On December 21, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Iovance Biotherapeutics, DEC 21, 2018, View Source;p=irol-newsArticle&ID=2381465 [SID1234532223]). Details of the presentation are as follows:

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Presenter: Maria Fardis, Ph.D., President and Chief Executive Officer
Date: Thursday, Jan. 10, 2019
Time: 10:30 a.m. PST
Webcast: A live and archived audio webcast of the presentation will be available in the "Investors" section at www.iovance.com.

On December 21, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, "TECENTRIQ Intravenous Infusion 1200 mg" (generic name: atezolizumab [genetical recombination]) from the Ministry of Health, Labour and Welfare (MHLW) for additional dosing for the treatment of "previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) (Press release, Chugai, DEC 21, 2018, View Source [SID1234532240])."

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"Following the approval for previously treated NSCLC obtained in January, 2018, we are pleased to gain another approval which enables us to provide a new treatment option as an initial treatment for patients with advanced or recurrent non-squamous NSCLC," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management unit. "Chugai has been conducting five clinical studies in NSCLC in Japan to evaluate TECENTRIQ alone or in combination with other drugs. We are committed to work closely with Roche to provide patients with as many new treatment options as possible to meet their needs."

This approval is based on results from the Phase III IMpower150 study, which showed that TECENTRIQ in combination with AVASTIN and chemotherapy helped people live significantly longer, compared to AVASTIN and chemotherapy. The safety profile of the TECENTRIQ combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.

[Reference]
Press release issued by Roche on May 17, 2018
Phase III IMpower150 study showed Roche’s Tecentriq and Avastin plus carboplatin and paclitaxel helped people with a specific type of metastatic lung cancer live significantly longer compared to Avastin plus carboplatin and paclitaxel
View Source

In Japan, the annual prevalence of lung cancer is estimated to be approximately 134,000 in 2015 (male: 91,000, female: 43,000). The annual mortality of lung cancer, the leading cause of cancer death in Japan, is approximately 77,000 (male: 55,000, female: 22,000; predicted figure for 2015).*

As a top pharmaceutical company in oncology in Japan, Chugai is committed to contribute to patients and medical professionals by offering TECENTRIQ as a new treatment option.

Prescribing Information

The underlined part has been newly added and changed.

Product name
TECENTRIQ Intravenous Infusion 1200 mg
Generic name
atezolizumab (genetical recombination)
Indications
Unresectable, advanced or recurrent non-small cell lung cancer
Dosage and administration
In case of patients with untreated unresectable, advanced or recurrent non squamous non-small cell lung cancer.
The usual adult is 1200 mg atezolizumab (genetical recombination) in combination with carboplatin, paclitaxel and bevacizumab (genetical recombination) by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.

In case of patients with unresectable, advanced or recurrent non squamous non-small cell lung cancer who has undergone chemotherapy.
The usual adult dosage is 1200 mg atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
Drug price
TECENTRIQ Intravenous Infusion 1200 mg JPY 625,567/per vial
Conditions for approval
1. A risk management plan should be created and appropriately implemented.
2. Because the number of participants in Japanese clinical trials was very limited, post-marketing drug use surveillance of all patients receiving TECENTRIQ treatment should be conducted until data for a certain number of patients have been accumulated, in order to understand background information on people using TECENTRIQ as well as to collect safety and efficacy data on TECENTRIQ promptly, and take necessary measures for the appropriate use of TECENTRIQ.
About TECENTRIQ
In Japan, TECENTRIQ was approved for the indications on "unresectable advanced or recurrent NSCLC" in January, 2018 and was launched in April. In addition, a supplementary application for the first-line treatment of small cell lung cancer was filed in December 7, 2018.

On December 21, 2019 Helix BioPharma Corp. (TSX, FSE: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a third tranche of a private placement financing for gross proceeds of CAD700,800 (Press release, Helix BioPharma, DEC 21, 2018, View Source [SID1234533056]). Helix closed the first and second tranches of the private placement on December 6, 2018 and December 20, 2018 for gross proceeds of CAD871,200 and CAD342,000, respectively. The Company expects to complete a final tranche of the private placement financing before the end of December.

