On July 20, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that its 64Cu SAR-bisPSMA clinical trial in patients with confirmed prostate cancer is open for recruitment at two sites, GenesisCare CTA Medical Clinic, Perth and Nepean Hospital, Sydney (Press release, Clarity Pharmaceuticals, JUL 20, 2021, View Source [SID1234584961]).

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to open this trial for patients with newly diagnosed prostate cancer using our optimised PSMA agent, 64Cu SAR-bisPSMA, that has the novel combination of two targeting agents attached to our SAR Technology. The preclinical data to date is compelling, with both higher tumour uptake and greater tumour retention compared to the single targeted products utilised by other radiopharmaceutical products on the market, and we look forward to recruiting our first patient for this trial shortly."

The PROPELLER trial is a Phase I Positron Emission Tomography (PET) imaging trial of participants with confirmed prostate cancer using 64Cu SAR-bisPSMA. It is a 30-patient clinical trial conducted across three sites in Australia (NCT04839367)1. PROPELLER is a multi-centre, blinded review, dose ranging, non-randomised study of 64Cu-SAR-bisPSMA administered to patients with confirmed prostate cancer prior to radical prostatectomy. The primary endpoints of the trial are safety, tolerability and efficacy in the detection of primary prostate cancer compared to histopathology.

Dr Taylor said: "Prostate cancer is one of the largest indications in oncology, and due to the logistical, manufacturing and imaging issues related to other radiopharmaceuticals, represents a lucrative opportunity for us to enter this space with our Targeted Copper Theranostics (TCT) platform. Clarity’s centralised manufacture and broad distribution model coupled with the flexibility of imaging at later time points, gives us confidence to believe that we can provide a large patient population with early, accurate and precise detection of prostate cancer and improve patient outcomes. We look forward to further progressing the development of our SAR-bisPSMA product and exploring the benefits of our TCT platform for patients with prostate cancer, including in our upcoming US based 64Cu/67Cu bis-PSMA theranostic trial (SECuRE trial (NCT04868604)2 which is due to commence shortly. The progress of these two trials will get us one step closer to our ultimate goal of developing better treatments for children and adults with cancer."

On July 20, 2021 Micronoma, the first cancer detection company to harness tumor-associated circulating microbial biomarkers to diagnose cancer at an early stage via microbiome-driven liquid biopsy technology, reported a collaboration with the University of New South Wales (UNSW), Sydney for a $4 million grant from the Australian Government to fund research into hepatocellular carcinoma (HCC), the most common type of primary liver cancer (Press release, Micronoma, JUL 20, 2021, View Source [SID1234584976]).

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The collaboration, led by Associate Professor Amany Zekry and Professor Emad El-Omar from UNSW Medicine & Health will enable the development of microbial-based biomarkers powered by artificial intelligence for early detection of liver cancer. Micronoma’s Chief Scientific Officer, Eddie Adams, joins these world-class, multi-disciplinary experts at UNSW in the fields of liver disease, liver cancer, microbiome, metabolomics, and artificial intelligence as a co-principal investigator on the grant.

This research will use machine learning to examine thousands of microbiome plasma features to discover, validate, and translate microbial-derived biomarkers for the early detection of HCC, thus improving the chances of survival of HCC patients and making effective risk disease stratification possible.

"This collaboration with UNSW combines a rare and exciting set of expertise in liver cancer and gut microbiome with our proprietary method of analyzing circulating microbiome signatures. Importantly, being awarded this grant by the Australian Government serves as a strong external validation of our technique and will serve to showcase Micronoma’s unique approach to diagnostics," Micronoma CEO Sandrine Miller-Montgomery said. "There has been growing interest in the compelling link between circulating microbiome signatures and early detection since our publication in Nature. Developing a method to enable the identification of robust microbial plasma biomarker signatures of HCC is in our product pipeline and this collaboration enables us to fast-track product development."

"Our ongoing collaboration with Micronoma strengthens the innovative potential of this research. Micronoma is currently the only cancer diagnostic company in the world that uses microbial DNA signatures in the blood (mb-DNA) to detect early-stage cancer," said Professor Zekry. "Their minimally invasive microbiome-driven liquid biopsy approach is focused on detecting early-stage lung cancer and will provide valuable expertise in establishing an HCC-related microbiome platform."

