On May 16, 2019 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported the results of the effect of STP705 on the growth of HuCCt-1 (a human cholangiocarcinoma cell line) as a xenograft tumor in nude mice (Press release, Sirnaomics, MAY 16, 2019, View Source [SID1234536452]). The work is published as an online abstract at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Abstract Title: Effect on tumor growth by TGF-β1/COX-2 siRNA combination product (STP705) in a human cholangiocarcinoma (HuCCT-1) xenograft tumor model in nude mice

Cholangiocarcinoma (CCA) is the second most common form of incurable hepatobiliary cancer and represents a massive health care burden worldwide with no effective treatment. Over expression of the genes for TGF-β1 and COX-2 have been well-characterized as playing key roles in tumorigenesis of CCA. STP705 consists of a combination of 2 siRNAs silencing the TGF-β1 and COX-2 genes delivered using a polypeptide nanoparticle delivery system based on Histidine-Lysine co-Polymer (HKP). We have demonstrated that STP705 inhibits the growth of HuCCt-1 xenograft tumors in nude mice (a human cholangiocarcinoma model) and the data is presented in the abstract.

On May 16, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it has entered into definitive agreements with institutional investors to purchase approximately $5.0 million in a registered direct offering of 1,982,000 common shares and approximately $5.0 million in a concurrent private placement of 2,018,000 common shares (Press release, Cellectar Biosciences, MAY 16, 2019, View Source [SID1234536405]). In conjunction with the offerings the company issued 4,000,000 unregistered warrants to purchase common stock.

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The offerings are expected to result in total gross proceeds of $10.0 million before deducting estimated offering expenses. The company intends to use the net proceeds from the offering for research and development, funding clinical studies, working capital and general corporate purposes. The shares of common stock and warrants were priced at $2.50 per fixed combination. The warrants sold in the private placement will be exercisable immediately, expire five years after the date of issuance, and have an exercise price of $2.40.

Roth Capital Partners served as sole placement agent for the transaction. The offering is expected to close on May 20, 2019, subject to customary closing conditions.

The registered offering described above is being made pursuant to a Registration Statement previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). Copies of the prospectus supplement and accompanying base prospectus relating to the registered offering may be obtained, when available, from Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

The unregistered common shares and warrants were offered pursuant to the exemption from registration afforded by Section 4(a)(2) under the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder. Such common shares, warrants and common shares issuable upon exercise of such warrants 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. The Company has agreed to file a registration statement registering for resale the unregistered common shares and common shares issuable upon exercise of the warrants within fifteen days of today’s date.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 May 16, 2019 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that five abstracts relating to selinexor, the Company’s first in class, oral SINE compound, will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2019 Annual Meeting taking place June 13-16, 2019 in Amsterdam (Press release, Karyopharm, MAY 16, 2019, View Source [SID1234536421]). The first abstract, which was selected for an oral presentation, will highlight updated data from the Phase 1b/2 STOMP study arm evaluating selinexor and dexamethasone in combination with Darzalex (daratumumab) in patients with relapsed or refractory multiple myeloma. Two abstracts selected for poster presentations will feature new and updated data, respectively, from the STOMP arms evaluating selinexor and dexamethasone in combination with Kyprolis (carfilzomib) or Pomalyst (pomalidomide) in patients with relapsed or refractory multiple myeloma.

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Two additional abstracts will also be presented regarding selinexor in acute myeloid leukemia (AML). One is an oral presentation which describes data from a Phase 2 study evaluating selinexor in combination with cytarabine and idarubicin in patients with relapsed or refractory AML, and the other is a poster that summarizes clinical data from the Phase 2 SOPRA study evaluating single-agent selinexor in patients with relapsed or refractory AML. As reported previously by Karyopharm in 2017, the SOPRA study did not meet its pre-specified primary endpoint.

"The Phase 1b/2 STOMP study continues to generate encouraging efficacy and safety data from multiple ongoing arms evaluating once weekly oral selinexor and dexamethasone in combination with the standard approved myeloma therapies," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "Of note, at EHA (Free EHA Whitepaper) this year, we will be presenting new data from the STOMP arm evaluating selinexor and dexamethasone in combination with the proteasome inhibitor Kyprolis as well as updated data from both the Darzalex and Pomalyst arms. There remains a growing need for new therapies, especially ones with novel mechanisms, for myeloma patients whose disease progresses despite treatment with currently available combination regimens. As such, the aim of the STOMP study is to establish that selinexor holds the potential to be a safe and effective backbone combination therapy option for patients with multiple myeloma."

Updated STOMP data from what appears in the abstracts will be presented at this meeting.

