On October 17, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported that the United States Patent and Trademark Office issued a new patent protecting the company’s lead product candidate, Rigosertib (Press release, Onconova, OCT 17, 2018, View Source [SID1234529944]). U.S. patent 10,098,862 "Formulations with enhanced stability and bioavailability for administration of (E)-2, 6-Dialkoxystyryl 4-Substituted Benzyl Sulfones" describes novel compositions directed towards improving stability and enhancing bioavailability of Rigosertib. The issued patent claims novel formulations for oral and parenteral administration and oral dosing regimens of Rigosertib for the treatment of cancer and proliferative disorders.

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"Rigosertib is well protected by issued US and foreign patents as well as by Orphan Designation in the U.S., Europe, and Japan. We remain focused on our broader IP strategy that provides additional barriers to entry and expanded geographical coverage for our lead product candidate, which is in advanced clinical trials for unmet medical needs of patients with Myelodysplastic Syndromes," commented, Ramesh Kumar, Chief Executive Officer of Onconova. "Ensuring multi-faceted intellectual property protection around Rigosertib helps enhance the potential value of this innovative program."

U.S. patent 10,098,862 complements and adds to coverage provided by previously issued Composition of Matter patent U.S. 7,598,232 and its international counterpart patents and patent applications, including Rigosertib drug combination patents. While previous patents cover compositions, methods, formulations and other aspects of utility, the new patent provides additional coverage related to an oral dosing regimen of Rigosertib. The novel formulation patent was filed in 2017 as a PCT application globally and as National Phase applications in the U.S. and in Non-PCT countries including Taiwan and various countries in Latin America.

The named inventor of the patented technology is Dr. Manoj Maniar, Senior Vice President of Product Development for Onconova. The patent was filed by and is assigned to the Company.

On October 17, 2018 ArQule, Inc. (Nasdaq: ARQL) reported it will report financial results for the third quarter of 2018 before the market opens on Wednesday, October 31, 2018 (Press release, ArQule, OCT 17, 2018, View Source [SID1234529945]). The Company will hold a conference call and webcast on the same day at 9:00 a.m. ET to discuss these results and provide a general business update.

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The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

On October 17, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the closing of an underwritten public offering of 25,300,000 shares of its common stock at a public offering price of $9.97 per share (Press release, Iovance Biotherapeutics, OCT 17, 2018, View Source;p=irol-newsArticle&ID=2372014 [SID1234529946]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are approximately $252.2 million. The shares of common stock issued and sold in the offering include 3,300,000 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price, less the underwriting discounts and commissions.

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Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel, to fund its commercial manufacturing capabilities and facilities, to fund its ongoing clinical trials for its current product candidates, including its on-going Phase 2 clinical trials of LN-144, TIL for the treatment of metastatic melanoma, and LN-145, TIL for the treatment of cervical and head and neck cancers, to fund its planned clinical trials for its current product candidates, including its ongoing Phase 2 clinical trial of LN-145 for the treatment of non-small cell lung cancer, or NSCLC, in collaboration with MedImmune, and its ongoing Phase 2 clinical trials of Iovance TIL as an early-line therapy alone or in combination with pembrolizumab in melanoma, head and neck cancer, and NSCLC, and for other general corporate purposes. Additional indications may be explored with the use of proceeds.

Jefferies LLC acted as sole book-running manager for the offering.

The shares of common stock described above were offered by Iovance pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering has been made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus was filed with the SEC, copies of which may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a 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.

On October 17, 2018 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported its upcoming milestones and operational highlights, as well as revenue and cash position for Nicox and its subsidiaries (the "Nicox Group") as of September 30, 2018 (Press release, NicOx, OCT 17, 2018, View Source [SID1234530253]).

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Key Upcoming Milestones
Q1 2019: Planned Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) for NCX 4251 to enable a Phase 2 clinical study1 in patients with acute exacerbations of blepharitis.
Q1 2019: Expected delivery of ZERVIATETM (cetirizine ophthalmic solution), 0.24% commercial product to partner Eyevance Pharmaceuticals LLC, followed by a commercial launch in the U.S. planned for the spring 2019 allergy season.
H2 2019: Expected top-line data from the NCX 470 Phase 2 clinical study for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Third Quarter 2018 and Recent Operational Highlights
In September 2018, Nicox and Fera Pharmaceuticals amended their 2015 agreement granting Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market. The development of naproxcinod will focus on an undisclosed rare disease for which Fera expects to apply for an Orphan Drug Designation from the FDA. Nicox will be eligible to potentially receive a single $40 million sales-based milestone if naproxcinod reaches $1 billion yearly sales (for any indication) in the U.S. Royalties remain at 7% of net sales of naproxcinod in the U.S. Fera remains responsible for all clinical development, manufacturing, regulatory, and commercialization activities.
In Q3 2018, our lead product candidate NCX 470, a novel second generation nitric oxide (NO)-donating prostaglandin analog entered Phase 2 clinical study to evaluate its efficacy and safety compared to latanoprost 0.005% for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension and to select the optimal Phase 3 dose. The study is expected to randomize 420 patients in clinical sites across the U.S. Top-line data are expected in the second half of 2019.
Third Quarter 2018 Financial Highlights
As of September 30, 2018, the Nicox Group had cash and cash equivalents of €25.7 million as compared with €32.7 million at June 30, 2018 and €41.4 million at December 31, 2017. Net revenue2 for the third quarter of 2018 was $0.438 million, comprised exclusively of royalties on third quarter 2018 sales of VYZULTATM by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. This represents an increase of 66% in net revenue3 received by Nicox compared to the second quarter of 2018. The Nicox Group recorded no revenues for the third quarter of 2017.

On October 17, 2018 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary immune cell-activating cancer treatments, reported that preliminary data from a Phase 1/2 clinical study of INT230-6 will be presented in poster sessions at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, which is being held October 19-23 in Munich, Germany, and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC (Press release, Intensity Therapeutics, OCT 17, 2018, View Source [SID1234530320]).
Details of the posters are below.

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ESMO 2018 Congress

Title: Phase 1/2 trial evaluation of intratumoral INT230-6 for the treatment of solid tumors

Abstract Number: 4458

Presentation Number: 1160P

Session: Poster Display Session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

Date/Time: October 20, 2018, 12:30 p.m. CEST

Location: Hall A3; Poster Area Networking Hub, ICM München

Presenter: Anthony El-Khoueiry, MD (University of Southern California, USA)

For more information about the ESMO (Free ESMO Whitepaper) 2018 Congress, please visit View Source

SITC Annual Meeting

Title: Phase 1/2 evaluation of intratumoral INT230-6 for the treatment of solid tumors

Poster Number: P622

Poster Hall Hours: November 9, 8 a.m.-8 p.m.; November 10, 8 a.m.-8:30 p.m. EST

Poster Presentation Hours: November 10, 12:20-1:50 p.m. and 7-8:30 p.m. EST

Poster Hall Location: Hall E; Walter E. Washington Convention Center

Presenter: Anthony Olszanski, MD, RPh (Fox Chase Cancer Center)

For more information about the SITC (Free SITC Whitepaper) Annual Meeting, please visit View Source

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

About the Phase 1/2 Clinical Study

INT230-6 is being evaluated in a Phase 1/2 clinical study in patients with different types of advanced solid tumor malignancies. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. Secondary assessments are the measurement of injected and bystander tumor responses, and determination of the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. The study includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. Data will be used to assess the progression free and overall survival in patients receiving INT230-6. For more information, please visit www.clinicaltrials.gov (NCT03058289).