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]).

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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.

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.

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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.

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]).

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"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.

On June 8, 2021 Deepcell, a life science company pioneering AI-powered cell classification and isolation for cell biology and translational research, reported a collaboration with Dr. Jianyu Rao, MD, a vice chair of the department of pathology and chief of cytopathology at the University of California at Los Angeles (UCLA), to advance cancer research through an innovative approach to studying cytology samples (Press release, University of California at Los Angeles, JUN 8, 2021, View Source [SID1234583723]).

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The collaboration with Dr. Rao and his team of researchers is focused on using Deepcell’s AI-powered platform to identify and sort cancer cells from clinical cytology samples of body fluids (e.g. ascitic or pleural fluid) based entirely on morphological distinctions ‒ or the visual features of cells ‒ rather than on labeling or using biomarkers. This collaboration aims to enable increased accuracy of cell classification and deliver intact cells for molecular analysis. Deepcell’s platform for cell analysis includes a microfluidic-based imaging, real-time sorting system, powered by deep learning. The collaboration allows Deepcell to continue to expand their Cell Morphology Atlas and to demonstrate the performance of the platform.

"Cytologic analysis on a self-learning AI platform for cancer research could lead to a better understanding of the biology of malignant cells and contribute to future diagnosis and improved patient outcomes," said Dr. Rao, who is an internationally renowned cytopathologist and the director of Cytopathology, the director of gynecological pathology, and the medical director of the cytotechnology school. "Before Deepcell, cell morphology was limited by human interpretation and a lack of adequate tools for capturing and studying abnormal cells. Through the combination of AI, microfluidics, and single-cell analysis, the Deepcell platform provides a new way of understanding these cells."

This collaboration is the first to be announced as part of Deepcell’s new collaboration program with scientific researchers and medical experts. This initiative is designed to form a series of partnerships that will unlock the potential of single-cell, morphology-based sorting and analysis. The goals of the program are to demonstrate the performance of the Deepcell platform, continue to expand a unique Cell Morphology Atlas for the benefit of the scientific and medical communities, and co-develop AI models for specific applications.

"The launch of Deepcell’s collaboration program formalizes our engagement with leaders across basic and translational research and opens up a new phase for Deepcell," said Maddison Masaeli, Co-founder and CEO of Deepcell. "It is by focusing on the science and making Dr. Rao and future collaborators successful in their particular field that we will realize our vision to create a new lexicon for single cell morphology, paving the path that connects the genome to the patient."

Deepcell was spun out of Stanford in 2017 to re-invent single cell analysis by creating a new quantitative dimension of cell morphology. Since then, the company has developed its AI-powered technology to characterize, identify and sort cells relying solely on cell morphology.

Deepcell’s technology is able to differentiate among cell types with a novel approach compared to traditional cell isolation techniques that rely on antibody staining or similar methods. Unlike other approaches, Deepcell’s technology was developed to profile samples, and isolate and collect label-free cells of any type, keeping the cell intact for downstream biological characterization. The technology combines advances in AI, cell capture, and single-cell analysis to identify and sort cells based on detailed visual features.

For more information about Deepcell or future collaborations with Deepcell, go to www.deepcell.com.

On June 8, 2021 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, reported its partnership with GenScript ProBio, the biopharmaceutical contract research organization (CRO) and contract development and manufacturing organization (CDMO) segment of the global biotechnology company, GenScript, Inc., for assistance in the advertisement and distribution of Calidi’s proprietary technology platform: SuperNova-1 (SNV-1) (Press release, Calidi Biotherapeutics, JUN 8, 2021, View Source [SID1234583722]). The SNV-1 platform is composed of allogeneic, adipose-derived mesenchymal stem cells (AD-MSC) loaded with an oncolytic agent such as the vaccinia virus. Calidi’s research has shown the potential ability of the SNV-1 platform to shield the viral payload from the immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses.

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"SuperNova-1 is the culmination of Calidi’s years of research into the powerful capabilities of stem cells as a delivery and potentiation platform for oncolytic viruses," said Allan J. Camaisa, CEO and Chairman of Calidi Biotherapeutics. "We look forward to seeing this partnership with GenScript ProBio increase distribution of our enhanced oncolytic virotherapy delivery technology for potential therapeutic treatments of multiple cancer indications."

GenScript ProBio will promote SNV-1 to current, prospective, and future clients or third parties who may benefit from the product—in addition to negotiating potential manufacturing and licensing agreements with interested parties.

"The SuperNova-1 product indicates exciting potential for the future of cancer treatment," said Brian Hosung Min, CEO of GenScript ProBio. "With our expertise in global sales and distribution organization, this partnership is well-poised to generate global growth around Calidi’s revolutionary technology."

GenScript ProBio will pay Calidi a low double-digit percentage of the net revenue produced by its SNV-1 manufacturing services per the agreement reached.