On December 11, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, at the 64th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) taking place December 10 – 13, 2022 in New Orleans, Louisiana (Press release, Wugen, DEC 11, 2022, View Source [SID1234625035]).

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"Conventional NK cells (cNK) have proven dysfunctional in the harsh, acute myeloid leukemia (AML) tumor microenvironment (TME), and attempts to improve anti-tumor performance prior to adoptive transfer have proven limited in their success," said Sergio Rutella, M.D., Ph.D., FRCPath, FRSB, Professor of Cancer Immunotherapy at Nottingham Trent University and presenting author. "These data functionally characterizing the anti-tumor properties of WU-NK-101 are highly encouraging and support the potential for WU-NK-101 as a treatment for relapsed/refractory (r/r) AML. Further, the identification of a TME immune signature highly predictive of response may be an impactful tool to support future clinical studies."

"These data further validate our approach deploying WU-NK-101 for AML," said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen. "In early clinical studies, memory NK cells have already demonstrated impressive efficacy against AML. We look forward to building on those promising signals and advancing WU-NK-101 into the clinic as a novel, off-the-shelf therapy for this indication."

Today’s presentation highlighted the following:

An 8-gene TME immune signature showed excellent predictive ability for response to cytokine-induced memory-like (CIML) NK cells in patients with r/r AML. Responders exhibited TME modulation via innate and immune cell presence as well as metabolic re-programming reflected by enhanced glucose and amino acid consumption.
Compared to cNK cells, WU-NK-101 had enhanced anti-tumor activity, trafficked to the bone marrow, and showed metabolic flexibility, potentially mitigating the adverse effects of the highly immuno-suppressive AML TME.
WU-NK-101 may represent an effective treatment modality for r/r AML. A Phase 1 study evaluating WU-NK-101 in patients with r/r AML is expected to begin enrollment in the first half of 2023.
The details of Wugen’s presentation at ASH (Free ASH Whitepaper) are as follows:

Title: Putative Predictors of Response to WU-NK-101, an Allogeneic, Enhanced Memory (ML)

Natural Killer (NK) Cell Therapy Product, for Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

Publication Number: 3294

Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster II

Session Date and Time: Sunday, December 11, 2022 from 6:00 p.m. – 8:00 p.m. CT

Location: Ernest N. Morial Convention Center, Hall D

Presenting Author: Sergio Rutella, M.D., Ph.D., FRCPath, FRSB, Nottingham Trent University

Additional meeting information can be found at View Source

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

About the MonetaTM Platform

Wugen’s proprietary MonetaTM platform is a robust, scalable process to manufacture off-the-shelf memory natural killer (NK) cell therapies with enhanced anti-tumor functionality. The MonetaTM platform uses cytokine fusion complexes for streamlined and consistent manufacturing, is free of feeder cells for enhanced safety, and integrates cryopreservation to allow convenient dosing options for cancer patients.

On December 11, 2022 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that a poster presentation of preclinical data of Vincerx’s proprietary payload and linker technology and VIP943, the Company’s internalizing ADC targeting CD123, at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2022 (Press release, Vincerx Pharma, DEC 11, 2022, View Source [SID1234625034]).

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VIP943 is a novel ADC, which binds to the IL3-receptor alpha chain (CD123). VIP943 combines the unique payload class of kinesin spindle protein inhibitors (KSPi) with a proprietary legumain-cleavable linker. Vincerx’s CellTrapper modification of the KSPi prevents diffusion out of the cell, allowing intracellular accumulation. The nonpermeability of the payload prevents off-target toxicities, leading to favorable efficacy and safety profiles.

"I am truly excited about the preclinical results for VIP943 and our proprietary payload and linker technology presented at ASH (Free ASH Whitepaper)," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "For the first time, we showed a significant improvement in safety over an approved ADC, demonstrating in non-human primates the benefit of our KSPi payload and CellTrapper technology specifically designed to address some of the well-known challenges of ADCs on the market. The in vivo AML mouse model results also showed improved efficacy and survival for VIP943 in combination with venetoclax and azacitidine. This triple combination resulted in significant tumor regression as demonstrated by five complete responses and significantly prolonged survival time without increased toxicity," added Dr. Hamdy.

Dr. Anthony Tolcher, M.D., Chief Executive Officer, Founder and Director of Clinical Research at NEXT Oncology, added, "This ADC is innovative and exciting. The target is well understood and the novel payload that targets myeloid cells suggests this could be a valuable agent for patients with AML."

