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Phase 3 A.R.R.O.W. Study Of Once-Weekly KYPROLIS® (Carfilzomib) Regimen Meets Primary Endpoint Of Progression-Free Survival In Relapsed And Refractory Multiple Myeloma Patients

On October 23, 2017 Amgen (NASDAQ: AMGN) reported top-line results of the Phase 3 A.R.R.O.W. trial, which showed KYPROLIS (carfilzomib) administered once-weekly at the 70 mg/m2 dose with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than KYPROLIS administered twice-weekly at the 27 mg/m2 dose with dexamethasone (Press release, Amgen, OCT 23, 2017, View Source [SID1234521103]). The overall safety profile of the once-weekly KYPROLIS regimen was comparable to that of the twice-weekly regimen.

The study included 478 patients with relapsed and refractory multiple myeloma who received two or three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent (IMiD). Patients in the trial treated with the once-weekly KYPROLIS regimen achieved a statistically significant superior progression-free survival (PFS) with a median of 11.2 months compared to 7.6 months for those treated with the twice-weekly KYPROLIS regimen (HR = 0.69, 95 percent CI, 0.54 – 0.88).

“KYPROLIS has been demonstrated to be the most effective proteosome inhibitor available to patients with multiple myeloma,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We are encouraged by the efficacy and safety profile of KYPROLIS and dexamethasone administered once-weekly in the A.R.R.O.W. study.”

The most frequently reported treatment-emergent adverse events (greater than or equal to 20 percent) in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia.

Vical Reports Third Quarter 2017 Financial and Operational Results

On October 23, 2017 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended September 30, 2017 (Press release, Vical, OCT 23, 2017, View Source [SID1234521088]). Net loss for the third quarter of 2017 was $3.1 million, or $0.27 per share, compared with a net loss of $2.5 million, or $0.24 per share, for the third quarter of 2016. Revenues for the third quarter of 2017 were $3.2 million, compared with revenues of $2.6 million for the third quarter of 2016, reflecting revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements.

Vical had cash and investments of $35.2 million at September 30, 2017. The Company’s cash burn for the first nine months of 2017 was $6.9 million, which was consistent with the Company’s full year guidance of between $8 million and $11 million.

Program updates include:

ASP0113 CMV Therapeutic Vaccine

The multinational Phase 3 registration trial in HCT recipients completed enrollment in September 2016 with a total of 515 patients. As recently announced, the last patient completed their final assessment in the one year follow-up period in September 2017. The primary endpoint of the trial is a composite of overall mortality and CMV end organ disease which will be assessed one year after transplantation. Astellas expects top-line data to be available in the first quarter of 2018. Vical and Astellas continue to make progress towards a potential Biologics License Application filing with the U.S. Food and Drug Administration (FDA). Assuming a successful trial outcome, Astellas would seek to commercialize ASP0113 in North America, Europe, and Asia.
VCL-HB01 HSV-2 Therapeutic Vaccine

Vical is developing the HSV-2 therapeutic vaccine, VCL-HB01, to treat patients with symptomatic genital herpes infection. The vaccine is currently being evaluated in a Phase 2 study in healthy adult subjects, 18 to 50 years of age who are randomized 2:1 to receive either vaccine or placebo. Recruitment of 261 subjects at 15 U.S. clinical sites was completed in April 2017 and 4-dose vaccination series was completed in July 2017. Following the 4th vaccination, each subject entered a 12-month surveillance period during which each new lesion recurrence is assessed in the clinic by the investigator. Once all subjects have completed a minimum of 9-months of surveillance, the primary endpoint of annualized recurrence rate will be calculated based on those recurrences that are both clinically- and virologically-confirmed. This endpoint provides important information on the number of recurrences over time in this chronic disease setting and is clinically meaningful for both patients and treating physicians. Vical remains on target to deliver top-line results during the second quarter of 2018.
VL-2397 Antifungal

Vical is developing its novel antifungal, VL-2397, for the treatment of patients with invasive fungal infections. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis, assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agency’s advice. The final determination whether the drug is approvable will be made by FDA after review of all relevant data. The Company intends to initiate a Phase 2 trial of VL-2397 for the treatment of invasive aspergillosis in the fourth quarter of 2017. In addition, the FDA has granted Vical Qualified Infectious Disease Product, Orphan Drug and Fast Track designations to VL-2397 for the treatment of invasive aspergillosis.

Vical will conduct a conference call and webcast today, October 23, at noon Eastern Time, to discuss the Company’s financial results and program updates with invited participants. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719)457-2619 (preferred), or (888)349-9582 (toll-free), and reference confirmation code 3889356. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719)457-0820 (preferred) or (888)203-1112 (toll-free) and enter replay passcode 3889356. The webcast will also be available live and archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at (858)646-1127 or by e-mail at [email protected].

