On September 20, 2024 CD (Suzhou) Biopharma reported to have received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application of CD-001, entering a Phase I first-in-human trial (Press release, CD Biopharma, SEP 20, 2024, View Source [SID1234646775]).

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CD-001, the company’s leading clinical candidate, is built on its proprietary Bispecific Fusion Protein (BsFP) platform. This potential therapy, designed to target PD-1 positive CD8+ T cells using an anti-PD-1 antibody and engineered IL-21 mutant, aims to address unmet medical needs in oncology and viral infections.

"The FDA’s clearance of this IND reinforces our unwavering commitment to advancing groundbreaking immunotherapies." said Dr. Jian Xu, CEO of CD Biopharma. "CD-001 shows promise as a first-in-class and best-in-class treatment, and preclinical studies have demonstrated its effectiveness in various mouse tumor models, with excellent tolerance observed in non-human primates. We are excited to move forward with patient enrollment and expect initial clinical data in the upcoming months."

On September 20, 2024 AbbVie (NYSE: ABBV) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine (ELAHERE) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatment regimens (Press release, AbbVie, SEP 20, 2024, View Source [SID1234646774]). Patients with ovarian cancer are often diagnosed with late-stage disease, undergo surgery and are then primarily treated with platinum-based chemotherapy. Over time patients may become resistant to platinum-based treatment and will require another therapy. The CHMP’s opinion is supported by results of the Phase 3 MIRASOL clinical trial and the European Commission decision on this indication for mirvetuximab soravtansine is anticipated later this year.

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"Following many years of development by the ImmunoGen team that is now part of AbbVie, we are hopeful to make mirvetuximab soravtansine available to eligible patients with ovarian cancer in the European Union. This positive opinion recognizes the unmet need for certain patients with platinum-resistant ovarian cancer," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie.

ELAHERE (mirvetuximab soravtansine-gynx) was granted full FDA approval in the United States in March 2024. Marketing authorization submissions for mirvetuximab soravtansine are under review in multiple other countries.

ABOUT THE PHASE 3 MIRASOL TRIAL
MIRASOL is a global Phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine with the investigator’s choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum-resistant, high-grade serous ovarian cancer whose tumors express high levels of FRα (≥75% of cells with ≥2+ staining intensity). Participants had previously received one to three lines of prior therapy. The primary endpoint was investigator-assessed progression-free survival (PFS). Key secondary endpoints included objective response rate (ORR) and overall survival (OS).

Results of the study were previously shared in June 2023. More information can be found on www.clinicaltrials.gov (NCT 04209855).

About Ovarian Cancer
Ovarian cancer is one of the leading causes of death from gynecological cancers. According to the World Ovarian Cancer Coalition, in 2022 more than 320,000 women worldwide were diagnosed with ovarian cancer. By 2050 the annual incidence will have risen to nearly half a million, an increase of 55 percent. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with decreased efficacy and tolerability.

About Mirvetuximab Soravtansine
Mirvetuximab soravtansine is a first-in-class ADC comprising a folate receptor-alpha binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

Mirvetuximab soravtansine is not approved in the EU.

ELAHERE (mirvetuximab soravtansine-gynx) U.S. INDICATION and IMPORTANT SAFETY INFORMATION
ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

IMPORTANT SAFETY INFORMATION
WARNING: OCULAR TOXICITY

ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated.
Administer prophylactic artificial tears and ophthalmic topical steroids.
Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
Discontinue ELAHERE for Grade 4 ocular toxicities.
WARNINGS and PRECAUTIONS
Ocular Disorders
ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 59% of patients with ovarian cancer treated with ELAHERE. Eleven percent (11%) of patients experienced Grade 3 ocular adverse reactions, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; two patients (0.3%) experienced Grade 4 events (keratopathy and cataract). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%).

The median time to onset for first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced ocular events, 53% had complete resolution; 38% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of ELAHERE in 1% of patients.

Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions.

Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE.

Pneumonitis occurred in 10% of patients treated with ELAHERE, including 1% with Grade 3 events and 1 patient (0.1%) with a Grade 4 event. One patient (0.1%) died due to respiratory failure in the setting of pneumonitis and lung metastases. One patient (0.1%) died due to respiratory failure of unknown etiology. Pneumonitis led to permanent discontinuation of ELAHERE in 3% of patients.

Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)
Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 3% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (1%), peripheral motor neuropathy (0.9%), polyneuropathy (0.3%), and peripheral sensorimotor neuropathy (0.1%). Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

Embryo-Fetal Toxicity
Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose.

ADVERSE REACTIONS
The most common (≥20 %) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils.

