CD89

JJP Biologics has received a positive conclusion on the Clinical Trial Application assessment for a Phase I Study of a potential first-in-class anti-CD89 antagonist, JJP-1212 monoclonal antibody for the treatment of various IgA-mediated autoimmune- and fibrotic diseases. WARSAW, Poland--(BUSINESS WIRE)-- JJP Biologics, a private biopharmaceutical company developing innovative antibody-based therapies, announces a positive decision, issued by the European Medicines Agency, on the Clinical Trial Application to conduct a phase I clinical study in healthy participants (EudraCT: 2023-508661-33-00) with their potential first-in-class anti-CD89 antagonist, JJP-1212. Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody. The Phase I trial will be executed in Poland. The study endpoints are designed for a comprehensive evaluation of the treatment's safety profile. The drug will be administered via intravenous infusion in single and multiple ascending dose cohorts. Population size was determined as 48 healthy adult volunteers. The study results will provide data on the safety and tolerability of JJP-1212, and full PK/PD profiles that subsequently enable the determination of optimal treatment regimens in future studies with patient populations. JJP Biologics intends to use Phase I read-outs as supporting data for a set of Phase II trials, in a range of therapeutic areas, and regions (including EU and the US). “I clearly remember the day when, Prof. Marjolein van Egmond, VU University Medical Center Amsterdam and Scientific Advisory Board member at JJP Biologics, told me about the exciting biology of the IgA-CD89 axis and its pathological consequences in autoimmunity. Stratification of patients can easily be achieved by measuring IgA autoantibodies beyond IgG and IgM levels. While safety data are still needed, this decision is an important milestone for patients suffering from IgA-mediated autoimmune or fibrotic diseases and validates the preclinical package of JJP-1212. I am very grateful towards the JJP Biologics team for all their efforts and the Starak family for their continued trust and support.” - Louis Boon, Ph.D., CSO and Management Board Member at JJP Biologics. According to Paweł Szczepański, COO and Management Board Member at JJP Biologics - “This is a historically unprecedented approval of a first-in-human clinical trial for a novel large molecule therapy from Poland. It forms a landmark that will further strengthen the position of the Polish biotech sector on the global map blazing the trail for many innovative therapies to come from this part of Europe. Including the next ones from the development platform of JJP Biologics.” “At JJP Biologics, we value science that helps to improve outcomes for rare-disease patients via delivery of innovative treatments. The recently approved study is ambitiously designed to swiftly build a foundation for further development to offer new treatment options for those living with high-burden autoimmune disorders.” – Dawid Łyżwa, Ph.D., Head of Clinical Development at JJP Biologics. “Expected study results will not only validate the safety but also contribute to deciding on extension of JJP‑1212’s development scope.” “I am delighted to hear that JJP Biologics is now starting its clinical program striving for delivery of a first-in-class treatment for IgA-mediated disease. I hope that JJP-1212-01-01 read-outs will deliver a strong foundation for further clinical development in various therapeutic areas, well beyond dermatology.” – Prof. Christoph Hammers, University Medical Center Regensburg, Germany. “As JJP-1212 targets the underlying cause of the disease – in case of success, it will be a valuable treatment option for a set of conditions with high unmet medical needs and may drive the clinical remissions for the multiplicity of severe patients. JJP Biologics demonstrates the commitment and devotion to the safety and wellbeing of patients.” – Prof. Pascal Joly, Rouen University Hospital, France JJP-1212 JJP-1212 is a first-in-class IgG4-κ anti-CD89 antagonist that is being developed to treat autoimmune and fibrotic diseases in which IgA autoantibodies are a key element of the disease pathophysiology. Alongside Linear IgA Bullous Dermatosis (LABD), JJP-1212 is being developed for a wide range of autoimmune- and fibrotic diseases where IgA is known to have significant pathogenic involvement (e.g. rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, neutrophilic asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, hidradenitis suppurativa, nonalcoholic steatohepatitis, IgA nephropathy, IgA vasculitis). JJP Biologics is exploring the development of companion diagnostics in various indications using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212. LABD LABD, also known as Linear IgA Bullous Dermatosis or linear IgA disease, is a chronic, debilitating disease that leads to skin separation, blistering, and in extreme cases, vision loss. Currently, no medicinal products are approved for the treatment of LABD in the European Union. The estimated incidence of LABD ranges from 0.2 to 2.3 cases per 1,000,000 people per year. JJP Biologics JJP Biologics is a clinical-stage biotechnology company that specializes in the development of therapeutic monoclonal antibodies accompanied by companion diagnostics for personalized treatment. JJP Biologics pursues the development of its product candidates as well as projects executed in cooperation with scientific partners. The company’s programs target general immune pathways that have applications in autoimmune diseases and cancer. JJP Biologics’ pipeline includes the most advanced JJP-1212, a potential first-in-class anti-CD89 antagonist for the treatment of autoimmune- and