On December 15, 2019 Ally Bridge Group ("ABG"), a leading global life science investment group, reported that it has announced that it recently led investments in three new medical technology companies (Press release, Ally Bridge Group, DEC 15, 2019, View Source [SID1234552379]). Each of the three companies is a commercial-stage, leading innovator re-setting the standard of care in its respective category. They include:

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Imperative Care (Campbell, CA) — A company that is singularly dedicated to improving the way stroke is treated by advancing medical technology, equipping healthcare providers to evolve best practices and elevate the standard of care for stroke patients. Imperative Care has received FDA approval for its first families of access and aspiration catheters. Website: View Source
Venclose Medical (Santa Clara, CA) — A commercial-stage company developing next-generation solutions for the treatment of venous reflux disease, also known as chronic venous insufficiency. Venclose has been commercializing in the US and Europe since 2018. Website: View Source
Mavrik Dental Systems (Tel Aviv, Israel) — A company with proprietary technologies and products for in-office teeth whitening with unparalleled efficiency and outcomes, and gum care. Mavrik represents ABG’s first investment in an Israel-based company. Website: View Source
"Medtech, as with biotech, remains a must-invest sector for ABG, where we focus on best-in-class technologies to disrupt current standards of care," said Frank Yu, CEO and CIO of Ally Bridge Group. "The closing of these investments brings the aggregate amount of ABG-led private life science investments to above $500 mm over the last 18 months, which include ABG’s lead role in investments in Grail (early cancer detection), Pulmonx (interventional pulmonology), Quantum Surgical (interventional oncology). All of these companies, with the exceptions of one in Israel and one in France, are based in Silicon Valley, California, USA."

"Our active investments that leverage powerful synergies across private and public markets, coupled with our M&A knowhow and cross-border value-add, position ABG uniquely as a leading investor in late-stage best-in-class life science technologies", adds Yu.

