On September 8, 2021 HaemaLogiX Pty Ltd, a clinical stage biotech company developing novel immuno-oncology and immune therapies for patients with blood cancers, reported the close of a fully subscribed $10 million placement to sophisticated investors and welcomes Platinum Asset Management as core new institutional investor within its Platinum International Health Care Fund (Press release, HaemaLogiX, SEP 8, 2021, View Source [SID1234587437]).

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Bryce Carmine, HaemaLogiX Chairman and CEO commented: "We are pleased to have secured $10 million in new capital which will enable HaemaLogiX advance the development of our lead asset KappaMab. In clinical studies to date, KappaMab has shown strong potential as an efficacy-boosting adjunct to the standard of care across multiple lines of treatment for multiple myeloma patients. Funds raised will contribute significantly to HaemaLogiX’s efforts to address the patient need in this underserved market and expedite our commercialisation efforts.

"Both new and existing shareholders have supported the raise and I’m very pleased to welcome the world-class Platinum Asset Management as a new institutional investor."

HaemaLogiX’s lead drug is a monoclonal antibody called KappaMab. It targets a cancer cell surface kappa myeloma antigen (KMA), which is believed to play a role in protecting the cancerous myeloma cell from the patient’s own immune response. When KappaMab specifically binds to the myeloma cell, it enables the patient’s immune system to recognise the cell as abnormal, triggering the natural response to attack and kill the myeloma cell.

Importantly the specificity of KappaMab has demonstrated excellent safety and efficacy in myeloma patients whose disease has relapsed. Due to its unique mode of action, KappaMab works in partnership with drugs that represent standard of care for treating multiple myeloma. These standard of care drugs have been shown to upregulate the KMA target on the myeloma cells and increase the patient’s own immune response, leading to a more effective synergistic drug combination treatment.

KappaMab’s potential to boost the efficacy of standard of care treatment has been validated by interim Phase IIb data. It is anticipated that final results of the Phase IIb clinical trial will be published in late 2021.

Placement and Use of Funds

Approximately 873k new fully paid ordinary shares in the Company (New Shares) will be issued under the Placement at the issue price of $11.60 per new share (Issue Price).

The funds raised under the placement will directly support manufacturing of the next batch of the Kappa antibody plus the conduct of a higher dose, 30mg/kg, monotherapy study and prepare for two further studies. One study demonstrating the clinical relevance of KappaMab in patients on a maintenance regime – which represents more than 50% of the overall market potential of the treatment landscape[1] – and a second study in patients who have relapsed or become refractory to other immunomodulatory drugs in previous lines of treatment.

The Company also plans to progress its antibody for lambda-type multiple myeloma (which account for 30% of multiple myeloma patients) and continue activities to secure pharmaceutical partners for technology development, which may generate income through a licence or asset sale.

On September 8, 2021 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported the Phase Ib results of the dual Bcl-2/Bcl-xL inhibitor, APG-1252 (pelcitoclax), in combination with osimertinib in patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) resistant non-small cell lung cancer (NSCLC), during a Mini Oral Session at the 2021 World Conference on Lung Cancer (WCLC) (Press release, Ascentage Pharma, SEP 8, 2021, View Source;mini-oral—ascentage-pharma-announces-latest-data-of-its-investigational-bcl-2bcl-xl-inhibitor-pelcitoclax-apg-1252-combined-with-osimertinib-in-patients-with-egfr-tki-resistant-non-small-cell-lung-cancer-301371959.html [SID1234587436]). The data was presented by Prof. Li Zhang, the principal investigator of the study from Sun-Yat Sen University Cancer Center.

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Organized by the International Association for the Study of Lung Cancer (IASLC), the World Conference on Lung Cancer (WCLC) is the world’s largest multidisciplinary oncology event dedicated to lung cancer and other thoracic cancers, with a focus on the most cutting-edge research and clinical advances in the field. Results presented by Ascentage Pharma at this year’s WCLC are from a single-arm, multicenter Phase Ib dose-escalation and dose-expansion study designed to evaluate the pharmacokinetics (PK), safety and preliminary efficacy of pelcitoclax in combination with osimertinib in patients with advanced EGFR-mutant NSCLC.

