On September 3, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that the underwriters of its previously announced public offering of common stock have exercised their option to purchase an additional 1,621,621 shares of the Company’s common stock at a price of $37.00 per share before underwriting discounts (Press release, Deciphera Pharmaceuticals, SEP 3, 2019, View Source [SID1234539240]). The option exercise closed on September 3, 2019. On August 19, 2019, Deciphera announced the closing of its registered underwritten public offering in which 10,810,810 shares of the Company’s common stock at a price to the public of $37.00 per share were issued and sold. The gross proceeds to Deciphera from the offering inclusive of the exercise of the underwriters’ option to purchase additional shares, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $460.0 million.

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J.P. Morgan, Piper Jaffray and Jefferies acted as joint book-running managers for the offering. Guggenheim Securities acted as lead manager for the offering. SunTrust Robinson Humphrey acted as co-manager for the offering.

Deciphera intends to use the net proceeds of the offering to fund: clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trials, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material; Investigational New Drug-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; and working capital purposes, including general operating expenses.

The offering was made only by means of a prospectus supplement and accompanying prospectus forming part of a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on October 12, 2018. The final prospectus supplement and the accompanying prospectus was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does 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.

On September 3, 2019 Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, reported that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s orally administered fixed-dose combination of cedazuridine and decitabine (ASTX727 or C-DEC) for the treatment of myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML) (Press release, Astex Pharmaceuticals, SEP 3, 2019, View Source [SID1234539239]). The designation follows on from the recent announcement that the phase 3 ASCERTAIN study of ASTX727 in adults with intermediate and high-risk MDS or CMML met the primary endpoint of decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and IV decitabine. The data from the study will be presented at an upcoming scientific meeting. The designation provides for seven years of marketing exclusivity in the US following product approval, as well as certain tax incentives and grants.

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"We are delighted that the FDA has granted orphan drug designation for the fixed dose combination of cedazuridine with decitabine," said Mohammad Azab, MD, Astex Pharmaceuticals’ president and chief medical officer. "Subject to regulatory review and approvals, ASTX727 could bring a new treatment option to patients with these deadly diseases. We are extremely grateful to all the patients, caregivers, partner research and manufacturing organizations, as well as the healthcare professionals who contributed to the clinical development program of ASTX727."

ASTX727 is an investigational compound and is not currently approved in any country. Astex plans to file an NDA with the US FDA by the end of 2019.

Astex’s parent company, Otsuka Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd. previously announced that, subject to regulatory approvals, commercialization of ASTX727 in the US and Canada will be conducted by Taiho Oncology, Inc. and Taiho Pharma Canada, Inc. respectively. Astex, Otsuka and Taiho are all members of the Otsuka group of companies.

About Cedazuridine and Decitabine Fixed-Dose Combination (ASTX727)

ASTX727 is a novel, orally administered fixed dose combination of cedazuridine, an inhibitor of cytidine deaminase,1 with the anti-cancer DNA hypomethylating agent, decitabine.2 By inhibiting cytidine deaminase in the gut and the liver, ASTX727 is designed to allow for oral delivery of the approved DNA hypomethylating agent, decitabine, at exposures which emulate exposures achieved with the approved intravenous form of decitabine administered over 5 days.3

ASTX727 has been evaluated in a phase 1/2 pharmacokinetics-guided dose escalation and dose confirmation study in patients with MDS and CMML (see View Source NCT02103478) and a pivotal phase 3 study (ASCERTAIN) (see View Source NCT03306264) conducted at investigator sites in the US and Canada and designed to confirm the results from the phase 1/2 study. The phase 3 study is being extended to include patients with acute myeloid leukemia (AML) unsuitable to receive intensive induction chemotherapy.

The concept of using cedazuridine to block the action of cytidine deaminase is also being evaluated in a low dose formulation of cedazuridine and decitabine for the treatment of lower risk MDS (see View Source NCT03502668).

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. US incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.4,5 The prevalence has been estimated to be from 60,000 to 170,000 in the US.6 MDS may evolve into acute myeloid leukemia (AML) in one-third of patients.7 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML. CMML is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. The incidence of CMML in the US is approximately 1,100 new cases per year,8 and CMML may transform into AML in 15% to 30% of patients.9 The hypomethylating agents decitabine and azacitidine are effective treatment modalities for hematologic cancers and are FDA-approved for the treatment of higher risk MDS and CMML. These agents are administered by IV infusion, or by large-volume subcutaneous injections.

On September 3, 2019 Boehringer Ingelheim and Lupin Limited (Lupin) reported a licensing, development and commercialization agreement for Lupin’s MEK inhibitor compound (LNP3794) as a potential targeted therapy for patients with difficult-to-treat cancers (Press release, Boehringer Ingelheim, SEP 3, 2019, View Source [SID1234539238]). The partnership aims to develop Lupin’s lead MEK inhibitor compound in combination with one of Boehringer Ingelheim’s innovative KRAS inhibitors for patients with gastrointestinal and lung cancers harboring a broad range of oncogenic KRAS mutations.

