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Chugai Files an Application for Expanded Use of Genomic Mutation Analysis Program “FoundationOne® CDx Cancer Genomic Profile”

On January 18, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for expanded use of "FoundationOne CDx Cancer Genomic Profile," a next-generation sequencing based program currently under preparation for launch, to include a companion diagnostic for the drug candidate entrectinib (Press release, Chugai, JAN 18, 2019, View Source [SID1234532776]). Entrectinib is currently under regulatory review for the treatment of NTRK fusion-positive solid tumors.

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FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program was approved by the MHLW in December 2018 as the first cancer genomic test in Japan with the two functions of cancer genomic profiling and companion diagnostics for molecular-targeted drugs.

The filing aims to expand the program for use as a companion diagnostic to identify people likely to benefit from entrectinib by detecting NTRK fusion genes (fusion genes between NTRK1, NTRK2, NTRK3 and other genes). Chugai filed a regulatory application for entrectinib to obtain approval for the treatment of very rare NTRK fusion-positive solid tumors in December 2018. The drug was granted both Sakigake designation and orphan drug designation in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

[Notes]

A press release issued on December 27, 2018: Chugai Obtains Approval for Genomic Mutation Analysis Program "FoundationOne CDx Cancer Genomic Profile"
View Source
A press release issued on December 19, 2018: Chugai Files a New Drug Application for a ROS1/TRK Inhibitor Entrectinib for the Treatment of NTRK Fusion-Positive Solid Tumors
View Source
About FoundationOne CDx Cancer Genomic Profile
FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx Cancer Genomic Profile is intended to be used as a comprehensive companion diagnostic for patients with certain types of cancers to identify those patients that may benefit from approved molecular targeted therapies in Japan.

About entrectinib
Entrectinib is an investigational, oral medicine in development for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 or ROS1 gene fusions. It is a selective, CNS-active tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Entrectinib can block ROS1 and NTRK kinase activity and inhibit proliferation of cancer cells with ROS1 or NTRK gene fusions. Entrectinib is being investigated across a range of solid tumor types, including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.

About NTRK fusion gene positive cancer
NTRK fusion gene is an abnormal gene that can be formed by fusing the NTRK genes (NTRK1, NTRK2, NTRK3 encode TRKA, TRKB, TRKC protein, respectively) and other genes (ETV6, LMNA, TPM3, etc.) as a result of chromosomal translocation. The TRK fusion kinase made from NTRK fusion gene is thought to promote cancer cell proliferation. There is very rare expression of NTRK fusion but in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, gastrointestinal stromal tumor (GIST), infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas.

Can-Fite BioPharma Announces Registered Direct Offering

On January 18, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with a single institutional investor to receive gross proceeds of approximately $2.35 million (Press release, Can-Fite BioPharma, JAN 18, 2019, View Source [SID1234532775]).

In connection with the offering, the Company will issue 2,238,096 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $1.05 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one ADS. The warrants will have an exercise price of $1.30 per ADS, will be immediately exercisable and will expire five and one-half years from the issuance date. The closing of the offering is expected to take place on or about January 23, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent in connection with this offering.

The ADSs described above (but not the warrants or the ADSs underlying the warrants) are being offered pursuant to a shelf registration statement (File No. 333-220644) which became effective on October 11, 2017. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to such ADSs. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone: (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction

argenx announces closing of exclusive global collaboration and license agreement for cusatuzumab (ARGX-110) with Janssen

On January 18, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported the closing of the exclusive, global collaboration and license agreement for cusatuzumab (ARGX-110), a highly differentiated anti-CD70 SIMPLE Antibody, with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, argenx, JAN 18, 2019, View Source [SID1234532774]). The collaboration agreement became effective following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the closing of the private placement described below.

argenx and Janssen have agreed to a joint global clinical development plan to evaluate cusatuzumab in acute myeloid leukemia, myelodysplastic syndromes and other potential future indications. Under the terms of the agreement, Janssen will pay argenx $300 million in an upfront payment. argenx will be eligible to receive potentially up to $1.3 billion in development, regulatory and sales milestones, in addition to tiered, double-digit royalties. Janssen will be responsible for commercialization worldwide. argenx retains the option to participate in commercialization efforts in the US, where the companies have agreed to share economics 50/50 on a royalty basis, and outside the US, Janssen will pay double-digit sales royalties to argenx.

