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Blood Test Accurately Identifies HPV-related Head and Neck Cancer Recurrence; Prospective Clinical Study Published in Journal of Clinical Oncology

On February 5, 2020 Naveris reported a novel blood test can detect recurrent Human Papilloma Virus (HPV)-related head and neck (oropharyngeal) cancers, according to a study published online in the Journal of Clinical Oncology by researchers at the University of North Carolina School of Medicine (Press release, Naveris, FEB 5, 2020, View Source [SID1234553899]). The multi-year, prospective study underscores the test’s potential to allow patients with recurrent disease to begin earlier treatment and spare disease-free patients from repeated invasive testing.

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The technology underlying the research is licensed from the University of North Carolina to Naveris, which has designed and validated NavDx, a laboratory developed test for cancer-associated HPV detection. NavDx identifies minute fragments of tumor-modified viral HPV DNA, which is distinct from native viral HPV DNA. The company recently began providing the test through its CLIA laboratory to leading head and neck oncology treatment centers.

"This study shows how an exceptionally accurate, DNA-based blood test can be used to enhance the clinical management of patients with HPV-related cancers," said Piyush Gupta, PhD, CEO of Naveris. "The test identified all patients who recurred, doing so earlier than the current standard of care for most patients, while all patients that tested negative remained disease free for the duration of the study."

This study is timely as the incidence of HPV-related head and neck cancer has increased exponentially in recent decades and it is now the most prevalent HPV-related cancer in the United States, surpassing cervical cancer.

The prospective study at UNC was led by Associate Professor Dr. Bhisham Chera and Assistant Professor Dr. Gaorav Gupta. 115 patients treated for HPV-related head and neck cancers, with no evidence of disease post-therapy, were monitored for the development of recurrence for up to 3.5 years with radio-imaging and fiberoptic nasopharyngeal endoscopy. Patients also received the blood test prior to and during treatment, and at post-treatment follow up visits. All patients who eventually developed a recurrence had positive blood tests (sensitivity of 100%), while no patient with a negative blood test developed a recurrence (negative predictive value of 100%). Of the patients with two consecutive positive blood tests, all but one developed a biopsy-proven recurrence (positive predictive value of 94%). A positive blood test preceded the detection of recurrence by imaging for 91% of patients, with a median lead-time of 3.9 months.

The publication, by Chera et al., is entitled, Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-associated Oropharyngeal Cancer, and is available Open Access.

Puma Biotechnology to Host Conference Call to Discuss Fourth Quarter and Full Year 2019 Financial Results

On February 5, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 20, 2020, following release of its fourth quarter and full year 2019 financial results (Press release, Puma Biotechnology, FEB 5, 2020, View Source [SID1234553898]).

The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

Actinium Pharmaceuticals, Inc. to Present at the 22nd Annual BIO CEO & Investor Conference

On February 5, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that Sandesh Seth, Actinium’s Chairman & CEO, will be presenting at the 22nd Annual BIO CEO & Investor Conference (Press release, Actinium Pharmaceuticals, FEB 5, 2020, View Source [SID1234553897]). Hosted by the Biotechnology Innovation Organization (BIO), the 22nd Annual BIO CEO & Investor Conference will take place February 10th and 11th at the New York Marriott Marquis in New York City.

Presentation Details

Date: Tuesday, February 11
Time: 10:15 am ET
Presenter: Sandesh Seth, Chairman and CEO
Location: New York Marriott Marquis, Ziegfeld Room

Members of Actinium’s Executive team will be available for one-on-one meetings with conference attendees. Those interested in scheduling a meeting with Actinium may do so by contacting Steve O’Loughlin, Principal Financial Officer via email at [email protected].

Moleculin to Seek Accelerated FDA Approval and Plans for Pivotal Phase 2 AML Trial

On February 5, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported it intends to discuss with the FDA and EMA (European Medicines Agency) plans to conduct a single arm Phase 2 trial that would serve as the basis for accelerated approval of Liposomal Annamycin ("Annamycin") to treat relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, FEB 5, 2020, View Source [SID1234553896]). This will follow the establishment of a recommended Phase 2 dose ("RP2D") in the Company’s ongoing Phase 1 dose escalation trial in Europe. The FDA has already granted Annamycin Fast Track status and Orphan Drug Designation for AML. FDA grants Fast Track designation to drugs intended to treat serious conditions that demonstrate the potential to address unmet medical needs, which can include providing efficacy comparable to available therapy while avoiding toxicity associated with the existing treatment. The benefits of Fast Track include FDA actions to expedite development and review, including "rolling review," where the agency reviews portions of a marketing application before the complete application is submitted.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

The announcement follows continuing positive results from Moleculin’s open label, single arm Phase 1 trials in AML patients in Europe and the US. Most recently, the US Phase 1 study met its primary objective of demonstrating the safety of Annamycin at a dose that was cumulatively at or below the lifetime maximum anthracycline dose. Those results are consistent with results achieved with the parallel Phase 1 study being conducted in Europe, which has demonstrated the safety of escalating doses of Annamycin in AML patients, including doses that significantly exceed the maximum lifetime dose of anthracyclines imposed in the US. In both trials, the primary endpoints are aimed at demonstrating the product’s safety, primarily the lack of cardiovascular risk. This is a key characteristic that, if borne out, could significantly differentiate Annamycin from other anthracyclines, which generally are well-known to have treatment-limiting cardiotoxicity.