On December 13, 2020 Ultimovacs reported that the universal cancer vaccine UV1 will be investigated in a randomized, multi-center phase II trial in mesothelioma. The trial, named NIPU, investigates UV1 in combination with the checkpoint inhibitors nivolumab and ipilimumab as second-line treatment in mesothelioma. Oslo University Hospital (‘OUS’) is the sponsor of the study (Press release, Ultimovacs, DEC 13, 2019, View Source;lang=en-GB&companycode=no-ulti&v= [SID1234598614]). Bristol-Myers Squibb (‘BMS’) and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. A total of 118 patients will be included in the study. Half of the patients will be treated with the combination of UV1, nivolumab and ipilimumab, whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at 6 hospitals in 5 countries (Norway, Sweden, Denmark, Finland, and Australia). The study is about to be initiated and patient inclusion is expected to start in Q1 2020. The primary endpoint of the trial is progression-free survival (PFS) and the PFS read-out is expected mid-2022. The necessary approvals from the Norwegian Medicinal Agency and the ethics committee in Norway are in place to initiate the trial. Ultimovacs will cover the costs associated with its participation in the study from existing funds. Dr. Åslaug Helland, Oslo University Hospital, principal investigator of the study, says: "We are enthusiastic about the initiation of this clinical trial which will be run with the support from BMS and Ultimovacs. Malignant pleural mesothelioma is the most common type of mesothelioma and is a disease with a high unmet medical need. The immunotherapy combination of nivolumab, ipilimumab and UV1 could represent a highly interesting treatment regime where the different mechanisms of action of the three drugs could provide synergistic effects that could be of clinical benefit to patients. " Øyvind Kongstun Arnesen, CEO of Ultimovacs, says: "We are pleased to take part in this exciting clinical trial with our universal therapeutic cancer vaccine, UV1. As we have previously seen, the combination of UV1 and ipilimumab provided rapid and durable immune responses in our phase I melanoma trial suggesting a synergistic immunological activity. The simultaneous administration of another checkpoint inhibitor, nivolumab, may further support the immune system’s ability to recognize and effectively kill the cancer cells. " The initiation of the NIPU trial brings UV1 in clinical investigation in its fourth cancer type to date. Previously, UV1 has been tested within prostate cancer, non-small cell lung cancer, and malignant melanoma. In Q1 2020, Ultimovacs expects to include the first of 154 patients in a randomized trial in malignant melanoma where UV1 is combined with nivolumab and ipilimumab. Øyvind Kongstun Arnesen, CEO of Ultimovacs, adds: "The fact that UV1 will be investigated in two large randomized clinical trials in different cancer types and with a total of 272 patients is a major step forward for Ultimovacs and the development of UV1. This will enhance the opportunities for successful clinical results in an additional cancer indication and support that UV1 may be broadly applicable across cancer types." About NIPU NIPU is an investigator-initiated, Oslo University Hospital sponsored, randomized, multi-center, open-label, proof of concept study comparing the efficacy and safety of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) with and without UV1 in patients with inoperable malignant pleural mesothelioma (MPM) who have progressed after first-line platinum-based chemotherapy. Biological material will be sampled, and there will be several explorative analyses aiming at identifying biomarkers and revealing mechanisms of action. In total, 118 patients will be randomized into two patient groups treated with ipilimumab and nivolumab with or without UV1 together with sargramostim (GM-CSF) as vaccine adjuvant. The objective of the study is to induce a meaningful progression-free survival (PFS) benefit in patients with MPM after progression on first-line standard platinum doublet chemotherapy. The study sites are planned to be Oslo University Hospital in Norway, Karolinska University Hospital and Skåne University Hospital Lund in Sweden, Rigshospitalet in Denmark, Helsinki University Hospital in Finland, and Sir Charles Gairdner Hospital in Perth, Australia. About Malignant Pleural Mesothelioma Malignant pleural mesothelioma (MPM) is a rare malignant tumor originating from the cells lining the mesothelial surface in the lungs. MPM is the most common type of mesothelioma and is a disease with a high unmet medical need with a median overall survival of approximately 1 year. Most patients are treated with palliative chemotherapy. Patients with disease progression after first-line therapy have few therapeutic options. Asbestos exposure is heavily linked to the development of the disease. It may take 10-50 years for symptoms of mesothelioma to manifest after initial asbestos exposure. Even though the use of asbestos to a large extent is banned today, new incidences of mesothelioma will continue to be a medical challenge for decades. About Ipilimumab Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. About Nivolumab Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, nivolumab has become an important treatment option across multiple cancers. 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 a 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. With its mechanism of action, UV1 is potentially a universal cancer vaccine that can be applied across most cancer types.

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On December 13, 2019 Susan G. Komen, the world’s leading breast cancer organization, reported the results of the INFORM trial that were announced at the 2019 San Antonio Breast Cancer Symposium (Press release, Susan G Komen, DEC 13, 2019, View Source [SID1234552378]). The Komen-funded INFORM trial led by Dr. Nadine Tung shows that HER2-negative patients with a BRCA1/2 gene mutation have multiple effective treatment options.

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Dr. Tung and colleagues sought to determine if cisplatin chemotherapy is a more effective treatment than the current, standard of care treatment, chemotherapy with doxorubicin and cyclophosphamide (commonly referred to as "AC"). Prior retrospective studies, which looked at treatment that has already occurred as part of the study, had indicated that cisplatin chemotherapy might work better than AC. The INFORM clinical trial was the first prospective study, or a study that evaluates treatment moving forward, to actually test this idea.

"For HER2-negative breast cancer patients with BRCA1/2 mutations, the INFORM trial confirmed that cisplatin chemotherapy is not more effective than standard chemotherapy with doxorubicin and cyclophosphamide. The results suggest that BRCA carriers may respond to both types of chemotherapy – which kill cancer cells by damaging DNA – giving them multiple options to treat their cancer," said Dr. Tung. Prospective studies are essential for improving clinical practice.

She added, "Funding from Susan G. Komen was essential for this work." Funded in part by a Komen Opportunity Grant, the INFORM trial is also part of the Translational Breast Cancer Research Consortium (TBCRC), which has been supported by Komen for more than 10 years.

