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Aldeyra Therapeutics to Participate in the Jefferies and A.G.P./Alliance Global Partners Virtual Investor Conferences

On November 13, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that the company’s senior management will participate in the following virtual investor conferences (Press release, Aldeyra Therapeutics, NOV 13, 2020, View Source [SID1234571066]):

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Jefferies Virtual London Healthcare Conference: Aldeyra President and CEO Todd C. Brady, M.D., Ph.D., is scheduled to participate in a fireside chat at 1:10 p.m. ET on Wednesday, November 18, 2020. The fireside chat will be broadcast live and archived for 90 days on the company’s website at View Source the "Events & Presentations" page. In addition, company executives are scheduled to host virtual one-on-one meetings with institutional investors.
A.G.P./Alliance Global Partners Virtual Healthcare Symposium: Aldeyra executives are scheduled to host virtual one-on-one meetings with institutional investors on November 19, 2020.

IMV to Host a Key Opinion Leader Webcast on the Ovarian Cancer Treatment Landscape and Data Highlights from the Phase 2 Trial of a Novel T-Cell Therapy

On November 13, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that the Company will host a key opinion leader (KOL) webcast on the treatment options in ovarian cancer and competitive landscape within the disease state on Thursday, December 3, 2020 at 8.00am Eastern Time (Press release, IMV, NOV 13, 2020, View Source [SID1234571064]).

The webcast will feature presentations by KOLs Oliver Dorigo, MD, PhD and Jeannine Villella, DO, FACOG, FACS who will discuss the treatment options in ovarian cancer and competitive landscape within the disease state. The KOLs will also provide an update on the ongoing Phase 2 trial with IMV’s novel T cell therapy in patients with advanced ovarian cancer, along with insights about the patients’ experience. Drs. Dorigo and Villella will be available to answer questions from financial analysts following the formal presentation.

IMV management will discuss trial results and their significance to DPX, the company’s delivery platform, as well its outlook on next steps.

To register for the webcast, please click here. A webcast of the presentation will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, the replay will be available for approximately 30 days. Financial analysts are welcome to ask questions during the live Q&A and are invited to submit their request via email.

About the KOLs

Dr. Oliver Dorigo is the director and associate professor of the division of gynecologic oncology and the director of the gynecologic clinical care program at the Women’s Cancer Center at Stanford University. He is also director of the Mary Lake Polan Gynecologic Oncology Research Laboratory. Dr. Dorigo received his MD from the University of Heidelberg Medical School in Germany. He did a residency in obstetrics and gynecology at the University of Munich, followed by a research fellowship in cancer gene therapy at the Sidney Kimmel Cancer Center in San Diego. He completed his PhD in molecular biology at University of California, Los Angeles, and a clinical fellowship in gynecologic oncology at UCLA/Cedars Sinai Medical Center. Dr. Dorigo was an assistant professor at UCLA until he joined the Stanford faculty in 2013.

Dr. Jeannine Villella obtained her medical degree from New York College of Osteopathic Medicine in Old Westbury, New York and completed her residency training in Obstetrics and Gynecology at Winthrop University Hospital. Thereafter, Dr. Villella was granted a 2-year Henrietta Milstein Fellowship at Columbia University College of Physicians & Surgeons. As part of the division of gynecologic oncology, she performed research in the role of angiogenesis in ovarian cancer and was involved in the care of gynecologic oncology patients. She then completed a 3-year subspecialty fellowship in Gynecologic Oncology at Roswell Park Cancer Institute, where she expanded her research interests into immune response to malignancy and cancer immunotherapy. She has been granted a Winthrop University Hospital Pilot Grant to pursue her research interests in genetic polymorphisms in indoleamine 2, 3- dioxygenase and the effect on ovarian cancer outcomes. Her future goals include having ovarian cancer vaccine clinical trials available at Winthrop University Hospital. She also serves on the Society of Gynecologic Oncologists Clinical Practice Committee and the Gynecologic Oncology Group Vaccine Committee. Dr. Villella is board certified in Obstetrics & Gynecology and Gynecologic Oncology. She currently holds the title Associate Director of Gynecologic Oncology at Winthrop University Hospital and Assistant Professor of Stony Brook School of Medicine. She is the Principal Investigator for the Gynecologic Oncology Group Clinical Trials at Winthrop University Hospital. She also serves on the Society of Gynecologic Oncologists Clinical Practice Committee. She is also an active member of the research organization Society of Gynecologic Investigation.

