On May 9, 2022 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported the poster presentation of a substantial survival benefit of AllocetraTM combined with immune checkpoint inhibition in a preclinical mesothelioma study at the International Society of Cell and Gene Therapy Annual 2022 Meeting (Press release, Enlivex Therapeutics, MAY 9, 2022, View Source [SID1234613905]). The poster was titled, "Allocetra-OTS, an Early Apoptotic Cellular Therapy Synergize with Chimeric Antigen Receptor (CAR) T Cell Therapy or Immune Check Point Inhibitor Against Peritoneal Solid Tumor."

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Mesothelioma, Treatment Landscape, and Macrophage-Solid Tumor Dynamics

Mesothelioma is one of the deadliest solid cancers with few treatment options, all of which have limited efficacy. People who are most at risk to develop mesothelioma generally have had long-term exposure to asbestos (e.g., construction workers, pipe fitters, and shipyard workers). It takes many years for mesothelioma to develop; it can appear 30 years after asbestos exposure. Immune checkpoint inhibitors targeting CTLA4 and PD1 are FDA-approved as first-line treatments for patients with unresectable malignant pleural mesothelioma.

In mesothelioma and in some other solid cancers, tumor cells, as part of their defense mechanisms, facilitate the recruitment of macrophages which become "pro-tumor" tumor associated macrophages (TAMs) rather than "anti-tumor" macrophages. The TAMs typically form a physical layer on top of the solid tumor, and induce immunosuppression in the solid tumor microenvironment. This in-turn promotes tumor growth and metastasis and makes it very difficult for the immune system or any anti-cancer drug to efficiently attack the cancerous cells. Allocetra is a cell therapy in development that is targeted at these TAMs, and its proposed mechanism of action is to change the balance of macrophage populations to skew towards anti-tumor macrophages and away from pro-tumor macrophages.

The Mesothelioma Model

To test the potential effect of cell therapy-induced macrophage reprogramming on difficult-to-treat solid tumors, Enlivex ran preclinical studies in which five groups of mice were implanted with mesothelioma cancer cells. The difference between the groups was the treatment given, which started on day 12 after the cancer’s initial growth period.

Results from multiple studies strongly support the potential of AllocetraTM to assist in the process of macrophage reprogramming in the solid tumor microenvironment and significantly change survival outcomes. As expected, only 1/16 (6%) of the untreated mice remained alive at day 42 (that one last remaining mouse died on day 65), compared with up to 25% survival for the mice in the group that was treated with the anti-CTLA4 immune checkpoint inhibitor. Surprisingly, AllocetraTM as a stand-alone treatment provided comparable survival rates as anti-CTLA4 monotherapy, with a 28.5% survival rate and a delayed cancer growth rate observed. Notably, the synergistic effect of treating with both drugs resulted in up to 100% survival with complete disappearance of the cancer. The effect was correlated with the AllocetraTM treatment dose. A lower dose of AllocetraTM provided slightly lower survival and cancer complete remission rates (67% complete remission for the low-dose treatment vs. up to 100% for the higher dose). The following chart provides a visual guide to the progressions/regression of the mesothelioma cancer in the different groups, as recorded for study mesothelioma AB12 137:

Across multiple studies of the AB12 mesothelioma model, anti-CTLA4 therapy significantly improved survival duration from mean 34±9 to 44.9 ±20 days (p<0.05). Allocetra as a stand-alone therapy improved survival duration to 52.3 ±20 days (p<0.02). The synergistic effect of the combination therapy of anti-CTLA4 + AllocetraTM improved survival duration to 86.7±20 days (p<0.0001) with complete cancer remission in 60-100% of mice, depending on the dose administered.

Prof. Dror Mevorach, Chief Scientific Officer of Enlivex, stated: "This reproducible and statistically significant data strongly support Allocetra’s proposed therapeutic mechanism of action of reprogramming macrophages in solid tumors. We believe that, in contrast to CAR-T, CAR-NK and other anti-cancer cell therapies directed at tumor antigens, AllocetraTM restores macrophage homeostasis in the tumor environment via reprogramming of pro-tumor macrophages. This may ultimately allow immune checkpoint inhibitors to be exponentially more effective."

Oren Hershkovitz, Ph.D., CEO of Enlivex, added: "Based on these results, Enlivex is planning to initiate a series of clinical trials during 2022 that are designed to evaluate Allocetra in combination with FDA-approved immune checkpoint inhibitor therapies in patients with advanced-stage solid tumors. To date, we have infused AllocetraTM in dozens of hospitalized patients in fragile condition resulting from sepsis and COVID-19-related organ dysfunction. We believe that the proposed differentiated mechanism of action of AllocetraTM, together with the safety and tolerability it has demonstrated in these prior studies, as well as the encouraging efficacy results of our preclinical solid tumor models, highlight an intriguing opportunity for Enlivex to provide another layer of life-saving therapy for patients who have few available options."