Being developed by Ascentage Pharma, pelcitoclax is a novel small-molecule drug candidate that restores apoptosis by selectively inhibiting Bcl-2 and Bcl-xL proteins simultaneously. In preclinical studies, pelcitoclax in combination osimertinib has demonstrated synergistic anti-tumor effects in animal models of EGFR-mutant NSCLC that were sensitive or resistant to osimertinib. Therefore, pelcitoclax in combination with osimertinib has the potential of offering a new treatment option.

Highlights of the data presented during a Mini Oral Session at this year’s WCLC:

Phase 1b Study of Pelcitoclax (APG-1252) in Combination With Osimertinib in Patients With EGFR TKI-Resistant NSCLC

Abstract: MA02.06

Track: Novel Therapeutics and Targeted Therapies

Time: 10:05 – 10:10, September 8, 2021, Mountain Time / 00:05 – 00:10, September 9, 2021, Beijing Time

This single-arm, multicenter Phase Ib study of pelcitoclax in combination with osimertinib in patients with advanced EGFR-mutant NSCLC, comprised a dose-escalation phase and a dose-expansion phase. Pelcitoclax was administered at 160 mg or 240 mg by IV infusion once a week, and osimertinib was administered orally at 80 mg daily (QD). The dose-escalation primarily evaluated the safety and tolerability of the combination regimen in patients progressed on prior EGFR TKI treatments, and determined the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of pelcitoclax. The dose-expansion comprised two arms: 1) Patients with third-generation EGFR TKI-resistant NSCLC; 2) Patients with osimertinib-naïve NSCLC. Each arm planned to enroll 20 patients.

As of June 24, 2021, 56 patients were enrolled in the study. 33 of them were enrolled in the dose-escalation and dose-expansion arm 1. Those patients had received a median of 4 (range: 1-10) lines of prior treatment, 87.9% had received chemotherapies, 75.8% had been treated with osimertinib, and 63.6% had brain metastasis at the time of enrollment. The 23 patients enrolled in arm 2 had received a median of 0 (range: 0-2) lines of prior treatment, 8.7% had received chemotherapies, 17.4% had been treated with first-generation tyrosine kinase inhibitors (TKIs), and 30.4% had brain metastasis at the time of enrollment.

In dose-escalation, 1 partial response (PR) was observed in the 11 evaluable patients. In arm 1 of the dose-expansion phase, 3 PRs (2 were osimertinib-resistant) and 13 stable diseases (SDs) were observed in the 20 evaluable patients, at an objective response rate (ORR) of 15% and a disease control rate (DCR) of 80%. In arm 2 of the dose-expansion phase, 13 PRs and 8 SDs were observed in the 22 evaluable patients, including 3 patients harboring EGFR Exon 20 insertion, at an ORR of 59.1% and a DCR of 95.5%.

In dose-escalation, one case of dose-limiting toxicity (DLT) of grade 4 thrombocytopenia was observed at 240 mg; while no grade 3 or higher thrombocytopenia was observed at 160 mg, and the increase in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) also occurred at much lower rate than 240 mg. Thus, pelcitoclax 160 mg per week plus osimertinib 80 mg QD was selected as the RP2D. The most common treatment-related adverse events (TRAEs) included transient thrombocytopenia, increased AST, increased ALT, increased amylase, increased blood creatinine, decreased leukocytes, anemia, and rash.

