On March 21, 2019, MabVax Therapeutics Holdings, Inc. (the "Company") reported that it filed a voluntary petition for reorganization relief under Chapter 11 of Title 11 of the United States Bankruptcy Code (the "Bankruptcy Code") in the United States Bankruptcy Court for the District of Delaware (the "Bankruptcy Court") (Case No. 19-10603 (CSS)) (Press release, Blueprint Medicines, MAR 21, 2019, View Source [SID1234537257]). The Company continues to manage and operate its business as a debtor in possession pursuant to Bankruptcy Code Sections 1107 and 1108. The Company intends to sell substantially all of its assets pursuant to Section 363 of the Bankruptcy Code in the sixty days following the filing of its Chapter 11 petition under a Bankruptcy Court supervised sales process and, subject to sales proceeds and remaining assets, could convert its case to Chapter 7, at which point a Chapter 7 trustee will be appointed by the Bankruptcy Court.

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On March 21, 2019 Epic Sciences, Inc. reported that new data will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, in Atlanta, Georgia, March 29 to April 4, 2019 (Press release, Epic Sciences, MAR 21, 2019, View Source [SID1234534564]). The data from multiple studies and indications demonstrate the feasibility of Epic’s Functional Cell Profiling (FCP) technology to predict patients’ response to cancer immunotherapies and drugs that target DNA damage repair pathways.

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Epic’s FCP technology platform identifies and characterizes all circulating tumor cells in a blood sample to link their response or resistance to several drug classes. Following the highly successful development of Epic’s proprietary AR-V7 test for patients with metastatic castration-resistant prostate cancer, currently marketed as the Oncotype DX AR-V7 Nucleus Detect test, the company and its research partners are utilizing the FCP platform to analyze biomarkers to guide treatment decisions in breast cancer and small-cell lung cancer, expanding into new areas of unmet need.

"For years, Epic Sciences has been transforming late-stage prostate cancer treatment with our powerfully predictive Functional Cell Profiling technology by providing a comprehensive view of how populations of cancer cells change under selective pressure of different drug classes," said Katherine Atkinson, Chief Commercial Officer at Epic Sciences. "At AACR (Free AACR Whitepaper), we are presenting new data that demonstrates our technology’s significant value can be applied to new indications and drug classes in development, in addition to late stage prostate cancer, potentially improving the lives of many more patients."

Following are the AACR (Free AACR Whitepaper) 2019 posters and presentations:

Oral Presentation:

Title: Liquid Biopsies: From Validation to Clinical Utility
Session Description: Discussion of the development and clinical application of validated circulating tumor cell (CTC) and cell-free DNA assays to determine prognosis, predict response to treatment, identify mechanisms of resistance to guide future treatment, and assess drug effects.
Chairperson & Presentation: Howard I. Scher, Memorial Sloan Kettering Cancer Center; Predictive biomarkers in circulating tumor cells to direct management of metastatic castration-resistant prostate cancer (mCRPC)
Session Date and Time: April 1, 2019, 2:05 pm – 2:30 pm ET

Poster Presentations:

Title: HER2, AR protein expression and chromosomal instability in circulating tumor cells (CTCs) of metastatic breast cancer (MBC) patients (pts)
Session Category and Title: Clinical Research: Current Developments in Non-invasive Biomarkers for Assessment of Cancer 1
Session Date and Time: Sunday, March 31, 2019 1:00 pm – 5:00 pm ET

Title: Genomic instability as a marker of poor prognosis in advanced prostate cancer: Subclonal insights from whole-genome sequencing of single circulating tumor cells
Session Category and Title: Clinical Research: Current Developments in Non-invasive Biomarkers for Assessment of Cancer 1
Session Date and Time: Sunday, March 31, 2019, 1:00 pm – 5:00 pm ET

Title: Characterization of SLFN11 protein expression in circulating tumor cells (CTCs) of patients with metastatic castration-resistant prostate cancer (mCRPC) prior to platinum based chemotherapy
Session Category and Title: Clinical Research: Circulating and Cell-free Biomarkers for Diagnosis and Monitoring of Cancer 2
Session Date and Time: Monday, April 1, 2019, 8:00 am – 12:00 pm ET

Title: Comparison of the Epic CTC HRD assay vs. tumor DDR mutations in metastatic castration-resistant prostate cancer (mCRPC) patients (pts)
Session Category and Title: Clinical Research: Circulating and Cell-free Biomarkers for Diagnosis and Monitoring of Cancer 3
Session Date and Time: Monday, April 1, 2019, 1:00 pm – 5:00 pm ET

Title: Single-cell analyses reveal increasing intratumoral heterogeneity as an essential component of treatment resistance in small-cell lung cancer
Session Category and Title: Tumor Biology: Tumor Evolution and Heterogeneity 1
Session Date and Time: Tuesday, April 2, 2019 8:00 am – 12:00 pm ET

Title: Evaluation of pharmacokinetics of proxalutamide, a novel androgen receptor antagonist, in treatment for mCRPC patients via CTC enumeration and AR biomarker analysis
Session Category and Title: Experimental and Molecular Therapeutics: Pharmacokinetics and Pharmacodynamics/Preclinical Toxicology
Session Date and Time: Tuesday, April 2, 2019, 1:00 pm – 5:00 pm ET

