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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.

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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."

BioNTech to Raise USD 250 Million in Private Placement

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.

"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.

Novartis announces MET inhibitor Tabrecta™ approved in Japan for advanced non-small cell lung cancer with METex14

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.

"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).

Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options

On June 29, 2020 Novartis Pharma K.K. ("Novartis Pharma") reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) simultaneously approved five new treatment options for Japanese patients (Press release, Novartis, JUN 29, 2020, View Source [SID1234561519]):

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),
Entresto (sacubitril valsartan sodium hydrate) in chronic heart failure,
Mayzent (siponimod fumaric acid) in secondary progressive MS,
Enerzair (glycopyrronium bromide, indacaterol acetate, mometasone furoate) and
Atectura (indacaterol acetate, mometasone furoate) in different forms of asthma
"The simultaneous approval of five new products is remarkable for Japan and our industry. We are pleased to see that our innovative products gain the support from leading regulatory bodies", said Kazunari Tsunaba, Representative Director and President of Novartis Pharma. "All five medicines are truly novel and transformative treatments and therefore mark an important milestone in our mission to reimagine medicine. I would like to thank our Japanese and global colleagues for all their dedication to make this unprecedented milestone happen."

To date, Novartis has received seven new product approvals in Japan this year. In addition to today’s five approvals, in March, Novartis was granted marketing authorizations for spinal muscular atrophy treatment Zolgensma and for Beovu, an anti-VEGF treatment for wet AMD. These approvals and today’s very unprecedented milestone stand testament to the overall strength of Novartis innovative medicines pipeline and its commitment to ensure patients in Japan have timely access to these life-changing medicines.

Oblique Therapeutics and Targovax Enter Collaboration to Target Mutant RAS Cancers by Combining Their ONCOS and Abiprot™ Platforms

On June 29, 2020 Oblique Therapeutics reported that it has entered into a collaboration agreement with Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, to evaluate the potential of using ONCOS oncolytic adenoviruses as a vector to encode and deliver AbiprotTM antibodies against hard-to-reach intra-cellular targets (Press release, Oblique Therapeutics, JUN 29, 2020, View Source [SID1234561512]).

Oblique Therapeutics has developed a unique, proprietary methodology to identify epitopes on targets that have previously proven difficult to address with antibodies. This approach can be extended to intra-cellular targets such as mutant RAS, however, delivering antibodies into cells remains a major obstacle.Oblique Therapeutics and Targovax anticipate that expression of AbiprotTM antibodies against such targets using ONCOS as a vector can overcome this challenge and boost the specificity and power of the anti-tumor response.

Under the agreement the parties will jointly explore the technical feasibility and in vitro and in vivo functionality and anti-cancer activity of the ONCOS-Abiprot combination, initially focusing on mutant RAS as the target. If successful, this would provide a first-in-class oncolytic virus candidate directly targeting RAS and demonstrate proof-of-concept for ONCOS-AbiprotTM as a new technology platform.

Dr. Sreesha P Srinivasa, Ph.D., Senior Vice President, Translational R&D Oblique Therapeutics, commented, "We are delighted to partner with Targovax in extending the capabilities of our proprietary AbiprotTM platform to translate antibodies against difficult to reach intra-cellular targets into effective therapeutics. RAS is one of the most frequently mutated oncogenes but has until recently proven to be therapeutically intractable. Oblique has used its AbiprotTM platform to identify novel epitopes on mutant RAS and developed functional antibodies against these epitopes. The ONCOS platform potentially offers an efficient vehicle for intracellular delivery of these functional antibodies into cancer cells. If proven successful, this extends the target space addressable by antibodies to a large number of very important intracellular oncogenes"

Dr. Victor Levitsky, Ph.D., Chief Scientific Officer of Targovax, said: "We continue to explore innovative strategies to expand our ONCOS platform into mutant RAS immunotherapy, and we are very excited to initiate this collaboration with our colleagues at Oblique Therapeutics. With AbiprotTM they have built a cutting-edge methodology to develop antibodies against historically difficult targets to address, such as mutant RAS. By employing ONCOS as a vector for Oblique’s antibodies we believe we can both enhance antibody delivery into cancer cells and strengthen the oncolytic power of the ONCOS virus, and thus drive a synergistic effect between the two modalities"