DRUG INTERACTIONS
DM4 is a CYP3A4 substrate. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation
Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose.

Hepatic Impairment
Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

On September 20, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported the publication of the Phase 3 SIERRA results of Iomab-B in the peer-reviewed Journal of Clinical Oncology (JCO) (Press release, Actinium Pharmaceuticals, SEP 20, 2024, View Source [SID1234646772]). The article, titled, "Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation vs Conventional Care for Relapsed/Refractory Acute Myeloid Leukemia" and is available online on the ASCO (Free ASCO Whitepaper) Journal of Clinical Oncology website HERE.

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The Phase 3 SIERRA (Study of Iomab-B in Elderly Relapsed Refractory AML) trial was a randomized, multi-center, controlled trial that enrolled 153 patients aged 55 and above with active relapsed or refractory Acute Myeloid Leukemia (r/r AML), including heavily pre-treated patients and those with high-risk characteristics such as a TP53 mutation. The SIERRA trial compared outcomes of patients receiving Iomab-B (Iodine-131-apamistamab) and a bone marrow transplant (BMT) to physician’s choice of salvage chemotherapy and standard allogeneic BMT in the control arm.

The SIERRA trial met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission after BMT with high statistical significance (p-value of <0.0001) with 22% of patients (13/76) achieving dCR in the Iomab-B arm compared to 0% of patients (0/77) in the control arm. A significant improvement in Event Free Survival (EFS), a secondary endpoint of the SIERRA trial with a Hazard Ratio = 0.22 (p-value <0.0001) was also achieved. SIERRA did not meet the secondary endpoint of overall survival (OS) on an intent to treat basis analysis due to the high crossover rate with nearly 60% of control arm patients receiving Iomab-B followed by a BMT.

The Phase 3 SIERRA results were first presented in a late-breaker presentation at the Transplantation & Cellular Therapy (TCT) Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) in February 2023. Since TCT, the results of the SIERRA trial have been presented in several oral presentations at leading BMT, hematology, nuclear medicine and nursing meetings and congresses in the U.S. and EU. Supplemental analyses of the SIERRA results have shown improved survival outcomes in patients with a TP53 mutation, which is associated with poor outcomes, as well as increased 1-and 2-year overall survival in patients aged 65 and above.

Dr. Sergio Giralt, Deputy Division Head, Division of Hematological Malignancies and Attending Physician, Adult BMT Service at the Memorial Sloan Kettering Cancer Center, and leading SIERRA Trial investigator and corresponding author, said, "The SIERRA trial was important for the field of transplant and demonstrated for the first time in a randomized study that the CD45 antibody-radioconjugate Iomab-B can provide patients with improved access to a potentially curative hematopoietic stem cell transplant, and improved outcomes compared to current chemotherapy-based regimens. Importantly, Iomab-B demonstrated a statistically significant improvement in key efficacy endpoints including durable Complete Remission and event-free survival. The SIERRA trial was conducted as multiple new therapies gained approval and was designed to address the nuances and difficulty of treating this patient population including allowing physician’s choice of care in the control arm given the heterogeneity of treatment across institutions and the crossover design to provide best patient care. Despite multiple drug approvals for patients with AML, there remains no curative options for older patients with relapsed or refractory disease and outcomes for these patients also remain dismal. My fellow investigators and I are disappointed that the SIERRA trial will not support the approval of Iomab-B despite the positive results and significant unmet medical need of this patient population. However, there is continued significant interest from the transplant community to participate in the upcoming phase 3 study with Iomab-B to provide patients access to this important drug candidate."

On August 05, 2024, Actinium announced that after concluding both its clinical and Chemistry, Manufacturing and Controls ("CMC") interactions with the FDA regarding the BLA pathway for Iomab-B, the FDA determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing, and the SIERRA trial alone will not be adequate for BLA filing.

Sandesh Seth, Actinium’s Chairman and CEO, stated, "We are excited that the SIERRA results have been published in the peer-reviewed Journal of Clinical Oncology. We believe the SIERRA trial was a major advancement for the field of BMT and targeted radiotherapeutics but most importantly for patients with relapsed and refractory AML. We look forward to completing our interactions with the FDA to finalize the specifics of the additional Phase 3 randomized trial and working to secure a U.S. partner for Iomab-B. In doing so, we hope to accelerate Iomab-B reaching patients with high unmet need that can benefit from a bone marrow transplant."

On September 20, 2024 Biosyngen, an innovative biotechnology company specializing in immune cell therapies, reported its groundbreaking technology on gene-modified, functionally enhanced tumor-infiltrating lymphocytes (TILs) derived from liver cancer biopsy samples (Press release, BioSyngen, SEP 20, 2024, View Source [SID1234646771]).