"Current standard of care for AML patients is combination therapy with venetoclax and azacitidine, yet most patients eventually relapse with progressive disease. The efficacy and safety data for VIP943 we see in our studies suggest it may be a promising option for treating AML as a monotherapy in relapse/refractory elderly, unfit and high-risk patients as well as in combination with venetoclax and azacitidine. Our results also provide compelling evidence that VIP943 represents a substantial advancement and potential paradigm-shift in ADC technology. We look forward to continuing to advance the IND-enabling studies for VIP943 and expect to file our IND in mid-2023," concluded Dr. Hamdy.

Key Presentation Highlights:

Poster presentation titled, "VIP943 is a Novel CD123 Antibody Drug Conjugate with In Vitro and In Vivo Efficacy in Acute Myeloid Leukemia (AML) Models", presented by Beatrix Stelte-Ludwig, Ph.D., Vincerx Pharma GmbH, Monheim, Germany, includes:

Bone marrow samples derived from patients with AML were used to evaluate VIP943 monotherapy at different concentrations (0.1 pM to 1µM) in a depletion (without cytokine addition) and a proliferation assay. Combination treatment of VIP943 (using 8 different doses) and venetoclax (one fixed dose of 16.5 nM) was evaluated. All patient samples were analyzed by flow cytometry and were positive for CD123 cell surface expression. In the depletion assay, only the samples which showed spontaneous proliferation were sensitive to VIP943 treatment in accordance with the mode of action of the KSPi payload.

In a patient-derived AML xenograft model, the triple combination of VIP943 with venetoclax and azacitidine increased the number of complete responses (56% vs 22%) and the overall survival (>107 vs 83 days) compared with venetoclax and azacitidine.

VIP943 did not induce cytokine release in a human cytokine release assay when compared with positive controls. One dose of VIP943 in an immunophenotyping study in NHP resulted in a reversible reduction in CD123+ basophils.
In a NHP safety study, a newly generated ADC using a gemtuzumab biosimilar as the targeting antibody conjugated to our effector chemistry comprised of a proprietary linker and payload (Gem-KSPi ADC) and VIP943 (anti-CD123-KSPi ADC) were directly compared with Mylotarg.

CD33+/CD123+ basophils showed an expected decrease across treatments; however, the VIP943 and Gem-KSPi ADC groups demonstrated a full recovery over the observation period, whereas Mylotarg showed an increased severity. Over time, a significant deleterious effect was seen with a single dose of Mylotarg on platelets, WBC count, reticulocytes, hemoglobin, hematocrit and lymphocytes. In contrast, a single dose of Gem-KSPi ADC and VIP943 showed no effects on hematology parameters other than the aforementioned transient reduction of CD123+ basophils.

Evaluation of serum chemistry showed increases in liver function enzymes, bilirubin and urea nitrogen in the Mylotarg group. The female monkey treated with Mylotarg died before the end of the observation period and the male monkey had to be euthanized. All monkeys from the Gem-KSPi ADC and VIP943 groups were healthy and returned to the colony with no remarkable changes in serum chemistry.
Overall, these results demonstrate the substantial advancement in ADC technology with the development of VIP943. Further IND-enabling studies are ongoing, and the Company expects to file an IND in mid-2023.
A copy of this presentation can now be accessed on the Investors section of the Company’s website at www.vincerx.com. Other Vincerx presentations related to enitociclib will be available on the company website on Monday, December 12 at 9:00AM CST.

On December 11, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported data in six presentations at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place from Saturday, December 10 to Tuesday, December 13, 2022 in New Orleans, LA, which highlighted further progress with key technologies supporting Sana’s ex vivo allogeneic CAR T cell programs and in vivo platform (Press release, Sana Biotechnology, DEC 11, 2022, View Source [SID1234625030]).

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"Our HIP platform has the potential to transform the CAR T space, and with it, the treatment of hematologic malignancies, and we are pleased to share data from several drug candidates before our planned entry into the clinic in 2023," said Terry Fry, M.D., Sana’s Senior Vice President and Head of T Cell Therapeutics. "Separate oral presentations show that our HIP-modified allogeneic CD19-targeted CAR T cells can evade immune detection and kill tumor cells in a fully immunocompetent preclinical model, including with serial in vivo tumor stimulation, and that our manufacturing process is able to produce HIP-modified allogeneic CAR T cells reproducibly at scale with high gene editing efficiency and yield. We intend to develop this platform broadly to treat patients with lymphoma, leukemia, and multiple myeloma with a goal of three INDs over the next several years, including one this year for SC291 targeting CD19 positive cancers and one next year for SC263 for patients who have failed a CD19-directed CAR T therapy."