Atossa Genetics To Host Conference Call to Announce Preliminary Results from Phase 1 Study of Oral Endoxifen Wednesday, October 25, 2017 at 10 am EDT

On October 23, 2017 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported that it will host a conference call on October 25, 2017 at 10 am EDT to discuss preliminary results from its Phase 1 dose escalation study of its proprietary oral Endoxifen (Press release, Atossa Genetics, OCT 23, 2017, http://ir.atossagenetics.com/news/detail/826/atossa-genetics-to-host-conference-call-to-announce-preliminary-results-from-phase-1-study-of-oral-endoxifen-wednesday-october-25-2017-at-10-am-edt [SID1234521084]). Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is currently used to treat breast cancer and for breast cancer prevention in high risk patients.

The objectives of this double-blinded, placebo-controlled, Phase 1 study of 48 healthy female subjects were to assess the pharmacokinetics of proprietary formulations of both oral and topical Endoxifen dosage forms as single (oral) and repeat (oral and topical) doses, as well as to assess safety and tolerability. The study was conducted in two parts based on route of administration. Preliminary results from the topical arm of the study were announced on September 14, 2017.

To listen to the call by phone, interested parties within the U.S. should call 1-844-824-3830 and International callers should call 1-412-317-5140. All callers should ask for the Atossa Genetics conference call. The conference call will also be available through a live webcast at www.atossagenetics.com. Details for the webcast may be found on the Company’s IR events page at View Source

A replay of the call will be available approximately one hour after the end of the call through November 24, 2017. The replay can be accessed via Atossa’s website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658.

OncoSec Announces $7.1 Million Registered Direct Offering Priced At-the-Market

On October 23, 2017 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that it has entered into definitive purchase agreements with certain accredited investors to purchase 5,270,934 shares of its common stock, at a purchase price per share of $1.34375 in a registered direct offering priced at the market (Press release, OncoSec Medical, OCT 23, 2017, View Source [SID1234521081]). Additionally, OncoSec has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 3,953,200 shares of common stock at an exercise price of $1.25 per share for a term of 5.5 years. The warrants are immediately exercisable on the date of issuance. The offering is expected to close on or about October 25, 2017, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds of the offering are expected to be approximately $7.1 million. Net proceeds, after deducting the placement agent’s fee and other estimated offering expenses payable by OncoSec, are expected to be approximately $6.2 million. OncoSec intends to use the net proceeds from this offering for working capital and general corporate purposes, including primarily for the PISCES/KEYNOTE-695 study, and for other clinical, research and development activities.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 that was filed and declared effective by the Securities and Exchange Commission ("SEC") and the base prospectus contained therein (File No. 333- 213036). The offering of the shares of common stock will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

A prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered will be filed with the SEC. Copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 4th Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

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

ADC Therapeutics Announces Closing of $200 Million Private Financing to Fund Two Lead Programs Through Registrational Trials

On October 23, 2017 ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, reported that it has raised $200 million through a private placement (Press release, ADC Therapeutics, OCT 23, 2017, View Source [SID1234521080]). The financing was oversubscribed and supported by both existing and new investors, including Auven Therapeutics, Redmile, the Wild Family Office and AstraZeneca.

The proceeds will be used to progress ADCT-301 and ADCT-402 into planned registrational trials in 2018. Both candidates are currently in four clinical studies in important sub-types of lymphoma and leukemia. ADCT will also advance ADCT-301 into a combination study for solid tumors. Further it will allow the Company to continue the development of the Phase I study of ADCT-502 in patients with advanced solid tumors with HER2 expression, to file INDs for ADCT-602 and ADCT-601, and to progress a pipeline of pre-clinical ADC programs. ADCT expects to have a total of eight programs in clinical development within 18 months.

Dr. Chris Martin, CEO of ADCT, said: "With more than 250 patients dosed, and encouraging data to be presented at the upcoming congress of the American Society of Hematology (ASH) (Free ASH Whitepaper), this financing is a key step in our strategy and will enable us to accelerate our lead programs and to continue to develop our pipeline. This transaction also reflects the potential value to patients of rapidly developing these active drugs as stand alone and combination therapies. We continue to grow our pipeline of proprietary antibody-drug conjugates in important hematological and solid tumor indications both on our own and in partnerships."

ADCT is focused on the development of proprietary ADCs incorporating highly potent pyrrolobenzodiazepine (PBD)-based warheads. ADCT’s clinical and preclinical programs target major types of both hematological malignancies and solid tumours. Since inception in 2012, the Company has raised $455 million to advance its pipeline of proprietary ADCs. The Company has four PBD-based antibody drug conjugates in six ongoing Phase Ia and Ib clinical trials in the USA and in Europe.