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Entry into a Material Definitive Agreement

On January 15, 2019, Stemline Therapeutics, Inc. ("Stemline" or the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, as representative of the several underwriters named therein (the "Underwriters") (Filing, 8-K, Stemline Therapeutics, JAN 15, 2019, View Source [SID1234532699]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriters, in a firm commitment underwritten public offering, 8,888,889 shares (the "Firm Shares") of the Company’s common stock, $.0001 par value per share ("Common Stock"), at a price to the public of $9.00 per share, less underwriting discounts and commissions. Due to demand, this offering was upsized from the previously announced 6,600,000 shares. In addition, pursuant to the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 1,333,333 shares of Common Stock (the "Additional Shares," together with the Firm Shares, the "Shares"). The transactions contemplated by the Underwriting Agreement are expected to close on January 18, 2019, subject to the satisfaction of customary closing conditions. A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

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J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The net proceeds to the Company are expected to be approximately $80,000,000, assuming no exercise of the option to purchase Additional Shares and after deducting underwriting discounts and commissions and estimated expenses payable by the Company associated with the offering.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

Five Prime Therapeutics Announces Restructuring to Focus on Clinical Development and Later-Stage Research Priorities

On January 15, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate restructuring to focus resources on its development pipeline, comprising five clinical-stage cancer programs in various solid tumor types and addressing multiple cell types in the tumor microenvironment (Press release, Five Prime Therapeutics, JAN 15, 2019, View Source [SID1234532678]).

"While we are on track for multiple data read-outs and potential phase advances from our pipeline in 2019, the Executive Team and Board felt it was necessary to sharpen our focus on our current clinical programs and the advancement of our later-stage research initiatives," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "This was a hard decision to make, but we believe that effective use of capital is crucial to supporting our strong pipeline of anti-cancer drug candidates. We remain committed to successfully executing our clinical trials and advancing our later-stage research programs with the same intensity and quality for which Five Prime is known."

The company is eliminating 41 current positions, representing approximately 20% of its current headcount, and will take a disciplined approach to replacing and adding headcount. The positions eliminated are primarily in areas relating to research, pathology and manufacturing. The company expects that the restructuring and other cost-saving efforts will result in a $10 million reduction in net cash used for operating activities during fiscal year 2019 as compared to 2018, with additional expected savings in 2020 and beyond due to lower ongoing personnel expense. Five Prime estimates that it will incur approximately $2 million of pre-tax charges for severance and other costs related to the restructuring, primarily during the first quarter of 2019.

The company’s financial guidance that it anticipates ending 2019 with $148 to $153 million in cash, cash equivalents and marketable securities reflects the expected reduction in the company’s operating expenses due to the elimination of positions. The company has no debt and ended 2018 with $270 million in cash, cash equivalents and marketable securities and believes this cash is sufficient to fund programs through multiple data readouts.

Orion Biotechnology Reports Positive Results for Colorectal Cancer in Preclinical Study

On January 15, 2019 Orion Biotechnology Canada Ltd., a developer of novel medical treatments, reported preclinical data produced in collaboration with Charles River Laboratories, evaluating the efficacy of OB-002O (5P12-RANTES) in colorectal cancer (Press release, Orion Biotechnology, JAN 15, 2019, View Source [SID1234532673]). BALB/c mice were inoculated subcutaneously with the CT-26 colorectal cancer cell line. Three days after inoculation intraperitoneal treatment was started with OB-002O, a murine anti-PD-1 antibody, OB-002 + anti-PD-1, or saline placebo. Treatment was given daily or every third day. Treatment with OB-0020 alone led to statistically significant delayed tumor growth at multiple time-points. An even more profound effect on the decrease in mean tumor volume was observed in combination cohort where animals received both, OB-0020 and the anti-PD-1 antibody (p>0.05).

"There is growing awareness of the role of CCR5 antagonism as an important component of cancer immunotherapy. OB-002O is an extremely potent CCR5 antagonist and we are delighted to see that OB-002O has robust efficacy alone and in combination with an anti-PD-1 antibody in the CT-26 colorectal cancer model. These data support the further preclinical and clinical development of OB-002O for colorectal cancer" said Dr. Ian McGowan, Chief Scientific Officer for Orion Biotechnology.

