On February 28, 2023 Voltron Therapeutics, Inc, a Lucius Partners portfolio company, reported that it has signed a new Sponsored Research Agreement (SRA) with the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH), Harvard Medical School to initiate a pre-clinical immuno-oncology trial targeting prostate stem cell antigen (PSCA) in prostate, renal cell and urothelial cancers, adding important potential indications to its growing pipeline (Press release, Voltron Therapeutics, FEB 28, 2023, View Source [SID1234627939]).

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James Ahern, Director at Voltron Therapeutics, has announced that the biotechnology company recently generated robust and compelling data in two pre-clinical trials for human papillomavirus (HPV)-related cancers sponsored at MGH. The Self-Assembling Vaccine (SAV) targeting HPV demonstrated a positive and highly statistically significant survival improvement in a dose-related manner. This new pre-clinical program will leverage that important work and expand the Company’s potential pipeline into additional types of antigens and cancers.

Pat Gallagher, Voltron’s Chief Executive Officer, commented, "In our HPV-related cancer proof of concept trial, Voltron’s SAV demonstrated highly statistically significant increases in survival driven by reduced tumor growth as well as increased tumor infiltration by beneficial immune cells (e.g., CD8+ T cells) using two HPV targeting immunogenic peptides. By using a full protein in our PSCA trials to target cancers of interest instead of specific peptides, we hope to demonstrate unparalleled platform flexibility that would allow us to use full protein sequences to target tumors or viruses of interest. This affords broader targeting in heterogeneous immune systems and could, in theory, allow our vaccine to induce an immune response to any specific tumor antigen of interest."

Relative to other vaccine approaches, the SAV shows key advantages. It only requires two elements for all vaccines; it has not shown potential to date for off-target immune activation; it has no risks inherent with viral vectors; it does not require special synthetic processes, storage or a complex cold chain like mRNA vaccines.

Dr. Mark Poznansky, Director, Vaccine and Immunotherapy Center, MGH, commented: "This new and important industry sponsored study explores a broader acting therapeutic approach by exploiting the diverse immunologic functions of the SAV platform to enhance the targeting capabilities of immunogenic epitopes from full proteins. We will explore whether Voltron’s SAV platform is capable of presenting the tumor antigen, in this case PSCA, to multiple types of antigen-presenting cells and thereby facilitate epitope presentation to both MHC class I and class II in the context of immune stimulation."

James Ahern, who is also Managing Partner of Laidlaw & Company (UK) and Founder of Lucius Partners, stated, "The team continues to identify additional programs for Voltron, driven by their expertise and disciplined process. We will pursue indications in both oncology and infectious disease that leverage our highly flexible vaccine platform to create new solutions for clinicians and patients. We remain focused on de-risking our programs and to provide value to our shareholders."

On February 28, 2023 Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, reported that its IND application of its self-developed 9MW3811 injection for tumor and pulmonary fibrosis has been approved by the Therapeutic Goods Administration (TGA) in Australia (Press release, Mabwell Biotech, FEB 28, 2023, View Source [SID1234627938]). 9MW3811 is the first IL-11 targeting monoclonal antibody approved to clinical study at present.

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9MW3811 is an innovative humanized monoclonal antibody against IL-11, which can bind IL-11 through high affinity and effectively block the activation of IL-11 downstream signal pathway being developed for fibrosis and oncology.

9MW3811 is first IL-11-targeting monoclonal antibody and first non recombinant protein drug candidate targeting IL-11 approved to clinical study as well.

On February 28, 2023 Oricell Therapeutics Co., Ltd ("Oricell" or "the Company"), a China-based innovative pharmaceutical company committed to the development of tumor cellular immunotherapeutics, reported the close of a $45M Series B1 investment round after the completion of a $125M Series B fund-raise in July 2022 (Press release, OriCell Therapeutics, FEB 28, 2023, View Source [SID1234627937]). The round was led by premier global industry investors RTW Investments, LP ("RTW") and Qatar Investment Authority ("QIA"), with participation from existing investors, including Qiming Venture Partners and C&D Emerging Industry Equity Investment. The new injection of capital will be utilized primarily to support the company’s core product clinical development in the U.S.

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Oricell Chairman and CEO Helen Yang said, "We are thrilled with the momentum our team has built over the last several months and look forward to using this funding to further expand our platform and research. This round reflects our investors’ recognition of Oricell’s ongoing growth and the development of our robust pipeline of ground-breaking therapeutics. We look forward to continuing to help improving the lives of patients in need."

