-1 study with relapsed/refractory multiple myeloma (R/R MM) who received the fully human anti-BCMA CAR-T cell therapy Equecabtagene Autoleucel (Eque-cel, Fucaso) under different lymphodepletion regimensat the 2024 International Myeloma Society (IMS) Annual Meeting (Press release, IASO Biotherapeutics, SEP 29, 2024, IASO Bio Presented Comparative Clinical Outcomes on the Optimal Lymphodepletion Prior to Infution of Equecabtagene Autoleucel（FucasoTM）in Patients with Relapsed Refractory Multiple Myeloma at 2024 IMS Annual Meeting [SID1234646909]). Results indicate that a full lymphodepletion dose can significantly improve the depth and duration of remission, prolong progression-free survival, without more treatment-related toxicity in patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Abstract Number：P-094
Abstract Title: The Optimal Lymphodepletion Prior to Eque-cel in Patients with Refractory Relapsed Multiple Myeloma in FUMANBA-1 Study
Presentation Date：September 28, 2024（UTC-3)

The poster presents a post-hoc analysis of the FUMANBA-1 study which enrolled 91 subjects without prior CAR-T treatment to receive Eque-cel. The median follow-up period was 18.07 months. Of the 91 subjects, 33 underwent a lymphodepletion dose adjustment, while the remaining 58 received the standard lymphodepletion dose. Both groups had similar baseline characteristics, including age range, physical fitness scores, tumor staging, high-risk cytogenetic abnormalities, and previous lines of treatment.

The results indicate that, in terms of efficacy, the overall response rate (ORR) and stringent complete remission rate (sCR) for the standard-dose group were 100% and 82.8%, respectively, while the dose-adjusted group had rates of 97% and 78.8% .The standard-dose group also exhibited greater remission depth and better long-term prognosis, with 92.2% of patients maintaining a duration of response (DOR) exceeding one year, compared to 70.6% in the dose-adjusted group. Additionally, the median time to achieve minimal residual disease (MRD) negativity was longer in the dose-adjusted group at 22 days, compared to 15 days in the standard-dose group. The 12-month MRD negativity rate was 90.4% in the standard-dose group, significantly higher than the 63.7% observed in the dose-adjusted group (HR=3.33, P=0.0166). Regarding the 12-month progression-free survival (PFS) rate, the standard-dose group achieved 92.2% with a median PFS not yet reached, while the dose-adjusted group had a 12-month PFS of 73.5% and a median PFS of 30.28 months (HR=3.64, P=0.0032). A similar trend was noted in PFS among patients receiving a 90% dose adjustment.

In terms of safety, no significant differences in the severity and incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups. CRS (grades 1-2) occurred in 94.8% of the standard dose group and 93.9% of the dose-adjusted group, with no severe CRS (≥grade 3) in either group. Apart from one grade 2 ICANS case in the adjusted group, no ICANS (≥grade 3) occurred in either group .

Conclusions：lymphodepletion prior to CAR-T cell therapy is essential for achieving optimal CAR-T efficacy. The study further confirms that appropriate lymphodepletion regimen is crucial for effectiveness of eue-cel treatment, significantly improving treatment outcomes and prognosis. When patients can tolerate it, administering the full lymphodepletion doses, when possible, can lead to greater benefits without increasing toxicity.

The principal investigator of this study, Professor Lugui Qiu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated: "The lymphodepletion regimen is crucial for CAR-T cell therapy. Data from this study indicate that standardized and sufficient lymphodepletion can lead to a higher quality of remission and more ideal clearance of minimal residual disease without increasing the potential of adverse reactions. These findings provide a scientific basis to ensure the efficacy and safety of CAR-T cell therapy through optimizing regimens of lymphodepletion, which will ultimately lead to longer survival and improved quality of life for patients with R/R MM."

Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, said: "We are delighted to present new finding from our FUMANBA-1 study. This study demonstrated the critical role of standard lymphodepletion in enhancing treatment outcomes and prognosis for patients.. these findings will contribute significantly to the establishment and optimization of lymphodepletion preconditioning standards in the field of CAR-T cell therapy, Our goal is to drive the standardization of industry practices, ensuring that every patient receiving CAR-T therapy benefits from a more scientific and efficient treatment plan."

About FUMANBA-1 Study

The FUMANBA-1 Study is a Phase Ib/II, single-arm, multicenter study to assess the efficacy and safety of the investigational drug Equecabtagene Autoleucel, a fully human BCMA CAR-T cell therapy, in patients with R/R MM who have received 3 or more lines of treatment.