Transplanting cells or tissues from a donor to a different recipient currently requires intense immunosuppression to prevent rejection of the transplant. The goal of Sana’s hypoimmune (HIP) platform is to eliminate the need for immunosuppression by cloaking cells from immune recognition while at the same time generating the manufacturing scale and reproducibility of allogeneic cells. The challenge for the field to date in generating immune cloaked cells has been turning off both the adaptive and innate immune system concurrently. Sana’s platform includes disruption of major histocompatibility (MHC) class I and MHC class II expression to hide cells from the adaptive immune system, which includes antibody and T cell responses, as well as overexpression of CD47 to inhibit activation of the innate immune cell system, in particular macrophages and natural killer (NK) cells. The company has presented data across multiple preclinical models highlighting the potential of this platform to cloak cells from immune recognition. Sana’s goal is to use these HIP-modified cells to replace damaged or missing cells in the body in a number of different diseases, including, among others, cancer and type 1 diabetes.

On Sunday, December 11, Sonja Schrepfer, M.D., Ph.D., Sana’s Senior Vice President and Head of Hypoimmune Platform, gave an oral presentation (Abstract 485) titled "Engineered Hypoimmune CAR T Cells Provide Lasting Tumor Control in Fully Immunocompetent Allogeneic Humanized Mice." This presentation demonstrated that CD47 is an important mechanism to avoid innate immune rejection. CD47 overexpression comprehensively inhibits macrophage and NK cell killing after the disruption of MHC class I and MHC class II expression, making it a more complete approach against innate immune cell killing compared to other strategies. A single dose of HIP-modified CD19-targeted CAR T cells was able to eliminate CD19+ tumors in immune competent animals, including after tumor rechallenge, indicating that these cells may be able to persist and maintain anti-tumor efficacy without immunosuppression.

On Sunday, December 11, Christina Chaivorapol, Ph.D., Sana’s Vice President, Translational Technologies, gave an oral presentation (Abstract 663) titled "Efficient and Specific Multi-Locus Editing of Allogeneic CAR T Cells for Hypoimmunity during Large Scale Manufacture Using Cas12b." The presentation outlined the use of a novel of CRISPR enzyme, Cas12b, to engineer allogeneic hypoimmune CAR T cells at large scale in order to prevent recognition and clearance by the host immune system while maintaining anti-tumor efficacy. Cas12b has been highlighted in prior studies as exhibiting a high level of on-target editing specificity. Assessment of genome integrity of T cells manufactured using Cas12b demonstrated highly specific editing with no significant off-target editing and no evidence for editing-associated structural modifications beyond those expected from on-target cleavage. These data indicate that this scaled manufacturing process can produce fully engineered HIP-modified CD19-targeted allogeneic CAR T cells with high editing efficiency and specificity.

On Saturday, December 10, Sana scientist Darin Salloum, Ph.D., presented a poster (Abstract 1974) titled "Functional T Cell Assays Are Predictive of Pre-Clinical Potency to Generate Allogeneic, Hypoimmune CD19 CAR T Cells." The presentation highlighted the use of several in vitro and in vivo assays to categorize T cells derived from healthy, allogeneic donors into excellent-, good-, or poor-performing T cells. These "stress test" assays may be used to identify T cell quality differences which may be used to select donors and reduce batch variability for allogeneic, HIP-modified CAR T manufacturing. Sana’s manufacturing process appears to create, in a replicable fashion, high quality T cells at a scale with the potential for hundreds of doses per batch.

On Saturday, December 10, Sana scientist Adam Johnson, Ph.D., presented a poster (Abstract 1988) titled "A Dual-Antigen Targeting, Hypoimmune Allogeneic CAR T to Evade Innate and Adaptive Immune Rejection and Overcome Antigen Escape." The presentation showed that a dual-transduction method using lentivirus encoding CD47-CD19CAR and CD47-CD22CAR could reproducibly generate dual-targeted hypoimmune CAR T cells, maintain CD47 overexpression for HIP function, and eliminate both CD19 and CD22 knockout tumor cell lines. Sana is developing SC263, a HIP-modified, CD22-directed CAR T with a clinically-validated CAR with the potential to treat patients with B cell malignancies who have not responded, relapsed, or are refractory to previous CD19-targeted CAR T therapies. The company expects to file an IND in 2023.

