On October 24, 2024, Genprex, Inc. ("Genprex" or the "Company") reported that the Company has entered into a Sponsored Research Agreement ("SRA") with the University of Michigan Rogel Cancer Center to study TUSC2, the tumor suppressor gene used in Genprex’s lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), in combination with ALK-inhibitors in ALK-EML4 positive translocated lung cancer (Press release, Genprex, OCT 24, 2024, View Source [SID1234647366]). The Company also announced its collaboration with ALK Positive, a non-profit patient-driven research organization dedicated to improving the life expectancy and quality of life for ALK-positive (ALK+) lung cancer patients. As a part of this collaboration, both Genprex and ALK Positive will share the cost of the SRA with the University of Michigan Rogel Cancer Center.

The Company noted in its press release that as the Company further expands its research program to new tumor targets, REQORSA in combination with ALK-inhibitors could be a potential therapeutic treatment for ALK+ lung cancer. TUSC2 is a tumor suppressor gene that is frequently deleted in lung cancer. Research collaborators at the Rogel Cancer Center’s Judith Tam ALK Lung Cancer Research Initiative presented positive preclinical data at the April 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, reporting that REQORSA induced apoptosis in alectinib resistant EML4-ALK positive non-small cell lung cancer ("NSCLC") cell lines. Alectinib is an ALK-inhibitor commonly used to treat patients with ALK rearrangements such as EML4-ALK positive NSCLCs. Researchers found that overexpressing TUSC2 using REQORSA treatment in ALK+ lung cancer cell lines inhibited the ability of the cells to form colonies. Ultimately, the study found that the use of REQORSA or a TUSC2-containing plasmid to overexpress TUSC2 in ALK+ NSCLC cell lines was effective in decreasing cell growth and proliferation through the activation of apoptotic pathways. Researchers believe the results of this preclinical work support further clinical study of REQORSA as an anti-ALK NSCLC treatment strategy, and Genprex believes this research suggests that REQORSA may be an effective treatment in patients progressing on alectinib.

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On October 24, 2024, Erasca, Inc. (the Company) reported preliminary data from its SEACRAFT-1 Phase 1b trial in an oral presentation at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium (Press release, Erasca, OCT 24, 2024, View Source [SID1234647365]).

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In the Phase 1b trial of naporafenib plus trametinib (MEKINIST) in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations, the preliminary clinical activity of naporafenib plus trametinib in the melanoma cohort include, as of the efficacy cutoff date*:

•
40% (4/10) response rate observed in the efficacy-evaluable patients with NRAS Q61X melanoma, including three confirmed partial responses and one unconfirmed partial response; the melanoma cohort in SEACRAFT-1 is generally representative of the patient population currently being enrolled in the pivotal SEACRAFT-2 trial
•
70% (7/10) of patients remained on treatment as of the data cutoff, including all four responders

*Safety data cutoff date was September 3, 2024. Efficacy data cutoff date was September 5, 2024.

Naporafenib plus trametinib has been generally well tolerated as of the safety cutoff date, with mostly low-grade adverse events in the majority of patients. The Company believes that the use of mandatory primary rash prophylaxis helped reduce the frequency and severity of skin toxicities, reduced drug discontinuation rate due to adverse events, and improved the observed tolerability as measured by the increased relative dose intensity, as compared to the prior clinical trials of naporafenib plus trametinib conducted by Novartis, which did not include the use of mandatory primary rash prophylaxis.

The Company believes that the preliminary SEACRAFT-1 data reinforce the potential of the ongoing Phase 3 SEACRAFT-2 trial in patients with NRAS-mutant (NRASm) melanoma. The Company expects to read out randomized dose optimization data from Stage 1 of the SEACRAFT-2 Phase 3 trial in 2025.

On October 24, 2024 Epitopea, a transatlantic cancer immunotherapeutics company developing accessible off-the-shelf RNA-based immunotherapies, reported the closing of a USD $31 million pre-Series A financing (Press release, Epitopea, OCT 24, 2024, View Source [SID1234647364]).

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The pre-Series A financing brings the total capital raised by Epitopea to over USD $45 million. New investors Investissement Québec, adMare BioInnovations and Jonathan Milner join existing investors Advent Life Sciences, CTI Life Sciences, Cambridge Innovation Capital, Fonds de Solidarité FTQ, the Harrington Discovery Institute, IRICoR and Novateur Ventures, all of whom also participated in this financing round.

Dr. Alan C. Rigby, Epitopea’s CEO, said,

"We believe that more durable cancer therapies are needed to transform the lives of cancer patients diagnosed with hard-to-treat solid tumors where overall survival is still poor for most patients. We continue to make significant strides toward the clinic, which has strengthened investor enthusiasm, and resulted in an over-subscribed pre-Series A in support of our forward-looking mission and vision. This additional financing will support strategic pre-clinical discovery in solid tumors of interest while accelerating our near-term clinical development plans for Epitopea’s next generation, tumor selective, off-the-shelf, RNA-based immunotherapies that we believe have the potential to extend the durability of clinical response in patients."

"In this round we would like to warmly welcome new investors Investissement Québec, adMare BioInnovations and Jonathan Milner, whose participation complements the continued passionate support of our existing transatlantic investor syndicate. This pre-Series A raise provides the necessary finances to accelerate our development campaigns and transition to a clinical-stage company with a focused commitment of delivering our transformational RNA cancer immunotherapy into the clinic in 2026".

