On July 31, 2019 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the second quarter that ended June 30, 2019, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, JUL 31, 2019, View Source [SID1234537979]).

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"We made significant progress during the second quarter," said Steve Holcombe, chief executive officer, vTv Therapeutics. "We reported positive results from part 1 of our phase 2 Simplici-T1 trial in type 1 diabetes and began screening patients for our 488-305 trial evaluating azeliragon in patients with mild Alzheimer’s disease and type 2 diabetes. We look forward to continuing to execute successfully on our development plans for each of these drug candidates and advancing them as potential treatments for patients suffering from these diseases."

Recent Achievements and Outlook

Part 1 of the Simplici-T1 Study achieves positive topline results in patients with type 1 diabetes. In June 2019, we announced positive topline results from part 1 of the phase 2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an add-on to insulin therapy for patients with type 1 diabetes.

In this double-blind, placebo-controlled 12-week trial, the baseline mean HbA1c for the groups treated with TTP399 and placebo was 7.3% and 7.4%, respectively. Patients treated with TTP399 (n=8) showed a statistically significant mean reduction in HbA1c of 0.6% at 12 weeks, while the group treated with placebo (n=11) showed a mean increase in HbA1c of 0.1%, resulting in a mean improvement of 0.7% in the TTP399 group relative to the placebo group (p=0.03).

TTP399 was well tolerated in the study, with no serious adverse event reported, and no report of diabetic ketoacidosis or severe hypoglycemia.

Simplici-T1 Study enrolling patients in Part 2. In May 2019, we began enrolling patients in the part 2 confirmatory phase of the Simplici-T1 Study and expect to report results for that portion of the study in the latter part of the first quarter of 2020.

Screening patients for Phase 2/3 clinical trial of azeliragon. We began screening patients in June 2019 for a Phase 2 clinical trial to evaluate azeliragon as a potential treatment of mild-AD in patients with type 2 diabetes. The randomized, double-blind, placebo-controlled multicenter trial is designed as sequential phase 2 and phase 3 studies operationally conducted under one protocol. Each part of the study will evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer’s disease (screening MMSE 21 to 26, baseline MMSE 19 to 27; and ADAS-cog14 score ≥10) and type 2 diabetes (screening HbA1c 6.5% to 9.5%, inclusive).

vTv expects to report topline results from the phase 2 proof of concept study by the end of the fourth quarter of 2020.

Upcoming Events

vTv will present additional results from Part 1 of the Simplici-T1 Study at the 55th Annual Meeting of the European Association for the Study of Diabetes in Barcelona Spain, September 16–20, 2019 with a poster entitled "Results from the sentinel and learning phase of the Simplici-T1 study, the first clinical trial to test activation of glucokinase as an adjunctive treatment for type 1 diabetes".

Second Quarter 2019 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2019, were $1.5 million compared to $5.0 million as of March 31, 2019.

Revenue: Revenues were $1.8 million for the second quarter of 2019 versus $0.9 million in the first quarter of 2019. The increase in revenue was driven by the recognition of $1.0 million for one of our license agreements based on the satisfaction of a development milestone.

R&D Expenses: Research and development expenses were $4.2 million in the second quarter of 2019 and $2.8 million in the first quarter of 2019. This increase in R&D expenses was driven primarily by the increase in costs for the 488-305 Study for which we were performing start-up activities, including site activations, in the second quarter of 2019.

G&A Expenses: General and administrative expenses were $2.4 million in each of the second and first quarters of 2019.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $5.1 million for the second quarter of 2019 compared to net loss before non-controlling interest of $4.0 million for the first quarter of 2019.

Net Loss Per Share: GAAP net loss per share was $0.10 and $0.26 for the three months ended June 30, 2019 and March 31, 2019, respectively, based on weighted-average shares of 28.0 million and 22.9 million for the three month periods ended June 30, 2019 and March 31, 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.09 and $0.06 for the three months ended June 30, 2019 and March 31, 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 51.1 million and 46.0 million for the three months ended June 30, 2019 and March 31, 2019, respectively.

On July 31, 2019 Chimerix (NASDAQ: CMRX), reported the completion of an exclusive worldwide license of CX-01 from Cantex Pharmaceuticals, Inc.Chimerix intends to move quickly into Phase 3 development of CX-01 for the treatment of Acute Myeloid Leukemia (AML) in the first-line setting (Press release, Chimerix, JUL 31, 2019, View Source [SID1234568985]). CX-01 has received Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration for the treatment of AML.

