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FDA Grants Coordination Pharmaceuticals IND Approval for CPI-300, a Novel Antitumor Nanomedicine

On June 8, 2021 Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 clinical study of CPI-300 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, JUN 8, 2021, View Source [SID1234583729]).

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By leveraging CPI’s proprietary nanoscale coordination polymer (NCP) platform, CPI-300 selectively delivers two potent new chemical entities (NCEs) to tumors to achieve maximal antitumor efficacy. In preclinical studies, CPI-300 elicited prolonged tumor regression in multiple tumor models without any sign of hematological toxicities.

"FDA’s timely acceptance and approval of CPI-300 IND is an important milestone for the company. We are excited about the opportunity to study this NCP-based candidate in clinical trials," said Wenbin Lin, PhD, founder and chairman of CPI and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We anticipate that this study will generate important insights into the safety of CPI-300 and its preliminary therapeutic efficacy in cancer patients."

In addition, CPI is also conducting Phase 1 studies of CPI-100 and RiMO-301 on patients with advanced tumors. CPI-100 contains two synergistic NCEs for the activation of tumor-immune microenvironments, while RiMO-301 enhances antitumor effects of X-rays via a novel radiotherapy-radiodynamic therapy mode of action.

About the Studies

The Phase 1 study is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. The primary objectives in the study include determining maximum tolerated dose (MTD), pharmacokinetics and preliminary antitumor activity of CPI-300. For additional clinical trial details, please refer to View Source;draw=2&rank=1.

For CPI-100 Phase I study: View Source;rank=1.

For RiMO-301 Phase I study: View Source;rank=1.

Thermo Fisher Scientific to Present at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021

On June 8, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Marc N. Casper, chairman, president and chief executive officer, will present virtually at the Goldman Sachs 42nd Annual Global Healthcare Conference on Thursday, June 10, 2021 at 9:40 a.m. (EDT) (Press release, Thermo Fisher Scientific, JUN 8, 2021, View Source [SID1234583728]).

You can access the webcast of the presentation via the Investors section of our website, www.thermofisher.com.

Antengene’s Partner Karyopharm Therapeutics Announces Updated Data of Eltanexor in Patients with Hypomethylating Agent Refractory MDS

On June 8, 2021 Antengene’s Partner, Karyopharm Therapeutics Inc. (Nasdaq: KPTI), reported that updated data of eltanexor for the treatment of patients with hypomethylating agent (HMA) refractory myelodysplastic syndrome (MDS) at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Karyopharm, JUN 8, 2021, View Source [SID1234583727]).

This Phase I/II study evaluated single-agent eltanexor in patients with higher-risk MDS, ie, high-risk or intermediate-2 MDS by the International Prognostic Scoring System (IPSS) and 5%-19% myeloblasts. The patients enrolled in the trial were evaluated with eltanexor at the two daily doses of 10 mg (n=5) or 20 mg (n=10) for 5 days per week of a 28-day cycle.

Out of the 20 patients enrolled, 15 patients were evaluable for efficacy and constitute the population studied in this analysis. Of the 15 patients evaluable for efficacy, 7 (47%) had marrow complete response (mCR) and 5 (33%) had stable disease (SD) for a total disease control rate (DCR, mCR+SD) of 80% (60% for all patients’ analysis). In the 10 mg cohort (n=5), all patients derived clinical benefit with 3 patients (60%) reaching mCR and 2 patients (40%) reaching SD. In the 20 mg cohort (n=10), 4 patients (40%) had mCR and 3 (30%) had SD. Four patients had hematologic improvement (HI) and became transfusion-independent for at least 8 weeks including 2 patients with tri-lineage HI. The overall survival (OS) for patients who reached mCR (n=7) was significantly longer than that for patients who did not reach mCR (n=8): median 11.86 vs 8.67 months (hazard ratio [HR]=0.27, p=0.05), and significantly longer than the OS for patients with progression disease (PD, n=3, mOS=3.15 mo, HR=0.23, p=0.04). Patients with disease control (n=12) had numerically longer median overall survival (mOS) than patients with PD (9.86 vs 3.15 mo, HR=0.38, p=0.09). Patients with HI had a mOS of 10.58 months.

