On April 27, 2020 Actym Therapeutics, a privately-held immuno-oncology company, reported the completion of a $34 million series A financing led by Boehringer Ingelheim Venture Fund (BIVF) and Panacea Venture, with participation from Illumina Ventures, Korea Investment Partners (KIP), and JLo Ventures (Press release, Actym Therapeutics, APR 27, 2020, View Source [SID1234556658]). The company will use the proceeds to advance development of immunotherapies from its microbial-based STACT platform into the clinic for the treatment of various cancers. Actym is led by industry veterans Christopher Thanos, Ph.D., Chief Executive Officer, Laura Hix Glickman, Ph.D., Vice President Research, and Mark Frohlich, M.D., Chief Medical Advisor.

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With the close of the Series A financing, the Actym Board of Directors has expanded to include Kanad Das, Ph.D., Investment Director at BIVF, James Huang, MBA, Founding Managing Partner of Panacea Venture, and Alexis Ji, Ph.D., Partner at Illumina Ventures.

"Patients burdened with metastatic disease desperately need new and effective treatment options. Actym’s platform technology allows for the delivery of multiplexed immunological payloads to the tumor microenvironment (TME) after IV dosing, in a single therapeutic composition. This financing, from an esteemed group of investors, is a key validation of our approach," said Dr. Thanos. "Our goal is to bring therapeutic benefit to cancer patients. We are fortunate to be aligned with investors who can provide both the financial resources and real-world leadership experience to help build Actym, advance our pipeline, and ultimately help patients."

"On behalf of BIVF, we are excited to co-lead the investment in Actym. Actym’s unique approach has the potential to overcome the immunosuppressive TME and treat a broad range of malignancies via a systemic route of administration." said Dr. Das, of BIVF.

"Actym has developed a highly differentiated therapeutic platform. We are excited about its potential and are impressed by the scientific depth of the team. We are thrilled to co-lead the investor syndicate and our team looks forward to helping Actym develop potent immunotherapies." said Mr. Huang.

On April 26, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharmaceutical K.K. (Janssen) seeking approval of a new subcutaneous (SC) formulation of daratumumab, an intravenous (IV) treatment approved for patients with multiple myeloma (Press release, Halozyme, APR 26, 2020, View Source [SID1234556601]).

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"We are pleased to see this New Drug Application submission in Japan, which builds on Janssen’s prior regulatory submissions in the U.S. and EU that are currently under review," said Dr. Helen Torley, president and chief executive officer. "We are excited that patients with multiple myeloma in Japan may soon have a new therapeutic option that can be administered with a shorter infusion time when compared with a multi-hour intravenous infusion."

The NDA is supported by pivotal data from the Phase 3 COLUMBA (MMY3012) study – a randomized open label study – that included a non-inferiority comparison of daratumumab SC formulation versus daratumumab IV administration in patients with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both PI and IMiD. In addition to non-inferiority, daratumumab SC showed a lower rate of infusion-related reactions. Data from the Phase 2 PLEIADES (MMY2040) study – a non-randomized open label study conducted in newly diagnosed or relapsed or refractory multiple myeloma patients – are also included in the NDA. The subcutaneous formulation of daratumumab is co-formulated with Halozyme’s ENHANZE drug delivery technology, based on recombinant human hyaluronidase PH20 (rHuPH20).

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On April 26, 2020 The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division and Ipsen Biopharmaceuticals reported the preclinical discovery and early-stage clinical development of this novel drug (Press release, MD Anderson, APR 26, 2020, View Source [SID1234556628]). IPN60090, now under investigation in a Phase I trial, may hold benefit for certain patients with lung and ovarian cancers.

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MD Anderson’s GLS1 program was initiated and advanced by a team of scientists in the Institute for Applied Cancer Science (IACS) and Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platforms, both engines within Therapeutics Discovery. Development of the program continues in collaboration with Ipsen, which licensed the therapeutic in 2018.

Findings and information about the ongoing trial will be presented today at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I by Jeffrey Kovacs, Ph.D., institute group leader with TRACTION and co-leader of the GLS1 program.

"This effort is a great example of our strategy within Therapeutics Discovery, taking a comprehensive approach to personalized medicine," said Kovacs. "Our preclinical data suggest that IPN60090 may be effective in underserved groups of patients who need better treatment options, and we look forward to results from our ongoing clinical trials."

Dysregulation of cellular metabolism is a hallmark of cancer development, and the GLS1 enzyme plays a key role in many metabolic processes. Thus, it makes an attractive target for cancer therapy, explained Kovacs.

IACS drug-discovery scientists identified IPN60090 as a potent and selective inhibitor of GLS1 suitable for clinical trials, and translational researchers in TRACTION demonstrated its activity against subsets of lung and ovarian cancer preclinical models.

Further analysis revealed biomarkers of response, which have been leveraged to identify patients most likely to benefit. In lung cancers, mutations in the KEAP1 and NFE2L2 genes, which regulate response to oxidative stress, sensitize cells to treatment with IPN60090. Similarly, low expression of the metabolic protein asparagine synthetase (ASNS) in ovarian cancers predicts response to IPN60090 in preclinical models.