The diagnostic implications of microbiome markers in liquid and tissue biopsies are extensive, and Micronoma is prepared to lead the way on helping prevent unnecessary suffering caused by later-stage cancer diagnosis, as well as potentially enabling personalized and less invasive treatments at the earliest stages of cancer.

On July 20, 2021 Flatiron Health real-world data (RWD) reported the U.S. Food and Drug Administration (FDA)’s recent approval of a new dosing regimen for ERBITUX (Eli Lilly and Company’s cetuximab) that can have a direct positive impact on the lives of patients with metastatic colorectal cancer (CRC) or squamous cell carcinoma of the head and neck (SCCHN) (Press release, Flatiron Health, JUL 20, 2021, View Source [SID1234584993]).

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The FDA approved a supplemental biologics license application (sBLA) for ERBITUX which provides a new, biweekly dosing regimen for the medicine’s indicated use in patients with K-Ras wild-type, EGFR-expressing metastatic CRC or SCCHN, when used as a single agent or in combination with chemotherapy.

This alternate dosing regimen to the previously approved weekly dosing regimen allows ERBITUX infusions to be scheduled alongside other biweekly treatments, significantly reducing the frequency of patient visits to an infusion center.

"Time is a precious commodity for patients with advanced cancer – every moment that is not spent traveling to and from or in the clinic are moments spent living life," said Michael Vasconcelles, MD, Chief Medical Officer at Flatiron Health. "We are proud that Flatiron RWD brings the evidence we gather from patients’ real-life experiences to bear directly on improvements to their care."

"This dosing change approval allows physicians to provide our patients with the same efficacious treatments in less frequent clinic visits," says Lee Schwartzberg, MD, Chief Medical Officer at OneOncology, a longtime Flatiron community oncology partner. "It is encouraging to see the innovative use of real-world data and regulatory pathways that made this label change a reality."

The approval decision marked a foundational proofpoint for the successful use of RWD to fill evidence gaps in the post-approval setting for regulatory decision-making. Efficacy results from overall survival analyses using Flatiron RWD in patients with metastatic CRC, who received either the weekly or biweekly ERBITUX dosing regimens, supported the results of the population pharmacokinetic modeling analyses in the sBLA. The application was also supported by pooled analyses of overall response rates, progression-free survival, and overall survival (OS) from published literature in patients with CRC and SCCHN.

"We are proud that our long-standing partnership with Flatiron Health is helping to advance the adoption of real-world evidence to support regulatory decision-making," said Christian Nguyen, Pharm.D., vice president of global patient outcomes and real-world evidence, Lilly Oncology. "Being able to fill key evidence gaps through the rigorous analysis of high-quality real-world data will help us all to more quickly bring potential new treatment options for approved medicines to patients."

On July 20, 2021 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the second quarter of 2021 after the market close on Tuesday, August 10, 2021 (Press release, Akoya Biosciences, JUL 20, 2021, View Source [SID1234590278]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call may do so by dialing (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 8057237. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

On July 20, 2021 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported operational progress and cash position (unaudited) for the second quarter of 2021 (Press release, Nanobiotix, JUL 20, 2021, View Source [SID1234584977]).

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Second Quarter Financial Updates

Nanobiotix reported total revenue for the six-month period ended June 30, 2021 of €9.7k. Revenue for the first half of 2021 was primarily driven by cross charges related to the Company’s previous collaboration with PharmaEngine, Inc., during the first quarter 2021. Nanobiotix did not generate any revenue during the second quarter of 2021. Revenue for the second quarter and first half of 2020 amounted to €13.4k and €36.9k respectively.

Nanobiotix reported cash, cash equivalents, and short-term investments totaling €102.3 million as of June 30, 2021, compared to €107.1 million as of March 31, 2021. This amount includes the €16.5 million ($20.0 million) upfront payment associated with the LianBio collaboration announced in May 2021. As previously announced, PharmaEngine was eligible for and received a €2.1 million ($2.5 million) payment following the announcement of Nanobiotix’s collaboration with LianBio and has received €3.4 million ($4.0 million) in conjunction with the completion of various administrative steps in connection with the winding-up of the collaboration. PharmaEngine will be eligible to receive an additional $1.0 million in administrative fees and a final payment of $5 million upon a second regulatory approval of an NBTXR3-containing product.

