On November 15, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the third quarter ended September 30, 2018 (Press release, Heat Biologics, NOV 15, 2018, View Source [SID1234531356]).

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Jeff Wolf, Heat’s CEO, commented, "We continue to advance our Phase 2 trial investigating our lead candidate HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC). We intend to announce updates regarding interim Phase 2 data in the fourth quarter of 2018 and plan to complete patient enrollment in Q2 2019. Given the positive interim results we reported earlier this year, which included durable responses to HS-110 in difficult-to-treat low TIL and low PD-L1 patients, we have seen increased interest from within the industry for improving outcomes for those patients least likely to respond to checkpoint inhibitors alone.

"We have completed a Pre-IND Type B meeting with FDA for our next-generation ComPACT product and plan to file our Phase 1 Investigational New Drug (IND) in the first quarter of 2019. Our ComPACT therapy combines T-cell activation and co-stimulation within a single treatment, simplifying combination immunotherapy while potentially providing superior immune activation at reduced treatment costs.

"Finally, we are also on track to submit an IND for PTX-35, our novel co-stimulatory antibody designed to harness the body’s natural antigen-specific immune activation mechanisms, in the first quarter of 2019. We are encouraged by the preliminary pre-clinical efficacy and safety data which shows a positive toxicity profile across a wide range of doses.

"Importantly, we ended the quarter with a strong cash balance of $21.0 million and expect to receive an additional $6.9 million in CPRIT grant funds for PTX-35 within the next few months. Combined, these funds should provide us with sufficient capital to significantly advance our clinical programs through a number of key milestones, including completion of our Phase 2 trial of HS-110, which holds the potential to drive significant value for shareholders."

Third Quarter 2018 Financial Results

Recognized $1.8 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses increased approximately 144.4% to $4.4 million for the three months ended September 30, 2018 compared to $1.8 million for the three months ended September 30, 2017.
General and administrative expense increased approximately 33.3% to $1.6 million for the three months ended September 30, 2018 compared to $1.2 million for the three months ended September 30, 2017. The $0.4 million increase consists of professional services/consulting fees associated with our 2018 Annual Meeting of Shareholders as well as an increase in investor relations and new business development fees during the three months ended September 30, 2018.
Net loss attributable to Heat Biologics was $3.7 million, or ($0.16) per basic and diluted share for the three months ended September 30, 2018 compared to a net loss of $2.3 million, or ($0.64) per basic and diluted share for the three months ended September 30, 2017.
As of September 30, 2018, the Company had approximately $21.0 million in cash and cash equivalents.

On November 15, 2018 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it will make a presentation on its EZH2 inhibition program in prostate cancer at an upcoming biomedical conference (Press release, Constellation Pharmaceuticals, NOV 15, 2018, View Source [SID1234531377]).

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Bill Bradley, Ph.D., Associate Director, Translational Sciences, at Constellation, will give a poster presentation at the EORTC / NCI / AACR (Free AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in Dublin, Ireland, on November 16. The presentation is titled "EZH2 Inhibition as an Effective Treatment for Metastatic Castration-Resistant Prostate Cancer." The presentation discusses preclinical evidence showing the effectiveness of the EZH2 inhibitor CPI-1205 in treating metastatic castration-resistant prostate cancer (mCRPC) dependent on androgen receptor signaling (ARS). CPI-1205 was shown to combine synergistically with ARS inhibitors, such as enzalutamide or abiraterone acetate, to inhibit the growth of prostate cancer cell models and also was effective in overcoming mechanisms of resistance to ARS inhibitors. The poster also includes transcriptomic analysis, including single-cell RNA sequencing, highlighting the mechanisms by which CPI-1205 and its combination with ARS inhibitors restrict prostate cancer growth. The data shown in the poster supports the potential of EZH2 inhibition as a therapeutic approach for the mCRPC patient population and contributes to the rationale for Constellation’s ProSTAR trial of the EZH2 inhibitor CPI-1205 used in combination with ARS inhibitors.