Over the past year, Oricell’s cell therapy pipeline and drug discovery platform have seen tremendous growth. Since the debut of Oricell’s first key product Ori-C101 at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, the Company has been overcoming many difficulties and made unremitting efforts to achieve all the expected milestones, to attract widespread attention among investors worldwide with its increased presence in the global new drug market during 2022 and into 2023. The Company launched its red-chip restructuring in the fourth quarter of last year in parallel with series B round of financing. Ori-C101 received IND clearance from NMPA in September 2022. At 2022 ASCO (Free ASCO Whitepaper) annual meeting and European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") 2022 congress, Oricell presented the clinical research data of its proprietary CAR-T cell therapy targeting GPRC5D (OriCAR-017) for the treatment of Relapsed/Refractory Multiple Myeloma ("RRMM"). The oral presentation was very well received; subsequently, the product was granted an orphan drug designation by US FDA. Its follow-up data was published in Lancet Haematology on January 31 2023.

With this new funding, the Company is now well-positioned to expand its products to the U.S., specifically OriCAR-017, a GPRC5D CAR-T therapeutic that treats relapsed and refractory multiple myeloma, which is a product currently on the stage of IND enabling both in the US and China.

Roderick Wong, M.D., Managing Partner and Chief Investment Officer of RTW, said "RTW continues to focus on advanced tumor cellular immunotherapeutics. As a long-term investor in the primary and secondary markets, we have been closely following Oricell and have been duly impressed by its milestone achievements over the past year. Today, we feel honored to have established a partnership with the company through the Series B1 financing. With our years of experience working in the U.S. market, we look forward to empowering Oricell and its team as they continue to provide cancer patients across the world with better therapies and create more value for the community."

About RTW Investment

Headquartered in New York, with offices in Shanghai and London, RTW Investments, LP is a global life sciences investment and innovation firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to advance emerging medical therapies by building and supporting the companies and/or academics developing them. For further information about RTW, please visit www.rtwfunds.com

About Qatar Investment Authority

Qatar Investment Authority ("QIA") is the sovereign wealth fund of the State of Qatar. QIA was founded in 2005 to invest and manage the state reserve funds. QIA is among the largest and most active sovereign wealth funds globally. QIA invests across a wide range of asset classes and regions as well as in partnership with leading institutions around the world to build a global and diversified investment portfolio with a long-term perspective that can deliver sustainable returns and contribute to the prosperity of the State of Qatar.

About Qiming Venture Partners

Founded in 2006, Qiming Venture Partners is a leading China venture capital firm with offices in Shanghai, Beijing, Suzhou, Hong Kong, Seattle, Boston and the San Francisco Bay Area. Currently, Qiming Venture Partners manages eleven US Dollar funds and seven RMB funds with $9.4 billion in capital raised. Since our establishment, we have invested in outstanding companies in the Technology and Consumer (T&C) and Healthcare industries at the early and growth stages.

About C&D Emerging Industry Equity Investment

Xiamen C&D Emerging Industry Equity Investment Co., Ltd is a professional equity asset management company affliated to Xiamen C&D Corporation Limited, focusing on new economy sectors including healthcare, advanced manufacturing and innovative consumption.
The subsidiary manages a fund of RMB18 billion to help more emerging enterprises flourish.

On February 28, 2023 Nested Therapeutics, a biotechnology company pioneering a next-generation precision medicine platform to address hard-to-treat cancers, reported the nomination of the company’s first drug development candidate from its NEST-1 program, NST-628, a mechanistically novel non-degrading molecular glue that targets multiple nodes in the RAS/MAPK pathway (Press release, Nested Therapeutics, FEB 28, 2023, View Source [SID1234627936]).

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"This milestone was achieved in less than two years since inception of the company and represents an important step for Nested as it further validates our novel approach and the potential to unlock other cancer targets that are notoriously hard to drug," said Darrin Miles, Chief Executive Officer of Nested Therapeutics. "By targeting the RAS pathway via the differentiated mechanism of a pan-RAF/MEK and KSR/MEK molecular glue compound, along with a balanced metabolic profile that includes complete brain penetration, we can potentially address the unmet needs of a large patient group, including those who do not have precision medicine options today."

NST-628 is being developed with proprietary structural insights of how signaling complexes form and function in cancer and addresses common pitfalls of other MAPK-targeted compounds, which remain unable to circumvent the risk of intrinsic resistance via signaling pathway reactivation. In addition, NST-628 effectively crosses the blood-brain barrier, suggesting potential advantage for treatment of brain metastases and primary CNS malignancies with MAPK pathway alterations. Preclinical data evaluating several oncology biomarkers relevant to RAS/MAPK-driven models collectively demonstrate superior anti-tumor activity, including in central nervous system-implanted tumor models, and tolerability of NST-628 compared to other MAPK-targeted compounds administered as either single agents or combinations.

