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Diffusion Pharmaceuticals Chief Scientific Officer Dr. John L. Gainer to Present at 2018 Annual Meeting of the Society for NeuroOncology

On November 15, 2018 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it’s needed most, reported that Chief Scientific Officer Dr. John L. Gainer will join leading clinicians and researchers from around the world in presenting a poster at the 2018 Annual Meeting of the Society for NeuroOncology (SNO) on Saturday, November 17, 2018 from 5:00-7:00pm EST (Press release, Diffusion Pharmaceuticals, NOV 15, 2018, View Source [SID1234531433]).

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SNO’s 23rd Annual Scientific Meeting and Education Day will be held from Thursday, November 15, 8:00am through Sunday, November 18, 1:00pm at the Marriott Hotel, New Orleans, Louisiana. SNO is a "multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education" whose annual conference is an opportunity for top health care professionals who specialize in central nervous system tumors to gather and present the latest advancements to fellow researchers, hospital administrators, and potential investors.

Dr. Gainer, who in addition to serving as the Chief Scientific Officer of Diffusion is also the inventor of Trans Sodium Crocinate (TSC), will present a poster on the Company’s Phase 3 INTACT (INvestigation of TSC Against Cancerous Tumors) clinical trial for the treatment of glioblastoma multiforme (GBM) brain cancer in biopsy-only patients. Phase 2 of Diffusion’s INTACT trial showed potentially breakthrough results in the use of TSC in treatment: a fourfold increase in the two-year survival rate of biopsy-only patients, which jumped from 10 percent to 40 percent. This result is especially promising for these patients and their families: biopsy-only patients have historically faced lower survival rates than patients for whom resection (surgery for removal of the tumor) is an option.

"Dr. Gainer’s focus on innovation is what drew me to his research in the first place, and resulted in our co-founding of Diffusion, where we continue our efforts to find new and effective treatments for life-threatening diseases like GBM brain cancer," said David Kalergis, Chairman and CEO of Diffusion. "At the 2018 Annual Meeting of the Society of NeuroOncology, Dr. Gainer will have an opportunity to present the exciting results from our Phase 2 GBM cancer trial and share our continued Phase 3 efforts for biopsy-only participants – work which represents real potential and promise for patients and their families"

"Finding effective and life-saving treatment for patients living with biopsy-only GBM brain cancer has long been a significant challenge for researchers, scientists, and physicians, so I’m looking forward to my poster presentation at the 2018 Annual Meeting of the Society of NeuroOncology, as it’s a chance to share the progress we’ve made on this front," said Dr. John L. Gainer, Chief Scientific Officer of Diffusion. "Hypoxic tumors are resistant to radiation therapy, and our Phase 2 results showed that using TSC – which was developed to fight hypoxia by bringing oxygen to the areas where it’s needed most – in conjunction with radiation and temozolomide (TMZ) treatment led to a significant increase in survival for biopsy only patients. Our Phase 3 study will focus on these biopsy-only patients, and I am eager to share that work with my colleagues from around the world at SNO’s 2018 Annual Meeting."

Diffusion’s Phase 3 INTACT program is using TSC to target inoperable GBM brain cancer. Historically, these biopsy-only patients have faced lower survival rates and increased obstacles to inclusion in clinical trials. Current standard of care for these GBM patients following diagnosis involves 6 weeks of radiation therapy along with daily temozolomide (TMZ), followed by six 4-week chemotheraphy sessions which include a high dosage of TMZ. Phase 2 of INTACT saw treatment with TSC added to the initial six weeks of radiation therapy and TMZ treatment. Phase 3 of INTACT will include treatment with TSC during the initial six week of radiation therapy and TMZ treatment, but will also include administration of TSC during the six months of chemotheraphy. The Company is currently engaged in an FDA-requested, 8-patient lead-in, scheduled to complete in January 2019. Randomization can begin following read out and reporting of that data."

Dr. Gainer’s presentation at SNO is just the latest development for Diffusion, which recently received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial testing TSC for the treatment of both ischemic and hemorrhagic stroke. The Company also recently appointed William "Bill" Hornung to the position of Chief Financial Officer.

BIO-PATH HOLDINGS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS

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]).

"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.

Aradigm Announces Third Quarter 2018 Financial Results

On November 15, 2018 Aradigm Corporation (NASDAQ: ARDM) (the "Company") reported financial results for the third quarter and nine months ended September 30, 2018 (Press release, Aradigm, NOV 15, 2018, View Source [SID1234531428]).

