On May 11, 2021 GT Medical Technologies, Inc. reported the first patient has been enrolled in a multicenter, randomized controlled trial (Press release, GT Medical Technologies, MAY 11, 2021, View Source [SID1234579721]). The trial aims to compare outcomes of patients with newly diagnosed, large metastatic brain tumors who receive the standard of care treatment, resection surgery and Stereotactic Radiotherapy (SRT), to those treated with resection surgery and GammaTile Therapy.

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!

"Enrolling the first patient in this significant trial by such a well-respected group of brain tumor centers is a pivotal milestone for GammaTile Therapy, as we continue to see increased usage across the country for this FDA-cleared breakthrough treatment," said Matt Likens, President and CEO of GT Medical Technologies. "Previous trials that provided a robust set of evidence leading to FDA clearance have demonstrated very favorable clinical outcomes, but this is the first to compare surgery plus GammaTile therapy against the standard of care in patients with newly diagnosed metastatic brain tumors, and we look forward to the results."

Unlike SRT, which targets tumors using focused radiation beams delivered from outside of the body in repeat in-person clinical visits, GammaTile delivers an immediate, therapeutic radiation dose from the tiles placed inside the brain at the tumor site immediately after tumor removal. GammaTile is designed to protect healthy tissue and minimizes radiation side effects, including hair loss. Over time, the collagen tiles are naturally absorbed into the surrounding tissue, eliminating the need for surgery to remove them.

The study is enrolling 180 patients with large metastatic brain tumors of any pathology. The most common primary sources of metastatic brain tumors are lung, breast, renal, GI, and skin cancers, The largest lesion (>2.5-5 cm) will be treated with either surgery with GammaTile Therapy or surgery followed by SRT. Up to three additional unresected lesions may be treated with SRT alone. The randomization of the two trial arms will also be stratified by age, histology, number of brain metastases, size of the index lesion, the use of immunotherapy, and more. The trial will measure local tumor control, overall survival, functional status, neurocognition, and quality of life out to 24-months following treatment, with data collected at 1, 3, 6, 9, 12, 16, and 24-months.1

The trial is led by The University of Texas MD Anderson Cancer Center, joined by other top brain tumor centers across the U.S. The trial will be co-directed by Jeffrey Weinberg, M.D., professor, deputy chair and vice-chair of clinical operations for Neurosurgery at MD Anderson, and Thomas Beckham, M.D., Ph.D., professor of Radiation Oncology at MD Anderson.

"GT Medical Technologies was founded by a group of brain tumor specialists committed to a scientific, evidence-based approach, so having such a well-respected group of brain tumor centers participate in this study is very rewarding," said Dr. Lisa Misell, Vice President of Clinical Affairs, GT Medical Technologies. "It’s critical to elevate the standard of care and find a viable treatment option for patients diagnosed with large metastatic brain tumors."

On May 11, 2021 NANOBIOTIX (Euronext : NANO – NASDAQ: NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported a partnership with LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and major Asian markets, to develop and commercialize Nanobiotix lead product candidate NBTXR3, a potential first-in-class radioenhancer, in Greater China (mainland China, Hong Kong, Taiwan, and Macau), South Korea, Singapore and Thailand. (Press release, Nanobiotix, MAY 11, 2021, View Source [SID1234579720])

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!

Shanghai and Princeton-based LianBio was founded by Perceptive Advisors with an innovative partnership model to develop and commercialize therapeutics in China and other Asian markets. LianBio’s cross-border development and commercialization expertise includes strong capabilities in oncology and NBTXR3 is the third investigational cancer treatment in the company’s portfolio. Given the global high unmet need in locally advanced and metastatic cancers, along with data supporting the potential of NBTXR3 across solid and metastatic tumor types, Nanobiotix continues to leverage strategic relationships with world class collaborators to expand and accelerate its pipeline while prioritizing Company resources to support development in head and neck cancer and immunotherapy.

