On January 18, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported new findings identifying a potential association between CXCL12 expression and clinical benefit in patients with pancreatic cancer treated with tipifarnib (Press release, Kura Oncology, JAN 18, 2019, View Source [SID1234532792]). These findings are being presented today at the 2019 Gastrointestinal Cancers Symposium in San Francisco. A copy of the poster is available on Kura’s website at www.kuraoncology.com.

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Tipifarnib has been shown to downregulate CXCL12, and previously reported data support tipifarnib as a CXCL12/CXCR4 pathway inhibitor. Elevated CXCL12 expression is known to be a poor prognosis factor in patients with pancreatic, Iung and esophageal-gastric cancers. In the specific context of pancreatic cancer, high CXCL12 expressing tumors may evade early diagnosis by decreasing abdominal pain through the attraction of pain-suppressing Schwann cells.

To investigate the potential for association between CXCL12 expression and clinical benefit in pancreatic cancer patients, Kura conducted a retrospective analysis of study INT-11, a randomized, placebo-controlled Phase 3 study of gemcitabine plus tipifarnib compared with gemcitabine plus placebo in patients with advanced pancreatic cancer.

A total of 688 pancreatic cancer patients were enrolled in study INT-11, of whom 155 reported no abdominal pain at study entry. Although no differences in survival were observed in the overall study, the absence of patient-reported abdominal pain at study entry was associated with higher median survival in the tipifarnib plus gemcitabine arm (10.2 months vs. 5.9 months, HR=0.52, p<0.0001), whereas no significant effect was observed in the placebo plus gemcitabine arm (6.0 months vs. 6.1 months), suggesting that the absence of abdominal pain may serve as a surrogate of clinical benefit from tipifarnib in pancreatic cancer.

In addition, patients with nodal disease or distant metastases limited to the liver also appeared more likely to receive clinical benefit from tipifarnib. Significant clinical benefit was observed in 67 patients with nodal metastases (12.8 months vs. 8.2 months, HR=0.46, p=0.01) and in 233 patients with liver (only) metastases (6.8 months vs. 5.0 months, HR=0.7, p=0.02), respectively. Nodal and liver metastases of pancreatic cancer were found to express high levels of CXCL12.

Analyzing data from The Cancer Genome Atlas (TCGA), Kura also found an association between high CXCL12 expression and pancreatic tumors with low KRAS mutant allele frequency (≤ 5%, representing approximately 30% of pancreatic cancer patients), which may help identify patients with tumors overexpressing CXCL12.

"We are very encouraged by these results, which we believe support the development of tipifarnib in pancreatic cancer," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "In December 2018, we presented prospective proof-of-concept data in peripheral T-cell lymphoma which we believe validated our initial observations on tipifarnib as a CXCL12 pathway inhibitor in lymphoma and acute myeloid leukemia. This study now extends the therapeutic potential of tipifarnib to pancreatic cancer, and we intend to explore opportunities for further development of tipifarnib in this and other CXCL12-expressing hematologic and solid tumor indications."

About Tipifarnib

Kura Oncology’s lead drug candidate, tipifarnib, is a potent and highly selective inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. Tipifarnib was previously studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets, however no molecular mechanism of action had previously been determined that could explain its activity across a range of diverse clinical indications, including squamous tumors that carry mutant HRAS, as well as in lymphoid, myeloid and solid tumors that do not carry HRAS mutations. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura is seeking to identify those patients most likely to benefit from tipifarnib.

In December 2018, Kura reported activity from an ongoing Phase 2 study of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), including a significant association between CXCL12 expression and clinical benefit.

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]).

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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

On January 18, 2019 DXC Technology (NYSE: DXC), the world’s leading independent, end-to-end IT services company, reported that it will release financial results for the third quarter of fiscal 2019 on Thursday, February 7, 2019, at approximately 4:15 p.m. Eastern Standard Time (EST) (Press release, DynPort Vaccine Company, JAN 18, 2019, View Source [SID1234532793]).

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DXC Technology senior management will host a conference call and webcast on the same day at 5 p.m. EST. The dial-in number for domestic callers is (888) 254-3590. Callers who reside outside of the United States should dial +1 (323) 994-2093. The passcode for all participants is 6249774. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until February 14, 2019. Replay numbers can be found at the following link. The replay passcode is also 6249774.

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.

On January 18, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported the closing of a previously announced underwritten public offering of 10,222,222 shares of its common stock, which included the exercise in full of the option to purchase 1,333,333 additional shares, at a price of $9.00 per share (Press release, Stemline Therapeutics, JAN 18, 2019, View Source [SID1234532779]). The gross proceeds to Stemline from the offering, including the exercise of the option to purchase additional shares, before deducting underwriting discounts, commissions and other offering expenses payable by Stemline, were $92 million.

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J.P. Morgan Securities LLC and Cowen and Company, LLC acted as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC acted as co-lead managers and Roth Capital Partners, LLC, ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, National Securities Corporation, and Aegis Capital Corp. acted as co-managers for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL‑401) including clinical trials for additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other diseases; (ii) clinical development of SL‑801, SL‑701 and potentially SL-901; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.
Stemline has filed a prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-219794) with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. The prospectus supplement is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by email at [email protected].

The offering of these securities was made under an effective shelf registration statement on file with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other diseases