Details for the EHA (Free EHA Whitepaper) 2019 presentations are as follows:

Oral Presentations

Title: Safety and Efficacy of combination of Selinexor, Daratumumab, and Dexamethasone (SDd) in Patients with Multiple Myeloma (MM) Previously Exposed to Proteasome Inhibitors and Immunomodulatory Drugs
Lead author:Cristina Gasparetto, Duke University Cancer Center
Abstract #: S1606
Session: Myeloma and other monoclonal gammopathies – Clinical
Date and Time:Sunday, June 16, 2019; 09:00 – 09:15 CEST
Location: Auditorium

Title: A Phase 2 Study of Selinexor Plus Cytarabine and Idarubicin in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML)
Lead author:Walter Fiedler, Hubertus Wald University Cancer Center Hamburg
Abstract #: S880
Session: Acute myeloid leukemia – Clinical
Date and Time:Saturday, June 15, 2019; 17:00 – 17:15 CEST
Location: Elicium 2

Poster Presentations

Title: Selinexor, Pomalidomide, and Dexamethasone (SPd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Lead author:Christina Chen, Princess Margaret Cancer Center
Abstract #: PF587
Session: Myeloma and other monoclonal gammopathies – Clinical
Date and Time:Friday, June 14, 2019; 17:30 – 19:00 CEST
Location: Poster Area

Title: A Randomized, Open-Label, Phase II Study of Selinexor Versus Physician’s Choice (PC) In Older Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Lead author:Kendra Sweet, Moffitt Cancer Center
Abstract #: PF261
Session: Acute myeloid leukemia – Clinical
Date and Time:Friday, June 14, 2019; 17:30 – 19:00 CEST
Location: Poster Area

Title: A Phase 1b/2 Study of Selinexor, Carfilzomib, and Dexamethasone (SKd) in Relapsed/ Refractory Multiple Myeloma (RRMM)
Lead author:Cristina Gasparetto, Duke University Cancer Center
Abstract #: PS1414
Session: Myeloma and other monoclonal gammopathies – Clinical
Date and Time:Saturday, June 15, 2019; 17:30 – 19:00 CEST
Location: Poster Area

About Selinexor

Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. In 2018, Karyopharm reported positive data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with triple class refractory multiple myeloma who have been previously exposed to all five of the most commonly prescribed anti-myeloma therapies currently available. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm’s New Drug Application (NDA) has been accepted for filing and granted Priority Review by the FDA, and oral selinexor is currently under review by the FDA as a possible new treatment for patients with triple class refractory multiple myeloma. The Company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval. Selinexor is also being studied in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In 2018, Karyopharm reported positive top-line results from the Phase 2b SADAL study evaluating selinexor in patients with relapsed or refractory DLBCL after at least two prior multi-agent therapies and who are ineligible for transplantation, including high dose chemotherapy with stem cell rescue. Selinexor has received Fast Track designation from the FDA for the patient population evaluated in the SADAL study. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On May 16, 2019 DURECT Corporation (Nasdaq: DRRX) reported that James E. Brown, Chief Executive Officer, and Michael H. Arenberg, Chief Financial Officer, will be participating in the 20th Annual B. Riley FBR Institutional Investor Conference, taking place at the Beverly Hilton Hotel, Beverly Hills, CA May 22-23 (Press release, DURECT, MAY 16, 2019, View Source [SID1234536453]).

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B. Riley FBR Institutional Investor Conference

Presentation Date:

Wednesday, May 22, 2019

Presentation Time:

8:30am PDT

Location:

Beverly Hilton Hotel, Beverly Hills, CA

Webcast:

View Source

The live audio webcast of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking on the "Investors" tab. If you are unable to participate during the live webcast, the call will be archived on DURECT’s website in the "Event Calendar" of the "Investors" section.

On May 16, 2019 Wellspring Biosciences, Inc., a wholly owned subsidiary of Araxes Pharma, LLC, reported that the U.S. Food and Drug Administration has cleared an investigational new drug (IND) application for ARS-3248, a small molecule KRAS G12C inhibitor (Press release, Wellspring Biosciences, MAY 16, 2019, View Source [SID1234537540]). ARS-3248 was discovered as part of an exclusive drug discovery and development agreement with Janssen Biotech, Inc, which will conduct the Phase 1 trial and have sole responsibility for clinical development.

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"Although KRAS was considered an undruggable target when we initiated this program in 2012, Wellspring scientists have shown considerable progress in being the first to demonstrate that direct and covalent inhibitors can specifically induce tumor regression in mouse tumor models harboring the mutation," said Yi Liu, Ph.D., Chief Scientific Officer of Wellspring Biosciences. "ARS-3248 represents the culmination of a significant and highly productive collaboration between scientists at Wellspring and Janssen, building upon the learnings of previous tool compounds. As we continue to advance this optimized clinical candidate that holds the potential to provide meaningful benefit to patients, we look forward to supporting Janssen as they evaluate the potential of ARS-3248 in patients with KRAS G12C-positive cancers."

About ARS-3248

ARS-3248 is an investigational, orally available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 12 percent of non-small cell lung cancer patients, as well as subsets of patients in other tumor types, such as those with colorectal and pancreatic cancers. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. ARS-3248 will be evaluated in a Phase 1 trial of patients with molecularly identified KRAS G12C-positive advanced solid tumors.