"Discovery of practice-changing therapeutics for major diseases through a physics-based approach, with the support of people committed to making a difference for humanity, is our mission at Nanobiotix. We have long believed that NBTXR3 will significantly improve treatment outcomes for patients with any solid or metastatic tumor, and we are grateful that a partner with the talent and capability of LianBio has agreed to walk with us in our journey. Cancer is a disease that knows no borders and bringing our innovation to patients in Greater China with speed and determination is an absolute necessity," said Nanobiotix CEO and co-founder Laurent Levy.

"We purpose-built LianBio with a next-generation licensing model that enables us to meaningfully contribute to our partners’ global development initiatives in order to accelerate the availability of transformative therapeutics for patients throughout Asia," said Konstantin Poukalov, Executive Chairman of LianBio and Managing Director of Perceptive Advisors. "We believe NBTXR3 has a highly targeted nature and broadly applicable mechanism of action and thus has the potential to change radiotherapy and immuno-oncology treatment paradigms by addressing key limitations of current standards of care."

"The NBTXR3 therapeutic approach offers a promising avenue to address the significant burden of disease across multiple tumor types," said Debra Yu, M.D., President and Chief Business Officer, LianBio. "Our partnership will provide Nanobiotix with access to LianBio’s regional expertise and is designed to enable Nanobiotix to reach the growing number of cancer patients in China and other Asian markets who are in need of improved treatment options."

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 will receive 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. Nanobiotix will also be eligible to receive tiered, low double-digit royalties based on net sales of NBTXR3 in the licensed territories. LianBio will participate in the Nanobiotix global phase III registrational study evaluating NBTXR3 for patients with locally advanced head and neck squamous cell carcinoma (HNSCC; head and neck cancer) by enrolling 100 patients in China in the study. In addition to the phase III head and neck cancer study, LianBio has committed to enroll patients in four additional registrational studies conducted by Nanobiotix across indications and therapeutic combinations potentially including immunotherapy. LianBio will fund all development and commercialization expenses in the collaboration territory, and Nanobiotix will continue to fund all development and commercialization expenses in all other geographies.

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 primarily in locally advanced head and neck squamous cell carcinoma (HNSCC). The company-sponsored phase I dose escalation and dose expansion study has produced consistently 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 The University of Texas MD Anderson Cancer Center entered into a broad, comprehensive clinical research collaboration with Nanobiotix to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

On May 11, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported financial and operating results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Biodesix, MAY 11, 2021, View Source [SID1234579719]).

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!

"We were pleased with our strong operating and financial performance in the first quarter and believe we are off to a solid start in 2021," said Scott Hutton, Chief Executive Officer. "We are encouraged by the trends in our core lung diagnostic testing. Additionally, Biodesix continues to innovate as demonstrated through our announcement of two new products and we are well-positioned for the future."

First Quarter 2021 Financial Results

Successfully secured additional liquidity and deferred principal repayments through February 2024 by closing a new $30.0 million term loan and retiring the prior term loan for $25.9 million;
Total revenue of $28.9 million, an increase of 466% over first quarter 2020 and 7% over fourth quarter 2020;
COVID-19 testing revenue of $23.2 million, an increase of 8% over fourth quarter 2020;
Lung diagnostic revenue of $4.0 million, representing continued recovery and growth of 10% over first quarter 2020 and 8% over fourth quarter 2020;
Services revenue of $1.7 million, an increase of 12% over first quarter 2020 and 12% decline over fourth quarter 2020;
Gross profit of $10.6 million and gross margin percentage of 37%, both aligned with management expectations, primarily as a result of growth in COVID-19 testing;
Operating expenses (excluding direct costs and expenses) of $16.2 million, which includes an investment in the planned expansion of our salesforce, increased 36% over first quarter 2020 and 8% over fourth quarter 2020;
Non-cash stock compensation expense of $1.8 million, $0 and $3.7 million recognized during first quarter 2021, first quarter 2020 and fourth quarter 2020, respectively; and
Net loss of $7.0 million, an improvement of 28% over first quarter of 2020 and a 54% increase over fourth quarter 2020.
Business Highlights