fibrotic diseases, and JJP-1008, a potential first-in-class anti-CD270 checkpoint inhibitor, for solid tumors. JJP-1212 Project is co-financed by the state budget by the Polish Medical Research Agency (No: 2022/ABM/05/00011). JJP Biologics is a privately funded biotech, partially financed from programs run by the Polish Medical Research Agency. In 2022, JJP Biologics became the first Polish company whose biological drug candidate (JJP-1212) received an Orphan Drug Designation from the European Commission, following the recommendation of the European Medicines Agency. For more information visit and join the #smartgoose community by following us on LinkedIn. For further information, please contact: Paweł Szczepański, COO, info@jjpbiologics.com. REFERENCES DISCLOSURE NOTICE We do not undertake any obligation to publicly update any forward-looking statements. View source version on businesswire.com: Contacts Paweł Szczepański, COO, info@jjpbiologics.com Source: JJP Biologics View this news release online at:

CAMBRIDGE, Mass., April 17, 2023 /PRNewswire/ -- Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company, today announced its presentation of two posters at the American Association for Cancer Research (AACR) Annual Meeting, being held in Orlando, Florida. "At AACR 2023, we are pleased to present late-breaking research on our in vivo engineering capabilities and clinical data from our Phase I IMAGINE study of MT-101 in PTCL patients," said Daniel Getts, Ph.D., Chief Executive Officer of Myeloid. "These data demonstrate the power of myeloid cells to orchestrate broad immune responses. We look forward to advancing our platform and expanding our clinical portfolio of in vivo programming candidates and ATAK™ CAR cell therapy candidates." Details of the poster presentations are below: Title: "In vivo delivery of novel CD89 fusion receptor to myeloid cells by mRNA activates anti-tumor immunity " Session: Late-Breaking Research: Experimental and Molecular Therapeutics 1 Session Date and Time: Sunday April 16, 2023, 1:30 PM - 5:00 PM Location: Poster Section 35 Poster Board Number: 19 Abstract Presentation Number: LB027 Abstract Highlights: Myeloid illustrates with this poster its ability to engineer circulating and tumor-penetrating myeloid cells so that these cells are activated within the tumor setting and elicit anti-tumor adaptive immunity. This approach is an attractive, novel manner to harness systemic anti-tumor immunity. Myeloid has applied its engineering insights to overcome challenges of specifically targeting and activating myeloid cells in vivo. Myeloid has developed a novel in vivo myeloid cell engineering platform, in which a chimeric antigen receptor (CAR) is generated by fusing a tumor recognition scFv with the alpha chain of human Fc receptors (CD89). The stable expression and function of these receptors requires the endogenously expressed common Fc receptor gamma chain (FcRg), which expression is mostly restricted to myeloid cells. For in vivo engineering, the construct is encapsulated and delivered in lipid nanoparticles (LNP). Myeloid's most-advanced in vivo programming candidate is a candidate referred to as MT-302, targeting trophoblast cell surface antigen 2 (TROP2) on cancer cells. TROP2 is overexpressed in most human solid epithelial cancers, as compared to low expression in corresponding normal tissue. Increased TROP2 expression has been linked to increased tumor growth and has been implicated as a prognostic marker in these cancers, supporting the development of earlier therapies targeting TROP2. Within immunodeficient xenograft models of hepatocellular carcinoma and triple negative breast cancer, delivery of LNP mRNA encoding GPC3-CD89 or TROP2-CD89 fusion proteins resulted in anti-tumor efficacy, confirming the ability of this approach to program myeloid cells. Repeat dosing studies showed significant anti-tumor efficacy following bi-weekly administration of TROP2-CD89. These studies highlight the potential of in vivo delivery of CD89 fusion proteins to program myeloid cells to recognize and kill cancer, thus providing a novel, promising approach to treating cancer. Title: "Initial Preclinical and Clinical Experience of Autologous Engineered Monocytes in T cell Lymphoma Patients" Session Category: Clinical Trials Session: Phase I Clinical Trials in Progress Session Date and Time: Monday April 17, 2023, 1:30 PM - 5:00 PM Location: Poster Section 46 Poster Board Number: 19 Published Abstract Number: CT131 Abstract Highlights: Myeloid developed the first engineered monocyte cell product, by engineering autologous monocytes to express a novel chimeric antigen receptor (CAR). This CAR contains a tumor recognition domain that is fused to a CD8 hinge domain, Fcγ and PI3K intracellular signaling domains. In addition to imparting tumor specificity, the Fcγ and PI3K signaling domains promote phagocytosis, cytokine production and antigen presentation upon activation. In a rodent model of melanoma (gp75+ B16/F10-OVA), Ly6C+ monocytes engineered with this receptor were able to phagocytose tumor cells and cross present antigen in vitro. In vivo infusion of engineered monocytes was associated with significant suppression of tumor growth. FACS analysis of tumor-infiltrates demonstrated that engineered monocytes preferentially infiltrated tumors and differentiated into antigen presenting cells. Based on these promising data, MT-101 is being assessed in humans in the Phase 1, open-label, first-in-human trial in patients with refractory or relapsed T cell lymphoma, IMAGINE trial (NCT05138458). The primary objective is the assessment of safety and tolerability at Day 28, following 3 weekly cycles of 2 infusions. Secondary objectives