On January 18, 2019 Kyn Therapeutics, a clinical-stage biotechnology company advancing research into new immunometabolic therapies for treating cancer, reported it has entered into a global strategic collaboration with Celgene Corporation (NASDAQ:CELG) (Press release, KYN Therapeutics, JAN 18, 2019, View Source [SID1234532783]). The goal of the collaboration is to develop novel immuno-oncology therapies through uniting Kyn’s immuno-oncology expertise and pipeline with Celgene’s capabilities for developing and commercializing medicines in areas of high unmet medical need. The collaboration begins with an upfront payment and an equity investment by Celgene, which receives exclusive options to license Kyn’s aryl hydrocarbon receptor (AHR) antagonist program and its kynurenine-degrading enzyme ("Kynase") program.

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AHR and kynurenine are associated with immunosuppression in a range of tumor types through multiple cellular metabolic mechanisms that modulate both innate and adaptive immunity. These attributes make them compelling targets for investigative therapies, in particular in patients who do not fully benefit from current treatments like checkpoint inhibitors.

"At Kyn, our team has built a diverse portfolio informed by the most compelling biology in the field of immunometabolism to establish a leadership position in this area of innovative cancer therapy development," said Mark Manfredi, Ph.D., president and chief executive officer of Kyn Therapeutics. "Celgene’s R&D capabilities and focus on groundbreaking biology are a strong strategic fit for Kyn’s programs. As a fast-growing immuno-oncology therapeutics developer, we also welcome Celgene on board as an equity investor and supporter of our R&D strategy and leadership."

"This collaboration signals our continued commitment to work with partners to develop innovative treatments for patients with unmet medical need," said Robert Hershberg, M.D., Ph.D., EVP, head of business development and global alliances for Celgene Corporation.

Under the terms of the agreement, Kyn will receive an upfront cash payment of $80 million and an equity investment from Celgene for exclusive options to globally license the Kynase and AHR antagonist programs. For each program, Kyn is responsible for R&D activities through Phase 1b, at which time Celgene can opt in to lead and fund global development and commercialization of the licensed programs. If successful, Kyn is eligible for substantial clinical, regulatory and commercial milestone payments. Kyn will also receive tiered royalties on worldwide net sales on products resulting from development of the licensed programs.

On January 18, 2019 Obsidian Therapeutics, a biotechnology company developing cell therapies with pharmacologic operating systems, reported a strategic collaboration with Celgene Corporation (NASDAQ: CELG) for the discovery and development of novel, regulated cell therapies that utilize Obsidian’s Destabilizing Domain (DD) technology (Press release, Obsidian Therapeutics, JAN 18, 2019, View Source [SID1234532782]). Specifically, the collaboration is based on Obsidian’s DD technology for the controlled expression of two immunomodulatory factors, IL12 and CD40L, that have the potential to augment the power of adoptive cell therapies but require precise control to optimize their therapeutic benefit.

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This multi-year collaboration provides Celgene with the exclusive option to in-license worldwide rights for cell therapy candidates that incorporate DD-regulated IL12 or CD40L for the treatment of cancer. The collaboration includes an upfront payment and equity investment by Celgene, and potential future milestone and royalty payments.

"Obsidian’s technology has the potential to unlock the activity of cell therapy in a number of new settings, particularly against solid tumor malignancies, and this is a prime example of the new technologies that we see enabling broader applications for CAR-T and cell therapies for the treatment of cancer," said Robert Hershberg, MD, PhD, Executive Vice President, Business Development & Global Alliances for Celgene Corporation. "We value the innovation that the Obsidian team can bring and we look forward to working together to bring powerful new immunotherapies to patients."

This strategic agreement is Obsidian’s first collaboration with a major pharmaceutical company to deploy its DD technology. Obsidian’s technology enables integration and precise pharmacologic control of potent new activities in cell therapies and offers additional capabilities to Celgene’s portfolio of cellular immunotherapies for cancer.

"This collaboration focuses the Obsidian team on product development, accelerates the advance of our innovative technology toward clinical applications, and positions us to expand our own platform and portfolio," said Michael Gilman, PhD, CEO of Obsidian. "We are thrilled to be partnering with Celgene and will benefit from their capabilities in the development and commercialization of cancer medicines. We share an ambitious vision of the potential for cell therapy to benefit patients with cancer and look forward to working together with the Celgene team to realize it."

About Obsidian’s Destabilizing Domain Technology

Obsidian is developing cell therapies that incorporate Destabilizing Domains (DDs) to regulate expression of immunomodulatory factors, thereby providing precise pharmacologic control of the potent activity of these agents to optimize their safety and efficacy in engineered cell therapies. DDs are small, human protein domains that confer conditional stability to a fused payload protein that is engineered into a cell or gene therapy product. In the absence of a specific small-molecule ligand, the fusion protein is rapidly degraded, whereas in the presence of the ligand the fusion protein becomes stable and functional. Obsidian uses this approach to equip engineered cell therapies with controllable functions that can be precisely and dynamically tuned by the administration of small-molecule medicines that are currently approved, readily available, and can be dispensed by the treating physician.

On January 18, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its fourth-quarter and full-year 2018 financial results on Wednesday, Feb. 20, 2019 (Press release, Valeant, JAN 18, 2019, View Source [SID1234532780]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EST to discuss the results and provide a business update . All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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Conference Call Details

Date:

Wednesday, Feb. 20, 2019

Time:

8:00 a.m. EST

Webcast:

View Source

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

4514727

Replay Dial-in:

+1 (877) 344-7529 (North America)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10127646 (replay available until Feb. 27, 2019)

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

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.