In addition, the private placement of 1,766,899 new argenx shares at a price of €100.02 ($113.19, based on the EUR/USD exchange rate as of December 2, 2018) per share to Johnson & Johnson Innovation Inc. — JJDC, Inc. (JJDC) was completed as part of the closing, with gross proceeds to argenx of €176.7 million (approximately $200 million). argenx’s share capital will be €3,789,576.40 after registration of the capital increase. Following Euronext Brussels’ approval of argenx’s request for the admission to listing and trading of the new shares, it is expected that the new shares will be admitted to trading and official listing on the regulated market of Euronext Brussels on January 23, 2019.

About Cusatuzumab

Cusatuzumab (ARGX-110) is an investigational SIMPLE Antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement dependent cytotoxicity, enhanced antibody-dependent cell-mediated phagocytosis and enhanced antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors (Silence K. et al. mAbs 2014; 6 (2):523-532). Cusatuzumab is currently being evaluated in patients with hematological malignancies, including a Phase 1/2 trial in combination with Vidaza in patients with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes. Recently,

cusatuzumab has been granted orphan drug designation for the treatment of AML by FDA. Preclinical work on cusatuzumab in AML was performed in collaboration with the Tumor Immunology Lab of Prof. A. F. Ochsenbein at the University of Bern, who won, together with Prof. Manz at the University Hospital of Zürich, the prestigious 2016 Otto Naegeli Prize for his breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients

Spectrum Pharmaceuticals Sells Marketed Portfolio to Acrotech Biopharma L.L.C. to Focus on New and Innovative Therapies for Cancer Patients

On January 17, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) reported that it has entered into a definitive agreement to sell its portfolio of seven FDA-approved hematology/oncology products to Acrotech Biopharma L.L.C. Acrotech Biopharma is a New Jersey-based wholly-owned subsidiary of Aurobindo Pharma USA Inc (Press release, Spectrum Pharmaceuticals, JAN 17, 2019, View Source [SID1234554010]).

"This divestiture marks a major strategic shift for Spectrum to ensure laser-focus on novel, oncology drug development and commercialization," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The proceeds generated by the sale will significantly strengthen the financial position of the company, providing the capital to develop and commercialize our two late-stage pipeline assets, and placing us in a solid position to evaluate additional growth opportunities."

The seven products included in the sale are: FUSILEV (levoleucovorin), FOLOTYN (pralatrexate injection), ZEVALIN (ibritumomab tiuxetan), MARQIBO (vinCRIStine sulfate LIPOSOME injection), BELEODAQ (belinostat) for injection, EVOMELA (melphalan) for injection, and KHAPZORY (levoleucovorin). The products generated combined sales of $76.4 million during the first nine months of 2018.

"Along with this divestiture, the majority of impacted staff will transition to Acrotech thereby right sizing Spectrum for our development efforts. Additionally, we are retaining a core group of commercial talent to lead the launch of ROLONTIS and poziotinib," added Joe Turgeon.

The Boards of Directors of Spectrum Pharmaceuticals and Aurobindo have both approved the transaction, which is subject to regulatory approvals and expected to close within 90 days. Jefferies LLC is acting as exclusive financial advisor to Spectrum. Paul Hastings LLP is acting as exclusive legal counsel to Spectrum.

Conference call details:

Thursday, January 17, 2019 at 8:30 a.m. Eastern/5:30 a.m. Pacific

Domestic: (877) 837-3910, Conference ID# 2890988
International: (973) 796-5077, Conference ID# 2890988

The conference call will also be webcast live. To access the webcast, please visit the Investor Relations page of the Spectrum Pharmaceuticals website at View Source

For interested individuals unable to join the call, a replay will be available from January 17, 2019 @ 11:30 p.m. ET/8:30 p.m. PT through January 24, 2019, until 11:30 p.m. ET/8:30 p.m. PT.

