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Ferring Pharmaceuticals successfully launches its inaugural Swiss Franc Bond offering for an amount of CHF 270 million

On June 29, 2020 Ferring Pharmaceuticals reported the successful launch of its inaugural Swiss Franc Bond offering for a benchmark amount of CHF 270 million (Press release, Ferring, JUN 29, 2020, View Source [SID1234561530]). This inaugural senior unsecured bond transaction issued by Ferring Holding SA has a fixed coupon rate of 1.05% per annum. The bond was issued at a price of 100.097% with a 5-year maturity on 9th July 2025, and will be listed on the SIX Swiss Exchange.

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The offering attracted much interest from high-quality institutional investors and banks, demonstrating recognition of the company’s successful track record and solid cash generation. The company is rated as BBB (Credit Suisse) and Baa- (Fedafin), both with a stable outlook.

Dominic Moorhead, Chief Financial Officer of Ferring Pharmaceuticals, said "We are very happy with the successful outcome of our inaugural bond offering – and for a private company, entering a public capital market is a significant step. This is strong acknowledgement of the company’s achievements, and will enable us to firmly move forward with our next phase of growth."

The net proceeds from the transaction will be used for general corporate purposes including repayment of debt. The issue was lead-managed by Credit Suisse AG and Basler Kantonalbank, with Banque Cantonale Vaudoise acting as co-manager.

Aptose Announces FDA Allowance of IND for Phase 1a/b Study of CG-806 in Acute Myeloid Leukemia

On June 29, 2020 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the U.S. Food and Drug Administration (FDA) completed its review of the company’s Investigational New Drug (IND) application and has granted IND allowance for the initiation of a Phase 1a/b clinical study of CG-806, the company’s highly potent, oral FLT3/BTK inhibitor, in patients with acute myeloid leukemia (AML) (Press release, Aptose Biosciences, JUN 29, 2020, View Source [SID1234561526]). CG-806 is currently in a Phase 1 dose escalation study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to current therapies.

"Our strategy was to identify a starting dose of CG-806 that we believe could be therapeutically active in critically ill patients with relapsed or refractory AML. We are pleased that the FDA has allowed us to initiate a clinical trial in these patients at a starting dose of 450mg BID. Despite recent advances in the treatment of AML, many patients relapse or remain refractory to current therapies leading to a poor overall prognosis," said Rafael Bejar, M.D., Ph.D., Senior Vice President and Chief Medical Officer. "Based on strong preclinical evidence of CG-806’s activity against AML – including demonstration of mutation-agnostic and genotype-agnostic potency, particularly compared against other FLT3 inhibitors, and its ability to safely cure AML in murine leukemia models – we believe CG-806 offers hope to the fragile and difficult-to-treat AML patient population. We continue to dose escalate in an ongoing study in patients with CLL and other B cell cancers, and are eager to advance this separate AML protocol through Institutional Review Boards at key clinical sites, recruit appropriate AML patients, and initiate dosing as soon as possible."

Aptose intends to initiate the Phase 1 a/b study in the second half of 2020 in AML patients who have relapsed, are resistant or refractory to current treatment.

About CG-806

CG-806 is an oral, first-in-class FLT3/BTK cluster selective kinase inhibitor and is in Phase 1 clinical studies for the treatment of hematologic malignancies. This small molecule demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of AML in the absence of toxicity in murine leukemia models, and represents a potential best-in-class therapeutic for patients with AML and other myeloid malignancies. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent or other non-covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.

Incyte Announces Approval of Tabrecta™ (capmatinib) in Japan for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with METex14

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.

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.

Achieve Life Sciences Announces Pricing of $6 Million Registered Direct Offering

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.

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].

Rakuten Medical Receives Conditional Early Approval Designation from Japanese Health Ministry for its Lead Drug, ASP-1929, to Treat Recurrent Head & Neck Cancer

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.

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."