On May 27, 2020 Imaging Endpoints reported that it has supported two additional U.S. Food and Drug Administration (FDA) approvals this month for new, life-saving therapies (Press release, Imaging Endpoints, MAY 27, 2020, View Source [SID1234558588]). The two New Drug Application (NDA) approvals, for two of the Company’s pharmaceutical company clients, included indications for adult patients with non-small cell lung cancer (NSCLC), adult and pediatric patients with thyroid cancer, and adult patients with advanced gastrointestinal stromal tumors (GIST).

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Imaging Endpoints serves as the imaging CRO that performed the blinded independent central review of imaging for these new cancer treatments. The large, global clinical trials that supported these approvals included complex imaging requirements, a double read paradigm with real-time reporting, and included imaging within the primary endpoint.

Imaging Endpoints’ robust processes are designed to meet or exceed industry standards. All inspections to date, including inspections in 2018, 2019 and 2020 by FDA and the European Medicines Agency (EMA), have resulted in zero observations, clearly demonstrating the Company’s leadership in quality and compliance.

Doug Dean Burkett, PhD., Chief Executive Officer and President of Imaging Endpoints added: "We are honored to have supported the FDA approval of these two additional life-saving therapeutics as part of our relentless endeavor to Connect Imaging to the CureTM. Our rapid growth and success is the result of our dedication to provide industry-leading expertise, technologies and services through our amazing global team."

On May 27, 2020 Seneca Biopharma, Inc. (Nasdaq:SNCA), a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need, reported the closing of its previously announced $5 million registered direct offering (Press release, Seneca Biopharma, MAY 27, 2020, View Source [SID1234558587]). Pursuant to the terms of the offering, Seneca sold an aggregate of 5 million shares of its common stock at a sales price $1.00 per share. Seneca intends to use the net proceeds from the offering for general working capital.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The shares of common stock are registered pursuant to a registration statement on Form S-3 (File No. 333-218608) which became effective by the Securities and Exchange Commission (SEC) on June 23, 2017. The offering was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On May 27, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported results reported for the first time from a Phase 1 – study (NCT04272944) of MSB2311, an investigational PDL1 targeting antibody with pH dependent and tumor recycling property developed by Transcenta’s subsidiary Mabspace Biosciences (Suzhou) Co., Ltd, in the treatment of Chinese patients with pre-treated advanced solid tumors and select hematological malignancies (Press release, Transcenta, MAY 27, 2020, View Source [SID1234558586]). Initial results suggest a favorable safety profile across all MSB2311 doses evaluated. Investigators reported that patients achieved durable responses which persisted with one durable beyond 12 months at the time of this press release. The data was published as an abstract (Abstract #e15011) in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program.

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The study enrolled Chinese patients with various types of solid tumors who had relapsed or were refractory to established therapies and had not previously been treated with a PD(L)-1 targeting agents. Patients had received at least 2 prior lines of treatment before starting the dose.

"While the treatment of solid tumors with immunotherapy has significantly advanced over recent years, providing patients with alternative agent with deeper response and better tolerability remains critical," said Professor Lin Shen, the lead investigator from Beijing Cancer Hospital. "Initial findings for MSB2311 in this heavily pre-treated population support further study of this investigational tumor recycling immunotherapeutic."

The study was conducted in two parts: dose escalation (part 1) and dose expansion (part 2). Results of the study showed durable responses among patients with solid tumors (n=18) who were treated with MSB2311 across dose groups, ranging from 3 mg/kg-20 mg/kg every three weeks. At the 20 mg/kg dose (n=12), the objective response rate (ORR) was 33 percent (4/12); responses were deep and persisted. At the time of data cut-off, 75 percent (3/4) of patients who achieved a response remained in the study with an ongoing response. Additional dose expansion with alternative dosing regimen at 10 mg/kg every two weeks of the study is ongoing. In addition, 6 patients with hematological malignancy (three T cell lymphoma and three B cell lymphoma) were tested at 20 mg/kg. One of the three T cell lymphoma patients achieved partial response lasting for 6 weeks.