Domestic Replay Dial-In: (855) 859-2056, Conference ID# 2890988
International Replay Dial-In: (404) 537-3406, Conference ID# 2890988

Terms of Purchase and Sale Agreement

Under the terms of the deal, Acrotech will make a $160 million up-front cash payment and up to $140 million in milestones listed below:

Marqibo Milestones

$30 million for FDA Product Approval for MARQIBO with label indicated for diffuse large B-cell lymphoma
$10 million for FDA Product Approval for MARQIBO for any indication other than the B-Cell Lymphoma Indication, single vial or pediatric ALL
$30 million for Net Sales of MARQIBO during any trailing twelve (12) month period during the Milestone Period are equal to or greater than $300,000,000
$10 million for Net Sales of MARQIBO during any trailing twelve (12) month period during the Milestone Period are equal to or greater than $400,000,000
Khapzory Milestones

$5 million for Net Sales of KHAPZORY during any trailing twelve (12) month period during the Milestone Period are equal to or greater than $50,000,000
$5 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $150,000,000 at any time during the Milestone Period
$10 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $200,000,000 at any time during the Milestone Period
$15 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $300,000,000 at any time during the Milestone Period
$25 million for Cumulative Net Sales of KHAPZORY are equal to or greater than $400,000,000 at any time during the Milestone Period
The milestone period lasts for five years post the closing of the transaction. KHAPZORY milestones only payable in the event KHAPZORY is assigned a unique J-code.

First Patient Dosed in Phase 1 Clinical Trial Evaluating Neoepitopes Formulated in IMV’s DPX Delivery Platform in Ovarian Cancer Patients

On January 17, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that the first patient has been treated in the Phase 1 trial evaluating neoepitopes formulated in the Company’s proprietary DPX delivery platform in patients with ovarian cancer (Press release, IMV, JAN 17, 2019, View Source [SID1234534099]). The study is part of the Company’s DPX-NEO program, which is an ongoing collaboration between UConn Health and IMV to develop neoepitope-based anti-cancer therapies.

"Expanding our DPX-based clinical immunotherapy program beyond DPX-Survivac is an important milestone for IMV, and we are pleased to be able to do so with this type of cutting-edge program in which the novel mechanism of action underscoring all DPX-based candidates plays a critical role," said Frederic Ors, Chief Executive Officer at IMV. "We believe that the potential of neoepitope-based therapies could be a significant advance in the way physicians treat patients with ovarian cancer who today face a high unmet medical need. We look forward to working with UConn Health to advance this program as IMV is committed to developing an immunotherapy option for women affected by this disease."

Investigators will assess the safety and efficacy of using patient-specific neoepitopes discovered at UConn Health and formulated in IMV’s proprietary DPX-based delivery technology in women with ovarian cancer. Investigators plan to enroll up to 15 patients in the Phase 1 study. UConn Health is funding the trial with IMV providing materials and counsel.

Epitopes are the part of the biological molecule that is the target of an immune response. Neoepitopes are the mutated proteins produced by a patient’s own tumors. Neoepitope immunotherapies target these patient-specific proteins and have been referred to as ‘the next immunotherapy frontier.’ (1)

"The first immunization of the first ovarian cancer patient with our personalized, patient-specific neoepitopes developed at the University of Connecticut using our proprietary technology, formulated in IMV’s excellent immunomodulatory DPX delivery platform, is a major milestone for us," said Study Investigator Pramod K Srivastava, PhD, MD, Director of the Neag Comprehensive Cancer Center at the University of Connecticut School of Medicine.

About the DPX-NEO Program

The DPX-NEO program is an ongoing collaboration evaluating the anti-cancer activity of proprietary patient-specific epitopes developed at UConn Health and formulated in IMV’s DPX-based novel immunotherapeutic delivery technology. IMV had previously announced the results from preclinical research in which researchers at UConn found that neoepitopes formulated in DPX-based

formulations demonstrated superior immunogenic activity over comparators in mouse tumor models. In addition, IMV also previously announced a breakthrough in formulating multiple peptides in DPX formulations. The Company has patented the technology, which allows for both a larger number and a broader potential range of peptides into a single formulation as compared to standard formulation technologies.