About EZH2 Inhibition in Prostate Cancer

EZH2 is an enzyme that acts as an epigenetic writer and normally regulates gene expression by placing one or more methyl groups on a histone protein, leading to the suppression of gene expression programs. While this effect of EZH2 on gene expression is a normal part of cellular development, some cancers depend on an abnormal pattern of gene expression and re-direct EZH2 to genes that become abnormally repressed. Cancer cells with these abnormal gene expression programs may be more resistant to anti-cancer therapies.

There is a strong association between EZH2 expression and disease progression in metastatic castration-resistant prostate cancer (mCRPC), and a therapeutic approach that targets EZH2 may result in better outcomes than those achieved with approved therapeutic agents that treat mCRPC. In prostate cancer, the androgen receptor is a key regulator of gene expression and acts as the mediator of androgen signaling in prostate cells. The AR signaling pathway is the primary pathway used by prostate cancer cells to promote tumor growth. We believe that EZH2, by suppressing certain gene sets, enhances AR signaling, which can lead to increased tumor growth. In preclinical studies, we observed enhanced gene expression changes in prostate cancer cells treated with a combination of enzalutamide and CPI-1205 as compared to enzalutamide treatment alone. This corroborates our hypothesis that EZH2 functionally cooperates with androgen receptor signaling to promote prostate cancer growth.

We also believe that EZH2 is utilized by prostate cancer cells to establish resistance to ARS inhibitors. We have observed in preclinical studies that EZH2 inhibitors, such as CPI-1205, in combination with ARS inhibitors synergistically killed tumor cells and demonstrated activity in models that are resistant to ARS inhibitors.

About CPI-1205

CPI-1205 is a small molecule designed to promote anti-tumor activity by specifically inhibiting EZH2, an enzyme that suppresses target gene expression. In preclinical studies, we observed that CPI-1205 inhibited tumor growth as a single agent and synergistically enhanced the efficacy of cancer therapies, including ARS inhibitors in a prostate cancer model and immune checkpoint inhibitors in other solid tumor models. Based on these observations and the limited options for patients who progress on ARS inhibitors or immune checkpoint inhibitors, we have prioritized clinical development of CPI-1205 as a combination therapy with ARS inhibitors in prostate cancer and immune checkpoint inhibitors in solid tumors. We are currently conducting the ProSTAR trial. We previously completed a Phase 1 clinical trial of CPI-1205 as a monotherapy in patients with relapsed B-cell lymphoma in which CPI-1205 demonstrated clinical activity and was well tolerated.

About the ProSTAR Clinical Trial

ProSTAR is an open-label Phase 1b/2 clinical trial of CPI-1205 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in combination with enzalutamide or abiraterone acetate, which are second-generation ARS inhibitors, in patients with mCRPC who previously progressed on treatment with either abiraterone acetate or enzalutamide. Patients who have previously progressed on treatment with abiraterone acetate are treated with a combination of enzalutamide and CPI-1205, and patients who previously progressed on treatment with enzalutamide are treated with a combination of abiraterone acetate and CPI-1205. In the Phase 1b portion of this trial, we aim to establish safety, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and a recommended Phase 2 dose of CPI-1205 with these agents. Based on results from the Phase 1b trial, we expect to select either abiraterone acetate or enzalutamide to be combined with the optimal dose regimen of CPI-1205 for the Phase 2 portion of the trial. In the Phase 2 trial, we will assess response rate as the primary endpoint, defined as the proportion of patients who have any of (i) a prostate-specific-antigen reduction of 50% or more from baseline, (ii) a decline of 30% or more in circulating-tumor-cell count from baseline or (iii) for patients with measurable soft tissue disease, an objective response, defined as a complete response or partial response per RECIST 1.1 criteria.

On November 15, 2018 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 its financial results for the third quarter ended September 30, 2018 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 15, 2018, View Source [SID1234531429]).