"Identifying these putative predictive biomarkers of response is critical for our ongoing clinical efforts to ensure that we’re able to offer patients the most relevant therapies," said Timothy A. Yap, M.B.B.S., Ph.D., F.R.C.P., associate professor of Investigational Cancer Therapeutics and medical director of IACS. "These patient groups in particular, which represent distinct niches within those cancer types, are in need of more effective treatment options."

For example, patients with lung cancers harboring KEAP1/NRF2 mutations have not benefited from treatment with immune checkpoint inhibitors and have poorer outcomes overall, explained Yap, who leads the IPN60090 clinical trial at MD Anderson.

IPN60090 currently is under investigation in a Phase I dose-escalation and dose-expansion study for patients with advanced solid tumors that harbor KEAP1/NFE2L2 mutations or have low ASNS levels. The team has developed novel CLIA-certified assays to identify patients likely to benefit and monitor how effectively the drug is acting. Initial data from the clinical trial indicate that IPN60090 is effectively inhibiting GLS1 activity in peripheral blood mononuclear cells from patients.

Future trial cohorts plan to investigate IPN60090 in combination with checkpoint inhibitors, chemotherapy and targeted therapies identified by the researchers as having potential synergistic benefits with GLS1 inhibition.

The ongoing research is supported by Ipsen through a global licensing and development agreement. The research is managed according to MD Anderson’s Institutional Conflict of Interest Management and Monitoring Plan. Kovacs is a co-inventor on material and method-of-use patent applications related to IPN60090. The Therapeutics Discovery division is supported in part by MD Anderson’s Moon Shots Program.

On April 26, 2024 The research team of Professor Min Jeong-jun and Kang Se-ryeong of the Department of Nuclear Medicine at Hwasun Chonnam National University Hospital recently reported the company developed the world’s first ‘positron emission tomography (PET) molecular imaging technology’ that visualizes bacteria for cancer treatment (Press release, CNCure, APR 26, 2020, View Source [SID1234649029]).

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This technology is registered as a domestic patent, and overseas patents are also being applied for. This research was first introduced in the online version of ‘Theranostics’ (impact factor 8.063), an authoritative international academic journal in the field of molecular imaging diagnosis and treatment, and is scheduled to be published as a cover paper in the upcoming June issue.

The research team succeeded in visualizing E. coli injected into the body for cancer treatment using radioactive sorbitol. Based on the fact that ‘sorbitol’, a substance produced by reducing glucose, is used as a nutrient for gram-negative intestinal bacteria such as E. coli and salmonella, they attempted PET imaging by producing sorbitol containing radioactive fluorine.

This sorbitol PET accurately showed the distribution of E. coli injected for treatment purposes in the body. It was analyzed that the greater the amount of sorbitol consumed in the tumor, the greater the cancer suppression effect.

In cell therapy using living immune cells or microorganisms, the distribution of the therapeutic agent in the tumor is very important. In other words, the therapeutic cells must be concentrated in the tumor area and removed from other organs in the body for the treatment to be effective and safe. Therefore, a molecular imaging technique that can evaluate the distribution of the therapeutic agent in the body in a non-invasive way that does not penetrate the skin is a very important technology that determines the success or failure of this treatment. Until now, in order to visualize bacteria for cancer treatment, it was necessary to artificially express image reporter genes, but in this study, visualization was successfully achieved using the unique mechanism of therapeutic bacteria without additional genetic manipulation, and the possibility of future clinical application is very high. This study was conducted with the support of the Ministry of Science and ICT’s Future Promising Convergence Technology Pioneer Project and the Ministry of Education’s Science and Technology Individual Basic Research Support Project. Reporter Jang Jong-ho [email protected]

On April 24, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported the pricing of the sale of 1,672,689 shares of common stock of OncoCyte Corporation at a price to buyers of $2.27 per share, representing the closing price of OncoCyte common stock on April 23, 2020 (Press release, Lineage Cell Therapeutics, APR 24, 2020, View Source [SID1234556581]). Net proceeds from the sale were approximately $3.7 million. The sale is expected to close by April 30, 2020, subject to certain closing conditions. Following the completion of the sale, Lineage will own approximately 4.3 million shares of OncoCyte. Based on the closing price of OncoCyte’s common stock on April 23, 2020, the value of Lineage’s remaining OncoCyte shares following the closing is approximately $9.7 million. Lineage has agreed not to sell additional shares of OncoCyte common stock prior to June 8, 2020 or unless the OncoCyte common stock price closes above $3.40.

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"In light of impacts to our industry from the COVID-19 pandemic, we have elected to make this sale to support our operations and maintain timelines," stated Brian M. Culley, Lineage CEO. "We believe this most recent transaction involving OncoCyte alongside our culture of focused and responsible spending will help us successfully navigate through this virus-related disruption. We are pleased that demand for OncoCyte shares was again available at market prices with no discount. Looking ahead, we look forward to providing our next OpRegen update at the upcoming 2020 ARVO Meeting, which will be hosted virtually via ARVOLearn."