Satish Jindal, Ph.D., General Partner with Advent Life Sciences added,

"As a founding investor of Epitopea, we are pleased to continue our robust support of the company as it makes major strides in exploiting its proprietary CryptoMapTM platform to identify novel targets that can serve as the basis for the development of a range of ground-breaking cancer immunotherapies. Through our investment in this exciting and growing company, we look forward to Epitopea advancing a first off-the-shelf RNA cancer immunotherapy into the clinic, which could bring significant improvements to cancer patients’ quality and duration of life."

"adMare is thrilled to invest in Epitopea and support the development of their highly differentiated RNA therapeutic platform. Epitopea’s innovative approach to cancer treatment aligns with our mission to drive scientific progress and bring transformative therapies to patients. We look forward supporting the growth of this promising company,"

said Frédéric Lemaître Auger, Vice President Investments at adMare BioInnovations.

"Alongside other key players in the financial ecosystem, Investissement Québec is proud to participate in this round of funding designed to accelerate preclinical stages and research into cancer immunotherapies. Our support will not only promote the development of homegrown expertise in Québec, but also help drive the growth of a promising young Montréal business at the heart of the strategic life-sciences sector".

said Bicha Ngo, President and CEO, Investissement Québec.

On October 24, 2024 Circio Holding ASA (OSE: CRNA), a biotechnology company developing next generation circular RNA vector technology for gene therapy, reported the publication of new, strong and statistically significant circVec circular RNA in vivo expression proof-of-concept data, presented both in the form of a poster and oral presentation by CTO, Dr. Thomas B Hansen, at the European Society of Cell and Gene Therapy (ESGCT) annual meeting 2024 (Press release, Circio, OCT 24, 2024, View Source [SID1234647363]).

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"Circio continues to build momentum with the unique and powerful circVec platform. We selected the prestigious ESGCT meeting to present our latest results as it provided a great opportunity to showcase our technology to a broad life science industry and academic audience," said Dr. Thomas B. Hansen, CTO of Circio. "circVec significantly outperforms mRNA-based expression both in vitro and in vivo and has the potential to offer substantial enhancement over current gold-standard gene therapy approaches."

In the ESGCT presentation, Circio showed the evolution and improvements of the circVec platform from the initial circVec 1.0 design to the current generation 2.1. Long-term in vivo experiments have now demonstrated that circVec 2.1 robustly outperforms classical mRNA-based expression over time, offering enhanced durability that reaches up to 15-fold higher reporter signals in mouse models. Additionally, a machine-learning approach to codon optimization has generated a novel circVec 2.2 design, delivering a further 2-4-fold increase in protein yield.

Circio is currently testing the performance of circVec 2.1 and 2.2 in both viral and DNA vector systems in multiple tissues and disease settings in vivo. These data will guide future development and partnering strategy for the circVec platform.

The ESGCT slides and poster are attached hereto, and will also be made available on www.circio.com

Title of presentation and poster:

Optimization of in vitro and in vivo performance of circVec, a vector-based circular RNA expression platform for enhanced gene therapy

Presenter: Dr. Thomas B Hansen, CTO

On October 24, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the results of non-clinical research on SAIL66, a Chugai’s in-house project under Phase I clinical development for CLDN6 positive solid tumors, have been published in the Journal for ImmunoTherapy of Cancer (Press release, Chugai, OCT 24, 2024, View Source [SID1234647362]). The journal is a renowned academic journal in the field of cancer immunotherapy, published by the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in the United States.

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"SAIL66, a next generation CLDN6-targeting T-cell engager, demonstrates potent antitumor efficacy through dual binding to CD3/CD137"
(View Source)

The following findings were demonstrated in this research, which suggest that SAIL66 may be useful as a treatment for CLDN6 positive solid tumors.

Creation of SAIL66, which is a novel tri-specific T-cell engager* (TCE) for Claudin-6 (CLDN6), CD3, and CD137, applying Dual-Ig technology, Chugai’s proprietary antibody engineering technology
*T-cell engager: A therapeutic agent that exerts anti-tumor effects by bringing T cells, which are immune cells, closer to tumor cells

SAIL66 binds to CLDN6, which is specifically expressed on tumor tissue, and does not bind to other CLDN family proteins (CLDN3, 4, or 9) with similar amino sequences

in vitro, SAIL66 was shown to strongly activate T cells and exert cancer cell cytotoxicity by not only triggering CD3 signaling like conventional TCEs, but also by providing CD137 co-stimulation

In experiments using mice, SAIL66 was shown to increase intratumor T-cells and decrease the number of exhausted T cells, leading to enhanced antitumor efficacy compared to conventional TCEs

About SAIL66
SAIL66 is an anti-CLDN6/CD3/CD137 trispecific antibody and one of the next-generation T-cell engagers (TCEs) applying Chugai’s proprietary Dual-Ig technology. Conventional TCEs are designed to guide T cells to the target cancer cells by activating and engaging T cells through its binding to CD3 on T cells. Dual-Ig technology is a novel technology providing antibodies with the ability to induce CD137 signaling, a co-stimulating molecule, in addition to CD3 signaling. This property enables to maintain T cell activity, potentially inducing more potent antitumor effects than conventional T-cell engagers.