On Sunday, December 11, Sana scientist Jeremy Kinder, Ph.D., presented a poster (Abstract 3168) titled "BCMA-Targeted, Hypoimmune Allogeneic CAR T Cells Exhibit Potent Anti-Tumor Activity Together with the Ability to Evade Innate and Adaptive Immune Rejection in Pre-Clinical Tumor Models." The presentation showed that, in pre-clinical tumor models, HIP-modified BCMA-directed CAR T cells with the clinically-validated CT103A CAR construct licensed by Sana in January 2022 controlled myeloma tumor cells equivalently to HIP-modified CAR T cells with approved BCMA CAR constructs. In addition, HIP-modified BCMA CAR T cells showed equal in vitro efficacy and cytokine production against BCMA+ target cells compared to non-HIP BCMA CAR T cells. These data support advancing an allogeneic, HIP-modified BCMA-directed CAR T product to treat myeloma. Sana expects to file an IND for product candidate SC255 as early as 2024 to treat multiple myeloma.

On Sunday, December 11, Sana scientist Jesse Green, Ph.D., presented a poster (Abstract 3457) titled "CD8-Targeted, Integrating Viral Vectors Transduce Resting T Cells and Enable Extracorporeal Delivery (ECD) for Rapid CAR T Cell Therapies." The presentation highlighted that CD8-targeted CD19 CAR fusosomes are able to specifically transduce primary, non-activated CD8+ T cells to generate highly functional CAR T cells capable of eliminating CD19+ tumor cells in animal models. This result was accomplished by both a short-term ex vivo incubation with T cells followed by infusion, termed extracorporeal delivery (ECD), or by direct IV injection of fusosomes into animals engrafted with peripheral blood mononuclear cells. Data generated demonstrate ECD and direct IV are potential dosing options for patients with this fusosome for the in vivo production of CAR T cells. The company expects to study SG295, an in vivo CAR T with CD8-targeted fusosome delivery of a CD19-targeted CAR, in patients with B cell malignancies. With increased potency from a second-generation manufacturing process, SG295 has the potential to generate a comparable number of CAR T cells to current ex vivo manufacturing processes. The company remains on track to file an IND in 2023.

On December 11, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported positive new and updated data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2) evaluating investigational odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (Press release, Regeneron, DEC 11, 2022, View Source [SID1234625029]). These included first data from a Phase 2 cohort of patients naïve to prior CAR-T therapy (CAR-T naïve), as well as updated data from a dose expansion cohort of a Phase 1 trial in patients who had progressed on CAR-T therapy (post-CAR-T). The results were presented in an oral session at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in New Orleans, LA, and will form the basis of planned submissions to regulatory authorities in 2023, including to the U.S. Food and Drug Administration (FDA). Odronextamab is an investigational bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

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"People with diffuse large B-cell lymphoma face a disease that often relapses and becomes more aggressive each time it returns, leaving doctors with a shrinking set of treatment options," said Won Seog Kim, M.D., Ph.D., Samsung Medical Center and Division of Hematology-Oncology at Sungkyunkwan University, in Seoul, South Korea, and trial investigator. "The Phase 1 and pivotal Phase 2 odronextamab data demonstrated deep and durable responses that were consistent in patients who progress after CAR-T therapy, which is important as they have particularly difficult-to-treat disease and no effective treatment options. Coupled with its overall safety profile, these clinically important results reinforce the potential of odronextamab to treat this aggressive blood cancer."

At ASH (Free ASH Whitepaper), efficacy in R/R DLBCL was presented from 130 CAR-T naïve patients in a Phase 2 cohort (includes those with an opportunity for assessment at 12 weeks; median follow-up: 21 months, range: 3 to 30 months) and 31 CAR-T experienced patients in a dose expansion cohort of a Phase 1 trial (median follow-up: 24 months, range: 3 to 38.5 months). All patients had received at least two prior therapies, including a CD20 antibody and alkylating agent. Patients were treated with a step-up regimen of odronextamab in the first cycle to help mitigate the risk of cytokine release syndrome (CRS) before receiving the full dose of 160 mg. The step-up regimen was modified part way through the trial to further mitigate CRS. Results as assessed by independent central review were as follows:

Among CAR-T naïve patients, a 49% objective response rate (ORR), with 31% achieving a complete response (CR). The median duration of complete response (mDOCR) was 18 months (95% confidence interval [CI]: 10 months to not evaluable [NE]).
Among post-CAR-T patients, a 48% ORR, with 32% achieving a CR. The mDOCR was not reached (95% CI: 2 months to NE).
Among 140 patients in the Phase 2 cohort assessed for safety, adverse events (AE) occurred in 99% of patients, with 79% being ≥Grade 3. The most common AEs occurring in ≥20% of patients were CRS (55%), anemia (42%), pyrexia (39%), neutropenia (28%) and hypokalemia (20%). Discontinuations due to an AE occurred in 10% of patients, and there were 5 deaths due to pneumonia (n=3), COVID-19 (n=1) and pseudomonal sepsis (n=1) where the relationship to odronextamab treatment could not be excluded.

