XNK Therapeutics Reports First Patient Treated in Phase II Study in Multiple Myeloma

On March 23, 2022 XNK Therapeutics AB ("XNK") reported that the first patient has been treated in a Phase II clinical study using XNK’s leading autologous natural killer (NK) cell-based candidate drug in combination with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab) (Press release, XNK Therapeutics, MAR 23, 2022, View Source [SID1234610775]).

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"Having the first patient treated with NK cells in this clinical study is an important milestone in the clinical development of our leading drug candidate," said Johan Aschan, CMO of XNK Therapeutics. "The study is progressing well, and we look forward to the results."

The present investigator-initiated, open, randomized, controlled, Phase II study ISA-HC-NK (EudraCT: 2020-000994-26) compares XNK’s leading candidate drug combined with Sanofi’s anti-CD38 antibody Isatuximab with Isatuximab alone as a consolidation treatment following autologous stem cell transplantation in patients with newly diagnosed multiple myeloma. The clinical study takes place at the Karolinska University Hospital at its Huddinge site and encompasses at total of 60 patients with 30 patients in each treatment arm.

CASI PHARMACEUTICALS TO REPORT FOURTH QUARTER AND YEAR END 2021 FINANCIAL RESULTS AND HOST CONFERENCE CALL MARCH 28, 2022

On March 23, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the Company will host a conference call reviewing the financial results for the fourth quarter and for the year ended December 31st, 2021, at 8:00 a.m. EDT on Monday, March 28th, 2022 (Press release, CASI Pharmaceuticals, MAR 23, 2022, https://www.prnewswire.com/news-releases/casi-pharmaceuticals-to-report-fourth-quarter-and-year-end-2021-financial-results-and-host-conference-call-march-28-2022-301508675.html [SID1234610774]).

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On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call can be accessed by dialing 1-877-870-4263 (U.S.) or 1-412-317-0790 (international) and ask to be joined into the CASI Pharmaceuticals call to listen to the live conference call.

This call will be recorded and available for replay by dialing 1-877-344-7529 (U.S.) or 1-412-317-0088 (international) and enter 4990100 to access the replay.

ICHNOS SCIENCES ANNOUNCES PRESENTATION OF ADDITIONAL PRECLINICAL DATA ON ISB 1442 FOR RELAPSED/REFRACTORY MULTIPLE MYELOMA AT AACR 2022 ANNUAL MEETING

On March 23, 2022 Ichnos Sciences Inc., a global biotechnology company developing novel multispecific antibodies for the treatment of cancer using the proprietary BEAT platform1, reported that preclinical data for ISB 1442, a first-in-class 2+1 biparatopic bispecific antibody that targets both CD38 and CD47, will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in New Orleans from April 8-13, 2022 (Press release, Ichnos Sciences, MAR 23, 2022, View Source [SID1234610773]). ISB 1442 is being investigated as a treatment for relapsed/refractory multiple myeloma, T-cell acute lymphoblastic leukemia and acute myeloid leukemia.

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"The data being presented at AACR (Free AACR Whitepaper) highlight the potential for ISB 1442, our first-in-class biparatopic CD38 x CD47 bispecific antibody, in multiple myeloma," said Stefano Sammicheli, Ph.D., Director of Innate Cell Engagers, at Ichnos Sciences. "This compound has shown higher potency and greater inhibition of tumor growth relative to daratumumab in both in vitro and in vivo models, suggesting that ISB 1442 may overcome common mechanisms of resistance to other CD38 targeted therapies, which is coupled with low potential for on-target off-tumor effects seen with other CD47 directed treatments."

"We are excited to have the opportunity to present at AACR (Free AACR Whitepaper), and to share ISB 1442 data that support our plan to move this drug into a Phase 1 study in the middle of this year," said Cyril Konto, M.D., President and Chief Executive Officer of Ichnos Sciences. "Advancing ISB 1442 is particularly important to Ichnos because it is built using BEAT 2.0, which is among the most advanced antibody engineering platforms and the basis of our discovery efforts for novel multispecifics to treat hematologic malignancies and solid tumors."

Ichnos Sciences continues to advance its pipeline of agents based on the proprietary BEAT technology platform. Using this platform, Ichnos Sciences is exploring the full design space for treating cancer and engineering multispecific antibodies capable of simultaneously engaging tumor and immune cells.

Details for the poster presentation are shared below:

Session PO.IM02.10 – Therapeutic Antibodies 2
April 12, 2022, 9:00 AM – 12:30 PM
2903 / 18 – ISB 1442, a first-in-class CD38 and CD47 bispecific antibody innate cell modulator for the treatment of CD38+ malignancies

Posters will be available on-demand on the AACR (Free AACR Whitepaper) website at www.aacr.org beginning at the start of the poster session and the abstract is available to view here.

1 Bispecific Engagement by Antibodies based on the TCR

Ampio Pharmaceuticals, Inc. to Hold Fourth Quarter 2021 Earnings and Business Update Call

On March 23, 2022 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis, reported that the Company will be hosting its fourth quarter earnings and business update call March 29 at 4:30pm EST (Press release, Ampio, MAR 23, 2022, View Source [SID1234610772]).

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TC BioPharm Receives MHRA and Research Ethics Committee Approvals to Initiate Phase 2B/3 Clinical Trials for the Treatment of Acute Myeloid Leukemia

On March 23, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported that it has received MHRA and Research Ethics Committee approvals to initiate gamma-delta T cell therapy clinical trials of OmnImmune for the treatment of Acute Myeloid Leukemia (AML) (Press release, TC Biopharm, MAR 23, 2022, View Source [SID1234610771]).

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OmnImmune an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells has already received orphan drug designation for the treatment of patients suffering from the blood and bone marrow cancer. Phase 2/3 trials will begin enrollment in the first half of 2022 in the UK with expansion into the US following shortly thereafter.

"We are extremely pleased to receive MHRA and Research Ethics approvals, which marks the final step in our protocol submission and commencing through the clinical trial process of our proprietary AML therapy," said Bryan Kobel, CEO of TC BioPharm. "On the heels of announcing our Orphan Drug Dsignation from the FDA, we have now further demonstrated our ability to run parallel processes for clinical trials in both the US and UK/EU. The positive results demonstrated by OmnImmune in Phase 1b/2a clinical trials are encouraging and bolsters our belief in its potential as an effective therapy for Acute Myeloid Leukemia."