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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.

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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.

Clovis Oncology to Highlight Results from Rubraca® (rucaparib) TRITON Prostate Program at ESMO 2018 Congress

On October 3, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that four posters featuring data and highlighting studies from the Rubraca clinical development program will be presented at the ESMO (Free ESMO Whitepaper) 2018 Congress (European Society for Medical Oncology), 19-23 October, 2018, in Munich, Germany (Press release, Clovis Oncology, OCT 3, 2018, View Source [SID1234529725]). These posters include the first presentation of initial results from the Phase 2 TRITON2 clinical trial of Rubraca, an oral, small molecule PARP inhibitor, in advanced mCRPC, as well as genomic profiling data based on tumor tissue and plasma cfDNA samples from patients who were screened following progression on prior therapy for enrollment in TRITON2 or the Phase 3 TRITON3 clinical study. Both datasets from the TRITON clinical program have been selected for inclusion in a poster discussion session that will be led by invited discussant Dr. Joaquin Mateo, of the Prostate Cancer Translational Research Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain.

"We look forward to presenting a first look at the TRITON2 prostate cancer data at ESMO (Free ESMO Whitepaper), with a primary focus on the BRCA mutant population"

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TRITON2 is an international, multicenter, open-label, Phase 2 study of Rubraca in men with advanced prostate cancer with BRCA gene mutations (germline or somatic) or other deleterious mutations in other homologous recombination (HR) repair genes in the metastatic castration-resistant setting. The study is currently recruiting at approximately 100 sites worldwide. On October 2, 2018, Clovis announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for Rubraca for the treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy. The FDA granted this designation based on the initial efficacy and safety results from TRITON2 that will be shared at the ESMO (Free ESMO Whitepaper) 2018 Congress.

"We look forward to presenting a first look at the TRITON2 prostate cancer data at ESMO (Free ESMO Whitepaper), with a primary focus on the BRCA mutant population," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The data and updates we will share at ESMO (Free ESMO Whitepaper) emphasize our commitment to developing Rubraca beyond its initial ovarian cancer indications."

The four Rubraca abstracts from Clovis Oncology that have been accepted for poster presentation at the ESMO (Free ESMO Whitepaper) 2018 Congress are:

Title: ARIEL3: Subgroup analysis of rucaparib in platinum-sensitive recurrent ovarian carcinoma: effect of prior chemotherapy regimens (abstract 947P)
Presenter: Dr. Domenica Lorusso, Unità di Ginecologia Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori and MITO, Milan, Italy
Session: Poster session
Date/Time: Saturday, 20 October, 12:30–13:30 CEST
Location: Hall A3

Title: Preliminary results from TRITON2: a phase 2 study of rucaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination repair (HRR) gene alterations (abstract 793PD)
Presenter: Dr. Wassim Abida, Memorial Sloan Kettering Cancer Center, New York, NY, USA
Session: Poster discussion session, genitourinary tumors, prostate
Date/Time: Sunday, 21 October, 09:15–10:30 CEST
Location: Room 14b
As the subject of a poster discussion session, this poster will be on display for the duration of the congress beginning at 9:00 CEST on Saturday, 20 October 2018.

Title: TRITON: Genomic profiling of circulating tumour DNA (ctDNA) and tumour tissue for the evaluation of rucaparib in metastatic castration-resistant prostate cancer (mCRPC) (abstract 795PD)
Presenter: Dr. Simon Chowdhury, Guy’s Hospital & Sarah Cannon Research Institute, London, UK
Session: Poster discussion session, genitourinary tumours, prostate
Date/Time: Sunday, 21 October, 09:15–10:30 CEST
Location: Room 14b
As the subject of a poster discussion session, this poster will be on display for the duration of the congress beginning at 9:00 CEST on Saturday, 20 October 2018.

Title: ATLAS: a phase 2, open-label study of rucaparib in patients with locally advanced (unresectable) or metastatic urothelial carcinoma (abstract 928TIP)
Presenter: Dr. Simon Chowdhury, Guy’s Hospital & Sarah Cannon Research Institute, London, UK
Session: Poster session
Date/Time: Monday, 22 October, 13:15–14:15 CEST
Location: Hall A3

Specific program times and locations are subject to change by ESMO (Free ESMO Whitepaper).

Clovis’ Rubraca poster presentations will be available online at clovisoncology.com at 07:30 CEST on Saturday, 20 October, 2018.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.

Rubraca EU Authorized Use

Rubraca is licensed for adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

Rubraca U.S. FDA Approved Indications and Important Safety Information

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutations (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca, and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long-term follow-up. Of these, 5 occurred during treatment or during the 28-day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA-damaging agents. Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration [2.2] in full Prescribing Information) and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample cytogenetic analysis. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1–4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%) and neutropenia (20%).

Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1–4) were increase in creatinine (98%), decrease in hemoglobin (88%), increase in cholesterol (84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes (44%), decrease in neutrophils (38%), increase in alkaline phosphatase (37%) and decrease in lymphocytes (29%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1–4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%) and thrombocytopenia (21%).

Most common laboratory abnormalities in Study 10 and ARIEL2 (≥ 35%; Grade 1–4) were increase in creatinine (92%), increase in alanine aminotransferase (ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets (39%) and decrease in absolute neutrophil count (35%).

Co-administration of Rubraca can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.