CEL-SCI Prices $5.5 Million Underwritten Public Offering of Common Stock

On December 24, 2019 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $5.5 million before deducting underwriting discounts and other estimated offering expenses (Press release, Cel-Sci, DEC 24, 2019, View Source [SID1234552602]). The proposed offering equates to 606,395 shares of the Company’s common stock at a price of $9.07 per share. The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, LEAPS and for other general corporate purposes.

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The Company has also granted the underwriters a 45-day option to purchase up to 90,959 additional shares of common stock to cover over-allotments at the public offering price. The offering is expected to close on or about December 27, 2019, subject to customary closing conditions.

Aegis Capital Corp. is acting as sole bookrunner for the offering. This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-226558) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 24, 2018. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source

Electronic copies of the final prospectus supplement and the accompanying prospectus, when available, may be obtained by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall 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.

Researchers identify immune-suppressing target in glioblastoma

On December 23, 2019 Researchers at The University of Texas MD Anderson Cancer Center reported that have identified a tenacious subset of immune macrophages that thwart treatment of glioblastoma with anti-PD-1 checkpoint blockade, elevating a new potential target for treating the almost uniformly lethal brain tumor (Press release, MD Anderson, DEC 23, 2019, View Source [SID1234553318]).

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Their findings, reported in Nature Medicine, identify macrophages that express high levels of CD73, a surface enzyme that’s a vital piece of an immunosuppressive molecular pathway. The strong presence of the CD73 macrophages was unique to glioblastoma among five tumor types analyzed by the researchers.

"By studying the immune microenvironments across tumor types, we’ve identified a rational combination therapy for glioblastoma," says first author Sangeeta Goswami, M.D., Ph.D., assistant professor of Genitourinary Medical Oncology.

Glioblastoma immunotherapy clinical trial planned

After establishing the cells’ presence in human tumors and correlating them with decreased survival, the researchers took their hypothesis to a mouse model of glioblastoma. They found combining anti-PD-1 and anti-CTLA-4 immunotherapies in CD73 knockout mice stifled tumor growth and increased survival.

"We’re working with pharmaceutical companies that are developing agents to target CD73 to move forward with a glioblastoma clinical trial in combination with anti-PD-1 and anti-CTLA-4 checkpoint inhibitors," says Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology.

Sharma and colleagues take an approach they call reverse translation. Instead of developing hypotheses through cell line and animal model experiments that are then translated to human clinical trials, the team starts by analyzing human tumors to generate hypotheses for testing in the lab in hopes of then taking findings to human clinical trials.

To more effectively extend immunotherapy to more cancers, Sharma says, researchers need to realize immune microenvironments differ from cancer to cancer. "Understanding what’s different in immune niches across cancers provides clues and targets for treating tumors," Sharma says. "That’s why we did this study."

The team tracked down the population of CD73-positive macrophages through a project to characterize immune cells found in five tumor types using CyTOF mass cytometry and single-cell RNA sequencing. They analyzed 94 human tumors across glioblastoma, non-small cell lung cancer and kidney, prostate and colorectal cancers to characterize clusters of immune cells.

CD73 cells associated with shorter survival

The most surprising finding was a metacluster of immune cells found predominantly among the 13 glioblastoma tumors. Cells in the cluster expressed CD68, a marker for macrophages, immune system cells that either aid or suppress immune response. The CD68 metacluster also expressed high levels of CD73 as well as other immune-inhibiting molecules. The team confirmed these findings in nine additional glioblastomas.

Single-cell RNA sequencing identified an immunosuppressive gene expression signature associated with the high-CD73-expressing macrophages. A refined gene signature for the cells was evaluated against 525 glioblastoma samples from The Cancer Genome Atlas and was correlated with decreased survival.

The team conducted CyTOF mass cytometry cluster analysis on five glioblastoma tumors treated with the PD-1 checkpoint inhibitor pembrolizumab and seven untreated tumors. They identified three CD73-expressing macrophage clusters that persisted despite pembrolizumab treatment.

Sharma and colleagues note the prevalence of CD73-expressing macrophages likely contributed to lack of tumor-killing T cell responses and poor clinical outcome.

Combination extends survival in mice

A mouse model of glioblastoma showed that knocking out CD73 alone slowed tumor growth and increased survival.

The team treated mice with either PD-1 inhibitors or a combination of PD-1 and CTLA-4 immune checkpoint inhibitors. Mice with intact CD73 treated with the combination had increased survival over untreated mice, while mice with CD73 knocked out lived even longer after combination therapy. There was no survival benefit from anti-PD-1 alone.