Biodesix continues to make significant progress in lung diagnostics testing, including the addition of a new test to the lung cancer testing portfolio as well as new data that continues to support the value and utility of the Biodesix lung diagnostics portfolio. As a result of on-going progress, the Company was pleased to announce the following:

Plans to add a blood-based 52-gene next generation sequencing (NGS) test to the portfolio were announced in April 2021. The NGS test has unprecedented turnaround time of only 72-hours, according to data presented in a recent publication in Diagnostics. The NGS test will complement the improved 36-hour turnaround time that the GeneStrat ddPCR and VeriStrat tests currently offer, providing expanded coverage of 52-genes and broader molecular markers. The test will be used for advanced, late-stage, or recurrent cancer mutation detection in non-small cell lung cancer (NSCLC) and is expected to begin to be offered to physicians in the first half of 2022.
The issuance of two U.S. patents in April 2021 that enhance the Company’s ability to develop blood-based immunotherapy and other pipeline testing strategies for cancer patients.
Presentation of data from three studies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021, including data from VeriStrat and the Primary Immune Response (PIR) test that further demonstrate the utility of protein biomarker data from blood-based proteomic testing to support targeted and immunotherapy treatment strategies for NSCLC patients.
Beyond advancements in the lung diagnostic portfolio, the Company continued to expand and progress its partnerships and services related to COVID-19 testing, including the following:

In April 2021, announced a partnership with GenScript Biotech to conduct performance verification of the cPassTM SARS-CoV-2 Neutralization Antibody Detection test in our laboratory, with expected commercial launch in mid-year 2021. The test is the first and only surrogate neutralizing antibody test with FDA Emergency Use Authorization (EUA) to date and uses ELISA technology to qualitatively detect circulating neutralizing antibodies to the receptor binding domain (RBD) in the spike protein of SARS-CoV-2 that are produced in response to vaccination or previous SARS-CoV-2 infection.
In February 2021, announced a partnership with the Chicago Public Schools to provide antigen and Droplet Digital PCR (ddPCR) testing for Chicago Public School teachers and staff.
In January 2021, collaborated with the Purdue University Protect Purdue Health Center, to test students taking classes on the West Lafayette, Indiana Campus living off-campus during the Spring 2021 semester.
Conference call and webcast information

Management will host an investor conference call and webcast today, May 11, 2021 at 4:30 p.m. Eastern Time.

On May 11, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the first quarter for the period ended March 31, 2021 (Press release, Navidea Biopharmaceuticals, MAY 11, 2021, View Source [SID1234579718]).

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!

"We are continuing a positive dialogue with the FDA and are moving as quickly as we can to fully document all the data from Arm 3 of NAV3-31," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We are also excited to begin patient enrollment for NAV3-32 both here in the U.S. and in the UK."

First Quarter 2021 Highlights and Subsequent Events

Submitted a formal Type B Meeting Request to the U.S. Food and Drug Administration ("FDA"). The FDA granted the Type B Meeting and reviewed the formal briefing documents Navidea submitted containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol. Following the feedback received from the FDA at the end of March 2021, the Company continues to work toward completing the analysis of the full trial dataset in preparation for the standard End of Phase 2 Type B meeting and in preparation for the Phase 3 study.
Achieved last patient, last visit in the Company’s NAV3-31 Phase 2B study. Study closeout and data analysis are ongoing.
Opened the first US site, Northwestern University, as well as the primary UK site, Queen Mary University of London, for enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active rheumatoid arthritis ("RA").
Opened the NAV3-35 trial to establish a normative database of healthy controls for Tc99m tilmanocept imaging in rheumatoid arthritis.
Continued enrollment in the Investigator-Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Received a notice of allowance from the United States Patent and Trademark Office for the patent application: "Compounds and methods for diagnosis and treatment of viral infections" (U.S. Patent Application 15/729,635).
Announced that the results from the Company’s preclinical studies of its targeted cancer immunotherapeutic agent will be presented as a poster at the New York Academy of Science’s ("NYAS") Frontiers in Cancer Immunotherapy Symposium 2021. The poster is titled, "Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4."
Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company issued to the investor 50,000 shares of newly-designated Series E Redeemable Convertible Preferred Stock (the "Series E Preferred Stock") for an aggregate purchase price of $5.0 million. The Series E Preferred Stock is convertible into a maximum of 2,173,913 shares of Common Stock.
Appointed Amit Bhalla to the Company’s Board of Directors. Mr. Bhalla brings a wealth of financial experience to the board.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. We are completing the analysis of the full dataset from the NAV3-31 Phase 2B trial as well as planning for the Phase 3 trial. We continue to prepare for initiation of this trial and have opened up key sites for enrollment into the NAV3-32 Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, some of which will be presented this month at the NYAS conference, and we expect to continue to advance these towards the clinic."

