On December 17, 2019 Herantis Pharma Plc ("Herantis" or "Company") reported that patient recruitment in the Company’s Phase 2 clinical trial AdeLE ("Adenoviral gene therapy for the treatment of LymphEdema") has been completed (Press release, Herantis Pharma, DEC 17, 2019, View Source [SID1234552451]). All of the 39 patients with breast cancer associated lymphedema have been randomized to receive either Lymfactin or placebo treatment, and their treatments have been completed according to the study protocol. The AdeLE trial will continue with a 12-month blinded follow-up to evaluate the safety and efficacy of Lymfactin in the treatment of breast cancer associated lymphedema, when combined with a conventional lymph node transplantation surgery. Herantis expects to unblind the study and announce its top-line results in the first quarter of 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The rapid enrolment completion demonstrates not only that there is a significant need for novel treatment options in lymphedema, but it is also an important milestone for our Lymfactin program as we are advancing into late-stage clinical development. We are truly grateful to the patients who participated in the AdeLE study, the supporting physicians and staff at the study sites, and to the international patient organization LE&RN, which fights to raise awareness for lymphedema as a significant unmet clinical need," commented Pekka Simula, CEO of Herantis. "Based on the cumulated safety data and assessments of the trial’s independent Data Safety Monitoring Board, we are encouraged by the established safety profile of Lymfactin. We look forward to the efficacy read-outs that could bring new hope to lymphedema patients all around the world."

Study Design

The AdeLE study is a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial that evaluates the safety and efficacy of Lymfactin in the treatment of breast cancer associated lymphedema, when combined with a conventional lymph node transplantation surgery. In total, 39 patients with breast cancer associated lymphedema have been recruited in the study and randomized 1:1 to receive a single dose of either Lymfactin or placebo as an adjunct to surgery. The active patient treatment period was completed with last dosing in December 2019 and the study continues with a 12-month blinded follow-up.

Study Objectives

The primary endpoint of the AdeLE study is efficacy in the treatment of breast cancer associated lymphedema. Efficacy will be assessed by changes in the volume of the affected arm compared with the unaffected arm, quality of life of the patient based on the Lymphedema Quality of Life Inventory and the assessment of the lymph flow of the affected arm by quantitative lymphoscintigraphy.

Further Information:

Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358-40-7300-445
Company web site: www.herantis.com
Certified Advisor: UB Securities Ltd, telephone: +358-9-25-380-225

About Lymfactin

Lymfactin is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication. Based on cumulated data from a Phase 1 clinical study in 15 patients with breast cancer associated lymphedema, Lymfactin is safe and well tolerated. The efficacy of Lymfactin is currently studied in the Phase 2 clinical study AdeLE in Finland and Sweden.

Lymfactin, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki. For more information please see View Source

About Breast Cancer Associated Lymphedema

Approximately 20% of breast cancer patients who undergo axillary lymph node dissection develop secondary lymphedema: a progressive, disabling, and disfiguring disease that severely affects the quality of life. Symptoms include a chronic swelling of an upper limb, thickening and hardening of skin, loss of mobility and flexibility, pain, and susceptibility to secondary infections. Secondary lymphedema is currently treated with compression garments, special massage, and exercises. While these therapies may relief the symptoms in some patients, they do not address the underlying cause of lymphedema, which results from damage to the lymphatic system. There are currently no approved medicines for the treatment of secondary lymphedema.

On December 17, 2019 ArcherDX, Inc., a molecular diagnostics company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, reported the close of a $55 million Series C financing round led by Perceptive Advisors, which was joined by new investors Redmile Group, Soleus Capital, Driehaus Capital Management and ArrowMark Partners, as well as existing investors Sands Capital, Longwood Fund, PBM Capital and its affiliates, Boulder Ventures and others (Press release, ArcherDX, DEC 17, 2019, View Source [SID1234552448]).

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!

Proceeds of the financing are intended to be used in part to expand the ArcherDX global commercial footprint, support the registration and launch of the STRATAFIDE pan-solid tumor companion diagnostic (CDx) and, in concert with ongoing biopharma collaborations, to support development of ArcherDX’s Personalized Cancer Monitoring (PCM) platform.

"We are grateful to receive such enthusiastic support from both new and existing investors. They share our vision of a future where all patients have access to personalized genomic information to better inform their care. The proceeds position ArcherDX to, upon approval, launch STRATAFIDE to deliver the first multi-gene, pan-solid tumor companion diagnostic that accepts both tissue and blood, to benefit late stage cancer patients," said Jason Myers, Ph.D., co-founder and chief executive officer of ArcherDX. "We will also advance our Personalized Cancer Monitoring platform, which is intended to leverage ArcherDX technology to improve detection of minimal residual disease (MRD) and address critical needs in the early stage solid tumor setting, including recurrence surveillance and therapy monitoring and evolution. We believe millions of cancer patients could benefit from a more accurate, personalized means of detecting relapse, when the cancer burden is low and more treatable. We remain driven to enable personalized molecular diagnostics that are accurate, actionable and local."

