On July 26, 2018 Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that it has entered a Sponsored Research Agreement ("Agreement") with The University of Texas MD Anderson Cancer Center under which Genprex will sponsor a pre-clinical study, entitled "A Novel Therapeutic Approach for the Treatment of Cancer Using a Combination of the Multifactorial Tumor Suppressor Gene TUSC2 and Immunotherapy," to be conducted under the direction of Jack A. Roth, MD, FACS (Press release, Genprex, JUL 26, 2018, View Source [SID1234529158]). TUSC2 is the active agent in Genprex’s investigational drug candidate Oncoprex.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study, which is built upon strong data from pre-clinical research conducted at MD Anderson, is intended to develop a novel therapeutic approach for the treatment of cancer using a combination of the multifactorial tumor suppressor gene TUSC2 and immunotherapy, including the immune checkpoint inhibitors anti-PD1 and/or anti CTLA-4. The study will include the identification of biomarkers to predict the response to TUSC2-immunotherapy combinations.

Under the Agreement, MD Anderson will provide all necessary personnel, equipment, supplies, facilities and resources to perform the study; and Genprex will pay MD Anderson an amount equal to its expenditures and reasonable overhead in conducting the study in an amount of $2.0 million.

"This research program will evaluate the ability of TUSC2 gene therapy to synergistically enhance the effect and clinical utility of anti-PD1 and/or anti-CTLA-4 therapies," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "Identifying biomarkers that can predict response rates for Oncoprex-immunotherapy combinations may allow us to explore the utility of this treatment regimen in a broader array of cancers."

Varner added, "While immunotherapies represent an important advance in treating cancer, even in highly immunogenic tumors, the majority of patients do not respond to checkpoint inhibition. Combination therapies targeting multiple anti-cancer pathways represent a promising approach to achieving greater response rates, and may also allow the expanded use of immunotherapies in a larger population of cancer patients who are not currently candidates for these treatments."

Researchers at MD Anderson reported data from preclinical research at the 2017 meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) demonstrating that TUSC2 alone or in combination with checkpoint blockade (anti-PD-1 and/or anti-CTLA4) significantly prolonged mouse survival in a non-small cell lung cancer metastasis model compared to checkpoint blockade alone. The greatest increase in survival was seen with TUSC2 combined with checkpoint blockade. The treatment response was associated with high infiltration of natural killer (NK) cells and CD8 T cells, and low infiltration of myeloid-derived suppressor cells (MDSC) in the tumor microenvironment.

On July 26, 2018 DCprime reported that the results of the phase I study with its lead product DCP-001 in AML have been published in Cancer Immunology, Immunotherapy (Press release, DCPrime, JUL 26, 2018, View Source [SID1234529906]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The phase I study was conducted with DCP-001 in 12 advanced-stage elderly AML patients. Primary objectives of the study (feasibility and safety) were achieved with 10 out of the 12 patients completing the vaccination program. Treatment was well tolerated and it is concluded that DCP-001 in elderly AML patients is safe, feasible and generates both cellular and humoral immune responses.

Prof Dr Arjan van de Loosdrecht, Amsterdam UMC, VU University Medical Center, The Netherlands commented: "We are very glad that the phase-I study with the DCP-001 vaccine in AML is published, showing that it is safe, feasible and well tolerated. In addition, the vaccine generates both cellular and humoral immune responses and maintenance of these responses are observed in patients with a relatively long survival, suggesting a possible correlation. We are looking forward to the data of the phase-2 study, ADVANCE-II for patients with AML in complete remission after induction therapy with persistence of minimal residual disease, which is currently open for inclusion."

Dr Erik Manting, CEO of DCprime added: "Compliments to Prof Dr Arjan van de Loosdrecht and Prof Dr Tanja de Gruijl at VU University Medical Center and all others including our DCprime colleagues who contributed to this publication on the clinical study data with DCP-001 in AML. It underlines the promise and potency of the DCOne platform, which we continue to explore in AML and other cancer types."