About the DeCidE Study

"DeCidE" is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. The trial is active but not recruiting. Patients received 2 subcutaneous injections of DPX-Survivac 3 weeks apart and every eight weeks thereafter, and intermittent low dose CPA one week on and one week off for up to 1 year. Paired tumor biopsies were performed prior to treatment and on treatment.

Primary endpoints of this study are overall response rate, disease control rate and safety. Secondary endpoints include cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival and biomarker analyses.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapy that generates targeted and sustained cancer cell killing capabilities in vivo. Treatments with the DPX-Survivac T cell therapy have demonstrated a favorable safety profile across all clinical studies.

IMV’s T cell therapy, DPX-Survivac, consists of survivin-based peptides formulated in IMV’s proprietary delivery platform (DPX). IMV’s lead compound is designed to generate a sustained cytotoxic T cell response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as Orphan Drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

Sanofi pumps €50M into rising French VC shop Jeito

On November 13, 2020 Sanofi reported that it has invested €50 million ($59 million) in French VC firm Jeito Capital (Press release, Sanofi, NOV 13, 2020, View Source [SID1234571041]). The investment, Sanofi’s first in a private French fund, boosts Rafaèle Tordjman’s efforts to establish Jeito as an emerging force in the European biotech VC scene.

Tordjman spent 16 years as a managing partner at Sofinnova Partners before leaving and founding Jeito in 2017. Jeito flew below the radar in its early years. That changed in January when Jeito broke cover with €200 million in cash from institutional investors and family offices. Since then, Jeito has disclosed two of the approximately 15 investments it plans to make using the money.

In September, Jeito co-led a $110 million series A financing in Neogene Therapeutics, a transatlantic developer of fully personalized neo-antigen T cell therapies. The next month, Jeito participated in a €44.5 million investment in French gene therapy startup SparingVision. Sanofi has signed up to help Jeito make more bets and, in doing so, strengthen its ties to the European biotech scene.

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"This investment provides Sanofi with access to the very best in French and European healthcare innovation and reinforces our commitment to investing in our medium and long-term development pipeline," Sanofi CEO Paul Hudson said in a statement.

Hudson went on to say Sanofi strongly believes France and the rest of Europe have the potential to become a world-class hub for life science innovation, provided "the appropriate conditions and a stimulating environment" they need to thrive are in place. The comments come months after a report that Sanofi is set to ax up to 1,680 jobs in Europe, including 1,000 in France, its home market.

Sanofi previously worked with Bpifrance, the French investment bank, to set up two public-private investment funds focused on the life sciences industry in France and the rest of Europe. Jeito is the first private French fund to receive investment from Sanofi.

Positive Results from RhoVac’s Clinical Phase I/II Study published in Journal of ImmunoTherapy of Cancer

On November 13, 2020 RhoVac reported, November 13, 2020, that the results of its clinical phase I/II study have been published in the Journal for ImmunoTherapy of Cancer (JITC) (Press release, RhoVac, NOV 13, 2020, View Source [SID1234570950]). The scientifically reviewed article reports that the treatment with RhoVac’s drug candidate RV001 was safe and well tolerated, and that a long-lasting immune response could be generated in the vast majority of patients. In the patients who had a measurable PSA when they started the study, a markedly increased PSA doubling time was seen, indicating cancer-specific effectiveness.