Mark Groper, President and CEO of Orion Biotechnology added; "We are delighted by these preliminary data and look forward to the later stage development of OB-002O in colorectal cancer as well as exploring the efficacy of OB-002O in other cancer models."

New Data on Kitov’s NT219 Demonstrates its Unique Mechanism of Action and Anti-Cancer Effect

On January 15, 2019 Kitov Pharma (NASDAQ/TASE: KTOV), an innovative pharmaceutical company, reported new findings from its ongoing collaboration with researchers from the Hebrew University of Jerusalem (Press release, Kitov Pharmaceuticals , JAN 15, 2019, View Source [SID1234532669]). The data reveal NT219’s high affinity and selective binding to its target proteins.

Hadas Reuveni, Ph.D., Chief Technology Officer at Kitov’s subsidiary, TyrNovo Ltd., in collaboration with Dr. Galia Blum and Dr. Ofra Moshel from the Hebrew University demonstrated that NT219 binds directly to Insulin Receptor Substrates (IRS) 1/2 and to the Signal Transducer and Activator of Transcription 3 (STAT3), both known modulators of tumor survival, metastasis and drug resistance. Data showed that a short exposure of cancerous cells to NT219 was sufficient to trigger irreversible shutdown of these pathways, resulting in a long-term anti-cancer effect.

Based on these latest findings, Kitov and Yissum, the Technology Transfer company of the Hebrew University of Jerusalem, have extended their collaboration agreement in order to deepen the understanding of NT219’s efficacy in overcoming tumors’ resistance to immunotherapy.

As previously reported (Reuveni et al, Cancer Research, 2013) upon binding to IRS1/2 a three-step mechanism is activated. IRS1/2 dissociates from the cell membrane, undergoes serine phosphorylation which prevents rebinding to the receptor, and is finally degraded by the proteasome. This sequence of events leads to the blockage of AKT – a major cancer cell survival pathway.

"We are excited about the new data which demonstrate NT219’s unique mechanism of action. NT219, a new and promising concept in cancer therapy, is designed to prevent, reverse, and delay resistance to anti-cancer drugs. We are developing NT219 as a drug to be used in combination with other therapies that has a potential to overcome cancer drug resistance and to boost the efficacy of numerous oncology drugs on the market today," stated Kitov CEO, Isaac Israel.

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and inhibiting the phosphorylation of two oncology-related signal transducers, Insulin Receptor Substrates (IRS) 1/2 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it had been acquired. NT219 is licensed from Yissum, the technology transfer company of the Hebrew University of Jerusalem

The Center for Cell and Gene Therapy at Baylor College of Medicine to Present at the Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR 2019

On January 15, 2019 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that data from four abstracts—including three oral presentations—were accepted for presentation at the Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research (ASBMT and CIBMTR) (Press release, TapImmune, JAN 15, 2019, View Source [SID1234532667]). The studies summarize data achieved using multi-tumor antigen specific T cells that were developed at Baylor College of Medicine in the laboratories of Dr. Swati Naik, Dr. Ann Leen, and Dr. Premal Lulla, and exclusively licensed to Marker.

The TCT meetings of ASBMT and CIBMTR 2019 will take place in Houston, TX from February 20-24.

Oral Presentation Details

Presentation Title: "Targeting Lymphomas Using Non-Engineered, Multi-Antigen-Specific T Cells" (Abstract #24)

Session Title: Session C – Lymphoma and Myeloma

Session Date/Time: Wednesday, February 20, 2019, 5:00 p.m. CST

Presentation Title: "Administering Leukemia-Directed Donor Lymphocytes to Patients with AML or MDS to Prevent or Treat Post-Allogeneic HSCT Relapse" (Abstract #11)

Session Title: Session A – Acute and Chronic Leukemia

Session Date/Time: Wednesday, February 20, 2019, 5:45 p.m. CST

Presentation Title: "Adoptive T-Cell Therapy for Acute Lymphoblastic Leukemia Targeting Multiple Tumor-Associated Antigens" (Abstract #78)

Session Title: Session K – Immune and Gene Therapy

Session Date/Time: Saturday, February 23, 2019, 5:00 p.m. CST

Poster Presentation Details

Presentation Title: "Safety and Efficacy of Multiantigen-Targeted T Cells for Multiple Myeloma" (Abstract #621)

Presentation Date/Time: Saturday, February 23, 6:45 p.m. CST