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"Throughout the third quarter, we continued to make meaningful progress advancing and expanding our robust clinical development pipeline of RNAi nanoparticle drugs to bring innovative new treatments to cancer patients with high unmet medical need," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Most recently, we were delighted to report that interim data from our ongoing Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia (AML) were accepted for poster presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) taking place in early December 2018. This is an exciting opportunity to showcase this very promising program as earlier studies showed 47% of evaluable patients demonstrated some degree of response to prexigebersen in combination with LDAC in this patient population. In addition, we were pleased to report the dosing of the first patient in Stage 2 of this Phase 2 clinical trial where, at the recommendation of the study’s principal investigators, we are implementing a change in the dosing regimen administering a higher dosing of prexigebersen prior to starting treatment with LDAC. We also initiated a cohort of the Phase 2 AML trial assessing prexigebersen in combination with decitabine. We look forward to having interim results from these cohorts next year.

"We are also making progress expanding our clinical programs beyond AML. Enrollment in our global Phase 2 clinical trial of prexigebersen for the treatment of chronic myeloid leukemia (CML) continues apace and we continue to advance work on an Investigational New Drug (IND) application for prexigebersen for the treatment of solid tumors. In addition, we plan to submit an IND application by year-end to begin studies of our second drug candidate, BP1002, which targets Bcl-2 for the treatment of lymphoma and CLL. Finally, we continue our work to advance our third investigation drug candidate, BP1003, in pancreatic cancer. Toward that end, we were especially pleased to welcome Jason Fleming, MD, FACCP, to our Scientific Advisory Board (SAB). Dr. Fleming is a renowned gastrointestinal cancer specialist whose insight and guidance will be of particular value to the development of this clinical program.

"The considerable progress made in 2018 provides the foundation from which we expect to build and advance our new pathway in DNA-powered medicines into 2019 and beyond," concluded Mr. Nielsen.

Recent Corporate Highlights

·Interim data from the ongoing Phase 2 clinical trial of prexigebersen for the treatment of AML accepted for poster presentation at ASH (Free ASH Whitepaper) 2018. In November 2018, Bio-Path announced that data from its ongoing Phase 2 clinical trial of prexigebersen will be presented at ASH (Free ASH Whitepaper) 2018 by Maro Ohanian, MD, Assistant Professor of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, before an audience of the world’s leading blood cancer specialists.

·Commenced Stage 2 of the Company’s Phase 2 trial of prexigebersen in AML. In August 2018, Bio-Path announced the dosing of the first patient in the open-label Phase 2 study evaluating the efficacy and safety of prexigebersen in conjunction with LDAC and a second cohort of prexigebersen and decitabine, both therapeutic regimens well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether these combinations with prexigebersen provides greater efficacy than what would be expected with LDAC or decitabine alone in this de novo patient population.

·Appointed Dr. Fleming to the Company’s Scientific Advisory Board. In August 2018, Bio-Path appointed Dr. Fleming, a world-leading gastrointestinal cancer expert, to its SAB. Dr. Fleming offers substantial insight as the Company seeks to advance its lead drug candidate, prexigebersen, and its third drug candidate, BP1003, towards the clinic for the treatment of pancreatic cancer.

·Raised $1.5 million in a registered direct offering. In September 2018, Bio-Path issued and sold 2,261,538 shares of its common stock (or common stock equivalent) for a price of $0.65 per share, for gross proceeds of approximately $1.5 million. Additionally, in a concurrent private placement, Bio-Path issued to such investors unregistered warrants to purchase up to 2,261,538 shares of common stock with an exercise price of $0.96 per share and an exercise period commencing six (6) months following the issuance date and a term of five and one-half (5.5) years from the date of issuance.

Financial Results for Third Quarter Ended September 30, 2018

·The Company reported a net loss of $3.1 million, or $0.27 per share, for the three months ended September 30, 2018, compared to a net loss of $2.5 million, or $0.25 per share, for the three months ended September 30, 2017.

·Research and development expenses for the three months ended September 30, 2018 increased to $2.3 million, compared to $1.6 million for the three months ended September 30, 2017 primarily due to costs related to the release of drug material for our Phase 2 clinical trials for prexigebersen in AML and CML.

