On September 8, 2023 Novocure (NASDAQ: NVCR) reported its participation in the upcoming International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) from September 9 – 13, 2023 in Singapore (Press release, NovoCure, SEP 8, 2023, View Source [SID1234635037]). Novocure will take part in presentations and symposia throughout the event and will exhibit several posters exploring the use of Tumor Treating Fields (TTFields) therapy in the treatment of lung cancer, including a new post-hoc analysis of data from its LUNAR trial in metastatic non-small cell lung cancer.

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The LUNAR trial was designed to evaluate the use of TTFields therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer, following progression on or after platinum-based therapy. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful extension in overall survival (OS) for patients treated with TTFields and standard systemic therapies, as well as a pronounced extension in OS for patients randomized to receive physician’s choice immune checkpoint inhibitor (ICI) together with TTFields.

In a new post-hoc analysis of data from the LUNAR trial, researchers reviewed survival patterns of patients with known Tumor Proportion Scores (TPS) randomized to receive ICI together with or without TTFields. Among patients with TPS >1%, median OS for patients treated with TTFields therapy and ICI (n=22) was 23.6 months compared to 10.5 months for patients treated with ICI alone (n=26; HR: 0.49, P=0.045).

Further analysis shows evidence of a relationship between increasing PD-L1 expression and improved survival outcomes. In patients with TPS 1–49%, median OS was 19.0 months for patients treated with TTFields therapy and ICI (n=17), compared to 9.7 months for patients treated with ICI alone (n=18; HR: 0.55, P=0.14). In patients with TPS >50%, median OS was not reached for patients treated with TTFields therapy and ICI (n=5) compared to 30.0 months for patients treated with ICI alone (n=8; HR: 0.17, P=0.07).

These data will be presented on September 12, 2023 at 2:30 p.m. UTC+8 by primary investigator Ticiana Leal, M.D., a researcher and medical oncologist at Winship Cancer Institute of Emory University and associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta.

"This analysis further elucidates the promising results from the LUNAR trial and the potential benefit of utilizing TTFields therapy for the treatment of metastatic non-small cell lung cancer," Dr. Leal said. "I look forward to sharing these data with the global thoracic oncology community and continuing to analyze the data from this impactful study."

Novocure’s presence at the 2023 WCLC will also include:

An Industry Sponsored Symposium: A Spotlight on Tumor Treating Fields in Thoracic Oncology, on September 10 at 6:30 p.m. UTC+8
A poster displayed in the Exhibit Hall on September 10 from 5:30-7:30 p.m. UTC+8: P1.12-10 – Sensitization of Cancer Cells to Tumor Treating Fields (TTFields) via Inhibition of the PI3K/AKT Signaling Pathway
Three ePosters on demand:
EP02.02-02 – Transcriptomic Response to Tumor Treating Fields (TTFields) Across Tumor Types
EP09.02-06 – Long-term Efficacy of Tumor Treating Fields (TTFields 150 kHz) in metastatic NSCLC: A Case Report
EP17.03-02 – Utilities Used in HTAs in mNSCLC Following Progression on or After Platinum-Based Chemotherapy
In addition, Novocure is partnering with the IASLC, host of the WCLC, to provide research opportunities to investigators worldwide who are conducting innovative research on TTFields in the treatment of non-small cell lung cancer and other thoracic malignancies. These grants offer $100,000 to fund projects to be completed in a two-year timeframe.

"We are honored to partner with the IASLC in their mission to study and eradicate lung cancer and other thoracic malignancies," said Moshe Giladi, Ph.D., Novocure’s Chief Science Officer. "We look forward to supporting researchers and together expanding understanding of how TTFields therapy can be beneficial in the treatment of these diseases."

To learn more about these grants, please visit View Source application deadline is noon MDT on October 9, 2023.

About LUNAR

LUNAR was a phase 3 trial testing the safety and effectiveness of TTFields therapy when used together with ICI or docetaxel versus ICI or docetaxel alone for patients with metastatic NSCLC who progressed during or after platinum-based therapy. The trial met its primary endpoint, exhibiting a statistically significant and clinically meaningful improvement in median OS when TTFields therapy was added to standard therapies. Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139; HR: 0.74, P=0.035).

The trial also demonstrated a statistically significant and clinically meaningful improvement in median OS when TTFields therapy was added to ICI. Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with ICIs alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.

TTFields therapy is intended principally for use with other concomitant standard therapies, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful.

About NSCLC

Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, docetaxel, immune checkpoint inhibitors or pemetrexed. It is estimated that approximately 46,000 patients receive second-line treatment for metastatic NSCLC each year in the U.S.

On September 8, 2023 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) reported that the Company has received additional guidance from the U.S. Food and Drug Administration (FDA) regarding the planned resubmission of the Company’s Biologics License Application (BLA) for LYMPHIR (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy (Press release, Citius Pharmaceuticals, SEP 8, 2023, View Source [SID1234635036]).