"By expanding to a 3-D view of mutations, we have the ability to look beyond active sites as targets, which allows us to locate unexplored driver mutations and druggable pockets across a protein’s surface," said Klaus Hoeflich, Ph.D., Co-Founder and Chief Scientific Officer at Nested Therapeutics. "Leveraging such structural insights allow us to gain a deeper understanding of the underlying molecular interactions that cause cancer progression and identify the right druggable pockets and novel targeting strategies."

Nested Therapeutics plans to submit an IND for NST-628 following completion of ongoing preclinical and IND-enabling studies, to support first-in-human studies to start in 2024. The company’s pipeline also includes NEST-2, an allosteric molecule targeting a transcriptional regulator frequently mutated in cancer. Selective target binding to novel cryptic pockets has been demonstrated and lead chemical series are advancing to in vivo proof-of-concept. For its NEST-2 program, Nested Therapeutics anticipates nominating its second development candidate in 2024.

About DeCRYPTion Platform

Nested Therapeutics’ DeCRYPTion Platform is a purpose-built, insightful drug discovery platform that enables Nested to identify new, overlooked areas of opportunity in the form of high value targets and design therapeutics for a perfect fit. The platform includes three critical components: (1) mapping mutational clusters onto the structural proteome, (2) identifying druggable pockets and cancer-driving mechanisms, and (3) designing novel drugs optimized for the druggable pocket.

On February 28, 2023 JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported the initiation of clinical study of JWATM214 in patients with advanced hepatocellular carcinoma (HCC) and the first patient infusion (Press release, JW Therapeutics, FEB 28, 2023, View Source [SID1234627935]).

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Primary hepatic cancer is a common malignant tumor of the digestive system worldwide, with high malignancy and hepatic prognosis. As the most common pathological type, HCC accounts for 85% to 90% of primary liver cancer. China has the highest incidence rate and mortality rate of primary hepatic cancer in the world, with 466,000 new cases and 422,000 deaths each year. The median progression-free survival of patients after first- and second-line current treatment is approximately 6 months, providing limited benefits for patients. Therefore, there is an urgent need to develop an effective treatment for patients with recurrent and metastatic advanced HCC.

This first-in-human study of JWATM214 aims to evaluate the safety and tolerability, determine the recommended phase 2 dose (RP2D), and evaluate the pharmacokinetic profile and preliminary efficacy of JWATM214 in adult patients with GPC-3-expressing advanced HCC.

As overexpressed in many malignant tumors including HCC, glypican-3 (GPC-3) has become a target for the diagnosis and treatment of HCC. The feasibility of T-cell immunotherapy targeting GPC-3 for the treatment of HCC patients has been preliminarily demonstrated and reported. JWATM214 is an autologous T-cell immunotherapy candidate drug targeting GPC-3, independently developed by JW Therapeutics based on the ARTEMIS platform of Eureka and Lyell’s T cell anti-exhaustion technology. It combines the high affinity and specificity of GPC-3 monoclonal antibody, and added cJun protein regulation based on JWATM204 to delay T cell exhaustion, to achieve more durable and superior anti-tumor activity, potentially providing novel treatment for GPC-3-expressing advanced HCC patients.

JW Therapeutics reached agreements with Eureka and Lyell in 2020, and in-licensed the rights of Eureka’s ARTEMIS technology and Lyell’s T cell anti-exhaustion technology to develop, manufacture and commercialize products in China (including mainland China, Hong Kong, Macao and Taiwan) and the member countries of the Association of Southeast Asian Nations.

References

Di-Yang Xie, Zheng-Gang Ren, Jian Zhou, Jia Fan, and Qiang Gao. 2019 Chinese clinical guidelines for the management of hepatocellular carcinoma: updates and insights. Hepatobiliary Surg Nutr. 2020 Aug; 9(4): 452–463.

Shi, D., Shi, Y., Kaseb, A.O., Qi, X., Zhang, Y., Chi, J., Lu, Q., Gao, H., Jiang, H., Wang, H., et al. (2020). Chimeric Antigen Receptor-Glypican-3 T-Cell Therapy for Advanced Hepatocellular Carcinoma: Results of Phase I Trials. Clin Cancer Res 26, 3979-3989. 10.1158/1078-0432.CCR-19-3259.

About JWATM214

JWATM214 is an autologous T-cell immunotherapy candidate drug targeting GPC-3, independently developed by JW Therapeutics based on the ARTEMIS platform of Eureka and Lyell’s T cell anti-exhaustion technology. It combines the high affinity and specificity of GPC-3 monoclonal antibody, and added cJun protein regulation based on JWATM204 to delay T cell exhaustion, to achieve more durable and superior anti-tumor activity, potentially providing novel treatment for GPC-3-expressing advanced HCC patients.