Title: Simultaneous quantification of activated immune cells and PD-L1 expressing circulating tumor cells (CTCs) in peripheral blood of cancer patients receiving checkpoint inhibitor therapy
Session Category and Title: Immunology: Biomarkers and Immune Monitoring
Session Date and Time: Tuesday, April 2, 2019, 1:00 pm – 5:00 pm ET

On March 21, 2019 Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing proprietary liquid biopsy tests that provide clinically actionable information to physicians to improve cancer treatment, reported that it will release financial results for the three and 12 months ended December 31, 2018, after the market closes on Thursday, March 28, 2019 (Press release, Biocept, MAR 21, 2019, View Source [SID1234534563]). The Company will host a conference call for the investment community to discuss the results and answer questions at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

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Individuals interested in participating on the conference call may do so by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers, or (412) 902-4109 for other international callers. Those interested in listening to a webcast of the live conference call may do so by visiting View Source

A replay of the conference call will be available for 48 hours following the conclusion of the call by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers, or (412) 317-0088 for other international callers, and entering the replay access code 10128915. A webcast replay will be available for 90 days at http://ir.biocept.com/events.cfm.

On March 21, 2019 Cellular Biomedicine Group, Inc. (Nasdaq: CBMG) (CBMG or the Company), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the pricing of an underwritten public offering of 1,029,412 shares of its common stock at a public offering price of $17.00 per share (Press release, Cellular Biomedicine Group, MAR 21, 2019, View Source [SID1234534562]). In addition, the underwriters have been granted a 30-day option to purchase up to 154,411 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. Closing of the offering is expected to occur on or about March 25, 2019, subject to customary closing conditions. The gross proceeds to CBMG from this offering are expected to be approximately $17.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by CBMG. CBMG intends to use the net proceeds from this offering for preclinical studies, clinical trials, continued technology platform development, as well as for working capital and other general corporate purposes.

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Cantor Fitzgerald & Co. and Robert W. Baird & Co. Incorporated are acting as joint book-running managers for the offering.

The shares of common stock described above are being offered by CBMG pursuant to its shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (or SEC) and declared effective by the SEC on June 17, 2016. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by sending a request to: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, Wisconsin 53202, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of CBMG, nor will there be any sale of these securities in any state or other 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.

On March 21, 2019 CStone Pharmaceuticals ("CStone"; HKEX: 2616) reported that China’s National Medical Products Administration (NMPA) has approved the clinical trial application to begin a Phase 1 trial in China for BLU-667 (CS3009), a highly selective and potent RET inhibitor discovered by CStone’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, MAR 21, 2019, View Source [SID1234534561]). The study is part of Blueprint Medicines’ ongoing, global Phase 1 ARROW clinical trial for patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors. Trial objectives include overall clinical response, duration of response, pharmacokinetics, pharmacodynamics and safety.

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In June 2018, CStone and Blueprint Medicines entered into a license and collaboration agreement in which Blueprint Medicines granted CStone exclusive rights to develop and commercialize BLU-667 and two other drug candidates in Mainland China, Hong Kong, Macau and Taiwan.

Recently, BLU-667 was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of RET-mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

Based on the early clinical data and regulatory feedback, Blueprint Medicines has announced plans to submit a New Drug Application (NDA) to the U.S. FDA for BLU-667 in the first half of 2020.

"BLU-667 has already demonstrated its potential to produce clinical responses in several RET-altered tumor types, and there are currently no selective RET inhibitors approved globally," noted CStone Chairman and CEO Dr. Frank Jiang. "If the data generated in Chinese patients are consistent with global results, we plan to use the global and China data from the ARROW study to support NDA filings in China."

CStone’s Chief Medical Officer Dr. Jason Yang commented: "Currently available data show that non-small cell lung cancer and medullary thyroid cancer patients with RET altered tumors may benefit from BLU-667, with the potential to advance standards of care in these genetically defined populations. We will move forward on development of BLU-667 in China and hope to make this drug candidate available to Chinese patients as quickly as possible."

About BLU-667

BLU-667 is an investigational, once-daily oral precision therapy specifically designed for highly potent and selective targeting of oncogenic RET alterations. In preclinical studies, BLU-667 consistently demonstrated sub-nanomolar potency against the most common RET fusions, activating mutations and predicted resistance mutations. In addition, BLU-667 demonstrated markedly improved selectivity for RET compared to approved multi-kinase inhibitors, including more than 80-fold improved potency for RET versus VEGFR2. By suppressing primary and secondary mutants, BLU-667 has the potential to overcome and prevent the emergence of clinical resistance. This approach is expected to enable durable clinical responses across the range of RET alterations, with a favorable safety profile.

BLU-667 was designed by Blueprint Medicines’ research team, leveraging the company’s proprietary compound library. Blueprint Medicines is developing BLU-667 for the treatment of people with RET-altered NSCLC, MTC and other solid tumors. The U.S. FDA has granted Breakthrough Therapy Designation to BLU-667 for the treatment of RET-mutation-positive MTC.