Based on these results, Moleculin will continue to focus the Company’s efforts on the European trial to establish an RP2D. Once that is complete, the Company intends to enter discussions with the FDA and EMA about conducting a single arm Phase 2 study that would be the pivotal trial supporting US and European approval of Annamycin for relapsed or refractory AML.

Walter Klemp, Chairman and CEO of Moleculin commented, "We believe relying upon the European trial to establish an RP2D is the fastest and most efficient way to reach a pivotal Phase 2 trial. Recruitment in Europe has been faster than in the US and the trial is progressing well. The US Phase 1 trial was designed to demonstrate that Annamycin is indeed non-cardiotoxic when delivered to patients at or below the lifetime maximum anthracycline dose, and it has served that purpose. Beyond that, we have now treated 9 patients in the European trial above the lifetime maximum, also without any evidence of cardiotoxicity."

The U.S. trial met its primary endpoint, demonstrating the safety of Annamycin in AML patients, most importantly the absence of cardiotoxicity (potential damage to the heart), as determined by echocardiograms, as well as cardiac health biomarkers, principally blood troponin levels. Based on testing to date, no patients in either the US or European trial have exhibited evidence of cardiotoxicity. Additionally, there were no unexpected serious adverse events (SAE) and no dose limiting toxicities (DLT) at any dose tested. Although a primary objective of the Phase 1 trial was to evaluate safety, the study also gathered data to support a preliminary assessment of the product’s efficacy. Among other things, the study recorded complete response (CR), partial response (PR), event-free survival (EFS), overall survival (OS; Kaplan-Meier), and time to and duration of remission/response. The Company reported efficacy in 33% of the US patients, even though the drug was dosed at what was expected to be sub-therapeutic levels. The evidence of efficacy consisted of 1 patient who achieved a "morphologically leukemia-free state," which the protocol defined as a CR with incomplete recovery of platelets or neutrophils, and another patient who had a substantial remission of leukemia cutis (a somewhat rare leukemia symptom), from diffuse to 3 lesions.

Dr. Rob Shepard, Chief Medical Officer – Annamycin, added, "Because of this early success in the US trial and our continued progress in the parallel European trial, and given our new Fast Track status, we have made a strategic decision on how best to move forward. Once we have established an RP2D with the European trial, we intend to discuss with the FDA conducting a Phase 2 single arm registration trial that would form the basis for accelerated approval. This should allow us to combine efforts between the U.S. and Europe, creating one global Phase 2 trial. The European trial continues with its dose escalation, and although dosing had now taken patients well beyond the lifetime maximum anthracycline limit with no evidence of cardiotoxicity, we are still below what we believe to be a therapeutic dose. We look forward to reaching a therapeutic dose and a recommended Phase 2 dose in the coming quarters."

AIM ImmunoTech Announces Completion of Third-Party Clinical Trial Using Ampligen in Combination with Other Therapies as Adjuvant Treatment of Peritoneal Surface Malignancies

On February 5, 2020 AIM ImmunoTech Inc. (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, reported posting by the University of Pittsburgh Medical Center (UPMC) on January 28, 2020 via ClinicalTrials.gov of completion of an independent, third-party clinical trial to evaluate the safety and activity of a triple combination (chemokine modulatory regimen or CKM) of celecoxib, interferon alfa (IFN), and Ampligen (rintatolimod), given with a dendritic cell (DC) vaccine, as a potential treatment for metastatic peritoneal surface malignancies after standard of care surgery (Press release, AIM ImmunoTech, FEB 5, 2020, View Source [SID1234553895]).

The principal investigator of the trial was David L. Bartlett, MD, an internationally recognized cancer researcher at UPMC, in collaboration with the National Cancer Institute. Detailed analysis of the clinical data by the investigators is expected to be reported by publication. For more information on the results, including limitations of the clinical trial, which according to the filing saw a median survival rate of 52 months for the 64 patients treated in the study, please visit: View Source

"We were honored to have Ampligen included in this trial and believe the outcome of this trial will be informative given the growing body of evidence supporting the important role Ampligen may play in modulating the immune system in oncology," said AIM ImmunoTech CEO Thomas K. Equels. "Ampligen is a broadly applicable immune therapy that has the potential to be used in a wide range of therapies with a generally well-tolerated safety profile based on approximately 100,000 IV doses in humans to date, as well as Phase 1 safety studies in intraperitoneal (IP) and intranasal (IN) administration. Ampligen is also being studied in six immuno-oncology clinical trials in combination with checkpoint blockade drugs or other immuno-therapies at highly respected NCI-Designated Cancer Centers. We appreciate the strong third-party interest in our platform drug candidate Ampligen."