Conclusion: Pelcitoclax in combination with osimertinib was safe and well-tolerated. Preliminary synergistic anti-tumor effects were observed in some patients with osimertinib-resistant NSCLC. In patients who received osimertinib for the first time, pelcitoclax has demonstrated preliminary synergistic anti-tumor effects with osimertinib similar to that of navitoclax.
Prof. Li Zhang, the principal investigator of the study from Sun-Yat Sen University Cancer Center, said: "Although osimertinib is currently the preferred first-line treatment for patients with EGFR-mutant NSCLC, there are still no effective treatments for patients who are resistant to osimertinib. Our data presented at this year’s WCLC has demonstrated synergistic anti-tumor effects of pelcitoclax plus osimertinib in some osimertinib-resistant patients, thus indicating the potential as a new clinical strategy that could address this unmet medical need. In the next step, we will carry out additional analysis of biomarkers in an effort to enrich the patient population responding to this regimen."

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented: "There is currently an enormous unmet medical need in patients with NSCLC, especially in the EGFR TKI-resistant subgroup that is in desperate need of effective treatment options. These results reported at the WCLC this year showed the therapeutic potential of pelcitoclax plus osimertinib in patients with EGFR TKI-resistant NSCLC, therefore provided rationale for the continued clinical investigations. We will press forward with this clinical development program which hopefully will offer a new treatment option to patients in need."

On September 8, 2021 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported its half year financial results for the six-month period ended June 30, 2021 (Press release, Nanobiotix, SEP 8, 2021, View Source [SID1234587435]).

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First Half Operational Highlights, Pipeline Status and Upcoming Milestones

Priority Pathway in Head & Neck Cancer, Local Control as Single Agent Activated by Radiotherapy: Leveraging proof-of-concept demonstrated in a successful Phase II/III study and subsequent EU marketing authorization for soft tissue sarcoma, Nanobiotix is currently evaluating NBTXR3 as a single agent activated by radiotherapy in other solid tumor indications with an initial focus on locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Updated data from Study 102 Expansion, a phase I dose expansion study evaluating NBTXR3 as a single agent activated by radiotherapy in LA-HNSCC presented at the 2021 Annual Meeting of The American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) continue to support NBTXR3 administration as feasible and well-tolerated 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.1 These results are consistent with those observed in the dose escalation part of the study and suggest durability of effect.
Expect to report an analysis of progression free survival (PFS) and overall survival (OS) from 41 evaluable patients in Study 102 at a medical conference during the fourth quarter of 2021.
Initiation of NANORAY-312, a pivotal phase III global registration study evaluating NBTXR3 as a single-agent activated by radiotherapy for patients with LA-HNSCC expected late in the fourth quarter of 2021.
Priority Pathway in Immunotherapy for Advanced Cancers, Priming Immune Response in Combination with Anti-PD-1 Treatment: Given early data showing anti-cancer immune activity triggered by its physical mechanism of action, Nanobiotix is evaluating the potential for NBTXR3 to improve current approaches to immunotherapy by combining NBTXR3 with anti-PD-1 therapies in advanced cancers to potentially increase the number of patients that respond to treatment and improve outcomes for patients regardless of their prior exposure to immune checkpoint inhibitors.

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.
Expect to provide updated data including approximately 16 evaluable patients at medical conference during the fourth quarter of 2021
Plan to initiate discussions with FDA regarding potential registration pathway for NBTXR3 immunotherapy combination in H2 2021
On-track to report recommended Phase II dose for each cohort in 2022
Expanding NBTXR3 Opportunity, Collaborating with World-Class Partners to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:

