On February 15, 2023 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT) reported that, as recently reported in The Journal of Clinical Investigation, PP2A, the pharmacologic target of LIXTE’s lead clinical compound, LB-100, when deficient, enhances the effects of immune checkpoint blockade of cancer in a mouse model by a previously unappreciated mechanism (Press release, Lixte Biotechnology, FEB 15, 2023, View Source [SID1234627264]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The article, entitled "PP2Ac/STRN4 negatively regulates STING-Type I interferon signaling in tumor associated macrophages," was recently published and is available online at View Source The authors state that "PP2A/STRN4-YAP/TAZ is a previously unappreciated mechanism that mediate[s] immunosuppression in tumor-associated macrophages and targeting PP2A/STRN4-YAP/TAZ axis can sensitize tumors to immunotherapy."

John S. Kovach, M.D., CEO and Founder of LIXTE, said, "This paper lends additional support to the potential immunotherapy application of LB-100 in cancer treatment. Dr. Winson S. Ho, Assistant Professor of Neurological Surgery at the UCSF School of Medicine, co-lead author of the article, and a former member of the LIXTE Board of Directors, bolsters the case for testing LB-100 in combination with immunotherapy in the clinic. Studies in animals show that low doses of LB-100 enhance the effectiveness of immunotherapy against a variety of cancer types by several mechanisms (Ho et al., Nature Comm 2018; Yen et al. Nature Comm 2021)."

Dr. Kovach added, "LIXTE is currently recruiting for a clinical trial in patients with previously untreated extensive stage small cell lung cancer in which LB-100 is first added to chemotherapy and an immune checkpoint blocker and then administered with the immune blocker alone in the maintenance phase of treatment (NCT04560972). We are presently seeking to develop other collaborative clinical studies to determine whether LB-100 significantly enhances the effectiveness of immunotherapy of cancer in general."

On February 15, 2023 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Wednesday, March 1, 2023 to discuss its 2022 operating results (Press release, ImmunoGen, FEB 15, 2023, View Source [SID1234627263]). Management will also provide a brief update on the business.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CONFERENCE CALL INFORMATION
To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

On February 15, 2023 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it has executed financing to provide further working capital and support its ongoing business operations (Press release, ImmunityBio, FEB 15, 2023, View Source [SID1234627262]). The Company entered into a securities purchase agreement for a registered direct offering with multiple institutional investors, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $50 million before deducting any offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to $60 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies LLC is acting as the exclusive placement agent for the registered direct offering.

The securities to be sold by the Company are offered under its shelf registration statement on Form S-3 (Registration No. 333-269608). A final prospectus supplement, which contains additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement may be obtained for free by contacting Jefferies, LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected].

Before investing in this offering, interested parties should read the prospectus supplement, the accompanying prospectus, and the other documents that are incorporated by reference in such prospectus supplement and the accompanying prospectus in their entirety.

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.

On February 15, 2023 Nexcella, Inc. ("Nexcella", "Company"), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications and a subsidiary of Immix Biopharma, Inc. (NASDAQ: IMMX), reported that it has entered into a manufacturing agreement with a well-known United States Good Manufacturing Practice (GMP) cell therapy manufacturer that will supply a US Phase 1b/2 clinical trial of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis (Press release, Immix Biopharma, FEB 15, 2023, View Source [SID1234627261]). As Nexcella plans to expand the ongoing Israel trial to the U.S., it is necessary to demonstrate that clinical trial drug supply has been secured when submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). This U.S. manufacturing site is expected to supply NXC-201 material for the Phase 1b/2 clinical trial in the U.S. following an IND submission to the FDA and approval.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Over the coming months, Nexcella plans to initiate a pre-IND meeting with the FDA, submit an IND application to the FDA, and obtain IND approval for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis. We believe recently reported Phase 1b clinical data from the ongoing clinical trial in Israel supports expanding the NXC-201 trial to the U.S.