CRS was the most common AE, of which 64% of cases were mild (Grade 1) and all resolved within a median time of 2 days (range: 1-133 days). There were no Grade 4 or 5 CRS cases, and the incidence of Grade 2 or higher cases was reduced with the modified step-up regimen when compared to the original (original regimen n=67 vs. step-up regimen n=73; Grade 2: 18% vs. 14%, Grade 3: 7.5% vs. 1%).

Based on these data, the OLYMPIA Phase 3 development program investigating odronextamab in earlier stages of the disease is in the process of being initiated. In the U.S., odronextamab has been granted Fast Track Designation for DLBCL by the FDA. In the European Union, Orphan Drug Designation was granted for DLBCL by the European Medicines Agency. Odronextamab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on the company’s hematology portfolio on Wednesday, December 14 at 8:30 AM ET. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

About the Trials
ELM-2 is an ongoing, open-label, multicenter Phase 2 trial investigating odronextamab in more than 500 patients across five independent disease-specific cohorts, including DLBCL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-cell non-Hodgkin lymphoma (B-NHL). The primary endpoint is ORR according to the Lugano Classification, and secondary endpoints include CR, progression free survival, overall survival, duration of response, disease control rate, safety and quality of life.

ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy. Subcutaneous administration is being evaluated in two disease specific cohorts.

About Diffuse Large B-cell Lymphoma (DLBCL)
One of the most common subtypes of B-NHL, DLBCL is an aggressive form of B-NHL with up to 50% of patients with advanced stage disease progressing after first-line treatment (e.g., relapsing or becoming refractory to treatment). For patients with relapsed/refractory DLBCL, treatment options are limited and prognosis is poor.

On December 11, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported detailed results from the completed Phase 1b CIMON trial with MaaT033 at the Annual Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, U.S.
To access the abstract, please click here (Press release, MaaT Pharma, DEC 11, 2022, View Source [SID1234625026]).

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"MaaT Pharma’s mission is to improve cancer patients’ lives by driving innovation in the microbiome therapeutics field," said Hervé Affagard, CEO and co-founder of MaaT Pharma. "These positive Phase 1b results reinforces the strong potential for our MET oral formulation, MaaT033, and we plan to investigate it as an adjunctive and maintenance treatment in patients with hematological malignancies."

Prof. Mohamad Mohty added, "Allo-HSCT is often the only curative approach for patients with hematological malignancies such as acute leukemia. Evidence of a significant reduction in the risk of infection and GvHD-related mortality following stem cell transplantation has been associated with a higher gut microbiome diversity. Our ability to maintain or induce a high richness, and a high diversity gut microbiome would be key to prevent or minimize these adverse effects and contribute to a better overall prognosis for these patients."

Key clinical findings with MaaT033 in Phase 1b study CIMON

In the dose-finding Phase 1b CIMON trial, 21 patients with acute myeloid leukemia (AML) were treated with MaaT033 and evaluated for safety, tolerability, and initial signs of microbial species engraftment.

MaaT033 was shown to be safe and tolerable in 21 patients. 4 severe adverse events (SAEs) were reported in 4 patients, only one considered as possibly related by the investigator.
Treatment with MaaT033 induced increased microbiota richness as well as strong and persistent engraftment in cohorts 3 and 4 of the dose escalation study, which consisted in the intake of 3 capsules of the drug candidate per day.
Engraftment following MaaT033 treatment correlated with increased anti-inflammatory marker levels and reduced inflammatory marker levels.
Detailed results from the Phase 1b CIMON trial were presented in a poster on December 11 at the ASH (Free ASH Whitepaper) Annual Meeting by Prof. Mohamad Mohty, Head of the Clinical Hematology and Cellular Department at the Saint-Antoine Hospital and Sorbonne University. As previously announced, MaaT Pharma is currently preparing a pivotal Phase IIb randomized, double-blind, placebo-controlled to evaluate MaaT033’s safety, engraftment, and efficacy in improving overall survival at 12 months and preventing complications in patients with blood cancers receiving hematopoietic stem cell transplantation. Initiation should take place shortly and the Company will provide a detailed status update in January 2023.

About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem TherapyTM. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory ButycoreTM species.