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"We are pleased to have made such rapid progress in repositioning the company and transforming our pipeline with this important cancer therapy. We are excited to advance this promising product candidate in AML as it has shown compelling activity across multiple endpoints in first-line patients as opposed to later lines of therapy where most of the recent advances in this disease area have occurred. With more than 21,000 new cases of AML diagnosed annually in the U.S. alone and a five-year survival rate of less than 30%, the patient need is clear. CX-01’s mechanism of action, targeting multiple proteins involved in protecting and supporting the growth of cancer cells, provides opportunities for potential development across a range of hematologic malignancies," stated Mike Sherman, Chief Executive Officer of Chimerix. "This transaction exemplifies our commitment to pursuing and accelerating programs where we can quickly address unmet patient needs with a meaningful clinical benefit."

"While several new agents have been recently approved for AML, a backbone of cytotoxic chemotherapy continues to be necessary for treatment with curative intent. If our results are confirmed, combining CX-01 with chemotherapy has the potential to have a significant impact on the outcomes of patients suffering from one of the most challenging hematologic malignancies," said Paul Shami, MD, clinical investigator at Huntsman Cancer Institute and Professor of Medicine at the University of Utah.

CX-01 is a new chemical entity derived from unfractionated heparin with very low anticoagulant activity. CX-01 targets key protein pathways important for AML blast cell migration to the bone marrow and retention of these cells in the marrow where they are protected from chemotherapy. CX-01 also binds with proteins involved in chemotherapy resistance and the delay in platelet recovery after chemotherapy. Together, these activities are understood to sensitize AML blasts to chemotherapy and improve clinical responses. These mechanisms of action support the potential for development in myelodysplastic syndrome, multiple myeloma, and lymphomas.

In a recently completed Phase II study, 75 patients over 60 years of age with newly diagnosed AML were randomized 1:1:1 to one of two doses of CX-01 (0.125 mg/kg/hr or 0.250 mg/kg/hr) plus standard 7+3 chemotherapy (7 days of cytarabine, 3 days of anthracycline) or to the control arm of standard 7+3 chemotherapy alone. Data presented at the 2019 ASCO (Free ASCO Whitepaper) conference indicated an advantage across multiple endpoints for patients treated with 0.25 mg/kg/hr CX-01. In the evaluable patient population, results of the 0.25 mg/kg/hr CX-01 arm compared favorably to the control arm: complete response rate (complete response or complete response without complete hematologic recovery) of 89% vs. 58% (p=0.03), median event-free survival of 23.4 months vs. 9.0 months (p=0.011), and median overall survival which had not yet been reached in the CX-01 arm vs. 11.2 months (p=0.042). These data were consistent with a single arm pilot study of first line therapy in patients with AML (n=12), including a complete response rate of 92%.

CX-01 was well tolerated with adverse events similar across all treatment arms. The most common serious adverse event was febrile neutropenia with three cases in each CX-01 treatment group and one case in the control group.

Stephen Marcus, M.D., CEO of Cantex, stated, "We are very pleased to be partnering with Chimerix and their world-class scientists. We believe that Chimerix management’s track record in developing novel cancer therapeutics makes Chimerix the perfect partner to aggressively advance the development of CX-01 for the treatment of AML and other hematologic malignancies."

Transaction Terms

Under the terms of the agreement, Chimerix has exclusive worldwide rights to develop and commercialize CX-01. Chimerix will make an upfront payment of $30 million to Cantex. In addition, Chimerix has issued 10 million shares of Chimerix common stock to Cantex. Cantex is eligible for regulatory and commercial milestones of up to $587.5 million, and tiered royalties starting at 10%.

Conference Call
Chimerix management will host a conference call today at 8:30AM ET. To participate, please dial:
US and Canada: (877) 354-4056
International: (678) 809-1043
Conference ID: 9558159
A live, listen-only webcast of the conference call may also be accessed by visiting the Investors section of the Chimerix website, www.chimerix.com.

On July 31, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported the dosing of the first patient in its Phase 1/2 open-label study of GPS in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), in patients with selected WT1-positive advanced cancers, including both solid tumors and hematologic malignances (Press release, Sellas Life Sciences, JUL 31, 2019, View Source [SID1234537945]).