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On May 9, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into a definitive agreement with a single leading healthcare investor for the purchase and sale of 10,563,380 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing ten (10) ordinary shares, at a purchase price of $1.42 per ADS (or ADS equivalent), in a registered direct offering (Press release, RedHill Biopharma, MAY 9, 2022, View Source [SID1234613885]). RedHill has also agreed to issue to the investor unregistered private warrants to purchase up to an aggregate of 13,204,225 ADSs in a concurrent private placement. The warrants have an exercise price of $1.48 per ADS, are exercisable six months after the issuance date and have a term of five and one-half years. The closing of the offering is expected to occur on or about May 11, 2022, subject to the satisfaction of customary closing conditions.

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Cantor Fitzgerald & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $15 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital, acquisitions, and general corporate purposes.

The securities described above (but not the warrants or the ADSs underlying the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form F-3 (File No 333-258259) previously filed with the Securities and Exchange Commission (the "SEC") on July 29, 2021, and declared effective by the SEC on August 9, 2021. The offering of the securities is made only 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 Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a 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.

On May 9, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the acceptance of a poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, to be held in-person on June 3-7, 2022, in Chicago, Illinois (Press release, Delcath Systems, MAY 9, 2022, View Source [SID1234613884]).

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Title: FOCUS Phase 3 Trial Results: Percutaneous Hepatic Perfusion (PHP) With Melphalan for Patients With Ocular Melanoma Liver Metastases (PHP-OCM-301/301A)
Session Title: Melanoma/Skin Cancers
Session Date and Time: June 6, 2022, 1:15-4:15 PM CDT (Display) and 4:30-6:30 PM CDT (Discussion)
Abstract Number: 9510
Presenter: Dr. Jonathan Zager, Director of Regional Therapies and Chief Academic Officer, Moffitt Cancer Center; Professor and Chair, Department of Oncologic Sciences, USF Morsani School of Medicine

For more information, visit the ASCO (Free ASCO Whitepaper) Annual Meeting website.

The poster will be available at View Source when the ASCO (Free ASCO Whitepaper) embargo is released on May 26, 2022, at 4:00 PM CDT.

On May 09, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that its board of directors has authorized a share repurchase program to acquire up to $1 million of the Company’s common stock (Press release, Immix Biopharma, MAY 9, 2022, View Source [SID1234613883]). The Company may purchase common stock on the open market, through privately negotiated transactions, or otherwise, in compliance with the rules of the United States Securities and Exchange Commission and other applicable legal requirements. As of December 31, 2021, the Company had approximately $18 million of cash, cash equivalents and marketable securities. The Company had approximately 13.9 million shares of common stock outstanding as of April 15, 2022.

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"We are confident that with the $24.2 million gross proceeds raised in our recent IPO, ImmixBio is sufficiently capitalized to reach what we believe will be 2 upcoming inflection points: clinical data from IMX-110 monotherapy clinical trial, as well as clinical data from the IMX-110 combined with BeiGene anti-PD-1 tislelizumab clinical trial," said Ilya Rachman, MD PhD, CEO of ImmixBio. "The current market situation allows us to capture additional value for all shareholders through this measured buyback program. Our interests have always been, and continue to be, aligned with all IMMX shareholders."

The timing, amount of shares repurchased and prices paid for the stock under this program will depend on market conditions as well as corporate and regulatory limitations, including blackout period restrictions. The repurchase program does not obligate the Company to acquire any particular amount of shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion.

On May 9, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that the first participant has been treated in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with atezolizumab (Tencentriq) during the maintenance phase of treatment in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC) (Press release, Imago BioSciences, MAY 9, 2022, View Source [SID1234613882]).

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The study is being conducted in Seattle and led by Rafael Santana-Davila, M.D., associate professor at the University of Washington School of Medicine and Joseph Hiatt, M.D., Ph.D., of Fred Hutchinson Cancer Center ("Fred Hutch"), and in collaboration with the National Cancer Institute (NCI) funded Fred Hutch Lung Specialized Project of Research Excellence.

Bomedemstat is an inhibitor of lysine-specific demethylase 1 (LSD1), an enzyme that plays a central role in cell growth. Atezolizumab is an anti-PD-L1 monoclonal antibody medication approved by the U.S. Food and Drug Administration (FDA) in 2021 as adjuvant treatment for non-small cell lung cancer. The Phase 1/2 open-label study will enroll approximately 34 participants diagnosed with ES-SCLC to establish the safety and tolerability of a combination treatment with bomedemstat and atezolizumab. Treatment cycles will last for 21 days, consisting of an oral administration of bomedemstat once daily and intravenous administration of atezolizumab on day 1. Participants are followed up after 30 days and every 12 weeks thereafter.

"We are excited to work with UW Medicine and Fred Hutch to explore the expanded use of bomedemstat in solid tumors," said Hugh Y. Rienhoff, Jr., M.D., Chief Executive Officer of Imago. "A combination of bomedemstat, which in some solid tumors enhances their immunogenicity, and atezolizumab, an established checkpoint inhibitor, represents a promising clinical opportunity in lung cancer treatment. This new regimen may provide more long-term disease management possibilities for patients who suffer from extensive stage small cell lung cancer."

In ongoing Phase 2 studies in bone marrow cancers, bomedemstat has been generally well-tolerated and has demonstrated significant symptom improvement for patients with essential thrombocythemia and advanced myelofibrosis.

Additional information about the study can be found at www.clinicaltrials.gov using the identifier NCT05191797.