"Based on our data and earlier studies, we propose a combination therapy strategy to target CD73 plus dual blockade of PD-1 and CTLA-4," the team concludes in the paper, noting that anti-CD73 antibodies have yielded promising results in early studies.

Co-authors with Goswami and Sharma are Swetha Anandhan of Genitourinary Medical Oncology; Sreyashi Basu, Ph.D., Irina Fernandez, Ph.D., Luis Vence, Ph.D, Jorge Blando, Ph.D., Hao Zhao, Ph.D., Shalini Singh Yadav, Ph.D., and Jim Allison, Ph.D., of MD Anderson’s Immunotherapy Platform; Martina Ott, Ph.D., Ling Kong, Ph.D., and Amy Heimberger, M.D., of Neurosurgery; John de Groot, M.D., of Neuro-Oncology; Boris Sepesi, M.D., of Thoracic and Cardiovascular Surgery: Michael Overman, M.D., and Scott Kopetz, M.D., Ph.D., of GI Medical Oncology; Thomas Walle, Ph.D., of the National Center for Tumor Diseases in Heidelberg, Germany; and Andrew Cornish and Dana Pe’er, Ph.D., of the Computational and Systems Biology Program, Sloan-Kettering Institute, New York. Anandhan is a graduate student in the MD Anderson/UTHealth Graduate School of Biomedical Sciences.

This research was supported by the Immunotherapy Platform of MD Anderson’s Moon Shots Program and funded by MD Anderson’s Glioblastoma Moon Shot and Lung Cancer Moon Shot and by grants from the National Cancer Institute of the National Institutes of Health (CA1208113, P30CA016672) and NCI Cancer Center Support Grant (CA016672). Sharma and Allison are members of the Parker Institute for Cancer Immunotherapy.

Press Release: EpiVax Announces Record Year for Growth in 2019 and Sets New Milestones for 2020

On December 23, 2019 EpiVax ("EpiVax, Inc.") reported its record-breaking performance and growth in personnel in 2019 while identifying new milestones to aspire to in 2020 (Press release, EpiVax, DEC 23, 2019, View Source [SID1234552616]).

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The Business Development team closed 15% more contracts over 2018 and acquired two new clients for ISPRI, the in silico immunogenicity screening and protein re-engineering interface, bringing the total number of licenses to 14. Over one million sequences were screened in ISPRI for both academic and commercial clients this year.

The Immunoinformatics team upgraded all in silico platforms and developed new strategies for analyzing highly complex biologics, including those containing unnatural amino acids. These improvements have enabled the Protein Therapeutics team to address the growing peptide therapeutics industry.

EpiVax’s Tregitope and Vaccine Development teams pushed science forward in the fields of autoimmune therapy, infectious disease, and animal health. Notably, data highlighting the potential for Tregitopes, an EpiVax discovery, to treat Type I Diabetes was featured in Nature Scientific Reports. The number of funded collaborations also increased by 15%, contributing to the list of joint publications. A total of nine publications appeared in highly-ranked scientific journals.

Team members attended over 50 conferences around the globe, in locations such as Bern, Bamako, Lisbon, Hamburg, Paris, Edinburgh, the United States and beyond. EpiVax also hosted five scientific seminars, bringing "Science without Fear" concepts in the fields of immunogenicity and vaccine development to contacts in Cambridge, Seoul, Tokyo, Amsterdam and Ghent.

The company also expanded personnel by 15%, welcoming new Epi-Team members to the Tregitope, Immunoinformatics, Protein Therapeutics, Vaccine Development and Laboratory staff. EpiVax maintains its tradition of workplace diversity with a scientific team composed of greater than 50% women and women leading four out of seven departments.

EpiVax looks forward to exceeding these milestones in 2020 and is already looking forward to a new multi-institutional collaboration in the European Union researching an improved flu vaccine starting in January 2020.

MATEON THERAPEUTICS ANNOUNCES POSITIVE CLINICAL STUDY RESULTS FOR ITS LEAD ANTI-LEUKEMIA DRUG COMBRETASTATIN A1 PLUS CYTARABINE IN ADULT PATIENTS WITH RELAPSED ACUTE MYELOID LEUKEMIA

On December 23, 2019 Mateon Therapeutics Inc. (OTCQB:MATN), dedicated to the development of innovative treatments for cancer, reported that the multi-institutional OXI1222 study in people with previously treated relapsed acute myeloid leukemia (AML) met its primary endpoint (Press release, Mateon Therapeutics, DEC 23, 2019, View Source [SID1234552601]).