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"The licensing of Lupin’s novel MEK inhibitor enables us to pair with our innovative KRAS inhibitors to develop new combination treatment concepts providing more effective and durable responses for patients with cancers driven by activated KRAS who currently have limited treatment options available," said Norbert Kraut, Ph.D., Head of Global Cancer Research at Boehringer Ingelheim. "We believe this collaboration will significantly strengthen our KRAS program. We have developed comprehensive approaches to successfully tackle the oncogenic KRAS–RAF–MEK–ERK pathway from the ground up and this partnership is another key building block in our long-term strategy to bring novel treatments to patients in our quest to defeat intractable cancer types."

Commenting on the partnership, Nilesh Gupta, Managing Director, Lupin Limited said, "With the success of our second new drug discovery program in oncology, we have made a significant mark in bringing novel treatments to patients. Lupin’s MEK Inhibitor program successfully cleared early clinical stages, demonstrating our capabilities in delivering world class innovation. We are proud of the achievements of our team and the capabilities we have built which enable us to further our new drug discovery program. We are delighted to partner with Boehringer Ingelheim in developing treatments that will truly benefit patients in need".

Dr. Raj Kamboj, President of Lupin’s Novel Drug Discovery and Development (NDDD) stated, "The success of our second NDDD program in Oncology has added to our confidence in bringing highly differentiated and best-in-class innovation from India for patients globally. Carrying forward our founder, Dr. Desh Bandhu Gupta’s dream in shaping true innovation, we have delivered a novel treatment from conceptualization to clinical stage development with promising results that can be a potential combination treatment for precision oncology."

The collaboration has a strategic goal to focus on patients with gastrointestinal or lung cancers defined by KRAS mutations, sub-populations that currently need more effective therapeutic options. KRAS mutations occur in 1 in 7 of all human metastatic cancers making it the most frequently mutated cancer-causing gene, with mutation rates of more than 90 percent in pancreatic cancers, more than 40 percent in colorectal cancers and more than 30 percent in lung adenocarcinomas. Preclinical data has shown that the combination of Boehringer Ingelheim’s novel KRAS inhibitors with MEK inhibitors results in increased anti-tumor activity based on their complementary mechanisms of action in keeping KRAS-driven cancers in check.

Lupin’s MEK inhibitors developed as part of its oncology pipeline have shown pre-clinical activity as a single agent as well as in combination. Furthermore, they have also shown early clinical benefit in a small subset of patients. Lupin’s Novel Drug Discovery and Development team is focused on building a pipeline of highly differentiated and innovative new chemical entities in the therapeutic areas of oncology, immunology and metabolic disorders. Lupin’s NDDD activities were started with the vision to use cutting-edge research in bringing novel molecules that address unmet medical needs in multiple therapeutic areas to market globally.

Lupin will receive an upfront payment of $20 million and potential additional payments for successful achievement of defined clinical, regulatory and commercial milestones for a total deal value of more than $700 million. Additionally, Lupin will be entitled to receive double-digit royalties on the sales of the product.

On September 3, 2019 Physicians’ Education Resource (PER), a worldwide leading resource for continuing medical education, reported that it will present the 4th Annual International Congress on Immunotherapies in Cancer: Focus on Practice-Changing Application on Saturday, Dec. 14, at the InterContinental New York Times Square in New York City (Press release, Physicians’ Education Resource, SEP 3, 2019, View Source [SID1234539237]).

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The program will be co-chaired by Naiyer A. Rizvi, M.D., professor of medicine; director, thoracic oncology; co-director, cancer immunotherapy program; and the Price Family Professor of Medicine, Columbia University Medical Center; and Mario Sznol, M.D., professor of medicine; leader, melanoma disease related translational team; co-director, YALE SPORE in skin cancer; and co-director, cancer immunology program, Yale Cancer Center.

"We look forward to this year’s International Congress on Immunotherapies in Cancer," said Phil Talamo, president of PER. "This annual educational program brings together oncologists, nurses and pharmacists to highlight the fundamental principles and pivotal advancements within the past year surrounding the evolving role of immunotherapies and their role in cancer treatment."

The 4th Annual International Congress on Immunotherapies in Cancer is a one-day interactive program that will provide attendees with a comprehensive review of the key data sets that are most relevant to the application of these novel strategies for the clinician who manages some of the most difficult-to-treat forms of cancer. Top experts will lead discussions that focus on the practical application of recent clinical trial results that have shaped current and evolving clinical management, evolving biomarker information, the latest basic science findings and the most highly anticipated clinical trials in the field. As an exciting, fast-paced congress, this meeting will provide a multimodule, curriculum-based program that focuses exclusively on immunotherapies and their application to the management of cancer.

On September 3, 2019 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that Geert Kersten, Chief Executive Officer, is scheduled to present at the H.C. Wainwright 21st Annual Global Investor Conference on Tuesday, September 10th at 11:15 a.m. Eastern Time (Press release, Cel-Sci, SEP 3, 2019, View Source [SID1234539236]).

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A live webcast of Mr. Kersten’s presentation will be available in the Investors section of the Company’s website at View Source The webcast will be available for 90 days following the presentation.