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Stemline Therapeutics to Present at the 38th Annual J.P. Morgan Healthcare Conference

On January 8, 2020 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that management will present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 9:30 AM PT at the Westin St. Francis Hotel in San Francisco, CA (Press release, Stemline Therapeutics, JAN 8, 2020, View Source [SID1234552935]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

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

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

Vertex to Present at the J.P. Morgan Healthcare Conference on January 13

On January 8, 2020 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the J.P. Morgan Healthcare Conference on Monday, January 13, 2020 at 2:30 p.m. ET (11:30 a.m. PT) (Press release, Vertex Pharmaceuticals, JAN 8, 2020, View Source [SID1234552934]).

The audio portion of management’s remarks can be accessed live through Vertex’s website, www.vrtx.com, in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

Kitov Pharma Announces Closing of FameWave Acquisition

On January 8, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported the closing of its previously announced acquisition of privately-held, FameWave Ltd (Press release, Kitov Pharmaceuticals , JAN 8, 2020, View Source [SID1234552926]). The acquisition adds CM-24, a first-in-class inhibitor with a unique and differentiated mechanism of action of a multi-role immune checkpoint inhibition, to Kitov’s oncology pipeline. CM-24 has demonstrated a favorable safety and tolerability profile and an initial signal of monotherapy efficacy in a phase 1 clinical study. As previously announced, Kitov, in collaboration with Bristol-Myers Squibb Company, intends to initiate a phase 1b/2a clinical trial of CM-24 in combination with Bristol-Myers Squibb’s nivolumab (Opdivo) in patients with non-small cell lung cancer in the second half of 2020.

Kitov has acquired 100% of FameWave from its shareholders in exchange for $10 million worth of Kitov’s newly issued ADSs with a long-term lock-up period, priced at $1.23 per ADS, plus 50% warrant coverage based on an exercise price of $1.98 per ADS with a 4-year term. Under the terms of the agreement, OrbiMed, Pontifax and Arkin Holdings, leading life-science focused investment funds, are exchanging their shares in FameWave for Kitov ADSs and warrants, and investing $3.5 million in Kitov in exchange for additional newly issued ADSs of Kitov. OrbiMed, Pontifax and Arkin Holdings will now each hold approximately 11% of Kitov’s shares on a non-diluted basis.

"The closing of the FameWave acquisition and the addition of CM-24 to our emerging oncology pipeline is a significant milestone for our company and seamlessly aligns with our strategic focus on the development of differentiated oncology product candidates," said Isaac Israel CEO of Kitov Pharma.

"CM-24 demonstrated encouraging signs of monotherapy anti-tumor activity in a successfully completed phase 1 trial, in addition to preclinical data that showed CM-24’s synergistic benefit with anti-PD(L)1s. This product candidate is an exciting addition to our pipeline, and we will concurrently continue to focus on advancing NT-219, our novel dual inhibitor of IRS 1/2 and STAT3, into a phase 1/2 trial for the treatment of recurrent or metastatic head and neck cancer, which we expect to commence in 2020. In addition to acquiring this promising asset, this transaction also further strengthens our leadership team and product development capabilities, as we welcome Dr. Michael Schickler, FameWave’s CEO and pharmaceutical industry veteran, to Kitov."

Dr. Schickler will join Kitov Pharma as the Head of Clinical Operations and will lead the clinical development of CM-24 and NT-219. "The initial clinical development work with the CM-24 program has suggested the antibody’s potential in overcoming the immune system exhaustion that mitigates the effectiveness and therapeutic duration of approved checkpoint inhibitors, and I am thrilled with Kitov’s commitment to advancing its development," said Dr. Schickler. "With manufacturing of the antibody well underway and having collaborated with Bristol-Myers Squibb on the phase 1/2 protocol, I look forward to the anticipated initiation of this study in the second half 2020."

This communication does not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The securities of Kitov will be issued to the selling shareholders in FameWave, and to the investors in the cash investment transaction, on a private placement basis pursuant to applicable exemptions from the prospectus requirements under applicable Israeli securities laws and from the registration requirements of the United States Securities Act of 1933, as amended (the "U.S. Securities Act"). The securities offered have not been registered under the U.S. Securities Act or any U.S. state or Israeli securities laws, and may not be offered or sold in the United States or in Israel, or to, or for the account or benefit of, United States persons or persons in Israel absent registration or any applicable exemption from the registration and/or prospectus requirements of the U.S. Securities Act and applicable U.S. state and/or Israeli securities laws.

About CM-24
CM-24 is a clinical-stage monoclonal antibody blocking CEACAM1, a well-validated target which is highly expressed in many solid tumors as well as on immune cells and plays a pivotal role in the immune system by blocking immune cells’ access to tumors by CEACAM1-CEACAM1 and CEACAM1-CEACAM5 interaction. CEACAM1 was also shown to regulate TIM3 which induce immune fatigue. This unique mechanism of action positions CM-24 with a differentiated inhibitor of a multi-role immune checkpoint. In a monotherapy phase 1 study, CM-24 demonstrated safety and efficacy with standard dose in about 30% of patients.

Sutro Biopharma to Present at 38th Annual J.P. Morgan Healthcare Conference

On January 8, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that the company will present at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, Jan. 16, 2020, at 9:00 AM PST at the Westin St. Francis in San Francisco (Press release, Sutro Biopharma, JAN 8, 2020, View Source [SID1234552904]).

A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.sutrobio.com. A replay of the webcast will be available for approximately 30 days following the event.

Targovax and IOVaxis Therapeutics Enters Option Agreement for TG Mutant RAS Vaccine License and Clinical Development in China

On January 8, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses and cancer vaccines to target hard-to-treat solid tumors, reported that it has entered into an exclusive option agreement with IOVaxis Therapeutics of Nantong, China, for clinical development and licensing of the Targovax mutant RAS vaccines TG01 and TG02 in China, Hong Kong, Macau and Singapore (Press release, Targovax, JAN 8, 2020, View Source [SID1234552888]).

IOVaxis, a spin-off from ImmuOn Therapeutics, has secured an exclusive option to develop and license the TG01 and TG02 mutant RAS neoantigen vaccines in the above mentioned territories. The option can be exercised into an exclusive license by the earlier of i) the first regulatory approval to start a clinical trial in the territory, or ii) one year from the effective date of the Option Agreement. IOVaxis will pay Targovax USD 250.000 for this exclusive option. The milestone payment for the exercise of the option to license TG01/02 is USD 3 million.

Under the Option Agreement, IOVaxis and Targovax will jointly define a development plan in the territory, and IOVaxis will be responsible for all local regulatory filings and be the sponsor of clinical trials. The full License Agreement remains to be finalized, but the parties have pre-agreed the key commercial and operational terms in the Option Agreement. If exercised, the total potential development and commercial milestones for the TG01/02 license may reach up to USD 100 million, plus tiered royalties on net sales up to mid double digits.