On July 17, 2020 NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenue for the second quarter of 2020 as well as for the first half of 2020 (Press release, Nanobiotix, JUL 17, 2020, View Source [SID1234562074]).

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!

Revenue for the second quarter of 2020 (unaudited)

Nanobiotix’s revenue for the second quarter 2020 and for the first half of 2020 amounted to €13.4k and €36.9k respectively.

Most of the revenue generated by the Company during these periods result from the cross-charge to its partner, PharmaEngine, of shared external contract research organization costs pursuant to the license and collaboration agreement.

The amount of cash and cash equivalent as of June 30, 2020 is €26.6m. This amount reflects in particular the payment by HSBC of a €5m State-Guaranteed Loan (prêt garanti par l’Etat or PGE) granted pursuant to an agreement approved on June 22, 2020. The second PGE of €5m granted by Bpifrance has been received on July 17, 2020.

In April 2020, the Company provided updates on clinical development continuity in the context of the COVID-19 crisis. In light of the pandemic and to protect the interests of employees, patients, partners, and shareholders, Nanobiotix made organizational adjustments to control costs while priorities regarding clinical development remained unchanged.

Nanobiotix also announced that the protocol for the phase I clinical trial for NBTXR3 in pancreatic cancer under its clinical collaboration with The University of Texas MD Anderson Cancer Center has been allowed to proceed by the US Food and Drug Administration (FDA).

At ASCO (Free ASCO Whitepaper) 2020, Nanobiotix announced positive new data from the expansion part of its phase I trial, evaluating the potential of first-in-class NBTXR3 activated by radiation therapy to improve treatment outcomes for elderly patients with locally advanced head and neck cancer ineligible for chemotherapy or intolerant to cetuximab. In particular, the analysis of 30 evaluable patients for efficacy showed a primary tumor objective response rate of 83%, including a complete response rate of 60% in the target lesion.

At AACR (Free AACR Whitepaper) 2020, Curadigm, a wholly owned subsidiary of the Company, presented results demonstrating that its novel "Nanoprimer" technology could potentially improve the efficacy of therapeutics delivered intravenously (IV). In the study, the Nanoprimer was paired with RNA-based therapeutics and showed to improve treatment outcomes up to 50%.

On June 17, 2020, the US Food and Drug Administration (FDA) provided feedback necessary to proceed with the design of NANORAY-312, a pivotal phase III trial investigating NBTXR3 for elderly head and neck cancer patients ineligible for platinum-based chemotherapy. The FDA also accepted the NBTXR3 chemistry, manufacturing and controls (CMC) development plan to support the future New Drug Application (NDA) for the product and its use in the NANORAY-312 phase III clinical trial.

On July 17, 2020 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported two presentations featuring its Bladder EpiCheck technology at the 35th Annual European Association of Urology (EAU) Virtual Congress (Press release, Nucleix, JUL 17, 2020, View Source [SID1234562072]).

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 first presentation, titled "Feasibility of the EpiCheck test in upper tract tumor: interim analysis of a prospective trial," evaluated 47 patients who underwent an ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018. For each patient, cytology and Bladder EpiCheck tests were performed on voided urine and selective urine (urine collected from the ureter) samples. In the study, 46% of patients were positive for UTUC as confirmed by endoscopic biopsy – half of which were high grade. This interim analysis reported a significantly higher overall sensitivity of Bladder EpiCheck compared to cytology in voided urine (75% vs 39%, p=0.03). Bladder EpiCheck also outperformed cytology in high-grade UTUC with a sensitivity of 89% vs. 64% and a negative predictive value (NPV) of 95% vs. 88% in voided urine.

"Accurately identifying patients with high-grade UTUC is critical, as the disease progression can be deadly and the standard treatment – removal of ureter and kidney – leads to major morbidity. Unfortunately, identifying the presence of high-grade UTUC today is done through ureteroscopy, a very complex procedure under general anesthesia that has low yield," said Dr. Alberto Breda, head of the oncological urology unit and the kidney transplant team in Fundacio Puigvert, Barcelona, Spain and the lead investigator of the study. "We are encouraged that these data demonstrate the promise of Bladder EpiCheck’s ability to accurately rule-out high-grade upper tract urothelial cancer with a simple voided urine test. As a result, we hope to be able to identify more patients who can safely keep their kidney and undergo conservative treatment."