"We are encouraged by the initial response of heavily pre-treated patients with solid tumors to MSB2311," said Jason Huang, M.D., Senior Vice President, Global Head of Clinical Development, Transcenta Holding. "MSB2311 is an example of one of our innovative antibodies where we look to harness our antibody engineering expertise to advance potentially new options for patients."

In the Phase 1 study, no dose limiting toxicity (DLT) was reported and maximum tolerated dose (MTD) has not been identified. The most common treatment emergent adverse events (TEAEs) ( >10%) included anemia, hypothyroidism, hyperglycemia, hypertriglyceridemia, nausea, vomiting, fatigue, malaise, pyrexia and cough.

About MSB2311

MSB2311 is an investigational pH-dependent humanized antibody targeting PDL1. PDL1 is involved in inhibiting the immune system’s response to fight cancer, and PDL1 is expressed at significantly higher levels in tumor cells of people with solid tumors. MSB2311 employs engineered IgG1 which lacks FcR binding. It binds PDL1 on tumor cells and blocks the interaction of PDL1 and PD1, the receptor on T effector cells. In addition, the binding of MSB2311 to PDL1 results in internalization of MSB2311 and MSB2311 can dissociate from bound PDL1 when enter endosome with pH level lower than pH5.5. This allows MSB2311 to recycle to plasma membrane with the help of FcRn and be reused to bind with PDL1 on another tumor cell. Results from preclinical studies demonstrate that MSB2311 can inhibit tumor growth of PDL1 expressing tumor cells in syngeneic mouse-model.

On May 27, 2020 Bold Therapeutics, a clinical-stage biopharmaceutical company, reported it has executed an option agreement with an undisclosed publicly traded company for exclusive rights to BOLD-100 in South Korea (Press release, Bold Therapeutics, MAY 27, 2020, View Source [SID1234558585]). BOLD-100 is a first-in-class anti-resistance ruthenium-based small molecule drug which selectively inhibits stress-induced upregulation of GRP78 – an important resistance, survival and proliferation pathway common across cancers. Under the terms of the agreement, Bold Therapeutics and its new partner will collaborate on Bold Therapeutics’ upcoming Phase 1b / 2a adaptive trial in gastric, pancreatic, colorectal and bile duct (cholangiocarinoma) cancers – and explore the potential development of BOLD-100 in triple-negative breast cancer (TNBC).

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"I am pleased to partner with one of the fastest growing and most successful pharmaceutical companies in South Korea on the development of BOLD-100. This collaboration allows us to leverage our partner’s significant oncology development and commercialization expertise in South Korea to accelerate development of BOLD-100," stated E. Russell McAllister, CEO of Bold Therapeutics. "Under this collaboration, we expect to both add clinical sites in South Korea to our planned Phase 1b / 2a adaptive trial by early 2021, potentially accelerating enrollment and the resulting timing of interim efficacy data, as well as add triple-negative breast cancer (TNBC), an indication where our partner has significant expertise, as a potential development indication – the first of many win-win partnerships."

Jim Pankovich, EVP of Clinical Development at Bold Therapeutics, added, "The quality of clinical data from South Korea is viewed favorably throughout the world. This promising partnership speaks to BOLD-100’s remarkable potential and allows us to generate data in an Asian population earlier than would otherwise have been possible. I look forward to working with our new clinical and regulatory colleagues in the coming weeks."

On May 27, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that it intends to offer and sell, in an underwritten public offering and subject to market and other conditions, $250,000,000 of its common stock (Press release, Arena Pharmaceuticals, MAY 27, 2020, View Source [SID1234558584]). All of the shares are being offered by Arena . In addition, Arena intends to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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BofA Securities, Citigroup and SVB Leerink are acting as the joint book-running managers for the offering. Credit Suisse and Cantor are also acting as book-running managers for the offering. JMP Securities and Needham & Company are acting as co-managers for the offering.

The shares of common stock described above are being offered by Arena pursuant to a shelf registration statement filed by Arena with the Securities and Exchange Commission (SEC) that became automatically effective on February 27, 2020. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus related to this offering, when available, may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or from Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or from SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.