Financial Results

Total net revenues for the first quarter of 2021 were $124,000, compared to $156,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by the partial recovery in the first quarter of 2021 of debts previously written off in 2015.
Research and development expenses for the first quarter of 2021 were $1.2 million, compared to $999,000 in the same period in 2020. The increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic and therapeutic development costs and increased Tc99m development costs, offset by decreased employee compensation.
Selling, general and administrative expenses for the first quarter of 2021 were $2.2 million, compared to $1.8 million in the same period in 2020. The net increase was primarily due to increased legal and professional services, insurance, investor relations services, and employee compensation, offset by decreased franchise taxes.
Navidea’s net loss attributable to common stockholders for the first quarter of 2021 was $3.0 million, or $0.11 per share, compared to $2.7 million, or $0.13 per share, for the same period in 2020.
Navidea ended the first quarter of 2021 with $7.5 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.D:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On May 11, 2021 Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, reported the publication in Frontiers in Immunology of its positive long-term Overall Survival (OS) data from the Phase I trial evaluating the Company’s universal cancer vaccine, UV1, in combination with checkpoint inhibitor ipilimumab in patients with metastatic malignant melanoma (Press release, Ultimovacs, MAY 11, 2021, View Source [SID1234579716]). As published in the journal, in addition to the achievement of the primary endpoints of safety and tolerability, 50% of the patients were still alive at the data cut-off, supporting the combination of the Company’s proprietary UV1 vaccine with ipilimumab, a CTLA-4 checkpoint inhibitor and standard-of-care treatment, in this late-stage patient population.

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!

"Publishing our clinical trial data in such a prestigious peer-reviewed publication adds validation for UV1 as a promising therapeutic option for cancer patients. As we continue to evaluate UV1 in various combinations and indications, it is valuable to gain increased international recognition from the clinical community for this study," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "Historical data on the use of ipilimumab as monotherapy in malignant melanoma have shown a 5-year survival rate below 20%, therefore the results published today reinforce UV1’s potential in this indication."

The data published in Frontiers in Immunology covers 4.8 years of follow-up on the total of 12 metastatic malignant melanoma patients that were enrolled in the Phase I trial. As reported in the journal, the OS was 50% at 4.8 years, which was confirmed by the results of 5 years of follow-up announced by the Company in December 2020.

Building on these promising Phase I results, Ultimovacs is currently enrolling INITIUM, its Phase II clinical trial evaluating UV1 in combination with ipilimumab and nivolumab in patients with metastatic malignant melanoma. The company expects to announce data on the trial’s primary endpoint in 2H2022. In addition, Ultimovacs has an ongoing and fully-enrolled Phase I trial evaluating UV1 in combination with pembrolizumab, a PD-1 checkpoint inhibitor, as a first line treatment in metastatic malignant melanoma patients.

The publication in Frontiers in Immunology can be found under doi: 10.3389/fimmu.2021.663865.

About UV1

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as an "off-the-shelf" therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs

As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials: INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. The DOVACC study is sponsored by the Nordic Society of Gynaecological Oncology. In total, 184 patients with high-grade ovarian cancer will be enrolled to evaluate UV1 in combination with durvalumab and olaparib, both provided by AstraZeneca. FOCUS is an investigator-sponsored, randomized clinical trial enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, and will evaluate the impact of adding UV1 to this regimen. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2H2022 and for the DOVACC and FOCUS studies in 2023.