Victoria Wolodzko, senior vice president of Mission at Susan G. Komen, added, "Patients with BRCA mutations face many challenges, especially those in rural or underserved areas. This work confirms that physicians have more options for these patients. Patients won’t need to wait for a specific treatment to ensure they are getting the best care no matter where they live."

On December 13, 2019 Aethlon Medical, Inc. (Nasdaq:AEMD) (the "Company"), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported the pricing of an underwritten public offering of 3,333,334 shares of common stock (which includes pre-funded warrants to purchase shares of common stock in lieu thereof), and common warrants to purchase up to an aggregate of 3,333,334 shares of common stock at a public offering price of $1.50 per share (Press release, Aethlon Medical, DEC 13, 2019, View Source [SID1234552375]). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with a common warrant to purchase one share of common stock. The common warrants have an exercise price of $1.50 per share, are immediately exercisable, and will expire five years from the date of issuance. The Company has granted the underwriter a 45-day option to purchase up to an additional 499,999 shares of common stock and/or common warrants to purchase up to 499,999 shares of common stock, at the public offering price, less underwriting discounts and commission.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds of the offering are expected to be approximately $5 million, prior to deducting underwriting discounts and commissions and estimated offering expenses and excluding the exercise of any common warrants and the underwriter’s option to purchase additional securities. The Company intends to use approximately $700,000 of the net proceeds from this offering for the currently planned clinical trials for the Hemopurifier over the next 12 months, with the remainder for working capital and other general corporate purposes. This offering is expected to close on or about December 17, 2019, subject to customary closing conditions.

A registration statement on Form S-1 (File No. 333-234712) relating to these securities (and the shares of common stock underlying the common warrants and pre-funded warrants) was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on December 12, 2019. This offering is being made only by means of a prospectus forming part of the effective registration statement. A final prospectus relating to and describing the terms of the offering will be filed with the SEC and, when available, may be obtained for free by visiting the SEC’s website at www.sec.gov. Electronic copies of the final prospectus relating to the offering may also be obtain by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 13, 2019 Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL), reported the approval from the United States Patent and Trademark Office (USPTO) for a patent covering the clinical use of a biomarker analysis to detect cancer patients ability to respond to folate-based therapy cancer treatments (Press release, Isofol Medical, DEC 13, 2019, View Source [SID1234552374]).

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The patent is valid until 2035 and extends Isofol’s patent portfolio for its lead asset arfolitixorin, the company’s drug candidate entity with the potential to increase the effectiveness of folate-based chemotherapy regimens. Arfolitixorin is currently being studied in the ongoing global Phase 3 study AGENT, in patients with metastatic colorectal cancer.

Ulf Jungnelius, M.D., Chief Executive Officer of Isofol, comments: "We consider the patent to be of great strategic importance for Isofol. It can increase the benefit of folate-based cancer treatment by detecting patients’ ability to respond to the treatment. The patent can be applied to all types of cancer undergoing folate-based cancer treatment. It is our belief that the method can be extended to further cancer indications in the long term. Currently, we are focusing on validating arfolitixorin in our global Phase III study AGENT, in patients with metastatic colorectal cancer."

The granted patent, U.S. Patent No. 10,487,364, is directed to a method of treating cancer using a combination of an anti-cancer agent and a folate substance, such as arfolitixorin or leucovorin (LV). The patent pertains to detection of the levels of a number of biomarkers involved in folate transport and metabolism, which can predict an individual patient’s responsiveness to a conventional folate substance such as leucovorin. Following biomarker analysis, patients unresponsive to current prodrugs (LV) could be selected for treatment with arfolitixorin on the basis of the biomarker level to potentially helping increase the effectiveness of the treatment regimen used. Unlike leucovorin, which must be metabolised into MTHF in the body in order to be effective in the treatment of cancer, arfolitixorin is the active substance MTHF, which means that no metabolic activation is required and arfolitixorin consequently has the potential to achieve a more powerful antitumoural effect for all patients in combination with 5-FU treatment.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 15:45 CET on December 13, 2019.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 trial, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.