On February 27, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, March 5, 2020 to report its fourth quarter and full year 2019 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, FEB 27, 2020, View Source [SID1234554892]).

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To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 2764269. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On February 27, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported updated results from the combination arms of the Company’s ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC) at the Immuno-oncology 360° Conference in New York, New York (Press release, Advaxis, FEB 27, 2020, View Source [SID1234554909]). The trial is evaluating ADXS-503, part of the Company’s ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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Key findings presented by Dr. Andres Gutierrez, Chief Medical Officer of Advaxis, include:

●Demonstrated substantial tumor shrinkage in the first two evaluable patients in the combination arm, Part B; with ne patient who achieved a partial response (PR) and the other patient who achieved stable disease (SD) with 25% reduction in a target lesion
●These new data build upon previous results presented at the IASLC 2020 Targeted Therapies of Lung Cancer Meeting from seven evaluable patients demonstrating:

○50% (3 of 6) of evaluable patients from the monotherapy arm, from Part A, showed stable disease (SD)
○ADXS-503 monotherapy and in combination with pembrolizumab appeared safe and tolerable in this heavily pretreated population of patients with no dose limiting toxicities observed

"The first two patients treated in the combination arm of ADXS-503 and pembrolizumab were older patients with up to four prior lines of therapy" said Dr. Jonathan W. Goldman, Director of Clinical Trials in Thoracic Oncology at UCLA. "These data are very encouraging as they preliminarily demonstrate the ability of ADXS-503 to enhance or restore sensitivity to checkpoint inhibitors as we had hypothesized during the design of the study based on preclinical data." He added, "We will follow the durability of the responses to therapy and look forward to moving into Part C in ADXS-503 later this year, which will enroll patients for first line therapy in combination with pembrolizumab."

Dr. Andres A. Gutierrez, Chief Medical Officer and EVP at Advaxis , said, "These initial signals of anti-tumor activity in non-small cell lung cancer correlate with the clinical benefit observed with ADXS-PSA and pembrolizumab in our KEYNOTE-046 study in advanced prostate cancer, highlighting the potential synergistic effects of Lm immunotherapies and checkpoint inhibitors."

The Phase 1/2 clinical trial of ADXS-503 will seek to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a checkpoint inhibitor in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed and Part B in combination with a checkpoint inhibitor is currently open to enrollment.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

About KEYNOTE-046

KEYNOTE-046 (NCT02325557) is a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA (Part B; n= 37) in heavily pretreated patients with progressive and refractory metastatic castration-resistant prostate cancer (mCRPC).

On February 27, 2020 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, reported it will host a conference call and webcast to report its financial results for the fourth quarter and full year ended December 31, 2019 on March 12, 2020 at 8:30 a.m. ET (Press release, X4 Pharmaceuticals, FEB 27, 2020, View Source [SID1234554928]).

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The conference call can be accessed by dialing (866) 721-7655 (domestic) or (409) 216-0009 (international), followed by the conference ID: 3816258. The live webcast can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com. The webcast replay will be available on the website approximately two hours after the completion of the call.

On February 27, 2020 Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, reported that it is developing several new products that could help advance precision medicine research by expanding the capabilities and applications of its CELLSEARCH and DEPArray technologies, for rare cells isolation and single cell analysis (Press release, Menarini Silicon Biosystems, FEB 27, 2020, View Source [SID1234554945]).

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The new solutions include an assay for the enumeration and molecular characterization of circulating multiple myeloma cells (CMMC) from peripheral blood samples, the DEPArraysystem upgraded to 9 colors and artificial intelligence software.

The company’s technological developments will be highlighted during a presentation by Mark Connelly, PhD, Chief Research and Development Officer at Menarini Silicon Biosystems Inc, as part of the Molecular Medicine Tri-Conference’s Circulating Tumor Cells & Liquid Biopsy track.

"We are continually working to develop additional tools that will facilitate the exploration of new areas of inquiry," said Connelly. "Providing researchers with more information from a wider variety of cell populations and the ability to examine tumor heterogeneity in real-time could help address some critical questions in pharmaceutical and clinical research."