The second presentation, titled "The diagnostic accuracy of Bladder EpiCheck in high-risk population," evaluated the diagnostic accuracy of Bladder EpiCheck compared to cystoscopy and cytology, the current gold standard, among 167 consecutive patients with a history or suspicion of high-risk bladder cancer. The results of the study found that in patients with history of high-grade non-muscle invasive bladder cancer (NMIBC) undergoing follow-up, the diagnostic accuracy of the Bladder EpiCheck was higher than cytology and cystoscopy in terms of sensitivity (93.5%, 73.9% and 58.1%, respectively) and NPV (96.4%, 87.5%, 79.3%, respectively).

"We are encouraged by the independent evidence of our Bladder EpiCheck technology, and its potential role in improving UTUC and NMIBC management for the benefit of patients," said Aharona Shuali, M.D., vice president of medical at Nucleix. "Bladder EpiCheck’s consistently excellent sensitivity and NPV in high-grade urothelial cancers allows urologists to start considering innovative approaches for managing these patients."

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92% of the high-risk (non Ta-LG) cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-risk cancer is present1. Bladder EpiCheck is intended for use as a noninvasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck is CE-marked and available in Europe. The test is not available for sale in the United States.

On July 17, 2020 ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that the first patient has been dosed in the pivotal Phase 2 portion of LOTIS 3, a Phase 1/2 clinical trial evaluating loncastuximab tesirine (Lonca, formerly ADCT-402) in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) (Press release, ADC Therapeutics, JUL 17, 2020, View Source [SID1234562071]).

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!

"Based on the encouraging interim data Lonca and ibrutinib demonstrated in Phase 1, the trial was amended to a Phase 1/2 protocol intended to support the submission of a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA)," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "We are pleased to have dosed the first patient in the pivotal Phase 2 portion of this trial as we continue advancing Lonca as both a single agent and in combination with other therapies for patients with non-Hodgkin lymphoma. We are on track to file a BLA with the FDA for Lonca as monotherapy for the treatment of relapsed or refractory DLBCL in the second half of 2020."

The 161-patient Phase 1/2 open-label, single-arm clinical trial is evaluating the safety and efficacy of Lonca in combination with ibrutinib in patients with relapsed or refractory DLBCL or MCL. The Phase 2 portion of the trial will enroll three cohorts: non-germinal center B-cell-like (non-GCB) DLBCL, GCB DLBCL and MCL.

"A significant proportion of patients with non-Hodgkin lymphoma relapse after treatment and their prognosis is poor, underscoring the need for new options for later-lines of therapy," said Murali Janakiram, MD, MS, Assistant Professor of Medicine, University of Minnesota, Division of Hematology, Oncology, and Transplantation, and an investigator for the trial. "The combination of Lonca, a CD19-targeted ADC, and ibrutinib, a small-molecule inhibitor of Bruton’s tyrosine kinase, has shown synergy and I look forward to its continued evaluation in patients with relapsed or refractory DLBCL or MCL."

Interim data from the Phase 1 portion of the Phase 1/2 clinical trial presented at the virtual 25th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June 2020 showed an overall response rate of 75.0% and complete response rate of 58.3% at the Lonca dose of 60 μg/kg, which is the selected dose for the Phase 2 portion of the trial, in combination with ibrutinib (560 mg/day) in patients with relapsed or refractory DLBCL or MCL. The combination has had a manageable toxicity profile, with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being thrombocytopenia (20%) and anemia (12%).

About Loncastuximab Tesirine (Lonca)

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

Lonca is being evaluated in LOTIS 2, a pivotal Phase 2 clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and LOTIS 3, a pivotal Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL).

On July 17, 2020 Astellas reported that NICE has recommended use of Astellas’ Xospata (gilteritinib) for adults with relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia (AML) (Press release, Astellas, JUL 17, 2020, View Source [SID1234562068]).

