On June 9, 2020 Menarini Silicon Biosystems, the pioneer of liquid biopsy and single cell technologies, reported that results from a new study presented at the virtual 2020 meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) suggest that circulating tumor cell (CTC) counts may be useful in determining long-term prognosis and guiding treatment selection in patients with metastatic castrate sensitive prostate cancer (mCSPC) (Press release, Menarini Silicon Biosystems, JUN 9, 2020, View Source [SID1234560952]). A second study showed predictive value of CTC counts in metastatic breast cancer. Researchers used Menarini’s CELLSEARCH Circulating Tumor Cell test,* considered the gold standard in liquid biopsy technology, to detect and count CTCs.

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A current challenge in treating mCSPC is the lack of accurate biomarkers that indicate which patients will do well with particular therapies, or how long patients will live, according to lead researcher, Amir Goldkorn, M.D., Associate Professor of Medicine at the University of Southern California’s Keck School of Medicine. With this study, researchers determined CTC counts are a non-invasive way to obtain valuable prognostic information at the start of treatment.

"These findings have important clinical implications, suggesting that patients with high initial CTC counts are less likely to respond and more likely to progress on hormonal therapy," said Dr. Goldkorn. "Though additional analysis is required, these results indicate that CTCs could become a valuable biomarker that can tell us about a patient’s long-term prognosis and help guide therapy."

The study (Abstract #5506) investigated mCSPC patients early in the disease, when participants were first being treated with hormone therapy. Researchers enumerated CTCs in 1200 men at the start of the study, and then looked at two endpoints: the level of prostate-specific antigen (PSA) after seven months, and progression-free survival (PFS) after two years.

The results showed clear prognostic value for the CTC count. The 63% of men who had no circulating tumor cells when the study began were more than six times more likely at seven months to have PSA values below 0.2, which has been shown to be highly correlated with longer survival times than higher PSA values. The men also were 3.7 times more likely to survive, with no cancer progression, after two years.

In addition to Dr. Goldkorn’s oral presentation on the study, the research was included in a live discussion among a panel of experts on the ASCO (Free ASCO Whitepaper) meeting site on Sunday, May 31.

The second study, presented as a poster at ASCO (Free ASCO Whitepaper) (Abstract #1028), examined the role of CTC counts and mutations in circulating tumor DNA (ctDNA) in predicting prognosis, treatment response and disease spread in metastatic breast cancer (MBC). Led by Massimo Cristofanilli, M.D., F.A.C.P., Associate Director for Translational Research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, the researchers looked at 36 Stage III and 203 Stage IV breast cancer patients.

They found that CTC counts were much higher in the Stage IV patients—an average of 62.2 cells per 7.5 mL of blood compared to 14.5 cells in Stage III patients — and that within each group, high CTC counts predict worse outcomes. In addition, they discovered that mutations in one particular gene in ctDNA — known as PI3KCA — dramatically increased in Stage IV patients compared to Stage III patients, and were also highly predictive of worse prognosis and treatment outcomes.

"These new studies demonstrate the important role our rare cell technologies play in advancing precision medicine research, which could one day translate to better, more personalized treatment options for patients with prostate and breast cancer," said Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems, Inc.

CELLSEARCH is the first and only clinically validated blood test cleared by the FDA for detecting and counting CTCs to aid physicians in managing patients with metastatic breast, prostate, and colorectal cancers when used in conjunction with other clinical methods of monitoring. The test is also approved by the China Food & Drug Administration for use in monitoring patients with MBC. The CELLSEARCH System is the most extensively studied CTC technology, with research published in more than 650 peer-reviewed publications.

On June 9, 2020 L.E.A.F. Pharmaceuticals LLC ("LEAF"), a global pharmaceutical company focused on developing novel anticancer drugs, reported that results from a preclinical study of LEAF-1401, the Company’s lead anticancer product, were presented at the 2020 Virtual Annual Meeting of ASCO (Free ASCO Whitepaper) held from May 29 – 31, 2020 (Press release, LEAF Pharmaceuticals, JUN 9, 2020, View Source [SID1234560951]). ASCO (Free ASCO Whitepaper) is the world’s largest cancer conference which brings together, from around the world, both cancer researchers and cancer healthcare providers to review and discuss new cancer treatments being developed worldwide. Treatment with LEAF-1401 resulted in 20-fold higher intratumoral exposure levels of pentaglutamated pemetrexed (the main active form of pemetrexed) and 30-fold higher intratumor exposure levels of pemetrexed itself, when compared to treatment with currently approved pemetrexed (Alimta).

