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Press release: Merck KGaA, Darmstadt, Germany Selects ArcherDX for Strategic Global Companion Diagnostic Assay Development Collaboration

On October 3, 2018 ArcherDX, a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and Merck KGaA, Darmstadt, Germany, the vibrant science and technology company which operates its biopharmaceuticals business in the U.S. and Canada as EMD Serono, reported that they have entered into an agreement to develop and commercialize a next generation sequencing (NGS)-based companion diagnostic (CDx) assay (Press release, ArcherDX, OCT 3, 2018, View Source,-darmstadt,-germany-selects-archerdx-for-strategic-global-companion-diagnostic-assay-development-collaboration [SID1234529767]).

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Under the terms of the agreement, ArcherDX will develop and seek regulatory approval for a CDx assay that will help physicians identify patients who may benefit from treatment with a Merck KGaA, Darmstadt, Germany drug candidate, by focusing on the detection of specific genomic alterations in plasma or formalin-fixed paraffin-embedded (FFPE) tissue samples. ArcherDX will develop the CDx using the Archer diagnostic platform, which combines the patented Anchored Multiplex PCR (AMP) technology with the Illumina MiSeqDx sequencing system and Archer Analysis bioinformatics software. The CDx assay will be designed to detect multiple classes of genomic alterations across a range of genes implicated in solid malignant neoplasms and is compatible with both FFPE tissue and plasma specimen types.

"We are pleased to launch this strategic companion diagnostic initiative," stated Jason Myers, Ph.D., president and chief executive officer for ArcherDX. "The work we’ve engaged in with Merck KGaA, Darmstadt, Germany highlights the importance and potential of utilizing our proprietary profiling approach to make available to physicians an FDA-approved companion diagnostic solution for use with targeted therapies."

Lilly Confirms Date and Conference Call for Third-Quarter 2018 Financial Results Announcement

On October 3, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will announce its financial results for the third quarter of 2018 on Tuesday, November 6, 2018 (Press release, Eli Lilly, OCT 3, 2018, View Source [SID1234529747]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

Nymox Reports Safety Benefits of Fexapotide Treatments for Prostate Cancer and Benign Prostatic Hyperplasia

On October 3, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that after long-term safety assessments of repeated Fexapotide Triflutate (FT) intraprostatic injections, there have been no identifiable risks or serious side effects or adverse events identified associated or linked with the drug (Press release, Nymox, OCT 3, 2018, View Source [SID1234529730]).

FT is Nymox’s lead drug for which the Company is in the process of seeking U.S. and European marketing approvals for BPH (prostate enlargement), and FT is also in late stage development for prostate cancer. Pivotal trial results for FT BPH studies involving 977 treated patients were published in 2018 in the prestigious World Journal of Urology (May 2018, Volume 36, pages 801–809), and the safety and efficacy results have been presented to the American Urology Association and previously to the European Association of Urology.

Dr. Paul Averback, CEO of Nymox said, "For prostate cancer in particular, repeated injection treatments will be needed and a focal molecular treatment will have negligible value if there cannot be reliable safety expected from repeated injection. Prostate cancer is a multi-focal disease and it is to be expected that multiple focal molecular treatments will be utilized for optimal outcomes. Follow-up and re-treatment will be needed. Nymox undertook 2 large FT re-injection safety studies in 2010-2014 involving 351 subjects with BPH, who were subsequently followed for up to 7 years. These mandatory and adequately sized safety studies are absolutely required in order to demonstrate safety of re-injection, and this is a standard requirement."

Dr Averback added, "In addition, Nymox undertook extensive immunological testing involving over 1000 subject samples, demonstrating that FT does not lead to detectable antibody formation, which underlines FT safety and supports the lack of risk for allergic reactions. All laboratory testing and sexual function tests including semen analyses showed no changes in FT treated men compared to controls."

Nymox’s lead drug Fexapotide (FT) has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 977 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo group study an 82-95% reduction in the number of these patients who required surgery after they received FT in the trial, as compared to patients who did not receive FT but instead later received conventional approved BPH treatments (p<.0001).

FT has been shown to produce long-term improvements in lower urinary tract symptoms associated with prostate enlargement (BPH), a problem that afflicts an estimated 100 million or more men in the world. FT does not cause the annoying side effects and risks found with available treatments for BPH. FT is also in development for low grade prostate cancer.