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 backing, as outlined in a Final Appraisal Determination, is contingent on a commercial agreement being offered by the company and does not include its use as a maintenance therapy after haematopoietic stem cell transplant.

AML is a rare and aggressive cancer of the blood and bone marrow that, if untreated, can be fatal within a few months.

Around 3,100 people in the UK are diagnosed with AML each year, of which one-third will test positive for the FLT3 gene mutation, which can result in higher relapse rates and lower rates of survival than other forms of the disease.

The prognosis of patients with AML has remained poor despite advances in chemotherapy and little progress has been made that improves the long-term outcome for these patients.

NICE’s recommendation of NHS funding for Xospata is based on data from the Phase III ADMIRAL trial, which showed that relapsed or refractory FLT3 mutation-positive AML patients who received the drug experienced significantly longer overall survival than those who received salvage chemotherapy.

Median overall survival for patients who received Xospata was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy, while rates of one-year survival were 37% and 17%, respectively.

"This marks a pivotal moment as, for the first time, adults in the UK with this specific form of AML have a much needed option at the point when current treatment no longer works or they relapse," said Jackie Williams, general manager for Astellas in the UK. "We are proud to bring such an important treatment option that could significantly extend the lives of these patients."

On July 17, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of BeiGene’s investigational inhibitor of PARP1 and PARP2, pamiparib, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (Press release, BeiGene, JUL 17, 2020, View Source [SID1234562044]).

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!

"This is our first NDA filing for pamiparib, which was discovered by BeiGene and is being developed as both a monotherapy and in combination with other agents, including our own anti-PD1 antibody, tislelizumab," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "For patients in China with advanced ovarian cancer, we are hopeful that pamiparib can offer a new treatment option. We look forward to presenting the clinical data that supports the NDA filing and additional results, including Phase 3 data, in the upcoming months."

This NDA is supported by clinical results from a Phase 1/2 trial of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915). The pivotal Phase 2 portion of the trial enrolled 113 patients in China with high-grade epithelial ovarian cancer (including fallopian or primary peritoneal cancer) or high-grade endometrioid epithelial cancer, harboring germline BRCA1/2 mutation, following at least two prior lines of standard chemotherapy. Patients received pamiparib 60 mg orally twice daily and the primary endpoint of the trial is objective response rate (ORR) by RECIST v1.1. Results of this study will be presented at an upcoming medical conference.

About Ovarian Cancer

In China, ovarian cancer is the tenth most common form of cancer among women, with over 50,000 new cases and more than 30,000 deaths in 2018.1 More than 60 percent of patients are diagnosed with advanced disease.2 The standard therapy for ovarian cancer consists of surgery followed by postoperative platinum-based chemotherapy. An estimated 70 percent of patients with epithelial ovarian cancer, which accounts for more than 90 percent of all ovarian cancer,3 who achieve a full remission following first-line therapy will develop recurrent disease.4

About Pamiparib

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies. To-date more than 1,200 patients have been enrolled in clinical trials of pamiparib.

A new drug applications (NDA) for pamiparib for patients with ovarian cancer has been accepted by the Center for Drug Evaluation (CDE) of the NMPA.

About the Pamiparib Clinical Program

Clinical trials of pamiparib include:

Phase 3 trial in China of pamiparib as maintenance versus placebo in patients with platinum-sensitive recurrent ovarian cancer (NCT03519230);

Phase 2 trial of pamiparib in patients with metastatic castration-resistant prostate cancer with homologous recombination deficiency (NCT03712930);

Phase 2 trial in China of pamiparib in patients with metastatic HER2-negative breast cancer with BRCA mutation (NCT03575065);

Phase 2 trial of pamiparib in patients with advanced or inoperable gastric cancer (NCT03427814);

Phase 1/2 trial in China of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915);

Phase 1b/2 trial of pamiparib in combination with radiation therapy and/or temozolomide in patients with first-line or recurrent/refractory glioblastoma (NCT03150862);

Phase 1b trial of pamiparib in combination with temozolomide in patients with locally advanced or metastatic solid tumors (NCT03150810); and

Phase 1b trial of pamiparib in combination with tislelizumab for a variety of solid tumor malignancies (NCT02660034).