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"This is an important milestone as this study allows us to potentially enhance our safety and activity profile of GPS in combination with anti-PD-1 therapies, particularly in combination with KEYTRUDA in multiple malignances, following intriguing initial combination clinical data with OPDIVO," said Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS. "We are confident this study will build on our body of clinical evidence in support of the use of GPS in combination with PD-1 inhibitors to benefit cancer patients with limited treatment options. We believe that our innovative WT1 immunotherapeutic, GPS, in combination with anti-PD-1 immunotherapy agents, may provide therapeutic benefit for patients with WT1 expression. These beliefs are shared by the renowned U.S. oncologists who are undertaking this work. We look forward to studying this combination in patients with a wide range of cancers and expect to provide the first clinical data from this study in the first quarter of 2020."

The Company also announced today that Richard Maziarz, M.D., Medical Director of the Adult Blood and Marrow Stem Cell Transplant & Cellular Therapy Program at the Knight Cancer Institute and Professor of Medicine at Oregon Health and Science University (OHSU) in Portland, OR, and Roisin O’Cearbhaill, M.D., Assistant Attending Physician in Gynecologic Medical Oncology Service at the Memorial Sloan Kettering Cancer Center (MSKCC), are serving as co-principal investigators for this study.

About the Study
The Phase 1/2 open-label, multicenter, multi-arm study is being conducted under a Clinical Trial Collaboration and Supply Agreement (CTSA) with Merck (known as MSD outside the United States and Canada) to assess the efficacy and safety of the combination of GPS and KEYTRUDA.

The primary endpoints of the study include safety and overall response rate, while secondary endpoints include progression-free survival, overall survival and immune response correlates. The study will enroll approximately 90 patients at up to 20 centers in the United States. The trial is initially evaluating patients with ovarian cancer (second or third line) and colorectal cancer (third or fourth line), to be followed by patients with acute myeloid leukemia (AML) who are unable to attain deeper morphological response than partial on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant and patients with triple negative breast cancer (TNBC) (second line), and small cell lung cancer (second line).

Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA., and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

On July 31, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that will report its second quarter 2019 financial results on Wednesday, August 7, 2019 after the U.S. financial markets close (Press release, Five Prime Therapeutics, JUL 31, 2019, View Source [SID1234537962]). Five Prime will also host a conference call and live audio webcast on August 7th at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss the company’s financial results and provide a general business update.

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The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 3575436.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

On July 31, 2019 US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC and the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS), LLC reported that the U.S. Food and Drug Administration (FDA) has approved the first clinical trial in the U.S. to evaluate Cold Atmospheric Plasma (CAP) Technology for the treatment of cancer (Press release, US Medical Innovations, JUL 31, 2019, View Source [SID1234537963]).

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USMI is the first company in the world to integrate a high frequency electrosurgical generator and plasma gas to deliver a Cold Atmospheric Plasma (Plasma Helium Beam) for the selective treatment of cancer US Patent #9,999,462 June 19, 2019 (Integrated Cold Plasma and High Frequency Plasma Electrosurgical System and Method). This novel non-thermal process has been developed for treating solid cancerous tumors. JCRI-ABTS and several plasma laboratories around the world have reported that CAP can trigger chemical and molecular changes in the cancerous cells that cause significant stress and drastically decrease the cancer cell’s viability and death. Canady Helios Cold Plasma System (CHCPS) has a selective action only on tumor cells and not healthy normal cells. CHCPS technology demonstrates a temperature equal or less than 30°C (85°F) and cause no thermal injury to normal tissue.

The Canady Helios Cold Plasma System and Canady Plasma Cold Plasma Ablator were developed by Jerome Canady, M.D. CEO, Chief Science Officer and the scientists at the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI/ABTS), USMI’s engineering team led by Taisen Zhuang, PhD VP Research & Development; Michael Keidar PhD, Professor School of Engineering and Applied Sciences, Director of Micropropulsion and Nanotechnology lab at The George Washington University (GWU); and Alex Shashurin, PhD, Assistant Professor School of Aeronautics and Astronautics at Purdue University.

Dr. Canady explained, "After the surgeon removes the cancerous tumor during surgery, CAP is subsequently sprayed at the surgical margins to target any remaining cancerous tissue or cells for 2 to 7 minutes, thus reducing the chances of cancer recurrence. We see our CAP treatment as an important adjunct to the current treatment protocols for solid cancerous tumors. The FDA has given approval for 20 patients and we plan to start the program in August 2019."

The JCRI-ABTS Translational Molecular Center has developed a robust research program targeting Breast, Ovarian, Lung, Renal Cell, Sarcoma, Prostrate, Melanoma and Gastrointestinal solid tumors.