On September 28, 2024 Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, reported the presentation of new data at the 66th Annual Meeting of the American Society for Radiation Oncology (ASTRO), taking place September 29 – October 2, 2024, in Washington, D.C. (Press release, Naveris, SEP 28, 2024, View Source [SID1234646911]). These presentations will showcase the role of the NavDx test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA blood test, in the management of HPV-driven oropharyngeal cancers, with a focus on integration into radiation oncology practices.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"ASTRO is the premier gathering for radiation oncology professionals, providing the perfect platform to showcase how the NavDx test is transforming the care of patients with HPV-driven cancers," said Barry M. Berger, M.D., Chief Medical Officer at Naveris. "These presentations will highlight the role of testing in personalizing treatment, enhancing real-time surveillance, and ultimately improving patient outcomes in the field of radiation oncology."

Oral Presentations:

The following presentation will be part of SS 37 – H&N 1: Envisioning the Future: Leading Edge Research in HPV-Associated Oropharyngeal Cancer on Tuesday, October 1, 2024, from 3:00 PM – 4:00 PM EDT at the Walter E. Washington Convention Center (WWCC), Room 145:

Tuesday, October 1, 2024 | 4:40 PM – 4:50 PM EDT
The Preliminary Analysis of Circulating Human Papillomavirus DNA in a Phase III Trial of Concurrent Chemoradiation (CRT) with Intensity Modulated Proton Therapy (IMPT) vs. IMRT in Oropharyngeal Squamous Cell Carcinoma
Presenting Author: Li Wang, M.D., Ph.D. | Senior Author: Steven Frank, M.D.
MD Anderson Cancer Center, Houston, TX
This large study analyzed over 1,000 blood samples and showed that the NavDx test can identify patients at risk for treatment failure earlier than imaging, demonstrating its potential as a robust biomarker to guide treatment intensity in HPV+ OPSCC.
The following educational session presentation will also incorporate a discussion of the NavDx test:

Monday, September 30, 2024 | 10:30 AM – 11:30 AM EDT | Room 151
EDU 24 – Integration of HPV ctDNA Testing into Clinical Practice for HPV+ OPSCC – Ready for Prime Time?
Moderator: John Lukens, M.D. | Speakers: David Routman, M.D., Michelle Mierzwa, M.D., Dan Faden, M.D.
University of Pennsylvania, Mayo Clinic, University of Michigan, Mass General Brigham
This educational session will explore the use of HPV ctDNA testing in clinical practice for HPV+ OPSCC, incorporating the NavDx test as part of a broader discussion on using ctDNA for treatment guidance and monitoring.
Poster Presentations:

The following posters will be part of PQA 10 – Head & Neck Cancer and Health Services Research/Global Oncology on Wednesday, October 2, 2024, from 10:30 AM – 11:45 AM EDT at WWCC, Hall C:

(3608) The Impact of Circulating Tumor Human Papillomavirus (HPV) DNA Clearance Kinetics on Disease Outcomes during Chemoradiation in Patients with HPV-Associated Oropharyngeal Cancer
Presenter: Sujith Baliga, M.D. | Senior Author: David M. Blakaj, M.D., Ph.D.
The Ohio State University, Columbus, OH
This study shows that changes in NavDx test results during treatment can predict outcomes, with rapid clearance indicating better control and persistent positivity suggesting higher risk, highlighting NavDx as a tool for adjusting radiation therapy intensity based on patient risk.
(3718) Tracking Circulating Tumor HPV DNA with Early Cessation of Radiotherapy in Oropharynx Cancer
Presenter: Zubir Rentiya, M.D., MSc | Senior Author: Charles McLaughlin, M.D.
University of Virginia, Charlottesville, VA
This study shows that using mid-treatment NavDx test results to guide early cessation of radiotherapy led to excellent outcomes, with superior progression-free survival compared to patients completing the full course of treatment.
(3639) Comparative Performance of ctHPVDNA and Imaging Surveillance for Oropharyngeal Cancer Following Radiotherapy
Presenter: Yifu Ding, M.D., Ph.D. | Senior Author: Walter A. Stokes, M.D.
Winship Cancer Institute of Emory University, Atlanta, GA
This study found that NavDx outperforms imaging in post-radiotherapy surveillance, with fewer false positives and higher specificity.
Naveris will be exhibiting at the conference at Booth #2037, where attendees can learn more about NavDx and its impact on improving care for patients with HPV-driven cancers in radiation oncology.

For more information about Naveris and NavDx, please visit www.naveris.com and www.NavDx.com.