On June 29, 2020 Incyte (Nasdaq: INCY) reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta (capmatinib) for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC) (Press release, Incyte, JUN 29, 2020, View Source [SID1234561525]). Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.

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Tabrecta is the third Incyte-discovered medicine to receive approval in Japan. Novartis has exclusive worldwide development and commercialization rights to Tabrecta. Approval of Tabrecta in Japan triggers a $20 million milestone payment to Incyte, and Incyte is also eligible to receive 12-14% royalties on global net sales of Tabrecta by Novartis.

"We are grateful for the efforts of Novartis Pharma K.K. and MHLW and are delighted that this important, targeted treatment option will now become available to patients in Japan diagnosed with METex14 NSCLC," said Lothar Finke, M.D., Ph.D., Group Vice President, Head of Development and General Manager, Asia, Incyte. "This approval highlights the strength of the Incyte in-house discovery program, and our commitment to finding solutions for serious medical needs."

The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 study. In the METex14 population (n=97), the confirmed overall response rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among treatment-naive (n=28) and previously treated patients (n=69), respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. In patients taking Tabrecta, the study also demonstrated a median duration of response of 12.6 months (95% CI, 5.5–25.3) in treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.5-13.0) in previously treated patients (28 responders). The most common treatment-related adverse events (AEs) (incidence ≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

About Tabrecta

Tabrecta (capmatinib) is a kinase inhibitor that targets MET discovered by Incyte and licensed to Novartis in 2009. Under the terms of the Agreement, Incyte granted Novartis exclusive worldwide development and commercialization rights to capmatinib and certain back-up compounds in all indications. Incyte is eligible for a total of over $500 million in milestones as well as royalties of between 12-14% on global net sales by Novartis.

On June 29, 2020 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported that it has entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of 14,634,146 shares of common stock at a price of $0.41 per share in a registered direct offering, resulting in total gross proceeds of approximately $6 million, prior to deducting placement agent fees and estimated offering expenses (Press release, OncoGenex Pharmaceuticals, JUN 29, 2020, View Source [SID1234561524]). The offering is expected to close on or about July 1, 2020, subject to customary closing conditions.

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Lake Street Capital Markets LLC is acting as exclusive placement agent for the registered direct offering.

The shares of common stock were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-229019), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 11, 2019. The Company intends to use the proceeds from the offering to fund clinical research and development, and for general working capital.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by the Company with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at [email protected].

On June 29, 2020 Rakuten Medical, Inc. (Rakuten Medical) reported that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has notified Rakuten Medical that its lead drug ASP-1929 will be reviewed under the Conditional Early Approval System (CEAS) (Press release, Rakuten Medical, JUN 29, 2020, View Source [SID1234561523]). Compared to standard review the CEAS speeds up the approval process, bringing potentially life-saving treatments to patients faster.

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Rakuten Medical is developing precision cell-targeting investigational therapies on its Illuminox technology platform. ASP-1929, the first investigational drug developed on this platform, is currently undergoing Phase III clinical development for the treatment of recurrent head and neck cancer.

Rakuten Medical submitted a Japanese Biological License Application (JBLA) for this drug on March 26, 2020 – based on results of Phase I / II clinical trials. In addition – on March 19, 2020 – the company applied for Japan approval of the laser illumination system which is utilized in conjunction with ASP-1929.

"This prestigious designation confirms the potential of our technology to bring the light of hope to cancer patients as quickly as possible," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical regarding the Conditional Early Approval designation of ASP-1929. "This designation further validates the success of our ongoing work and inspires us to rapidly develop additional innovative therapies on the Illuminox platform for the benefit of patients suffering from cancer."

On June 29, 2020 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and infectious diseases, reported a private investment of USD 250 million (EUR 223 million) by Temasek and other accredited investors (Press release, BioNTech, JUN 29, 2020, View Source [SID1234561522]). The private placement includes an investment of approximately USD 139 million in ordinary shares and a USD 112 million investment in 4-year mandatory convertible notes.

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"We are pleased to welcome Temasek onboard as a new shareholder. We believe their long-term investment approach, global presence, and deep experience in the biotechnology field are a good fit with our vision to build a leading global biopharmaceutical company," said Ugur Sahin, CEO and Co-founder of BioNTech.

Upon closing, private placement investors will receive 2,595,996 ordinary shares in BioNTech, which will be subject to a 180-day lock-up agreement. The 4-year mandatory convertible notes will come with a coupon of 4.5% per annum and a conversion premium of 20% above the reference price. The investment is expected to close in early- to mid-August, subject to customary closing conditions.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any security. The securities referenced herein have not been and will not be registered under the Securities Act of 1933, as amended (Securities Act), or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the Securities Act and applicable state securities laws or an applicable exemption from registration requirements.

On June 29, 2020 Novartis Pharma K.K. ("Novartis Pharma") reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC) (Press release, Novartis, JUN 29, 2020, View Source [SID1234561520]). Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"With the remarkable overall response rates seen both in treatment-naive and previously treated patients, we are thrilled that MHLW has added Tabrecta as a new treatment option for patients with advanced NSCLC with METex14," said Brian Gladsden, President of Novartis Oncology Japan. "Today’s approval reinforces the potential benefit this new MET inhibitor can bring to thousands of patients diagnosed in Japan each year and is a positive step in our journey to transform the lives of patients with lung cancer."

The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 Phase II multi-center, non-randomized, open-label, multi-cohort study. In the METex14 population (n=97), the confirmed overall response rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among treatment-naive (n=28) and previously treated patients (n=69), respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. In patients taking Tabrecta, the study also demonstrated a median duration of response of 12.6 months (95% CI, 5.5–25.3) in treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.5-13.0) in previously treated patients (28 responders). The most common treatment-related adverse events (AEs) (incidence ≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

The companion diagnostic to Tabrecta, FoundationOneCDx Cancer Genomic Profile, was approved by MHLW on May 25th of this year, to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue.

About Tabrecta (capmatinib)
Tabrecta (capmatinib) is a kinase inhibitor that targets MET. Tabrecta was licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications. In May 2020, Tabrecta was approved by the US Food and Drug Administration (FDA) for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).