The clinical trial results for Fexapotide treatment of BPH are published in the World Journal of Urology May 2018, Volume 36, pages 801–809 (View Source) in a peer review report entitled "Fexapotide Triflutate: Results of Long- Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement" authored by Neal Shore, MD, FACS (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); Mitchell Efros, MD, FACS (Accumed Research, Garden City, NY); Mohamed Bidair, MD (San Diego Clinical Trials, San Diego, CA); Barton Wachs, MD (Atlantic Urology Medical Group, Long Beach, CA); Susan Kalota, MD (Urological Associates of Southern Arizona, Tucson, AZ); Sheldon Freedman, MD, FACS (Freedman Urology, Las Vegas, NV); James Bailen, MD, FACS (First Urology, Louisville, KY); Richard Levin, MD, FACS (Chesapeake Urology Research Associates, Towson, MD); Stephen Richardson, MD (Jean Brown Research, Salt Lake City, UT); Jed Kaminetsky, MD, FACS (University Urology, New York, NY); Jeffrey Snyder, MD, FACS (Genitourinary Surgical Consultants, Denver, CO); Barry Shepard, MD, FACS (Urological Surgeons of Long Island, Garden City, NY); Kenneth Goldberg, MD, FACS (U T Southwestern Dept of Urology, Lewisville, TX); Alan Hay, MD, FACS (Willamette Urology, Salem, OR); Steven Gange, MD, FACS (Summit Urology Group, Salt Lake City, UT); Ivan Grunberger, MD, FACS (Brooklyn Urology, Brooklyn, NY).

RXi Pharmaceuticals Announces Closing Of $15 Million Underwritten Public Offering

On October 3, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported the closing of its previously announced underwritten public offering of 3,725,714 units at a public offering price of $0.70 per unit and 17,702,858 pre-funded units at a public offering price of $0.69 per pre-funded unit, raising gross proceeds of approximately $15 million (Press release, RXi Pharmaceuticals, OCT 3, 2018, View Source [SID1234529729]). The Company intends to use the net proceeds of this offering towards the development of RXi’s immuno-oncology program, for other research and development activities and for general working capital.

Each unit sold in this offering contained one share of common stock and one warrant to purchase one share of common stock. Each pre-funded unit sold in this offering included one pre-funded warrant to purchase one share of common stock, at an exercise of $0.01 per share, and one warrant to purchase one share of common stock. Each warrant has an exercise price of $0.70 per share, is exercisable immediately and will expire seven years from the date of issuance. The shares of common stock (or the pre-funded warrants, as the case may be) and the accompanying warrants included in the units or pre-funded units were purchased together in this offering but were issued separately.

A registration statement on Form S-1 relating to the public offering of the securities described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on September 28, 2018, and an additional registration statement on Form S-1 filed pursuant to Rule 462(b) became automatically effective on October 1, 2018. The offering was made only by means of a prospectus forming part of the effective registration statements. Copies of the final prospectus relating to the offering is available on the SEC’s website at www.sec.gov and may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected].

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

Harpoon Therapeutics Announces Appointment of Natalie R. Sacks, M.D., as Chief Medical Officer

On October 3, 2018 Harpoon Therapeutics, Inc., a clinical-stage immunotherapy company developing a new class of T cell engaging therapeutics, reported that it has appointed Natalie R. Sacks, M.D., as Chief Medical Officer (Press release, Harpoon Therapeutics, OCT 3, 2018, View Source [SID1234529726]).

"We are thrilled to welcome Dr. Sacks as our new Chief Medical Offer. Natalie brings a strong record of accomplishment in the development and commercialization of oncology therapeutics, which will be instrumental as we advance our pipeline in the clinic," said Jerry McMahon, Ph.D., President and Chief Executive Officer, Harpoon.

"As an oncologist, I look forward to joining a company that is pioneering new ways to treat cancer and impact the lives of patients in need," says Dr. Sacks. "I am excited about the potential of Harpoon’s clinical programs and its novel TriTAC platform to redirect a patient’s own T cells to attack tumor cells."

Dr. Sacks most recently served as Chief Medical Officer of Aduro Biotech, a company focused on the advancement of novel immuno-oncology technologies. Previously, she was Vice President of Clinical Development at Onyx Pharmaceuticals (acquired by Amgen) where she played a key role in the development and approval of Kyprolis, an FDA-approved therapy for the treatment of multiple myeloma, and in business development strategy. Prior to that, she served as Vice President of Clinical Research for Exelixis where she directed the development of a portfolio of small molecules, with responsibilities ranging from IND filings to late-stage development, including development of Cometriq. Earlier in her career, Dr. Sacks served as Vice President of Clinical Development at Cell Genesys, a company focused on the development of cancer vaccines and engineered chimeric antigen receptor (CAR)-T cells. She received her M.D. from the University of Pennsylvania School of Medicine, her M.S. in Biostatistics from the Harvard University T.H. Chan School of Public Health and her B.A. in Mathematics from Bryn Mawr College. Dr. Sacks was an Assistant Clinical Professor at the University of California, San Francisco, and served as volunteer Attending Physician in Hematology-Oncology at San Francisco General Hospital for more than a decade. She serves as a board member for Zymeworks Inc. and Caribou Biosciences.