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The terms of the placement are for the purchase of units at $1.20 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $1.50 and have an expiry of five years from the date of issuance. Helix intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

On December 21, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported that its Phase 2 TRAXAR trial evaluating TRC105 in combination with Inlyta (axitinib) in patients with advanced or metastatic renal cell carcinoma did not meet the primary endpoint of improving progression free survival (PFS) in the intent to treat population compared to Inlyta monotherapy (Press release, Tracon Pharmaceuticals, DEC 21, 2018, View Source [SID1234532224]).

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Prespecified statistical analyses of PFS according to expression of two plasma biomarkers, TGFβ receptor III and osteopontin, also did not achieve statistical significance. The safety profile observed in TRAXAR was consistent with that observed in previously reported studies of TRC105 in combination with VEGF inhibitors.

TRACON will work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

"We are disappointed that TRC105 in combination with Inlyta did not demonstrate clinically meaningful efficacy in patients with advanced or metastatic renal cell carcinoma. Importantly, data from TRAXAR, including analyses of an extensive biomarker panel, will contribute to our understanding of the role of endoglin inhibition in combination with VEGF inhibitors, and may inform our broad TRC105 clinical development program," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We remain focused on the interim analysis to determine the final sample size of the Phase 3 TAPPAS trial of TRC105 and Votrient in angiosarcoma, which is expected in the first quarter of 2019."

About the TRAXAR trial in Advanced or Metastatic Renal Cell Carcinoma

The TRAXAR trial compared treatment with TRC105 and Inlyta to treatment with single agent Inlyta in 150 patients with advanced or metastatic renal cell carcinoma with a clear cell component. Patients were randomized in equal numbers and the primary endpoint was progression free survival by RECIST 1.1. Key secondary endpoints included objective response rate, safety and tolerability.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

On December 21, 2018 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in large-scale PCR-based DNA manufacturing, reported the pricing of an underwritten public offering of 5,500,000 shares of its common stock and warrants to purchase up to an aggregate of 5,500,000 shares of the Company’s common stock (Press release, Applied DNA Sciences, DEC 21, 2018, View Source [SID1234532241]). Each share of common stock and each warrant to purchase one share of common stock is being sold at a combined effective price to the public of $0.50.

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Gross proceeds, before underwriting discounts and commissions and estimated offering costs, are expected to be approximately $2.75 million. Applied DNA has granted the underwriter an over-allotment option, exercisable for a period of 45 days, to purchase up to 825,000 additional shares of its common stock and/or 825,000 warrants to purchase common stock at the public offering price less discounts and commissions. The offering is expected to close on or about December 26, 2018, subject to satisfaction of customary closing conditions.

The warrants will be exercisable immediately at an exercise price of $0.50 per share and will expire five years from the date of issuance. The warrants include an adjustment provision that, subject to certain exceptions, reduces their exercise price if the Company issues common stock or common stock equivalents at a price lower than the then-current exercise price of the warrants, subject to a minimum exercise price of $0.14 per share.

Applied DNA intends to use the net proceeds from this offering for working capital, capital expenditures, business development and research and development expenditures.

Maxim Group LLC is acting as sole book-running manager for the offering.

The securities described above are being offered under the Company’s shelf registration statement on Form S-3 (No. 333-218158), previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). The securities were offered by means of a preliminary prospectus supplement and accompanying prospectus, forming a part of the effective registration statement. The final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the website of the SEC at View Source Electronic copies of the prospectus supplement and accompanying prospectus also may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at 212-895-3745. Before you invest, you should read the prospectus supplement and the accompanying prospectus in the registration statement and other documents Applied DNA has filed or will file with the SEC for more complete information about Applied DNA and the offering.

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 offer or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.