Patients with MDS refractory to HMAs have limited therapeutic options and a dismal prognosis with a median overall survival (mOS) of 4-6 months. Eltanexor is a next-generation, oral XPO1 inhibitor that showed anti-tumor activity and lower central nervous system penetration compared to selinexor, the first-in-class XPO1 inhibitor, in nonclinical models. It was hypothesized that eltanexor could be dosed more frequently than selinexor with a lower incidence of centrally mediated nausea.

Antengene has entered into a strategic collaboration with Karyopharm, through which it obtained the rights to develop and commercialize four drug candidates including eltanexor in 17 Asia Pacific markets. Antengene is currently conducting clinical trials of eltanexor in patients with MDS or advanced solid tumors in China. Of these, the Phase I/II trial of eltanexor for the treatment of MDS (the HATCH trial) has already dosed its first patient.

About Eltanexor (ATG-016)

Eltanexor is a next-generation selective inhibitor of nuclear export (SINE) compound. In preclinical models, compared to the first-generation SINE compound, eltanexor demonstrated lower blood-brain barrier penetration and broader therapeutic window which allows more frequent dosing and a longer period of exposure at higher levels with better tolerability. Therefore, eltanexor may be used to target a broader range of indications.

CEL-SCI Announces Bought Deal Offering

On June 8, 2021 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that it has entered into an underwriting agreement with Kingswood Capital Markets, division of Benchmark Investments, LLC under which the underwriter has agreed to purchase on a firm commitment basis a minimum of 1,000,000 shares of common stock of the Company, at a price to the public of $22.62 per share (the "Public Price"), representing a 5% discount to the Company’s June 8, 2021 closing share price (Press release, Cel-Sci, JUN 8, 2021, View Source [SID1234583726]). The closing of the offering is expected to occur on or about June 11, 2021, subject to customary closing conditions.

Kingswood Capital Markets, division of Benchmark Investments, LLC is acting as sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to 15% of the offering at the Public Price. The use of proceeds will be to fund the continued development of Multikine*, LEAPS and for other general corporate purposes.

The shares of common stock described above are being offered by CEL-SCI pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226558) filed with the Securities and Exchange Commission (SEC) and the accompanying prospectus contained therein. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained on the SEC’s website at View Source or by contacting Kingswood Capital Markets, Attention: Syndicate Desk, 590 Madison Avenue, 39th Floor, New York, NY 10022, by email at [email protected], or by telephone at (212) 404-7002.

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.

SHINE Medical announces irradiation agreement with MURR, will exhibit at SNMMI 2021 Virtual Annual Meeting

On June 8, 2021 SHINE Medical Technologies LLC reported that it has entered a multi-year contract with the University of Missouri Research Reactor, or MURR, for irradiation of ytterbium-176, the starting material for the production of lutetium-177 (Lu-177), a therapeutic isotope showing great promise for improving patient outcomes for a range of cancers (Press release, Shine Medical Technologies, JUN 8, 2021, View Source [SID1234583724]).

"MURR’s experienced team and reliable reactor make its irradiation services invaluable to SHINE as we commercialize our Lu-177," said Katrina Pitas, vice president and general manager of SHINE Therapeutics. "MURR’s high neutron flux will help us produce all the non-carrier-added Lu-177 we need to serve our rapidly growing customer base, treating a wide variety of cancers."

MURR is located on the campus of the University of Missouri at Columbia.

"The MURR team looks forward to serving SHINE as it commercializes Lu-177," said Ken Brooks, associate director for business development at the MU Research Reactor. "For more than 50 years, MURR has served researchers and industry partners around the world."

Lu-177 is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule. Energy from Lu-177 only travels a short distance once it reaches cancer cells, enabling the isotope to destroy those cells with little damage to surrounding tissue. Lu-177-based therapy is approved by the U.S. Food and Drug Administration for the treatment of neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate, breast, liver, brain and other cancers.

"The need for more effective cancer treatments continues to grow, particularly for those patients with metastatic or late-stage cancers," said Greg Piefer, SHINE’s founder and CEO. "We can help provide hope to those patients with a highly precise treatment that produces little damage in the tissue around the treatment site. SHINE expects to play a significant role in ensuring that patients around the world have access to Lu-177."

SHINE will host a booth in the SNMMI 2021 Virtual Exhibit Hall. The exhibit hall will be open June 11-15 as part of SNMMI’s Annual Meeting. The company will highlight its lutetium-177 product and progress on the commercialization of molybdenum-99.