Third Quarter 2018 Financial Results

The Company recorded $282,000 in revenue in the third quarter of 2018 compared with $2.7 million in revenue in the third quarter of 2017. The Company recognized $170,000 in contract revenue-related party, $52,000 in government contract revenue and $60,000 in government grant revenue for the third quarter of 2018, as compared to $2.7 million in contract revenue-related party, $6,000 in government contract revenue and $13,000 in government grant revenue for the third quarter of 2017.

Total operating expenses for the third quarter of 2018 were $2.8 million, compared with total operating expenses of $5.7 million for the third quarter of 2017. The decrease in research and development expenses of $2.0 million was due to a lower regulatory spend in support of Linhaliq during the ongoing EMA review process of the validated MAA submission and our ongoing interaction with the FDA to address the issues raised in their complete response letter dated 26 January 2018. The decrease in research and development expenses for the quarter was also due to lower employee related expenses from a reduction in headcount. The decrease in general and administrative expenses of $0.9 million was primarily related to lower legal expenses, lower consulting expenses and lower employee-related expenses due to a reduction in headcount.

Net loss for the third quarter of 2018 was $3.6 million or $(0.24) per share, compared with a net loss of $3.9 million or $(0.26) per share in the third quarter of 2017. For the quarter ended September 30, 2018, the net loss decreased by $0.3 million primarily from a decrease in operating expenses of $2.9 million offset by a decrease in revenue of $2.4 million and an increase of $0.2 million in other interest expense.

Liquidity and Capital Resources and Related Matters

As of September 30, 2018, the Company reported cash and cash equivalents of $2.9 million. During the second and third quarters of 2018 Aradigm raised an aggregate of approximately $7.0 million through the issuance and sale of promissory notes. In October 2018, Aradigm entered into an additional note purchase agreement for the issuance and sale of approximately $4 million in promissory notes, of which $2.0 million of promissory notes were issued and sold on October 25,

2018. Subject to the satisfaction of certain conditions, the Company anticipates that an additional closing for the issuance and sale of $2.0 million of promissory notes will occur prior to December 31, 2018. The Company believes that the $2.0 million received in October along with the cash balance of $2.9 million will be sufficient to fund operations through the fourth quarter of 2018. Aradigm is pursuing potential alternatives to resolve our cash position in the short-term as well as developing strategic options that would provide for our long-term viability. However, no assurance can be given that we will be successful in raising such additional capital on favorable terms or at all. Not achieving such funding on a timely basis would materially harm our business, financial condition and results of operations and could require us to delay or reduce the scope of all or a portion of our development programs, dispose of our assets or technology or to cease operations entirely.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the US. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition

Tolero Pharmaceuticals Presents Clinical Data of AXL Kinase Inhibitor TP-0903 Showing its Ability to Enhance Host Immune Responses to Tumors

On November 15, 2018 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported the presentation of clinical and preclinical data supporting the development of TP-0903 for the treatment of patients with solid tumors (Press release, Tolero Pharmaceuticals, NOV 15, 2018, View Source [SID1234531405]). TP-0903 is an oral, small molecule inhibitor of the AXL receptor tyrosine kinase. Key findings from syngeneic mouse models suggest that TP-0903 has immune activating potential leading to enhanced host immune responses in tumor models.

The data will be presented at the 2018 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in Dublin. Posters will be on display from 10:00 a.m. to 2:00 p.m. GMT on Nov. 16 in the Exhibition Hall of the Convention Centre Dublin.

"There is a significant need to develop new cancer therapeutic solutions aimed at strengthening the body’s own immune response," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals, Inc. "AXL kinase is an important oncolytic target; we are encouraged by the findings of TP-0903 showing the inhibition of AXL kinase, demonstrating enhanced host immunity. We look forward to further developments of TP-0903 in counteracting AXL-mediated effects."

The data show that TP-0903 treatment alters tumors by suppressing the mesenchymal phenotype of the cancer cells and favoring a tumor microenvironment amenable to an immune response. Preclinical models in immune competent animals show modulation of immune cell populations, including neutrophils, regulatory T-cells, and dendritic cells, in the tumors. Additionally, the predictive power of soluble AXL levels in the serum of cancer patients as a biomarker to select patients likely to benefit from TP-0903 treatment will be presented.

Recent data suggest that AXL kinase is involved in tumor cell proliferation and development of resistance to chemotherapeutics. TP-0903 is an AXL receptor tyrosine kinase inhibitor, which has showed nanomolar activity in biochemical assays. In this preclinical study, the immune modulating capabilities were assessed using immunohistochemical and real-time PCR techniques in syngeneic mouse models of solid tumors.

The associated abstract #413, PB-076, is available on the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) meeting program website.

