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 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 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.

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On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer (Press release, US FDA, OCT 16, 2018, View Source,advanced%20or%20metastatic%20breast%20cancer [SID1234613394]). Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

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Approval was based on EMBRACA (NCT01945775), an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

The primary efficacy outcome was progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review. Estimated median PFS was 8.6 and 5.6 months in the talazoparib and chemotherapy arms, respectively (HR 0.54; 95% CI: 0.41, 0.71; p<0.0001).

The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity. Most common (≥20%) adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite.

FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib. The effectiveness of the BRACAnalysis CDx test was based on the EMBRACA trial population for whom deleterious or suspected deleterious gBRCAm status was confirmed with either prospective or retrospective testing with BRACAnalysis CDx.

The recommended talazoparib dose is 1 mg taken as a single oral daily dose, with or without food.

View full prescribing information for TALZENNA.

FDA granted this application priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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