On June 8, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that the first patient has been dosed in its Phase 2 clinical trial of onvansertib in combination with nanoliposomal irinotecan and 5-FU as a second-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Cardiff Oncology, JUN 8, 2021, View Source [SID1234583702]).

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The Phase 2 open-label, multicenter trial, which is an integral part of Cardiff Oncology’s focus on KRAS-mutated solid tumor cancers, is designed to assess the safety and preliminary efficacy of onvansertib in combination with standard-of-care as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy. The trial is expected to enroll approximately 40 patients across six sites in the U.S., including the three Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center, The University of Nebraska Medical Center and Inova Schar Cancer Institute.

"We believe that adding onvansertib to standard-of-care therapy may improve the current dim prognosis for PDAC patients where currently second-line treatment confers only a 7.7% response rate and 3.1-month median progression-free survival," said Daniel H. Ahn, D.O., principal investigator for the trial and medical oncologist, Mayo Clinic Cancer Center, Arizona. "There is increasing evidence in the ongoing Phase 2 trial in KRAS-mutated mCRC that the synergistic effect of onvansertib in combination with irinotecan and 5-FU is resulting in meaningful clinical benefit and improving outcomes for patients with KRAS-mutated cancers and we are optimistic that we will see similar results in this PDAC trial."

Dr. Mark Erlander, chief executive officer of Cardiff Oncology added, "Onvansertib’s inhibitory effect on the proliferation and survival of KRAS-mutated tumor cells has, notably, shown synergistic clinical benefit in combination with irinotecan and 5-FU in our KRAS-mutated metastatic colorectal cancer trial (mCRC). As metastatic PDAC tumors bear KRAS mutations about 95% of the time, we see an opportunity for onvansertib to improve response rates and increase progression-free survival in this indication with such marked unmet need. The dosing of the first patient in our Phase 2 PDAC trial represents an important step in pursuit of this opportunity, and we look forward to its continued progress."
About the Phase 2 Trial of Onvansertib in Metastatic PDAC
This trial is an open-label, multi-center study designed to assess the safety and efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide), leucovorin, and 5-FU as

a second-line treatment in patients with metastatic PDAC. The trial is expected to enroll approximately 40 patients with histologically confirmed measurable and metastatic PDAC who have failed treatment with one prior line of gemcitabine-based chemotherapy. Patients will receive nanoliposomal irinotecan, leucovorin, and 5-FU on Day 1 of 14-day cycles in combination with onvansertib 12 mg/m2 on Days 1-10, or 15 mg/m2, on Days 1-5 of each 14-day cycle. The study will be conducted at six clinical trial sites across the U.S: Mayo Clinic (Arizona, Minnesota, Florida), Kansas University Medical Center, The University of Nebraska Medical Center and Inova Schar Cancer Institute. The primary endpoint will be objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Key secondary and exploratory endpoints include duration of response, median overall survival, ORR in patients receiving more than two treatment cycles, disease control rate (defined as complete response, partial response or stable disease by RECIST v1.1 over the entire treatment period), and assessment of KRAS allelic burden in liquid biopsies as measured by circulating tumor DNA (ctDNA). Please refer to clinicaltrials.gov NCT04752696 for additional clinical trial information.

On June 8, 2021 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported the first Clinical Trial Application (CTA) authorization in the European Union (EU) (Press release, NeoImmuneTech, JUN 8, 2021, View Source [SID1234583718]). This authorization comes from Italy’s Agenzia Italiana Del Farmaco (AIFA) for the company’s ongoing Phase 2 study of NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with Bristol-Myers Squibb Company’s (NYSE: BMY) Opdivo (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy.

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"We are excited to expand our investigation of NT-I7 as a potential therapeutic for cancers and other immune-mediated illnesses into the EU," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. "This authorization marks a significant milestone for the development of NT-I7 and provides the opportunity to include additional patients in this study whose treatment outcomes may be improved with the use of NT-I7."

This ongoing Phase 2, randomized, proof-of-principle study is to evaluate preliminary anti-tumor activity of NT-I7 and nivolumab, compared with nivolumab alone, in patients with previously treated advanced or metastatic gastric or gastro-esophageal junction (GEJ) cancer, or esophageal adenocarcinoma, and to assess safety and tolerability of the combination in these patients. AIFA’s CTA authorization is for the phase 2 part of the study, upon successful completion of the dose escalation phase. The results of this study will be used to further clinical development of this combination in selected clinical settings and tumor types. More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04594811

Opdivo is a registered trademark of Bristol Myers Squibb.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On June 8, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company pioneering the development of monoclonal antibodies targeting treatment of various cancers and viral infections, reported the beginning of enrollment of the second cohort in dosing patients for its Phase I trial for Brain Cancer (Press release, Nascent Biotech, JUN 8, 2021, View Source [SID1234583703]). This milestone allows the trial to triple the dosage levels over the first cohort to achieve the highest level without toxicity.