Formed strategic partnership with LianBio to develop and commercialize NBTXR3 across tumor types and therapeutic combinations in China and other Asian markets. LianBio will participate in the Nanobiotix global phase III HNSCC registrational study by enrolling approximately 100 patients. 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. 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.
Initiated fifth collaborator-led study at The University of Texas MD Anderson Cancer Center (MD Anderson). MD Anderson Collaboration now includes three Phase I and two Phase II clinical studies, including:
Phase I study evaluating NBTXR3 activated by radiation therapy (RT) for patients with non-small cell lung cancer (NSCLC) amenable to re-irradiation;
Phase I study evaluating NBTXR3 in combination with chemotherapy for patients with esophageal cancer;
Phase I study evaluating NBTXR3 as a single agent activated by RT for patients with pancreatic cancer; and
Two Phase II studies, each evaluating NBTXR3 in combination with anti-PD-1 for patients with head and neck cancer (inoperable locoregional recurrent amenable to reirradiation and recurrent metastatic with limited PD-L1 expression or refractory).
Presented preclinical data, developed in collaboration with MD Anderson, further suggesting that NBTXR3 could prime adaptive immune response and combine with several immune checkpoint inhibitors at the first American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference on Radiation Science and Medicine. This data demonstrated that a combination therapy including NBTXR3, anti-PD-1, anti-TIGIT, and anti-LAG3 augmented anti-tumor response in both irradiated and unirradiated tumors, improving local and distant tumor control and increasing survival rate. The survivor mice were immune to re-injections of tumor cells, maintained significantly higher percentages of memory immune cells and stronger anti-tumor immune activities than control.
Reported first clinical results in rectal cancer including recommended phase II dose from the complete phase Ib part of a phase Ib/II study evaluating NBTXR3 activated by radiotherapy with concurrent chemotherapy at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI 2021). The data showed that the intra-tumoral injection of NBTXR3 was feasible and well tolerated at all dose levels. More than 70% of patients showed objective tumor response and approximately 90% of patients underwent total mesorectal excision (surgery), and 17.6% achieved pathological complete response.
Initiated one-year collaboration between Sanofi and Nanobiotix subsidiary, Curadigm, to establish proof-of concept for Curadigm’s Nanoprimer as a combination product that could improve treatment outcomes for gene therapy product candidates.
"Given our clinical and operational progress in the first half of 2021, we believe we are on track to deliver on the promise of NBTXR3 as a potential first-in-class, solid tumor-agnostic, combination-agnostic product candidate that could change treatment paradigms in oncology," said Laurent Levy, co-founder and chairman of the executive board of Nanobiotix. "As we prepare for the initiation of our pivotal phase III study later this year, we are highly encouraged by the consistently strong findings from our phase I expansion study in head and neck cancer presented earlier this year and eagerly anticipate reporting progression free survival and overall survival data from this study in the fourth quarter. Taken together with data we have reported on the potential of NBTXR3 in immunotherapy and the series of studies initiated by MD Anderson exploring NBTXR3 across additional solid tumor types and therapeutic combinations, we continue to achieve critical milestones on our journey to improve outcomes for patients throughout oncology."

Financial Results for the First Half of 2021

Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2021, were €102.3 million, expected to support development plans into the first quarter of 2023. 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 the LianBio collaboration and has received €3.3 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, a final payment of $5 million upon a second regulatory approval of an NBTXR3-containing product as well as low-single digit royalties for a limited period following approval in the region.

Revenue: Revenue for the first half of 2021 totaled €9.7 thousand compared to €36.9 thousand for the first half of 2020. Revenue for the six months ended June 30, 2021 and June 30, 2020 mainly corresponded to the charging back of cost incurred in connection with the Company previous collaboration with PharmaEngine, Inc.

Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended June 30, 2021, were €15.5 million, compared to €13.1 million for the six months ended June 30, 2020. Purchases, sub-contracting and other expenses increased by €2.3 million for the six months ended June 30, 2021 as compared with the same period in 2020. This increase reflects the impact of COVID-19 pandemic in 2020 and the Company’s focus on advancing its clinical trial development priorities in 2021.

Selling, General and Administrative ("SG&A") Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the six months ended June 30, 2021, were €10.2 million, compared to €6.8 million for the prior-year six-month period. This increase of €3.4 million was primarily due to expenses relating to partnership agreements as well as consulting fees, legal & compliance expenses following the Company’s Nasdaq listing, and recruitment expenses.

