On November 11, 2024 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported enrollment of the first patient in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda (pembrolizumab) or Opdivo (nivolumab) (AEMD-2022-06 Hemopurifier Study) (Press release, Aethlon Medical, NOV 11, 2024, View Source [SID1234648087]). The patient was enrolled on October 29, 2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia.

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 first patient completed screening activities confirming their eligibility on November 8, 2024, and has now entered a two-month run-in period, receiving anti-PD-1 therapy. During this time, concentrations of Extracellular vesicles (EVs) and anti-tumor T cell activity will be measured. If imaging after this two-month run-in period reveals no improvement in the patient’s tumor, they will be treated with the Hemopurifier, followed by monitoring to identify decreases in EV concentrations and improvements in T cell anti-tumor activity.

"Enrollment of the first patient represents the achievement of a critical milestone for Aethlon Medical in the clinical development of the Hemopurifier in Oncology," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We are thrilled with the pre-screening activity being done to identify patients at Royal Adelaide, as well as the second site, Pindara Private Hospital in the Gold Coast. We are grateful to the patient for consenting to be part of this study. This trial is our initial step in determining if the Hemopurifier treatment can improve upon the 30-40% response rates to anti-PD-1 therapies such as Opdivo and Keytruda."

Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.

The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda or Opdivo monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.

On November 11, 2024 Pharma Two B Ltd. ("Pharma Two B"), a late-clinical stage company that is developing P2B001, an innovative combination product candidate for the treatment of Parkinson’s Disease ("PD") and Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) ("Hepion"), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, reported that the U.S. Securities and Exchange Commission ("SEC") has declared effective the registration statement on Form F-4 (as amended, the "Registration Statement") filed with the SEC related to Pharma Two B’s merger transaction with Hepion as previously announced on July 22, 2024 (the "Proposed Transaction") (Press release, Hepion Pharmaceuticals, NOV 11, 2024, View Source [SID1234648071]).

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 Proposed Transaction, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol "PHTB" and other customary closing conditions. Upon the anticipated closing of the Proposed Transaction, the combined company will operate under the "Pharma Two B" name.

Hepion also announced that a special meeting (the "Special Meeting") of its stockholders will be held on December 12, 2024 to approve the Proposed Transaction. The Special Meeting will be held at 9:00 a.m. Eastern Time via live webcast at www.virtualshareholdermeeting.com/HEPA2024SM. Hepion stockholders of record at the close of business on the record date of November 6, 2024 are entitled to vote at the Special Meeting. Hepion filed its definitive proxy statement/prospectus relating to the Proposed Transaction with the SEC and will mail it to stockholders on or about November 8, 2024. More details about the Proposed Transaction and the resolutions to be voted upon at the Special Meeting can be found in the definitive proxy statement/prospectus, available at View Source Hepion stockholders who need assistance in completing the proxy card, need additional copies of the proxy statement/prospectus, or have questions regarding the Special meeting may contact Hepion’s proxy solicitor, Campaign Management, by calling 1-855-422-1042 or emailing [email protected].

A.G.P./Alliance Global Partners is serving as financial advisor to Hepion and Sheppard, Mullin, Richter & Hampton LLP is acting as U.S. legal advisor to Hepion and Lipa Meir & Co.is acting as Israeli legal advisor to Hepion. Sullivan & Worcester LLP is serving as legal advisor to A.G.P.

Laidlaw & Company (UK) Ltd. is acting as financial advisor to Pharma Two B. and Meitar Law Offices and Goodwin Procter LLP are acting as legal advisors to Pharma Two B.

On November 11, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the selection of IDE034, a potential first-in-class B7H3/PTK7 topo-I-payload BsADC, as a development candidate and the exercise of its option for an exclusive worldwide license from Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315) for potential first-in-class B7H3/PTK7 BsADC program (Press release, Ideaya Biosciences, NOV 11, 2024, View Source [SID1234648088]).

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!

"We are pleased to nominate development candidate IDE034, a promising potential first-in class B7H3/PTK7 topo-I-payload bispecific ADC, which has demonstrated robust monotherapy tumor regressions in multiple preclinical models. The co-expression of B7H3/PTK7 in several solid tumors, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, highlights the potential addressable market, both as monotherapy and in combination with PARG inhibitor IDE161," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences. "We are excited to nominate our 6th development candidate in IDE034 and this program achieves several strategic objectives for IDEAYA, including the potential for monotherapy activity, application in multiple priority solid tumor types of lung and colorectal cancer, and the ability to enable wholly-owned rational combinations with our internal pipeline," said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences.

"We are excited to have IDEAYA exercise their option to license the worldwide rights to our B7H3/PTK7 BsADC IDE034 with a proprietary topoisomerase linker-payload. This important milestone in our partnership further validates Biocytogen’s RenLite platform and brings us one step closer to making an impact on patients with solid tumors. We look forward to our continued partnership with IDEAYA as they advance this program to the clinic," added Dr. Yuelei Shen, President and CEO of Biocytogen.

IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) in 2025 for IDE034, subject to satisfactory completion of ongoing preclinical and IND-enabling studies, to enable first-in-human study initiation.

The option was exercised for an exclusive worldwide license from Biocytogen pursuant to the option and license agreement between IDEAYA and Biocytogen. IDEAYA will pay Biocytogen upfront and option exercise fees, along with additional development and regulatory milestone payments, commercial milestone payments, and royalties on net sales, totaling $406.5 million, including up to $100 million in development and regulatory milestone payments.