About TP-0903
TP-0903 is an investigational oral, small molecule inhibitor of the AXL receptor tyrosine kinase (RTK), which has demonstrated effectiveness in cell-based and animal models of human cancers. The first-in-human Phase 1/1b study is underway identifying the safety and tolerability profile of TP-0903. In addition, the study is analyzing the pharmacodynamics of TP-0903 by assessing biomarkers in patients’ samples before and after treatment with TP-0903, including markers of immune suppression.

About AXL Kinase
AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers. It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.1,2

DNAtrix To Present Interim Phase 2 Results of DNX-2401 with Pembrolizumab for Glioblastoma

On November 15, 2018 DNAtrix, a leader in oncolytic virus immunotherapies for cancer, reported that it will present interim results from the ongoing Phase 2 trial of its oncolytic virus DNX-2401 (tasadenoturev) with pembrolizumab for patients with recurrent glioblastoma at the upcoming 2018 Annual Meeting of the Society for Neuro-Oncology (SNO) which is being held in New Orleans, Louisiana from November 15th – 18th (Press release, DNAtrix, NOV 15, 2018, View Source [SID1234531404]).

CAPTIVE / KEYNOTE-192 is a Phase 2 multicenter, dose escalation study evaluating a single intratumoral injection of DNX-2401 followed by standard dosing with pembrolizumab every three weeks to determine the optimal dose, safety, and efficacy in patients with recurrent glioblastoma. Preliminary results demonstrate that DNX-2401 with pembrolizumab is well tolerated, and associated with promising survival.

"I am excited by the early results of the trial. We have had some very remarkable responses. If I had not done the case myself, I would not have believed the complete response we have seen in one of our patients," said Gelareh Zadeh, MD, Associate Professor at the Department of Surgery University of Toronto, and presenting author for the CAPTIVE / KEYNOTE-192 study.

"There are limited treatment options for patients with this devastating disease, and we are encouraged by the initial data showing safety and disease control with the combination of DNX-2401 and pembrolizumab," added Frank Tufaro, PhD, CEO of DNAtrix. "We are pleased that enrollment is nearly complete and we are looking forward to maturation of the survival data."

DNAtrix collaborators will present additional results from studies of DNX-2401 (a.k.a. Delta-24-RGD) and murine DNX-2440 (a.k.a. Delta-24-RGDOX), an oncolytic adenovirus expressing the immune modulator OX40 ligand. Details of the presentations are as follows:

Interim results of a phase II multicenter study of the conditionally replicative oncolytic adenovirus DNX-2401 with pembrolizumab (Keytruda) for recurrent glioblastoma; CAPTIVE Study (KEYNOTE-192)
Date: Saturday, November 17
Abstract Number: ATIM-24
Presenter: Gelareh Zadeh, MD, University Health Network, University of Toronto, Toronto, ON, Canada
To access the abstract, click here >

Inflammatory reprogramming of gliomas using Delta-24-RGDOX and immunometabolic adjuvants
Date: Friday, November 16
Abstract Number: EXTH-27
Presenter: Teresa Nguyen, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
To access the abstract, click here >

Local oncolytic adenovirus treatment affects both the innate and adaptive arms of the immune system and provides an avenue for enhancing immunotherapies for GBM
Date: Friday, November 16
Abstract Number: EXTH-03
Presenter: Martine Lamfers, PhD, Erasmus Medical Center, Rotterdam, Netherlands
To access the abstract, click here >

In Situ Autovaccination Mediated by Oncolytic Adenovirus Delta-24-RGDOX Induces Efficacious Immunity Against Metastatic Melanoma
Date: Saturday, November 17
Abstract Number: EXTH-30
Presenter: Hong Jiang, PhD, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
To access the abstract, click here >

Delta-24-RGD in combination with positive regulators of the immune synapsis for gliomas in adults and children
Date: Sunday, November 18
Oral Presentation: Juan Fueyo, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

For more information about ongoing DNAtrix clinical studies, visit the ClinicalTrials.gov website: NCT02798406 (DNX-2401 + pembrolizumab for recurrent glioblastoma), NCT03178032 (DNX-2401 for newly diagnosed pediatric diffuse intrinsic pontine glioma, DIPG), and NCT03714334 (DNX-2440 for recurrent glioblastoma).

About DNX-2401 (Tasadenoturev)
DNX-2401 is an investigational oncolytic immunotherapy designed to treat cancer. DNX-2401 sets off a chain reaction of tumor cell killing by selectively replicating within cancer cells (but not normal cells), causing tumor destruction and further spread of the oncolytic virus to adjacent tumor cells. This process then triggers an immune response directed against the tumor. Previous studies demonstrated that DNX-2401 was well tolerated, provided clinical benefit, and extended survival for patients with recurrent glioblastoma.