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BioSyngen has secured ten clinical trial approvals in China and the U.S. for its innovative fourth-generation oncology therapies. Currently, our leading pipeline product, BRG01, is in the pivotal Phase II clinical trial stage for solid tumors. Additionally, the first patients have been enrolled in the Phase I trials for our other groundbreaking therapies, BST02 and BRL03, with completion of Phase I trials anticipated later this year.

Abstract Title

Pre-clinical Development of Genetically Modified Tumor-infiltrating Lymphocytes using Biopsy Samples from Liver Cancer Patients

Abstract No.

1034P

Tumor-infiltrating lymphocytes (TILs) are heterogeneous lymphocyte populations within the tumor microenvironment that contains T cells capable of recognizing tumor- or virus-associated antigens. In February of this year, the FDA approved the first TIL-based therapy used with IL-2 for advanced metastatic/recurrent melanoma. However, due to the variability in T cell infiltration between hot and cold tumors, differential abundance of antigen-specific T cells with robust immune response functionality, and the dependence of TIL anti-tumor efficacy on concomitant use of high-dose IL-2 combination therapy, the therapeutic applications of non-edited TILs are quite limited outside of melanoma.

To address these challenges, Biosyngen has developed a proprietary platform for expanding TILs from biopsy samples, achieving production of 1011 cells within four weeks. Additionally, the company has established a stable gene modification platform that reprograms TIL metabolism, enhances TIL activity and sustained antitumor efficacy by expressing membrane anchor proteins. Anti-tumor efficacy has significantly enhanced (without IL-2 co-injection) and no obvious toxicity observed.

Biosyngen houses best-in-class proprietary TIL platform aiming to expand the clinical applications of TIL technology with following features:

Efficient Automated TILs Manufacturing System: Pioneering the use of tumor biopsy samples for TIL preparation with the ability to cryopreserve both tumor tissue and final products, overcoming logistical constraints.
Effective In Vitro Gene-engineering System: Employs viral vector technology for stable gene modification, maintaining high gene expression efficiency in TILs.
Enhanced In Vivo Expansion and Persistence: Increased proportion of central memory T cells (TCM) in the final product, leading to prolonged persistence.
Powerful Antitumor Efficacy: Demonstrates strong tumor-killing effects without the need for concomitant use of IL-2.

On September 20, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported an increase to its previously announced non-brokered private placement offering of units of the Company ("Units") at a price of $0.05 per Unit (the "Private Placement") (Press release, BioVaxys Technology, SEP 20, 2024, View Source [SID1234646770]). Each Unit consists of one common share (a "Common Share") and one whole Common Share purchase warrant (a "Warrant"), whereby each Warrant is exercisable for one additional Common Share at an exercise price of $0.15 for a period of 24 months from the date of issue. The Private Placement initially comprised a maximum of 10,000,000 Units (see news release dated July 23, 2024) for total gross proceeds of $500,000 and was later upsized to a maximum of 20,000,000 Units (see news release dated July 26, 2024) for total gross proceeds of $1,000,000. The Company has now further increased the size of the Private Placement to up to 30,000,000 Units for total gross proceeds of up to $1,500,000.

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To date, the Company has issued an aggregate of 17,312,340 Units in connection with the Private Placement.

Closing of the Private Placement is subject to receipt of all necessary regulatory and other approvals. All securities to be issued pursuant to the Private Placement will be subject to a statutory hold period of four months from the date of issuance in accordance with applicable securities legislation.

The Company intends to use the net proceeds of the Private Placement for general working capital purposes, including enabling the Company to fund and advance its business plans in regard to its successful recent acquisition of the entire portfolio of discovery, preclinical, and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., which was purchased from IMV USA ("IMV") on February 16, 2024. The Company may pay finder’s fees in connection with the Private Placement.

In addition, the Company announces that it has entered into a debt settlement agreement with a consultant of the Company, to settle an aggregate of $76,625 in debt owed to the consultant by issuing 1,532,500 Common Shares at a deemed price of $0.05 per Common Share (the "Debt Settlement"). The board of directors of the Company has determined that it is in the best interests of the Company to settle the outstanding debt through the issuance of Common Shares in order to preserve the Company’s cash for working capital purposes.

All securities proposed to be issued in connection with the Debt Settlement will also be subject to a statutory hold period of four months from the date of issuance in accordance with applicable securities legislation. Closing of the Debt Settlement is conditional upon a number of conditions, including receipt of all applicable regulatory approvals.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom. This release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States.