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Details of the poster are as follows:

Poster #3524-254: Intratumoral Exposure Levels of Pentaglutamated Pemetrexed following Treatment with LEAF-1401 and Pemetrexed.

A copy of the poster is available on the LEAF website (click here).

LEAF-1401, a new generation onco-immuno antimetabolite designed to disrupt dysregulated 1-carbon metabolism in cancer and the immune system, is a liposomal formulation of gamma L-pentaglutamated pemetrexed. Gamma L-polyglutamated pemetrexed has been shown to be 80-times more potent than pemetrexed in inhibiting thymidylate synthase. In Oct 2018, LEAF received positive feedback following Pre-Investigational New Drug (Pre-IND) interactions with the United States Food and Drug Administration (US FDA) about LEAF-1401, where the Agency indicated that LEAF-1401 may be acceptable for development and registration under 505(b)(2) regulatory pathway. In addition, the Agency also provided guidance on how to establish a "bridge", between this product and Alimta, the US FDA approved listed drug, for the purpose of fulfilling the 505(b)(2) registration path requirements.

"The selection of LEAF-1401 by the ASCO (Free ASCO Whitepaper) Science Committee for presentation at this year’s annual ASCO (Free ASCO Whitepaper) meeting marked an important milestone in the recognition, by world’s leading cancer experts, of the future role this new investigational product is expected to play in the treatment of cancer," says Founder, President, and CEO of L.E.A.F. Pharmaceuticals, Dr. Clet Niyikiza.

"Although pemetrexed remains a backbone of treatment regimens approved for lung cancer, an unacceptable number of lung cancer patients treated with pemetrexed alone or in combination with novel drugs, such as immunotherapy, eventually succumb to this disease," says Dr. Victor Moyo, Executive Vice President, Global Head of Research and Development and Chief Medical Officer of L.E.A.F. Pharmaceuticals. Dr. Moyo added, "The results from LEAF-1401 preclinical studies, in which significantly higher levels of pemetrexed and the more potent pentaglutamated pemetrexed are delivered to the tumor with an increased antitumor effect, point to a high likelihood that LEAF-1401 could achieve improved outcomes for patients with lung cancer."

On June 9, 2020 Rafael Holdings, Inc., (NYSE: RFL), reported revenue of $1.2 million and a loss per share of $0.14 for the fiscal quarter ended April 30, 2020 (Press release, Rafael Holdings, JUN 9, 2020, View Source [SID1234560950]).

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Q3 FY 2020 Consolidated Highlights

Revenue of $1.2 million in Q3 FY2020, generated by Rafael Holdings’ real estate portfolio, decreased from $1.4 million in the year-ago quarter. The loss per share of $0.14 increased from $0.07 in the year ago quarter largely on increased R&D expense incurred by the Barer Institute.
Rafael Pharmaceuticals

On May 26, 2020, Rafael Pharma announced positive results of a single-arm, open-label, Phase 1 study of CPI-613 (devimistat) with gemcitabine and nab-paclitaxel in patients with locally advanced or metastatic pancreatic cancer. The data was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program.
On April 28, 2020, Rafael Pharma announced the expansion of its Phase 2 clinical trial of CPI-613 (devimistat) for patients with relapsed or refractory Burkitt’s lymphoma/leukemia. The clinical trial began enrolling patients at MD Anderson Cancer Center, where Dr. Raphael Steiner serves as principal investigator.
On March 24, 2020, Rafael Pharma announced that it had enrolled more than 75% of the 500 patients needed for its pivotal Phase 3 clinical trial for metastatic pancreatic cancer (AVENGER 500). The trial is evaluating the efficacy and safety of Rafael’s lead compound CPI-613️ (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy.
LipoMedix

At April 30, 2020, Rafael Holdings held 57.9% of the issued and outstanding ordinary shares of LipoMedix, a development-stage Israeli company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery.

Lipomedix was awarded a Seal of Excellence for its Promitil project by European Innovation Council of the European Union.
LipoMedix’s Phase IB study of Promitil in Israel continued to enroll patients with advanced cancer requiring palliative radiotherapy for inoperable tumors or metastatic disease.
Barer Institute

Rafael Holdings increased its investment in pharmaceutical development through its Barer Institute subsidiary. The Barer Institute is currently testing indications for lead compounds targeting cancer metabolism and has initiated a preclinical in-licensing effort on selected compounds that target the unique mechanisms of cancer.