·General and administrative expenses for the three months ended September 30, 2018 decreased to $0.7 million, compared to $0.9 million for the three months ended September 30, 2017 primarily due to decreased legal and audit fees.

·As of September 30, 2018, the Company had cash of $2.3 million, compared to $6.0 million at December 31, 2017. Net cash used in operating activities for the nine months ended September 30, 2018 was $4.8 million compared to $5.7 million for the comparable period in 2017. Net cash provided by financing activities for the nine months ended September 30, 2018 was $1.2 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these third quarter 2018 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 8564777. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On November 15, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that Lori Kunkel, M.D. has been named acting chief medical officer, effective November 26, 2018 (Press release, Tocagen, NOV 15, 2018, View Source;p=RssLanding&cat=news&id=2377408 [SID1234531471]). Asha Das, M.D., senior vice president and chief medical officer will be leaving the company effective November 23, 2018 to allow her to focus on unforeseen and immediate personal matters. The company has initiated a search process to fill the position.

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"On behalf of the management team and Board of Directors, we are thankful for the significant contributions Asha has made over the past three years," said Marty J. Duvall, chief executive officer of Tocagen. "With Lori’s remarkable track record in the biotechnology industry coupled with her deep familiarity of our program and clinical data we look forward to working closely with her to advance our cancer-selective gene therapy platform, and our lead product candidate. This transition is not expected to impact our current business plans or development timelines."

Among other responsibilities, Dr. Kunkel previously served as acting chief medical officer of Loxo Oncology, Inc, chief medical officer of Pharmacyclics LLC, acquired by AbbVie Inc., and chief medical officer of Proteolix, Inc., acquired by Onyx Pharmaceuticals. Dr. Kunkel currently serves on the board of directors of Loxo Oncology, Inc., a publicly held biotechnology company, Curis, Inc., a publicly held biotechnology company, and Maverick Therapeutics, Inc., a privately held biotechnology company. A full biography is available here. In connection with Dr. Kunkel’s appointment as acting chief medical officer of Tocagen, Dr. Kunkel will be temporarily leaving the board of directors of Tocagen in order for the company to maintain compliance with the Nasdaq listing rules regarding independent directors.

"Being dedicated to the development of new treatment options for patients with brain cancer, I am extremely grateful to have worked closely with the Tocagen team on advancing Toca 511 & Toca FC and regret having to leave the company at this time," said Dr. Das. "I am excited about the potential of the Toca 5 trial and future development in newly diagnosed brain cancer to positively impact patients around the world."

On November 15, 2018 Atlanta, GA and New York) Lori Chmura, CEO of Dune Medical Devices, reported that maker of the successful MarginProbe device is scheduled to present at the Canaccord Genuity Medical Technologies and Diagnostics Forum on Thursday, November 15th at 2:30 p.m. EST at the Westin Grand Central in New York, NY (Press release, Dune Medical Devices, NOV 15, 2018, View Source [SID1234531341]).

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The presentation will be available as a webcast at dunemedical.com/investors.

Dune Medical Devices is a commercial-stage company revolutionizing tissue characterization technology in breast cancer surgery, diagnosis and targeted treatment with its proprietary Radio-Frequency Spectroscopy Technology (RFST). Dune’s first commercial product, MarginProbe, in routine commercial use in 70 hospitals and in over 16,000 surgeries in the US and Israel, has been proven to identify positive margins during breast conservation surgery, enabling surgeons to immediately remove additional microscopic residual cancer, thereby reducing the need for repeat surgeries. The second generation of the RFST, in development, serves as a platform to enhance diagnostic accuracy by providing pathologists with tissue characterization data alongside biopsy samples to increase interpretation accuracy and eliminate unnecessary procedures and costs

Dune is entering a phase of commercial growth and expansion of its RFST platform to establish RFST data as a unique tissue biomarker that provides information complementary to molecular (e.g., genomic) biomarkers for optimal personalized treatment selection and adoption of new therapies