On February 13, 2019 NanOlogy, a clinical-stage oncology company, reported that it will present an abstract at the 2019 Genitourinary Cancer Symposium, co-sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), held February 14-16, 2019 in the Moscone West Building, San Francisco (Press release, NanOlogy, FEB 13, 2019, View Source [SID1234533287]).

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Data from preclinical studies of NanoDoce (submicron particle docetaxel suspension) administered via intratumoral injection will be presented showing prolonged, high concentration of drug at the tumor site and significant tumor regression in multiple xenograft animal models including clear cell renal carcinoma (768-O cell line), transitional cell bladder carcinoma (UM-UC-3 cell line), and prostate carcinoma (PC-3 cell line). Abstract title, location, and times follow:

Title: Evaluation of submicron particle docetaxel directly injected into uro-oncologic xenografts
Poster Session: B – Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers
Where: Board E17 Abstract #360, West Building Moscone, San Francisco
When: Friday, February 15, 2019, 12:15 to 1:45 PM and 5:15 to 6:15 PM
Data from the preclinical studies showed that tumor volume decreases with two and three intratumoral doses of NanoDoce were significantly greater than or similar to IV docetaxel. Immunohistochemistry evaluations for the renal and bladder cancer models revealed immune cell infiltration in NanoDoce-treated animals. Drug was detected in NanoDoce-treated tumor tissue up to 50 days after administration, and at levels far greater than IV-treated animals.

Persistent, therapeutic levels of docetaxel from intratumoral NanoDoce appear to kill tumor cells through direct and indirect means. NanoDoce is known to directly inhibit tumor cell mitosis, and its persistence results in prolonged release of tumor antigen, which appears to promote indirect immune cell-mediated tumor kill.

A clinical trial in high-risk non-muscle invasive (NMIBC) and muscle invasive bladder cancer (MIBC) will begin enrollment in the first quarter of this year. Following transurethral resection of bladder tumor, subjects will receive direct injections of NanoDoce into the base of the index tumor resection site in combination with intravesical instillations of NanoDoce.

In addition, IND-enabling studies are nearing completion on NanoDoce for renal cell carcinoma to allow for a clinical trial via intratumoral injection in the second half of 2019. This work is part of an extensive preclinical and clinical development program underway by NanOlogy in peritoneal cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, breast cancer, non-small cell lung cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036 in the US, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

On February 13, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported its intention to offer, subject to market and other conditions, $65 million aggregate principal amount of convertible senior notes due 2024 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Inovio, FEB 13, 2019, View Source [SID1234533305]). Inovio also expects to grant the initial purchasers of the notes a 13-day option to purchase up to an additional $20 million aggregate principal amount of notes.

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The notes will be senior unsecured Inovio obligations and will accrue interest payable semiannually in arrears. The notes will be convertible in certain circumstances into cash, shares of Inovio’s common stock, or a combination of cash and shares of Inovio’s common stock, at Inovio’s election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of the pricing of the offering.

Inovio anticipates using the net proceeds from this offering for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses and manufacturing expenses, and for other business development activities.

The offer and sale of the notes and the shares, if any, issuable upon conversion of the notes have not been and will not be registered under the Securities Act or applicable state securities laws, and the notes and such shares may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes or any shares issuable upon conversion of the notes, nor shall there be any sale of the notes or such shares, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.

On February 13, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that Terry Rosen, Ph.D., Chief Executive Officer, will participate in a fireside chat at the 8th Annual Leerink Partners Global Healthcare Conference on Wednesday, February 27, 2019 at 11:30 am ET at the Lotte New York Palace, in New York, NY (Press release, Arcus Biosciences, FEB 13, 2019, View Source [SID1234533288]).

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To access the live audio webcast of the presentation, please visit the "Events & Presentations" section of the Arcus website at View Source A replay of the webcast will be available for 30 days following the live event.

On February 13, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 28, 2019 following release of its fourth quarter and full year 2018 financial results (Press release, Puma Biotechnology, FEB 13, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-host-conference-call-discuss-fourth-quarter-and-full-year-financi-0 [SID1234533273]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On February 13, 2019 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell receptor (TCR) therapies for patients suffering from cancer, reported the pricing of the Company’s initial public offering of 5,000,000 shares of common stock at a public offering price of $15.00 per share, for aggregate gross proceeds of $75.0 million, before deducting underwriting discounts and commissions and offering expenses (Press release, TCR2 Therapeutics, FEB 13, 2019, View Source [SID1234533289]). The Company has also granted the underwriters a 30-day option to purchase from the Company up to an additional 750,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. All of the shares are being offered by TCR2.

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The common stock is expected to begin trading on The Nasdaq Global Select Market under the ticker symbol "TCRR" on February 14, 2019. The offering is expected to close on February 19, 2019, subject to customary closing conditions.

Jefferies, SVB Leerink and BMO Capital Markets are acting as joint book-running managers for the offering. Wedbush PacGrow and China Renaissance are acting as co-managers for the offering.

A registration statement relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on February 13, 2019. The offering of these shares is being made only by means of a prospectus forming part of the effective registration statement relating to these shares. Copies of the prospectus may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by e-mail at [email protected], or by phone at (800) 808-7525, ext. 6132; or BMO Capital Markets Corp., Attn: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, tel: (800) 414-3627, email: [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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.