The CMMC assay based on the capabilities of CELLSEARCH to enrich and enumerate rare cells allow researchers to monitor the number of CMMCs in peripheral blood; furthermore when combined with the DEPArray system, will allow to perform molecular analysis at single cell level**. Research suggests that the ability to obtain CMMCs via liquid biopsy may help clinical researchers to better monitor disease state and treatment response, though, not only the cell enumeration but also the real time cell molecular profiling. Menarini Silicon Biosystems currently offers a CMMC assay (Research Use Only) as a service through its Global Laboratory Services. The company plans to release the assay for Research Use Only in the summer of 2020.

The 9-Color DEPArray will offer more fluorescence channels to examine the heterogeneity of markers expression on various rare cells, enabling researchers to simultaneously identify and characterize multiple cell populations. The artificial intelligence software will reduce operator variability by automating cell identification and selection and will help researchers move beyond enumeration to unravel hidden information in the cell image data.

Connelly’s presentation will also feature new research supporting the potential use of CTCs as a response biomarker for prostate cancer treatment. A 2018 study published in the Journal of Clinical Oncology indicates that using CTC counts obtained from liquid biopsy after 13 weeks of treatment can provide an accurate assessment of response to treatment. PSA (prostate-specific antigen) is one of the only markers currently available for the disease but is not considered to be a sufficient indicator of treatment response.

Menarini Silicon Biosystems is working with the FDA to get this application qualified as a response biomarker. This would enable researchers to incorporate CTCs as a response biomarker into clinical trials to expedite the drug development process.

Jennifer Davids, PhD, Director of Field Scientific Support at Menarini Silicon Biosystems Inc, will also be presenting on how the DEPArray technology can overcome the challenges of sample heterogeneity by enabling rare cell sorting with single cell precision.

Presentation Details
Location: Moscone South Convention Center

Monday, March 2 at 1:05 pm
Title: Advancing Liquid Biopsy – presented by Mark Connelly, PhD
Program: Circulating Tumor Cells and Liquid Biopsy
Track: Companion Diagnostics with Liquid Biopsy

Tuesday, March 3 at 11:40 am
Title: Utilizing the Next Generation Single Cell Sorter, DEPArray – presented by Jennifer Davids, PhD
Program: Immuno-Oncology Biomarkers and Companion Diagnostics
Track: Neoantigen Approaches

"These exciting developments demonstrate our continued commitment in advancing the applications of liquid biopsy," said Fabio Piazzalunga, President of Menarini Silicon Biosystems. "Our goal at MSB is to contribute to the advancement of precision medicine through innovative rare cell technologies, and we are actively working with our partners in the research community to provide advanced integrated and automated solutions."

To learn more about the CELLSEARCH and DEPArray Systems, MMTC attendees can visit Menarini Silicon Biosystems at Booth #601.

The 27th International Molecular Medicine Tri-Conference will be held March 1-4, 2020 in San Francisco.

On February 27, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported an update to its financial outlook and raises its 2020 financial guidance (Press release, Ligand, FEB 27, 2020, View Source [SID1234554866]). Ligand now expects 2020 total revenues to be approximately $133 million and diluted EPS to be $3.62, up from previous guidance for total revenues of approximately $128 million and diluted EPS of $3.45. This increase is due to higher material sales of Ligand’s Captisol technology as a result of multiple recent orders for Captisol to be used with the investigational compound remdesivir. Material sales for 2020 are now expected to be approximately $40 million, up from previous guidance of approximately $35 million.

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This updated financial guidance continues to include the contribution from the core assets and business of Icagen, Inc. (Icagen). This acquisition was announced on February 11, 2020, is subject to certain closing conditions, including a vote of Icagen stockholders, and is expected to close in April 2020.

"Ligand’s Captisol technology has enabled several ground-breaking medicines, and we are now seeing partners increase their orders in support of clinical studies of the antiviral drug remdesivir, which is being actively assessed for the treatment of the new strain of the coronavirus, COVID-19," said John Higgins, Chief Executive Officer of Ligand. "We have invested significantly in the Captisol technology and supply chain over the years to enable the development and manufacture of important medicines that address significant medical needs. We stand ready to fulfill additional future orders of Captisol for use in formulating remdesivir, as needed."

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA and Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development.