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Patient enrollment continues for Phase I. Anyone interested may review trial requirements at www.clinicaltrials.gov, then search Pritumumab.

"Having completed the first cohort in a very short time, we are now in our second dose escalation with the second cohort being enrolled," noted Nascent CEO, Sean Carrick.

PTB is a natural human antibody that works by binding to Cell surface Vimentin (also referred to as ectodomain vimentin, or EDV), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy unlike chemotherapy targets only cancer cells without damaging healthy cells."

On June 8, 2021 Foundation Medicine, Inc. and Natera, Inc. (NASDAQ: NTRA), reported the launch of the research use version of FoundationOneTracker, Foundation Medicine’s personalized circulating tumor DNA (ctDNA) monitoring assay (Press release, Foundation Medicine, JUN 8, 2021, View Source [SID1234583719]). FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in ctDNA monitoring.

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FoundationOne Tracker uses optimized algorithms for identifying tumor-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma for use in both advanced- and early-stage research applications. Additionally, the creation of a robust, fully integrated workflow between Foundation Medicine and Natera is expected to provide rapid inclusion of ctDNA monitoring results into retrospective research studies.

"The addition of FoundationOne Tracker for research use provides our biopharma and academic partners access to Foundation Medicine’s broad, advanced-stage CGP footprint," said Foundation Medicine’s Chief Scientific Officer Priti Hegde. "In partnering with Natera, we have been able to leverage the best of both of our technologies to provide a cost-effective and efficient path to bring more personalized monitoring tools to our partners, and down the line, to physicians and patients, to help inform their treatment strategy."

"This partnership will help accelerate personalized ctDNA monitoring as the new standard of care in oncology," said Solomon Moshkevich, Natera’s general manager of oncology. "With Foundation Medicine’s strong track record of scientific leadership and its broad footprint within biopharma, we expect FoundationOne Tracker to become an important new tool for accelerating and improving drug development in oncology."

On June 8, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that its clinical trial of 64/67Cu SARTATE for paediatric patients with neuroblastoma has been expanded to include five sites in the U.S (Press release, Clarity Pharmaceuticals, JUN 8, 2021, View Source [SID1234583704]).

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"We are very excited to expand into additional clinical sites which are now open for recruitment in the trial of Clarity’s lead product in neuroblastoma," commented Dr Alan Taylor, Clarity’s Executive Chairman. "Some of the initial data we have received to date from our first clinical site has been shared at one of the industry’s leading conferences, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mid-Winter Meeting 2021 and was very well received. We look forward to continuing the 64/67Cu SARTATE clinical trial in this important patient population in some of the leading cancer centres in the U.S."

The 67Cu SARTATE trial is a Peptide Receptor Radionuclide Therapy administered to paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial with the following confirmed clinical sites:1

Memorial Sloan Kettering Cancer Centre (MSK);
Cincinnati Children’s Hospital Medical Centre;
Medical University of South Carolina;
University of Texas Southwestern Medical Centre; and
University of Wisconsin.
Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

Dr Taylor said: "We are very pleased to have received strong support on the development of 64/67Cu SARTATE for neuroblastoma to date from numerous supporters, such as the five clinical sites, Clarity’s team, our collaborators, and the U.S. Food and Drug Administration in granting both diagnostic 64Cu SARTATE and therapeutic 67Cu SARTATE products Orphan Drug Designations and Rare Paediatric Disease Designations. We believe this highlights the importance of SARTATE development in this important patient population to improve the prognosis of children with high-risk neuroblastoma, where current treatment strategies are limited. We are looking forward to further progressing this trial at five clinical sites and getting closer to our ultimate goal of better treating children and adults with cancer."

References
ClinicalTrials.gov Identifier: NCT04023331
Nadja C. Colon and Dai H. Chung 2011, "Neuroblastoma", Advances in Pediatrics, <View Source>
Valeria Smith and Jennifer Foster 2018, "High Risk Neuroblastoma Treatment Review", Children, <View Source>