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The FDA has agreed with the Company’s plans to address the requirements outlined in the complete response letter (CRL) received July 28, 2023. The guidance from the FDA provides Citius with a path for completing the necessary activities to support the resubmission of the Company’s Biologics License Application (BLA) for denileukin diftitox. No additional clinical efficacy or safety trials have been requested by FDA for the resubmission.

"We are encouraged by the constructive engagement with the FDA," stated Leonard Mazur, Chairman and CEO of Citius. "Based on the clear feedback from the FDA, Citius plans to complete the CRL remediation activities by the end of the year and file the resubmission in early 2024. We do not expect these efforts will impact our cash runway."

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. In 2011 and 2013, the FDA granted orphan drug designation to LYMPHIR for the treatment of PTCL and CTCL, respectively. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Subsequently in 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

On September 8, 2023 Grit Biotechnology reported the completion of a Series B financing round, raising over 60 million USD (Press release, Grit Bio, SEP 8, 2023, View Source [SID1234635035]). The investment was led by CICC with participation from Qianhai Ark, Liando Group, Yuanhe Capital, HeFangTian Venture Partnership and existing investors Sherpa Healthcare Partners, Decheng Capital and Matrix Partners China.

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The financing will support Grit Biotechnology’s Tumor-Infiltrating Lymphocyte (TIL) pipeline development, including the pivotal Phase II trial for GT101 and the advancement of next-gen gene-edited TIL products. Founded in 2019, Grit Biotechnology is a pioneering cell therapy company focused on delivering transformative cancer treatments. GT101 is currently the fastest-developing TIL therapy in China and will enter a Phase II trial by the end of 2023.

Grit Bio has four core technology platforms central to its TIL development: StemTexp, StaViral, KOReTIL and ImmuT Finder, a genome-wide CRISPR/Cas9 screening platform. These platforms have enabled the development of next-generation gene-edited TIL products.

GT201, a genetically engineered TIL product by Grit Biotechnology, boosts T cell survival and function by expressing a vital membrane-bound cytokine. It surpasses traditional TIL therapies in proliferation, tumor-killing and persistence with reduced reliance on IL-2. GT201 IND is approved by CFDA and entered Phase I clinical trials.

GT316, Grit Biotechnology’s next-gen TIL product, enhances TIL performance through knock-out of immunoregulatory targets identified via ImmuT Finder CRISPR/Cas9 screening. In PDX mouse models, GT316 effectively eliminates tumors supported by low-dose IL-2 support with minimal toxicity. It offers substantial clinical benefits compared to conventional TIL products and is currently in IIT clinical trials in China.

With 100+ experienced professionals and a 10,000 sqm GMP-level cell therapy manufacturing facility in Suzhou, China, Grit Bio is a leading player in cell therapy field in China aimed at expediting the development of GT101 and next-generation TIL pipelines and addressing the unmet medical needs of solid tumor patients.

On September 8, 2023 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, and WuXi XDC, a leading global CRDMO, reported that they have signed a LOI for long-term strategic collaboration on Mabwell’s multiple ADC projects (Press release, Mabwell Biotech, SEP 8, 2023, View Source [SID1234635034]).

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Mabwell has had multiple innovative products in clinical studies or preclinical research by their world-leading ADC technology platforms and CMC development capabilities. WuXi XDC will make further efforts to accelerate global layout of Mabwell’s R&D and commercialization, cost reduction and R&D efficiency improvement by their leading antibody-drug conjugate production technology platform and integration capabilities.

On September 8, 2023 ProMIS Neurosciences Inc. (Nasdaq: PMN) ("ProMIS" or the "Company"), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), reported that it closed its previously announced private investment in public equity ("PIPE") financing, for the issuance and sale of common share units, each consisting of one of the Company’s common shares (the "Common Shares") and one warrant to purchase one Common Share (the "Warrants") (the "Common Share Units") and pre-funded units, each consisting of one pre-funded warrant to purchase one Common Share and one Warrant (Press release, ProMIS Neurosciences, SEP 8, 2023, View Source [SID1234635033]). The Common Share Units were sold at a price of $1.88 per unit and the Pre-Funded Warrants were sold at a price of $1.87 per unit for gross proceeds of approximately $20.4 million, before deducting fees to the placement agents and other offering expenses payable by the Company.

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Proceeds from the PIPE financing will be used to advance the clinical development of PMN310, ProMIS’ lead therapeutic candidate, as well as for working capital and other general corporate expenses.

BTIG, LLC acted as the placement agent for this offering.

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. ProMIS Neurosciences has agreed to file a registration statement with the SEC registering the resale of the Common Shares and the Common Shares issuable upon the exercise of the Pre-Funded Warrants and Warrants issued in the PIPE financing.

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