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Professor Min Jeong-jun and Kang Se-ryeong’s team at Hwasun Chonnam National University Hospital develops world’s first ‘bacterial visualization technology for cancer treatment’

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]

MD Anderson, Ipsen advance new therapy with potential benefit for underserved lung and ovarian cancer patients

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.

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.

Halozyme Announces Janssen Submits New Drug Application In Japan For Daratumumab Subcutaneous Formulation Utilizing Halozyme’s ENHANZE® Technology For Patients With Multiple Myeloma

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]).

"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.

Oncocyte Announces $10.7 Million Registered Offering

On April 24, 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has entered into definitive agreements with, among other institutional investors, Blackcrane Capital, LLC, an investment management company employing an unconstrained, change-oriented investment approach, to purchase approximately $10.7 million of Oncocyte’s common shares in a registered offering priced "at market", which was the closing price immediately preceding the offering (Press release, Oncocyte, APR 24, 2020, View Source [SID1234556663]). This offering was completed directly with the institutional investors and the Company incurred no placement agent fees.

"Our continued ability to attract support from healthcare focused funds stems from our remarkable progress in advancing our expanding suite of tests which now address treatment stratification and immunotherapy response prediction for lung cancer and liquid biopsy to rule out malignancy in lung nodules," said Ron Andrews, Chief Executive Officer of Oncocyte. "Our strengthened balance sheet will facilitate our continued progress and execution, now as a commercial stage company, as we work to grow our market and further expand our offerings in lung and beyond."

Daniel Kim, founder and chief executive of Blackcrane Capital, LLC, said "We are excited to partner with Oncocyte as they work to provide decisive answers for patients across the lung cancer care continuum. We see tremendous potential at Oncocyte based on their deep clinical and commercial expertise and proven track record of success. We are very excited to support Oncocyte’s management team as it continues to work towards improving lung cancer diagnosis, treatment and patient outcomes."

In connection with the offering, the Company will sell an aggregate of 4,733,700 shares of its common stock at a purchase price of $2.27 per share, the closing price of the stock on April 23, 2020, the day prior to the execution of the agreement with the investors. The registered offering is subject to customary closing conditions and is expected to close during the week of April 27, 2020.

Proceeds from the registered offering provide the strategic capital to accelerate and support the commercial launch of DetermaRx, OncoCyte’s lung cancer treatment stratification test, DetermaIO, a research use only gene expression test to identify immune checkpoint inhibitor responders, and the continued development of DetermaDx a liquid biopsy test to rule out malignancies in lung nodules as well as general corporate and working capital purposes. The Company may also use proceeds to invest in or acquire businesses or technologies that it believes are complementary, although the Company has no binding agreements with respect to any strategic transactions or acquisitions as of the date of this press release.

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 offer, solicitation or sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful.

ADC THERAPEUTICS FILES REGISTRATION STATEMENT FOR PROPOSED INITIAL PUBLIC OFFERING

On April 24, 2020 ADC Therapeutics SA, a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission relating to a proposed initial public offering of its common shares (Press release, ADC Therapeutics, APR 24, 2020, View Source [SID1234556637]). The number of shares to be offered and the price range for the proposed offering have not yet been determined. ADC Therapeutics intends to list its common shares on the New York Stock Exchange under the ticker symbol "ADCT."

Morgan Stanley, BofA Securities and Cowen will act as joint book-running managers for the offering.

The offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. 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 registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. There is no intention to publicly offer, solicit, sell or advertise, directly or indirectly, these securities, or invest in securities of ADC Therapeutics SA, such as the common shares, in, into or from Switzerland and these securities will not be listed on the SIX Swiss Exchange or on any other exchange or regulated trading venue in Switzerland. The common shares may not be publicly offered, directly or indirectly, in Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and no application has or will be made to admit the common shares to trading on any trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.