Nanobiotix plans to report half-year financial results for the six-months ended June 30, 2021, including condensed consolidated financial statements for the period, on September 8, 2021.

Second Quarter Operational Highlights

Presented Updated Results from Priority Pathways in Head and Neck Cancer and Immunotherapy for Potential First-In-Class Radioenhancer NBTXR3 at 2021 Annual Meeting of The American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper):
Local Control as a Single-Agent for Patients with Head and Neck Cancer: Updated data from Study 102, a phase I study evaluating NBTXR3 as a single agent activated by radiotherapy in locally advanced head and neck squamous cell carcinoma (LA- HNSCC) presented at ASCO (Free ASCO Whitepaper) further support NBTXR3 administration as feasible, and well-tolerated with a favorable safety profile in highly vulnerable elderly LA-HNSCC patients with high unmet medical needs and significant burden of disease. At a median follow up of 8.1 months, evaluable patients (n=40) demonstrated a high primary tumor ORR of 82.5% and a 62.5% CRR. These results are consistent with those observed in the dose escalation part of the study and suggest durability of efficacy. Nanobiotix plans to launch a pivotal phase III global registration study evaluating NBTXR3 as a single-agent activated by radiotherapy for patients with LA-HNSCC in the second half of 2021.
Priming Immune Response and Immunotherapy Combination Across Oncology:Updated data from Study 1100, a phase I basket study evaluating NBTXR3 activated by radiotherapy (RT) in combination with nivolumab or pembrolizumab in locoregional recurrent or recurrent metastatic HNSCC, lung metastasis from any primary tumor and/or liver metastasis from any primary tumor showed tumor regression in 76.9% of evaluable patients (n=13) regardless of prior anti-PD-1 exposure. Data from this ongoing study show NBTXR3 plus radiotherapy could potentially stimulate immune response and convert anti-PD-1 non-responders into responders.
Formed Strategic Partnership with LianBio to Develop and Commercialize NBTXR3 Across Tumor Types and Therapeutic Combinations in China and other Asian markets:
LianBio’s cross-border development and commercialization expertise includes strong capabilities in oncology: LianBio will participate in the Nanobiotix global phase III HNSCC registrational study by enrolling 100 patients in China. In addition to the phase III head and neck cancer study, LianBio has committed to enrolling patients in four additional registrational studies conducted by Nanobiotix across indications and therapeutic combinations. Under the terms of the agreement, LianBio will obtain exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore, and Thailand. Nanobiotix received a $20 million upfront payment and is entitled to receive up to an aggregate of $220 million in potential contingent, development and commercialization milestone payments along with tiered, low double-digit royalties based on net sales of NBTXR3 in the licensed territories.
Strengthened Board & Leadership Team to Focus Efforts on Advancing Its Global Development Strategy:
Named Gary Phillips, MD, as the new chairman of the Company’s supervisory board: Dr. Phillips, who is the president and chief executive officer of OrphoMed, Inc., brings decades of experience in the pharmaceutical and healthcare industries where he has led commercial operations, clinical medicine, business strategy, and development functions.
Appointed Bart Van Rhijn, MBA, as chief financial officer and member of the Company’s executive board: Mr. Van Rhijn brings extensive experience in consultancy, technology, and life sciences industries and joins Nanobiotix after nearly 3 years as chief financial officer at Servier Pharmaceuticals, LLC (Servier US). Prior to Servier US, he held leadership roles in prominent organizations in Europe and North America, including PricewaterhouseCoopers, Philips and Galderma, including Head of Tax, Senior Director of Mergers and Acquisitions, and Head of Finance positions.
Updated Financial Agenda

September 8: Half-Year Corporate and Financial Update
October 20th: Third Quarter Corporate and Financial Update

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the planned phase III study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company-sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) for MD Anderson to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.