Based on patented technology, with more than 150 peer-reviewed publications, STRATAFIDE identifies actionable genomic alterations in tissue or blood samples, including alterations targeted by emerging therapies undergoing clinical trials, therapies already recommended in clinical guidelines such as NCCN, and therapies approved by the FDA. Unlike current centralized testing, STRATAFIDE allows tissue and blood samples to be analyzed at any local lab with a sequencer, thereby enabling faster turnaround times, while providing physicians with critical information needed to deliver targeted, personalized care. STRATAFIDE was granted FDA Breakthrough Device Designation in January 2019.

"We are delighted to continue to support ArcherDX as it works to launch multiple novel diagnostic products. We expect the Company’s flagship products to enable tailored therapeutic selection for cancer patients by providing actionable insights," said Mike Altman, Managing Director, Perceptive Advisors. "Moreover, ArcherDX’s AMP technology enables decentralized testing, which we believe uniquely positions the Company to broadly impact the molecular cancer testing market."

On December 17, 2019 Immix Biopharma, Inc., reported the first closing of a convertible note financing to support the clinical testing of its lead compound Imx-110 in advanced solid tumors. Mesa Verde managing director, Carey Ng, PhD, MBA, also joined the Board (Press release, Immix Biopharma, DEC 17, 2019, View Source [SID1234552447]).

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!

Immix CEO, Ilya Rachman, MD, PhD, MBA, shared, "We are thrilled to bring on Mesa Verde and Carey as we continue to build our team with executives and board members with successful experience in guiding early-stage clinical companies through similar phases of rapid growth."

With this additional funding, Immix will begin enrolling patients at US-based sites in its study testing Imx-110 in a Phase 1b/2a trial in advanced solid tumors. Immix received IRB approval to begin dosing patients at Synergy Hematology Oncology with offices in Los Angeles and Encino, CA. Dr. Levon Qasabian, MD will be the principal investigator, who stated that, "We are excited to explore the potential of this promising drug and offer it to patients with advanced tumors and limited treatment options."

Interim readouts from the Phase 1b/2a trial in Australia are 100% clinical benefit rate (akin to disease control rate) for all patients who completed the 5th cohort and at least 2 cycles as scheduled – with the longest duration of response being 8-months of stable disease. No treatment-related serious adverse events have been observed to-date and dose escalation is continuing. For information about participating in this study, please visit clinicaltrials.gov: View Source

Immix is also opening a call for investigator initiated studies where the company will provide its lead compound Imx-110 at no charge.

About Imx-110
Imx-110 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability while inducing apoptosis. Imx-110 contains NF-kB/Stat3/pan-kinase inhibitor curcumin combined with a small amount of doxorubicin encased in a nano-sized delivery system for optimal tumor penetration. The nanoparticle is tunable in that it can be bound to various targeting moieties, allowing it to deliver even more payload to tumors or other cell populations of interest, if needed. Imx-110 showed preclinical efficacy in glioblastoma, multiple myeloma, triple-negative breast, colorectal, ovarian, and pancreatic tumor models — with the mechanism of action being a 5x increase in cancer cell apoptosis compared to doxorubicin alone, and a wholesale shift in the tumor microenvironment post administration.

On December 17, 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 closing of the previously announced 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 17, 2019, View Source [SID1234552446]). Each share of common stock (or pre-funded warrant in lieu thereof) was 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 also 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.

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!

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

The gross proceeds of the offering are 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.

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 was 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 has been filed with the SEC and copies 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.

At the closing of the offering, the Company has 3,237,522 outstanding shares of common stock, assuming no exercise of any pre-funded warrants and warrants issued in the offering.

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.

About Aethlon and the Hemopurifier

Aethlon is focused on addressing unmet needs in global health. The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier depletes the presence of circulating tumor-derived exosomes that promote immune suppression.

These tumor derived exosomes also seed the spread of metastases and inhibit the benefit of leading cancer therapies. The Hemopurifier is an FDA designated "Breakthrough Device" related to the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease cancer. The Hemopurifier also holds a Breakthrough Device designation related to life-threatening viruses that are not addressed with approved therapies.

Aethlon also owns 80% of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disease progression. Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.com.

On December 17, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has priced its previously announced offering of $1,250,000,000 aggregate principal amount of 5.000% senior notes due 2028 (the "2028 Notes") and $1,250,000,000 aggregate principal amount of 5.250% senior notes due 2030 (the "2030 Notes" and, together with the 2028 Notes, the "Notes") (Press release, Bausch Health, DEC 17, 2019, View Source [SID1234552445]). The aggregate size of the offering of the Notes is $2,500,000,000, which reflects an increase of $1,250,000,000 from the previously announced offering size of $1,250,000,000. The 2028 Notes will be sold to investors at a price of 100% of the principal amount thereof and the 2030 Notes will be sold to investors at a price of 100% of the principal amount thereof. Bausch Health intends to use the proceeds from the offering of the Notes, along with cash on hand, to finance amounts owed under the Company’s recently announced $1.21 billion settlement agreement (the "Settlement") relating to the U.S. putative securities class litigation filed in the U.S. District Court for the District of New Jersey (which is subject to court approval), and redeem $1.24 billion aggregate principal amount of the Company’s outstanding 5.875% Senior Notes due 2023, as well as to pay related fees and expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Company’s credit agreement and existing senior notes. Consummation of the offering of the Notes is subject to various closing conditions, and there can be no assurance that the Company will be able to successfully complete this transaction on the terms described above, or at all.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis which is exempt from the prospectus requirements of such securities laws.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.