Remarks by Howard Jonas, Chairman and CEO of Rafael Holdings

"Rafael Holdings’ key pharmaceutical investments, Rafael Pharma and LipoMedix and our wholly owned Barer Institute, continue to execute on their development and clinical programs despite the challenges posed by the worldwide Covid-19 pandemic. I am especially gratified that Rafael Pharma has surpassed the 80% enrollment milestone in its pivotal Phase 3 Avenger 500 study of patients with pancreatic cancer. The Barer Institute is evaluating promising candidates for potential clinical development programs. And finally, we continue to work to monetize our New Jersey real estate assets, while our asset in Israel is now fully leased."

On June 9, 2020 Lyvgen, a biopharmaceutical company focused on developing innovative immuno-oncology therapeutics, reported that it has entered into a clinical trial collaboration agreement with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside of the U.S. and Canada (Press release, Lyvgen Biopharma, JUN 9, 2020, View Source [SID1234560948]). The collaboration will evaluate Lyvgen’s LVGN6051, a second generation 4-1BB (CD137) agonist antibody, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in a Phase 1 study in adult patients with advanced malignancy including lung cancer, melanoma, gastrointestinal cancer with MSI-high or DMMR, and lymphoma.

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"We are very excited about this clinical collaboration with MSD to evaluate the combination of KEYTRUDA with LVGN6051, our innovative 4-1BB (CD137) agonist antibody," said Jieyi Wang, Ph.D., Chief Executive Officer of Lyvgen. "CD137 signaling provides critical support for CD8+ effector T cells in a manner complementary to the effect of PD-1 blockade. We believe that the combination of LVGN6051 and KEYTRUDA has the potential to improve treatment outcomes for patients with advanced cancer and may broaden the applications of cancer immunotherapy."

Lyvgen has initiated a Phase I clinical trial (NCT04130542) in October of 2019.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LVGN6051
Lyvgen uses its xLinkAb platform that leverages IgG and FcγRIIB interaction to generate agonist antibodies targeting co-stimulatory receptors with selectivity for tumor microenvironment to enhance efficacy and therapeutic index. LVGN6051 specifically binds human CD137 (4-1BB) and activates its signaling only when the engineered Fc of LVGN6051 engages FcγRIIB. In contrast to the first generation CD137 agonist antibodies that entered clinic, LVGN6051 has bi-specificity for CD137 and FcγRIIB.

About Lyvgen’s xLinkAb Platform
xLinkAb platform creates agonist IgG antibodies by leveraging both Fab and Fc binding specificity to achieve target activation selectively in the tumor microenvironment. To increase selectivity for tumors, Lyvgen discovers antibodies that agonize their targets only in the presence of FcγRIIB (FCGR2B; CD32B), which is expressed on immune cells enriched in the tumor microenvironment, including B cells, monocytes and NK cells.

On June 9, 2020 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported the closing of its initial public offering of 21,188,750 American depositary shares (ADSs), each representing two ordinary shares, at a public offering price of $23.00 per ADS, for total gross proceeds of approximately $487.3 million (Press release, Legend Biotech, JUN 9, 2020, View Source [SID1234560947]). The number of ADSs issued at closing included the exercise in full of the underwriters’ option to purchase 2,763,750 additional ADSs. All of the ADSs were offered by Legend Biotech.

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Morgan Stanley, J.P. Morgan and Jefferies acted as joint book-running managers for the offering.

A registration statement relating to the securities sold in this offering was declared effective by the Securities and Exchange Commission on June 4, 2020. This offering was made only by means of a prospectus. A copy of the final prospectus may be obtained from Morgan Stanley & Co. LLC, 180 Varick Street, New York, NY 10014, Attention: Prospectus Department, or by telephone at (866) 718-1649; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by phone at (877) 821-7388.

In addition to the ADSs sold in the initial public offering, Legend Biotech closed the concurrent sale of 1,043,478 ordinary shares at the public offering price per share adjusted to reflect the ADS-to-ordinary share ratio in a private placement to GenScript Biotech Corporation, the parent majority shareholder of Legend Biotech. The sale of these ordinary shares was not registered under the Securities Act of 1933, as amended.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, 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.