B7H3/PTK7 has been reported to be co-expressed in multiple solid tumor types, including in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively, based on the Human Protein Atlas database.

On November 11, 2024 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole-tumor derived immunotherapies, reported an oral presentation and two poster presentations at the 2024 Society for NeuroOncology (SNO) 29th Annual Meeting in Houston, Texas, from November 21-24, 2024 (Press release, Imvax, NOV 11, 2024, View Source;utm_medium=rss&utm_campaign=imvax-to-present-safety-data-on-lead-program-igv-001-at-2024-sno-annual-meeting [SID1234648072]). Separately, the Company will also host a symposium focused on the development of IGV-001 for the treatment of newly diagnosed glioblastoma.

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!

Imvax will present blinded safety data from the Company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). The Phase 2b study to assess the safety and efficacy of IGV-001 in patients with ndGBM (NCT04485949) has completed enrollment and top-line results are expected to be presented in mid-2025. Imvax will also present follow-on data from its Phase 1b study of IGV-001 in patients with ndGBM, as well as preclinical data of IGV-001 in combination with checkpoint inhibitors.

The details of the oral presentation and two poster presentations are below:

Title: Early safety data from a randomized, multicenter, double-blind, phase 2b study of IGV-001, an autologous cell immunotherapy, versus placebo, in newly diagnosed glioblastoma (ndGBM)
Number: CTIM-14
Timing: November 22, 7:25 p.m. – 7:35 p.m. CST
Presenter: Brad Elder, M.D.

Title: Long-term survivors from a Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma
Number: CTIM-11
Timing: November 21-22, 7:30 p.m. – 9:30 p.m. CST
Presenter: Raul-Perez Olle, M.D., Ph.D.

Title: IGV-001: A biologic-device combination product elicits potent anti-GBM responses as a monotherapy and in combination with check point inhibition
Number: IMMU-30
Timing: November 21-22, 7:30 p.m. – 9:30 p.m. CST
Presenters: Jenny Zilberberg, Ph.D. & Mark A. Exley, Ph.D.

On Friday, November 22, 2024, from 12:45 p.m. – 1:45 p.m. CST, Raul Perez-Olle, M.D., Ph.D., SVP, Head of Clinical Development and Medical Affairs at Imvax, Brad Zacharia, M.D., M.S., FAANS, Associate Professor of Neurosurgery and Otolaryngology at Penn State Health, and Brad Elder, M.D., Director, Neurosurgical Oncology, and Associate Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center, will host a symposium, entitled "Development of IGV-001 for the treatment of newly diagnosed glioblastoma," focused on Imvax’s proprietary Goldspire platform and the development of IGV-001 for the treatment of ndGBM. Register for the session here.

About IGV-001
IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b ndGBM study also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC.

On November 11, 2024 STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, reported that it presented promising data from its Phase 1 clinical study evaluating its METTL3 RNA methyltransferase inhibitor, STC-15, at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, held in Houston, US, from 6-10 November 2024 (Press release, STORM Therapeutics, NOV 11, 2024, View Source [SID1234648089]).

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 Phase 1 clinical study enrolled 42 patients across five dose escalation cohorts ranging from 60mg to 200mg and explored daily and thrice weekly oral dosing regimens. Data presented at SITC (Free SITC Whitepaper) follows the Company’s presentation at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in October 2024.

The presentation at SITC (Free SITC Whitepaper) titled, ‘Phase 1 dose escalation and cohort expansion study evaluating safety, PK, PD and clinical activity of STC-15, a METTL3 inhibitor, in patients with advanced malignancies’, showed:

Gene expression pathways related to Interferon (IFN) signalling, response to virus and dsRNA binding were enriched in patients with longer duration of STC-15 treatment
Tumor regressions were achieved at all dose levels, 60 mg – 200 mg three times a week (TIW), with three sustained Partial Responses (PRs) at 60 mg, 100 mg, and 200 mg TIW in multiple tumor types
Treatment emergent adverse events, including target-related AE’s (e.g. platelet reductions, rash, pruritis) were mainly mild, transient and well managed with supportive care and were not treatment limiting
No maximum tolerated dose established up to 200 mg TIW
Evidence of M1 macrophages in the TME, consistent with preclinical data
Robust METTL3 target engagement indicated by rapid and long-lasting m6A inhibition
Kyriakos P. Papadopoulos, Co-Director of Clinical Research at START San Antonio, principal investigator for the STC-15 Phase 1 study and lead author of the SITC (Free SITC Whitepaper) presentation, said: "The ability to activate the innate immune system while maintaining tolerability and efficacy is what is truly unique about STC-15. STC-15 targets METTL3, initiating a novel immunologic mechanism that demonstrates remarkable safety for an immuno-oncology drug. The early efficacy and safety data in the advanced cancer setting supports further clinical development in Phase 2, in multiple tumor types."

Jerry McMahon, Chief Executive Officer at STORM Therapeutics, said: "STC-15 is first in its class – first to target METTL3, and first to target a RNA methyltransferase. We are pleased to report encouraging signs of clinical activity and corresponding upregulation of the gene pathways associated with the METTL3 mechanism of action. We look forward to developing and progressing our product into a Phase 2 study following these positive results."