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Patients were treated by participating leukemia experts affiliated with the University of Florida, University of Kansas Cancer Center, David Geffen School of Medicine at UCLA, and University of Miami Sylvester Comprehensive Cancer Center, Miami. This trial was registered at www.clinicaltrials.gov as NCT02576301.

The study showed that adding Mateon’s lead anti-AML drug Combretastatin A1, also known as OXi4503, to the standard chemotherapy drug cytarabine was generally well tolerated by AML patients and a maximum tolerated dose level of OXi4503 was identified as the recommended dose for further clinical development of this novel two-drug combination. In 26 evaluable AML patients, there were 4 complete remissions (CR/CRi) and one partial remission (PR). The CR responses were associated with >1-year overall survival times. The combination therapy exhibited a manageable toxicity and a promising benefit to risk profile in older adults with relapsed AML. Four of the 5 objective responders were in the ≥65-years poor prognosis age category with adverse cytogenetic features. The safety, feasibility, and early clinical activity of this new treatment in R/R AML deserves further clinical validation in a randomized registration study. Results from the study will be presented at an upcoming medical meeting and discussed with health authorities, including the U.S. Food and Drug Administration (FDA). A peer-reviewed article detailing the clinical data was accepted for publication last Friday in the oncology journal Cancers (Basel).

"This work emphasizes our commitment to advance our investigational drug OXi4503 which shows clinical impact potential to address unmet needs in relapsed/recurrent hematologic malignancies, especially AML," stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.

OXi4503 has received orphan drug designation for AML in both the US and the European Union. Further, the US FDA has granted fast-track designation to OXi4503 for the treatment of relapsed/refractory AML.

"The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen. By combining OXi4503 with the standard chemotherapy drug cytarabine, we hope to develop an innovative approach that improves outcomes for patients with relapsed AML, especially those who are older and have a dismal prognosis," explained Fatih Uckun, M.D., Ph.D., Chief Medical Officer of Mateon Therapeutics.

AML is the most common form of adult acute leukemia with >20,000 estimated new cases and >10,000 deaths in the United States (US) for 2019 (SEER Program, www.seer.cancer.gov). Despite recent advances in therapy, the five-year overall survival remains <30% and prognosis is grim in patients who experience a recurrence of their disease after first-line induction therapy, with <10% surviving five years after relapse. There is an urgent need for effective new treatment strategies for relapsed AML. Therefore, clinical development of new therapies has been the focal point of AML research over the last decade.

OXi4503 is cis-combretastatin A1 dipotassium diphosphate, a water-soluble prodrug of cis‑combretastatin A1 (OXi4500), a naturally occurring derivative of the South African bush willow tree, Combretum caffrum, that reversibly binds tubulin at the colchicine binding site to inhibit microtubule assembly. OXi4503 is a dual-function drug with vascular disrupting and cytotoxic properties that has exhibited single-agent anti-leukemia activity in animal models of AML and in a prior Phase 1A clinical study for relapsed/refractory (R/R) AML. Notably, the combination of OXi4503 with cytarabine in xenografted human AML models was more effective than either drug alone. The clinical safety profile of OXi4503 as a single agent has previously been evaluated in Phase 1A clinical trials. In the NCT00977210 Phase 1 dose-finding study in 43 advanced solid tumor patients, OXi4503 doses were escalated from 0.06 to 15.4 mg/m2, and 8.5 mg/m2 was defined as the MTD. In the NCT01085656 Phase 1A trial designed to evaluate the safety profile, MTD, and recommended Phase 2 dose (RP2D) of OXi4503 in patients with R/R AML and MDS, a total of 18 patients were treated with single agent OXi4503 and showed a manageable safety profile at single-agent dose levels up to of 7.81 mg/m2. There was early evidence of possible single-agent activity as one relapsed AML patient treated at the 2.5 mg/m2 dose level achieved a CRi. The primary purpose of the present multicenter Phase 1B study was to define the maximum tolerated dose and safety profile of OXi4503 and cytarabine administered in combination (OXA) in patients with relapsed/refractory R/R AML.

Mallinckrodt to Present at the 38th Annual J.P. Morgan Healthcare Conference

On December 23, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that Mark Trudeau, President and Chief Executive Officer, and other members of management will represent the company at the 38th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis on Union Square, 335 Powell St., San Francisco (Press release, Mallinckrodt, DEC 23, 2019, View Source [SID1234552598]). Mallinckrodt is scheduled to present on Monday, Jan. 13, 2020 from 9:00 a.m. to 9:55 a.m. Pacific Time.

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