Net loss: Net loss attributable to common shareholders for the six months ended June 30, 2021 was €30.4 million, or €0.88 per share. This compares to a net loss attributable to common shareholders of €20.6 million, or €0.91 per share, for the same period in 2020. The €9.8 million increase in net loss compared to the first half of 2020 was primarily driven by the €5.4 million in operating expenses associated with the termination of the PharmaEngine agreement during the first half of 2021.

These results are represented in the condensed consolidated financial statements as of June 30, 2021, approved by the executive board of the Company on September 8, 2021, and reviewed by the supervisory board of the Company on the same date, and have been subjected to a limited review by the Company’s statutory auditors.

Availability of the half-year financial report

The 2021 half-year financial report has been filed with the French Financial markets authority (Autorité des marchés financiers). It is available to the public and can be consulted on the company’s website, www.nanobiotix.com.

Updated Financial Agenda

October 20th, 2021: 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 to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

On September 8, 2021 Endomag repored that A pioneering new technique known as ‘delayed’ sentinel lymph node biopsy could spare as many as four in five Americans diagnosed with high-risk ductal carcinoma in-situ (DCIS) from an unnecessary additional underarm surgical procedure (Press release, Endomag, SEP 8, 2021, View Source [SID1234587433]).1

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Ductal carcinoma in-situ (DCIS) is the presence of abnormal cells inside a milk duct in the breast, and accounts for one in every five new breast cancer diagnoses.2 It is considered the earliest form of breast cancer and is non-invasive, meaning that the cancer has not spread beyond the milk duct and has a low risk of becoming invasive. If left untreated, DCIS can break down and become invasive, where the cancer spreads through the lymphatic system.

A common treatment for DCIS is a mastectomy, where the patient will undergo surgery to remove the entire breast. Until now, doctors would also remove the majority of lymph nodes in the underarm on the side of the affected breast tissue during the mastectomy, to assess whether the cancer has spread. This procedure is known as a sentinel lymph node biopsy. Every year over 50,000 American women with the earliest form of breast cancer receive this node surgery.3 Yet, 70-80% of women diagnosed with DCIS do not have invasive cancer,3,4 rendering this additional surgery unnecessary.

The new procedure, known as a ‘delayed’ sentinel lymph node biopsy, involves the use of the Magtrace lymphatic tracer, a magnetic lymphatic tracer used in axilla staging. It is the only tracer that will be retained long enough in the lymph nodes to enable this pioneering treatment. In the procedure:

The Magtrace lymphatic tracer is injected at the time of the mastectomy and DCIS surgery, naturally migrating to the nodes that the cancer is most likely to spread to, if the disease is invasive.
It remains in place for up to 30 days after it has been injected and will provide a magnetic signal to help the surgeon return to the nodes, if they need to.
This means that doctors can wait for pathologic analysis of the DCIS to confirm if it is invasive. This information can then determine whether a sentinel lymph node biopsy is necessary. In up to 80% of cases it will not be. 1
If pathology confirms that the DCIS is invasive, the long-lasting signal of Magtrace allows for the sentinel lymph node biopsy to still be performed to understand the extent of cancer migration to the lymph nodes.
"The delayed sentinel lymph node biopsy has really revolutionized our ability to maintain lymphatic integrity in women who have DCIS", explained Dr Kandace McGuire, Chief, Section of Breast Surgery Surgical Leader of the Multidisciplinary Breast Cancer Program at Massey Cancer Center, Virginia. "So, what we do is we inject the Magtrace lymphatic tracer at the time of the initial mastectomy. The great thing about this is that the tracer will stay in the lymph nodes for up to six weeks so that we have time to get pathology back. If there’s no invasive cancer, there’s no need to do a sentinel lymph node biopsy."