As of the October 23, 2022 data cutoff, updated clinical data from the ongoing Phase 1b portion of the NEXICART-1 (NCT04720313) study of the novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis (AL) showed:

Multiple Myeloma – 90% overall response rate (59% complete responses) for NXC-201 at the therapeutic dose in an ongoing 42-Patient Phase 1 expansion trial (Haematologica View Source, 5th European CAR-T cell meeting View Source) in relapsed/refractory multiple myeloma. All patients treated with NXC-201 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody)
AL Amyloidosis – 100% organ response rate, 100% complete responses (MRD negativity 10-5), published for NXC-201 in 5 relapsed/refractory patients (Clinical Cancer Research View Source, 5th European CAR-T cell meeting View Source)
The therapeutic dose of NXC-201 (800 million CAR+T cells) has already been established as the recommended Phase 2 dose (RP2D)
Additional information on NXC-201 clinical data as of October 23, 2022 is available here.

"We are excited about our progress toward bringing NXC-201 to United States clinical sites. Securing clinical supply is a critical step in advancing NXC-201 toward a potential U.S. regulatory submission. We believe NXC-201 could become a best-in-class therapy for patients suffering from AL amyloidosis and multiple myeloma," said Gabriel Morris, President of Nexcella.

Ilya Rachman, M.D., Executive Chairman of Nexcella added: "NXC-201 has a highly-differentiated, mild tolerability profile. We believe NXC-201 could be the world’s first outpatient CAR-T. We look forward to working with our partners at our new U.S. manufacturing site as we further our plans to bring NXC-201 to U.S. patients who need alternative treatments."

About NEXICART-1
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory multiple myeloma, all of which as of October 23, 2022 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody). The primary objective of the Phase 1b portion of the study, is to characterize the safety and confirm the Maximally Tolerated Dose (MTD) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 with endpoints of overall survival, progression-free survival and response rates according to International Myeloma Working Group (IMWG) Uniform Response Criteria.

About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.

About Multiple Myeloma
Multiple myeloma ("MM") is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 34,470 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor.

On February 15, 2023 GlycoMimetics, Inc. (Nasdaq: GLYC) reported the independent Data Monitoring Committee (DMC) reviewed the interim utility analysis of its Phase 3 study of uproleselan in relapsed/refractory (R/R) acute myeloid leukemia (AML) and recommended the study should continue to the originally planned final overall survival event trigger (Press release, GlycoMimetics, FEB 15, 2023, View Source [SID1234627260]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We thank the independent DMC for its recommendation and are strongly encouraged as the blinded pooled survival data continues to show patients living longer than historical benchmarks. Going forward, survival duration for new events in the study will be greater than 14 months since the last patient was randomized, giving us confidence in the potential for uproleselan to improve outcomes for people living with R/R AML," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "We are proud to be advancing a novel treatment with significant potential to address the urgent unmet medical need in this acute leukemia, and we look forward to continuing the study to the originally planned final overall survival analysis, now expected within the first half of 2024."

The interim utility analysis was added to the study in the fall of 2022 as blinded pooled survival data showed patients living longer than expected based on the historical benchmarks used to design the study. The plan for the independent DMC to review efficacy and safety data at approximately 80% of planned survival events was cleared with the U.S. Food and Drug Administration.

When designing the interim analysis, the company amended the protocol to create the opportunity to achieve unblinding at around 80% of survival events while maintaining the integrity of the final analysis should the DMC recommend the study continue to the final overall events trigger. The interim analysis plan required a high statistical threshold to be met for the independent DMC to recommend unblinding, reserving approximately 95% of the study’s statistical power for the final analysis.

Recent Sales under ATM Facility

Since the start of the fourth quarter of 2022, GlycoMimetics sold 11,776,784 shares of common stock under its existing "at-the-market" (ATM) sales facility, raising a total of $32.9 million in net proceeds. These additional proceeds are expected to extend the company’s cash runway into the fourth quarter of 2024. The company intends to use its capital resources to advance the clinical development of and prepare regulatory filings for marketing approval of uproleselan, and to plan for uproleselan’s potential commercialization to continue the evolution of GlycoMimetics into a commercial-stage company.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational first-in-class, E-selectin antagonist. Uproleselan (yoo’ pro le’se lan), currently in a comprehensive Phase 3 development program in acute myeloid leukemia (AML), has received Breakthrough Therapy designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect via NF-kB signaling. Uproleselan intends to provide a novel approach to disrupting established mechanisms of leukemic cell resistance.

The pivotal Phase 3 trial evaluating uproleselan in addition to a cytarabine-based chemotherapy regimen in patients with relapsed/refractory AML completed enrollment in November of 2021. A total of 388 patients across 70 sites in nine countries were randomized in the clinical trial, which has a primary endpoint of overall survival.