The Phase I / II clinical study included 22 patients who had previously undergone radical prostatectomy. These patients received injections subcutaneously with RV001 for a total of 30 weeks. Safety and vaccine-specific immune responses were evaluated during treatment and thereafter for a follow-up period of 13 months. As previously reported, RV001 was well tolerated, and no serious treatment-related adverse reactions were observed. Regarding immunological effects, most patients developed a strong CD4 T-cell response that lasted for at least ten months after the last injection of treatment. The RV001-induced T cells were polyfunctional and, according to the authors of the article, well equipped for anti-tumour effect. Serum levels of prostate-specific antigen (PSA) were also monitored before and after treatment and PSA doubling time was calculated. This is considered an important predictive factor for metastasis and recurrence in cancer. In those patients who had measurable PSA at the start of the study, a markedly prolonged PSA doubling time was seen after treatment. For further details, please refer to the publication – see link below.

RhoVac’s drug candidate, RV001, is based on a well-proven method for antigen-based T-cell activation (cancer vaccination) but adds two new components to the concept. On the one hand, the use of a new target protein, RhoC, which is a protein that is overexpressed in metastatic cancer cells of various tissue types. As the overexpression of RhoC is not tissue-specific, the treatment concept could therefore work in many different types of cancer. Initially, however, RhoVac intends to confirm that it works in prostate cancer. The other new parameter in RhoVac’s drug concept is the treatment paradigm. Previous developmental cancer vaccines have been targeted at late-stage cancer treatment, but RhoVac has done the opposite and targeted its drug candidate at early treatment, after surgery or radiation of the primary tumour, to delay or even prevent the formation of metastases.

"The study met both the primary and secondary endpoints, demonstrating an excellent safety and tolerability profile, and also that the vaccine developed with RhoC as the target protein induced a potent and long-lasting T cell immunity in the majority of patients. Based on these results, we believe that vaccination with RhoC as the target protein, after initial treatment against the primary tumour, can potentially delay or prevent recurrence and metastasis. The next step is to conduct further clinical trials to see if the substantial increase in PSA doubling time can be confirmed in a larger patient group", says Klaus Brasso, Scientific Advisor to RhoVac and Principal Investigator in the study.

Such a major trial is already well underway. A clinical phase IIb study that will include ca. 180 patients is currently ongoing in Europe (Denmark, Sweden, Finland, Germany, Belgium and the United Kingdom) and in the United States. The study is planned to be completed in early 2022 and it aims to produce results that show a solid clinical "proof of concept".

RhoVac’s CEO, Anders Månsson, comments: "We are extremely pleased that the detailed analysis of the results of our Phase I/II study has now been published. This will for sure attract attention in immuno-oncology in general, and in the field of prostate cancer specifically, all around the world."

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 13-11-2020 09:35 CET.

Milestone Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Clinical and Corporate Update

On November 13, 2020 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported financial results for the third quarter ended September 30, 2020 and provided a clinical and corporate update (Press release, Milestone Pharmaceuticals, NOV 13, 2020, View Source [SID1234570948]).

"We remain on track to reopen enrollment in the pivotal Phase 3 RAPID trial by year-end, and are confident that the updated study design will help us to best characterize the potential clinical utility of our product candidate etripamil in patients with paroxysmal supraventricular tachycardia (PSVT)," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "In light of the safety and efficacy data from the completed NODE-301 trial, as well as positive feedback from the physicians charged with treating patients with PSVT, we believe that etripamil has the potential to serve as a much needed at-home intervention for this population. Backed by a strong balance sheet, which includes gross proceeds of $51.7 million from our recent public offering, we look forward to continuing to execute the etripamil PSVT program, with the goal of bringing this investigational therapy to as many appropriate patients as possible if approved by the FDA."