By preventing surgery, the new ‘delayed’ sentinel lymph node biopsy spares women’s lymph nodes and leaves the lymphatic system undamaged, reducing the risk of life-altering complications connected with lymph node surgery. One of these is lymphedema, a condition affecting over 10 million Americans,5 caused by a build-up of lymphatic fluid that escapes into the body when the system is disrupted. Lymphedema, while manageable, is largely incurable,6 and causes lifelong swelling, altered sensation, pain and limitations in range of motion.7

"It felt wonderful to know that I would only have a sentinel lymph node biopsy if I truly needed it," explained Theresa Poon, who benefitted from the delayed Sentinel Lymph Node Biopsy procedure. "I was very scared of lymphedema. The swelling can just happen at any time, and even though it’s very rare, it’s always in the back of your mind. To be offered the possibility of not having any lymph nodes removed if I didn’t have invasive cancer was great."

Research from Uppsala University Hospital in Sweden and University Hospitals Cleveland has shown that the delayed Sentinel Lymph Node Biopsy procedure has reduced surgical interventions in 78.3% and 87% of cases respectively, and reduced costs to the healthcare system by 24.5% for women without invasive breast cancer.1,7 In total, over 160,000 women across more than 700 hospitals in over 45 countries have already been able to access more precise and less invasive breast cancer treatment thanks to Magtrace and Endomag’s other breast cancer treatment technologies.

"Women with breast cancer face so many difficult choices, so it’s gratifying to know that for high-risk DCIS patients, we can take one away without compromising their care and offer a real chance of avoiding unnecessary surgery," said Mathew Stephens, Chief Marketing Officer at Endomag. "Our new campaign, #SaveOurNodes, seeks to ensure that all women with high-risk DCIS are aware of this new surgical option. With advice from expert breast surgical oncologists who offer the technique and other patients who have had the procedure, we hope this campaign helps to provide more clarity on the best treatment approach for them."

Find out more about the campaign and the ‘delayed’ sentinel lymph node biopsy technique by visiting www.saveournodes.com, which features more information and resources about the procedure. There is now an ever-growing number of hospitals across the US practicing ‘delayed’ sentinel lymph node biopsy and Endomag will continue to work to improve access for all breast cancer patients.

On September 8, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, reported the signing of a supply agreement for the therapeutic medical radioisotope actinium-225 (Ac-225) (Press release, NorthStar Medical Radiostopes, SEP 8, 2021, View Source [SID1234587432]).

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Ac-225 is a high energy alpha-emitting radioisotope that is a mainstay for studies in targeted radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while its half-life limits unwanted radioactivity in patients. Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technology. NorthStar is positioned to be the first commercial-scale producer of Ac-225, applying its radioisotope production technology expertise to provide reliable supply for advancing clinical research and commercial radiopharmaceutical products.

Under the terms of the agreement, NorthStar will provide POINT with its electron accelerator-produced Ac-225 and POINT will use NorthStar’s Ac-225 in investigational studies of PNT2001, a next-generation Prostate-Specific Membrane Antigen (PSMA) for non-metastatic castrate-sensitive prostate cancer (nmCSPC); PNT2004, a Fibroblast Activation Protein-α candidate with potential pan-cancer applications; and to advance its novel Tumor Microenvironment (TME) tumor-targeting technology platform.

"NorthStar is at the forefront of U.S. radioisotope production as the only commercialized producer of the important medical radioisotope molybdenum-99 (Mo-99), and we are applying that same development expertise to rapidly advance large-scale availability of Ac-225," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Our Ac-225 process uses highly efficient electron accelerator production technology that provides increased capacity and scheduling flexibility. Like all NorthStar processes, it is environmentally friendly, non-uranium based and uses highly advanced technology. We are very pleased to enter this Ac-225 supply agreement with an industry leader such as POINT, with whom we share a vision to progress research and clinical availability of targeted radiotherapies for cancer patients as a potential treatment option."

"A resilient radioisotope supply chain is key to advancing our next-generation pipeline of targeted radiopharmaceuticals," said Dr. Joe McCann, Chief Executive Officer of POINT. "NorthStar’s deep experience and commercial competencies in radioisotope production make them an ideal partner, and we believe that their accelerator production technology will provide us with a differentiated and highly efficient supply route for the therapeutic radioisotope Ac-225."