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 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 JW Therapeutics, reported the completion of a US$100 million Series B round financing, the investment was co-led by CPE and Mirae Asset, jointed by CR-CP Life Science Fund and Oriza Holdings, as well as existing investors including Loyal Valley Capital, Temasek, Sequoia Capital China, ARCH Venture Partners, Juno Therapeutics, a Bristol Myers Squibb company, and WuXi AppTec (Press release, JW Therapeutics, JUN 9, 2020, View Source [SID1234560971]). This round of financing brings the total capital raised to over US$200 million.

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JW Therapeutics plans to use the proceeds to further advance its lead product JWCAR029 (a CAR-T cell product targeting CD19 in clinical phase II), further build-out a pipeline, and gear up to establish commercialization capabilities to support product launch.

James Li, Co-Founder and CEO of JW Therapeutics, commented: "We are very pleased to welcome our new investors and, by working together, we hope to accelerate our product development and serve Chinese Patients."

On June 9, 2020 NanOlogy, LLC, a clinical-stage oncology company, reported initiation of a clinical trial of IT NanoPac (submicron particle paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in NSCLC and SCLC (Press release, NanOlogy, JUN 9, 2020, View Source [SID1234560917]). The trial follows FDA allowance of an investigational new drug (IND) application for IT NanoPac in neoplasms of the lung. A second IND was also allowed by FDA for a nebulized inhaled form of NanoPac in NSCLC. Five INDs have been established for NanoPac allowing progress of clinical trials via multiple routes of targeted administration for a variety of solid tumors including pancreatic, prostate, ovarian, peritoneal, and now lung.

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Clinical Trial of NanoPac in Lung Cancer
The first study to proceed will be a Phase 2a dose-rising and expansion trial (NCT04314895) evaluating the safety and tolerability of up to 3 monthly IT injections of NanoPac delivered via EBUS-TBNI, concurrent with standard of care therapy, in patients with primary or recurrent NSCLC or SCLC. In addition to safety and pharmacokinetics (PK), the study will measure progression free survival, overall survival, and tumor response determined from CT scan imaging. Blood and biopsy samples will be evaluated for immune effect through flow cytometry and multiplex immunohistochemistry analysis. The trial will begin at two clinical sites: Parkview Healthcare Institute in Fort Wayne, Indiana and University of Florida Health Cancer Center in Gainesville, Florida. More clinical sites will follow. The first subject is expected to be enrolled in August 2020.

Preclinically, a nebulized inhaled form of NanoPac was retained in lung tissue for more than 14 days in a PK model and caused tumor regression and immune cell infiltration in an orthotopic model of NSCLC. Clinical plans for inhaled NanoPac are under development.

Other Clinical Experience with Targeted Delivery of NanoPac
To date, approximately 70 patients have received targeted injections of NanoPac across clinical trials in the prostate and pancreas. Another 30 patients have received intraperitoneal NanoPac for peritoneal and ovarian cancers. NanoPac has been well tolerated in these study subjects with no confirmed drug-related serious adverse events reported. Along with safety and tolerability, signs of activity have also been observed across the clinical programs.

NanOlogy Submicron Particle Therapeutic Platform
The NanOlogy submicron particle therapeutic platform is based on a proprietary production technology that converts taxane API crystals into stable submicron particles of pure drug with disproportionate size to surface area ratio. The particles are covered by two composition of matter patents (US 9,814,685) and (US 10,507,195) both valid until 2036 in the US and pending globally. In addition to lung cancer, NanOlogy clinical programs are advancing in pancreatic, genitourinary, peritoneal, ovarian, and dermal cancers.

About Lung Cancer
In 2020, an estimated 228,820 new cases of lung cancer will be diagnosed in the U.S. and 135,720 people will die from the disease. Lung cancer is by far the leading cause of cancer deaths in the U.S. responsible last year for 22% of all cancer-related deaths (SEER). Globally, lung cancer is also the most common form of cancer and the deadliest accounting for an estimated 2.1 million annual new cases and 1.8 million deaths (GLOBOCAN 2018).

On June 9, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that the company will present new preclinical data for its folate receptor alpha targeting antibody-drug conjugate, STRO-002, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II being held June 22-24, 2020 (Press release, Sutro Biopharma, JUN 9, 2020, View Source [SID1234560953]).

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Additionally, Sutro’s partner Merck KGaA, Darmstadt, Germany, will be presenting preclinical data from the collaboration’s pre-Development Candidate, M1231, a first-in-class bispecific antibody-drug conjugate targeting EGFR and MUC1.

Presentation Details:

Title:

STRO-002, an anti-FolRα ADC, demonstrates immune-modulating properties and potentiates PD-L1 blockade

Abstract Number:

2250

Session Title:

Immune Mechanisms Invoked by Therapies 2

Date/Time:

June 22, 2020, 9:00 a.m. – 6:00 p.m. EDT

Presenter:

Trevor Hallam, Ph.D.

Title:

M1231: A first-in-class bispecific antibody-drug conjugate targeting EGFR and MUC1

Abstract Number:

5686

Session Title:

Emerging Mechanisms of Resistance to Targeted Therapies

Date/Time:

June 24, 2020, 10:05 a.m. – 10:15 a.m. EDT

Presenter:

Jan Anderl, Ph.D.

The abstracts can be found on the AACR (Free AACR Whitepaper) website. The Sutro virtual poster presentation will be on the AACR (Free AACR Whitepaper) website on June 22, 2020, and will be also accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of Sutro’s website at www.sutrobio.com on the day of the poster presentation