Atara Biotherapeutics to Participate at Evercore ISI Second Annual HealthCONx Conference

On November 26, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Pascal Touchon, the Company’s President and Chief Executive Officer, will participate in a fireside chat at the Evercore ISI Second Annual HealthCONx Conference on Tuesday, December 3, 2019 at 3:50 p.m. EST (Press release, Atara Biotherapeutics, NOV 26, 2019, View Source [SID1234551696]).. The conference will be held at the Four Seasons Hotel in Boston, MA.

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A live audio webcast will be available by visiting the Investors and Media – Events and Presentations section of atarabio.com. An archived replay of the webcast will be available on the Company’s website for 14 days following the live webcast.

Applied DNA Sciences Subsidiary LineaRx Signs Agreement with TYME Technologies for Functional Invasive Circulating Tumor Cell Assay Services in Pancreatic Cancer Trial

On November 26, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN; the "Company" or "Applied DNA") reported that LineaRx, Inc., the Company’s majority-owned subsidiary focused on next-generation biotherapeutics and diagnostics, has signed a definitive agreement with Tyme Technologies, Inc. to supply the Company’s Vita-AssayTM invasive Circulating Tumor Cell (iCTC) capture assay and associated services for use in the pivotal stage of the TYME-88-PANC clinical trial for patients with third-line pancreatic cancer (the "Agreement") (Press release, Applied DNA Sciences, NOV 26, 2019, View Source [SID1234551695]).

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Under the terms of the Agreement, TYME has the option to purchase from the Company up to 3,000 Vita-Assay kits and associated iCTC analytical and storage services over the course of treatment of up to 250 patients. The potential value of the Agreement is the largest contract to-date for LineaRx, and the largest in the development history of the iCTC assay.

The Company and TYME have previously announced a study demonstrating correlation between the number of iCTCs in a patient’s blood and their disease status, as observed in TYME’s SM-88 Phase II trial for recurrent prostate cancer. The study demonstrated that SM-88 had very encouraging efficacy and safety outcomes for prostate cancer patients where sparing testosterone was important. The study also showed that reduction of CTCs, an important prognostic indicator, may prove to be a better surrogate for patient outcomes than PSA, particularly for SM-88 and other non-hormonal agents.

"We continue to commercialize our Vita-Assay functional iCTC capture assay and iCTC identification technologies, which we recently acquired in August of this year," said Dr. James Hayward, President, Chairman and CEO of Applied DNA. "We are excited to work with TYME to support their important pivotal stage trial for pancreatic cancer and, together with TYME, to potentially compile additional evidence of iCTC-count correlation with cancer disease status and therapeutic efficacy."

Dr. Giuseppe Del Priore, Chief Medical Officer of TYME, stated: "We are impressed by the distinguishing character of the iCTC assay developed by LineaRx; they have a functional assay which directly mimics the behavior of metastatic cells in the body, by capturing iCTCs after they invade a cellular adhesion matrix directly from fresh blood. These live metastatic cells can be counted and characterized by the unique biomarkers from LineaRx. iCTCs can be cultured and analyzed by the latest genomic methods."

Dr. Hayward concluded: "Our contract with TYME, and other recent collaborations not yet announced, will, we believe, help advance our understanding of the metastatic process and the underlying genomic changes that accompany late-stage cancers. We believe that an oral cancer treatment like SM-88 may be used as a monotherapy or in combination therapy across multiple cancers and potentially provide an opportunity to also intervene with genetic immunotherapeutic approaches that may one day be delivered via linear DNA."

Alexion to Present at the 2019 Evercore ISI HealthCONx

On November 26, 2019 Alexion Pharmaceuticals (Nasdaq:ALXN) reported that management will present at the 2019 Evercore ISI HealthCONx in Boston, MA on Tuesday, December 3rd, 2019 at 8:45 a.m. ET (Press release, Alexion, NOV 26, 2019, https://news.alexionpharma.com/press-release/financial-news/alexion-present-2019-evercore-isi-healthconx [SID1234551694]).

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

BIO-PATH HOLDINGS ANNOUNCES SUCCESSFUL COMPLETION OF SAFETY TESTING IN STAGE 2 OF PHASE 2 CLINICAL TRIAL IN ACUTE MYELOID LEUKEMIA

On November 26, 2019 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the successful completion of the safety testing of prexigebersen in combination with decitabine in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients in Stage 2 of the Phase 2 clinical study (Press release, Bio-Path Holdings, NOV 26, 2019, View Source [SID1234551689]). The safety segment of Stage 2 of the Phase 2 clinical trial comprised six evaluable patients who were treated with the combination of prexigebersen and decitabine.

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"We are especially pleased to have successfully completed this key safety segment of our Phase 2 study as it allows us to move forward to the next segment of this important clinical study, which is the final, efficacy portion of Stage 2 of the Phase 2 study," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We are in the process of completing the documentation to submit for final approval of this last portion of Stage 2 of the Phase 2 study. These results are encouraging and give us greater confidence in the successful development of this very promising combination therapy for AML and MDS patients."

Although the treatment combination of prexigebersen and decitabine is not the treatment planned for the efficacy evaluation of Stage 2 of the Phase 2 clinical trial, the efficacy profile in this safety segment of the study was encouraging with 50% of patients having a response, including two patients (33%) showing complete responses with incomplete hematologic recovery and one patient (17%) showing partial response. For reference, in this class of AML and MDS patients, the complete response rate to treatment with decitabine alone is approximately 20%. Some patients are continuing to receive treatment.

As previously reported, Stage 1 of the Phase 2 clinical trial, which treated de novo AML patients with a combination of low dose cytarabine (LDAC) and prexigebersen, demonstrated similar safety results and efficacy compared favorably to treatment of this class of patients with LDAC alone. We believe that prexigebersen with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapy. The recent approval of the frontline therapy venetoclax provided an opportunity for adding prexigebersen to the combination of venetoclax and decitabine for the treatment of AML and MDS patients. The first step in this process was establishing the safety of combining prexigebersen and decitabine prior to proceeding to a combination treatment of prexigebersen, decitabine and venetoclax.

Bio-Path’s amended Stage 2 of the Phase 2 clinical trial will have two cohorts of patients. The first cohort will include untreated AML patients as existed in the pre-amended trial but with the addition of untreated high risk MDS patients, and a second cohort will include refractory/relapsed AML patients and high risk MDS patients. Both cohorts of patients will be treated with the combination of prexigebersen, decitabine and venetoclax. The Company is finalizing amendments to add this combination treatment to Stage 2 of the Phase 2 clinical trial.

Curis to Present at 31st Annual Piper Jaffray Healthcare Conference

On November 26, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that James Dentzer, Chief Executive Officer of Curis, will present at the 31st Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2019 at 11:30 a.m. ET in New York, NY (Press release, Curis, NOV 26, 2019, View Source [SID1234551688]).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.