On July 26, 2018 Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, reported financial results for the second quarter ended June 30, 2018 (Press release, Pain Therapeutics, JUL 26, 2018, View Source [SID1234527905]). Net loss was $2.5 million, or $0.36 per share. This compared to a net loss of $4.2 million, or $0.64 per share, for the same period in the prior year. Cash and cash equivalents were $9.6 million as of June 30, 2018, with no debt.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target date of August 7, 2018 for the New Drug Application (NDA) for REMOXY ER, the Company’s lead product drug candidate, which is a unique, abuse-deterrent, twice-daily formulation of extended-release oxycodone.

On June 26, 2018, an FDA Advisory Committee voted 14-to-3 against REMOXY ER. The purpose of an Advisory Committee is to provide advice; however, FDA makes all final regulatory decisions.

Financial Highlights for Second Quarter 2018

Net loss for the quarter was $2.5 million, or a net loss per share of $0.36. This compared to a net loss of $4.2 million, or $0.64 per share, for the same period in the prior year, representing a 41% decrease.

Cash and cash equivalents were $9.6 million at June 30, 2018. This compared to $10.7 million in the prior quarter, representing a 10% decrease. We have no debt.

We believe existing capital resources are sufficient to meet our projected operating requirements for at least the next 12 months.

We received $0.4 million in research grant funding from the National Institutes of Health, recorded as a reduction in research and development expenses (R&D).

R&D expenses were $1.5 million. This compared to $3.1 million for the same period in the prior year, representing a 52% decrease. R&D expenses included non-cash stock related compensation costs of $0.3 million for both current period and the prior year period.

General and administrative (G&A) expenses were $1.0 million. This compared to $1.1 million for the same period in the prior year, representing a 10% decrease. G&A expenses included non-cash stock-related compensation costs of $0.4 million for both current period and the prior year period.
About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is in registration with the US Food and Drug Administration (FDA) as a new type of abuse-deterrent, twice-daily, capsule gel formulation of oral oxycodone, a strong opioid drug. REMOXY ER has physical/chemical properties intended to deter abuse and still provide 12 hours of steady pain relief when properly prescribed by physician and used appropriately by patients. REMOXY ER intends to address the public health epidemic related to prescription opioids by advancing the science of abuse deterrence, providing an additional treatment option for physicians and patients, and increasing the range of available abuse deterrent technologies.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remain serious, persistent problems. Opioid overdose deaths exceeded 64,000 in 2016, according to the Center for Disease Control (CDC). For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it more difficult, longer or aversive to abuse long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

Our Pipeline of Drug Assets also Includes:
PTI-125 – This proprietary, small molecule drug candidate is aimed at the treatment of Alzheimer’s disease. In 2018, we completed a successful Phase I study with PTI-125. The study was substantially funded by a research grant award from the National Institutes of Health (NIH).

PTI-125DX – This is a proprietary blood-based test to detect Alzheimer’s disease. PTI-125DX is an early-stage program, substantially funded by a research grant award from the NIH.

FENROCK (transdermal fentanyl patch system) – This is a proprietary, abuse-deterrent skin patch for severe pain. FENROCK is an early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse (NIDA).

On July 26, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its second quarter calendar year 2018 financial results on Thursday, August 9, 2018 (Press release, Perrigo Company, JUL 26, 2018, View Source [SID1234527906]). The Company will host a conference call beginning at 8:30 a.m. (EDT).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 877-870-4263, International 412-317-0790, and reference ID #2297446. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EDT) Thursday, August 9, until midnight August 24, 2018. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10122783.

On July 26, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will announce financial results for the Second Quarter 2018 and provide a general business update before the U.S. markets open on Thursday August 2, 2018 (Press release, Adaptimmune, JUL 26, 2018, View Source;p=RssLanding&cat=news&id=2360328 [SID1234527891]). Following the announcement, the company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) on the same day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address.

To participate in the live conference call, please dial (833) 652-5917 (U.S.) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (8149978).