Recent Updates

Pivotal Phase 3 RAPID Trial on Track to Reopen by Year-End. The Company remains on track to reopen enrollment in the pivotal Phase 3 RAPID trial by the end of the year. The RAPID trial is expected to randomize up to 500 patients and will be completed after a total of 180 confirmed supraventricular tachycardia (SVT) events are reached. Patients in the RAPID trial will be randomized 1:1 to etripamil or placebo. To help maximize the potential treatment effect of etripamil, patients who do not experience symptom relief within 10 minutes of the first study drug administration will be directed to administer a second dose of study drug. As previously announced, the primary efficacy endpoint for both the RAPID trial and the already-completed NODE-301 trial will be time to conversion of SVT within 30 minutes following initial study drug administration, with a target p-value of less than 0.05 for each trial. Milestone expects to report data from the RAPID trial in late 2021/early 2022. The RAPID and completed NODE-301 trials could potentially serve to fulfill the efficacy requirement for a future New Drug Application (NDA) for etripamil in patients with PSVT.
Raised $51.7 Million in Public Offering. In October 2020, Milestone announced the closing of an underwritten public offering of 5,095,897 of its common shares and, to certain investors in lieu thereof, pre-funded warrants to purchase 4,761,903 of its common shares at an exercise price of $0.01 per share. The public offering price of each common share was $5.25 and the public offering price of each pre-funded warrant was $5.24 per underlying share. Total gross proceeds to Milestone were approximately $51.7 million before deducting underwriting discounts and offering expenses.
Recent Changes to Board of Directors. In September 2020, Milestone announced the appointment of highly accomplished industry veterans Lisa Giles and Robert Wills to its Board of Directors. In addition, the Company reported that Dr. Wills will replace Paul R. Edick as Chairman of the Board of Directors. Mr. Edick will be stepping down from the Board, effective January 1, 2021, to focus on his role as Chief Executive Officer at Xeris Pharmaceuticals and their recent product launch.
Mr. Oliveto added, "On behalf of the entire Board of Directors, I would like to thank Paul for his insights and contributions over the last two years. We wish him the very best of luck in all of his future endeavors."

Third Quarter 2020 Financial Results

As of September 30, 2020, Milestone had cash, cash equivalents, and short-term investments of $102.9 million, 24.7 million shares outstanding and 6.7 million pre-funded warrants outstanding.
Research and development expenses for the third quarter of 2020 were $8.2 million compared with $9.5 million for the prior year period. For the nine months ended September 30, 2020, research and development expenses were $28.7 million compared with $27.8 million for the prior year period. The increase for the nine-month period ending September 30, 2020 reflects increased clinical development costs supporting Milestone’s Phase 3 clinical trials and efforts in developing a clinical trial pathway for etripamil.
General and administrative expenses for the third quarter of 2020 were $3.0 million compared with $2.1 million for the prior year period. For the nine months ended September 30, 2020, general and administrative expenses were $8.6 million compared with $4.7 million for the prior year period. The increase in the nine-month period ending September 30, 2020 reflects increasing insurance costs, as well as additional professional fees and head count to support the compliance requirements of being a public company.
Commercial expenses for the third quarter of 2020 were $0.9 million compared with $2.1 million for the prior year period. For the nine months ended September 30, 2020, commercial expense was $4.6 million compared with $6.4 million for the prior year period. The decrease in expenses in the nine-month period ending September 30, 2020 reflects efforts in reducing operating expenses affecting primarily pre-commercialization activities as Milestone focused its efforts on an optimized clinical development pathway for etripamil.
For the third quarter of 2020, operating loss was $12.1 million compared to $13.7 million in 2019. For the nine months ended September 30, 2020, Milestone’s operating loss was $41.9 million compared to $39.0 million in the prior year period.
About Paroxysmal Supraventricular Tachycardia

PSVT is a rapid heart rate condition characterized by intermittent episodes of SVT that start and stop suddenly and without warning. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions. However, calcium channel blockers approved for the termination of SVT episodes must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Etripamil

Etripamil, the Company’s lead investigational product, is designed to be a rapid-response therapy for episodic cardiovascular conditions. The novel calcium channel blocker is self-administered via a nasal spray, which has the potential to shift the current treatment paradigm for many patients with PSVT from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials underway in PSVT, and plans to commence a Phase 2 proof-of-concept trial in patients with atrial fibrillation with rapid ventricular rate.