include assessment of correlative markers of response, pharmacokinetics, and efficacy. In the first 3 subjects, MT-101 was well-tolerated, with no evidence of CRS, ICANS, or infusion reactions. Examination of biomarkers by CyTOF in one subject showed changes in circulating leukocytes, including B cells. In this subject, survival has been greater than 10 months, while the median overall survival of patients with R/R PTCL is 5.5 months. Abstracts and full session details can be accessed through the AACR meeting planner: AACR Annual Meeting 2023 | Meetings | AACR. About Myeloid's ATAK™ CAR receptors and in vivo mRNA Programming Myeloid's novel class of CARs, known as ATAK™ Receptors, combine tumor recognition with multiple proprietary innate-immune signaling domains. Myeloid scientists have screened multiple unexplored combinations of innate-immune signals and uncovered optimal multi-signal pathways. The combination of cancer recognition binders with these novel intracellular signaling domains allows myeloid cells to be reprogrammed with previously unexplored combinations of immune signals, leading to tumor killing and broad systemic anti-tumor responses. Myeloid's novel in vivo engineering platform specifically targets and activates myeloid cells to elicit broader anti-tumor adaptive immunity. Through this approach, Myeloid demonstrates that delivery of lipid-nanoparticles (LNPs) encapsulating mRNA results in selective uptake and expression by myeloid cells in vivo, leading to potent tumor killing in multiple cold tumor models. These data demonstrate the potential for Myeloid's technology to program cells directly in vivo. About Myeloid Therapeutics Myeloid Therapeutics is a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases. Integrating the fields of RNA, immunology and medicine, the Company's proprietary platform provides clinical solutions by matching therapeutic modalities to disease conditions, including use of autologous cell therapies, in vivo cell programming using mRNA, RNA-based gene-editing using RetroT™ and multi-targeted biologics. For more information, visit . Investor and Media Contact Amy Conrad Juniper Point [email protected] SOURCE Myeloid Therapeutics

CAMBRIDGE, Mass., Nov. 10, 2022 /PRNewswire/ -- Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company, today presented multiple posters on its therapeutics platforms, ATAK™ CAR receptors and in vivo mRNA programming, at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, being held in Boston, MA, November 8-12, 2022. "The data presented at SITC further highlight the power of Myeloid's platform to enable broad immune responses and attack cancer cells, supporting the accelerated development of our deep clinical and preclinical pipeline," said Daniel Getts, Ph.D., CEO of Myeloid. "In particular, we are really excited about the progress we've made with in vivo programming with MT-302, our TROP2-FcA-LNP, that has shown confirmed tumor killing activity and strong expression in myeloid cells in non-human primates. We are planning to advance this program into the clinic and expect to file an IND in 2023." Myeloid has combined the power of mRNA with proprietary ATAK™ CAR receptors, to program myeloid cells to target and kill cancer through direct mechanisms and the elicitation of a broad anti-tumor responses, including the activation of T cells. Myeloid cells are a primary orchestrator of immune response and accumulate naturally within solid tumors, in some cases representing up to seventy-five percent of the tumor mass. Myeloid's adaptations of mRNA for the myeloid compartment have enabled the evolution to deliver these receptors directly to the patient without any ex-vivo cell engineering. Myeloid's novel in vivo engineering platform specifically targets and activates myeloid cells to elicit broader anti-tumor adaptive immunity. Through this approach, Myeloid demonstrates that delivery of lipid-nanoparticles (LNPs) encapsulating mRNA results in selective uptake and expression by myeloid cells in vivo, leading to potent tumor killing in multiple cold tumor models. These data demonstrate the potential for Myeloid's technology to program cells directly in vivo. Myeloid's lead program from this platform, MT-302, is a TROP2-FcA-LNP currently in IND-enabling studies for the treatment of multiple indications including colon, lung and breast cancer. MT-302 has demonstrated strong expression and favorable safety in myeloid cells in two species, rodents and non-human primates. In addition, treatment with MT-302 demonstrates monotherapy activity in a TROP2/TNBC model, confirming the potency of programmed myeloid cells in the absence of T cells. Myeloid believes that MT-302 has significant advantages over TROP2-ADC approaches through its ability to engage the full immune response. Myeloid's novel class of CARs, known as ATAK™ Receptors, combine tumor recognition with multiple proprietary innate-immune signaling domains. Myeloid scientists have screened multiple unexplored combinations of innate-immune signals and uncovered optimal multi-signal pathways. The combination of cancer recognition binders with these novel intracellular signaling domains allows myeloid cells to be reprogrammed with previously unexplored combinations of immune signals, leading to tumor killing and broad systemic anti-tumor responses that support their clinical development in cell therapies. SITC poster details: Title: "ATAK receptors, a new class of chimeric antigen receptors that harness innate immunity in myeloid cells to target cancer" Poster Number: 393 Session: Cellular Therapies Date and Time: November 10, 2022 9:00 am – 9:00 pm Title: "In vivo programming of myeloid cells by mRNA-mediated delivery of novel Fc alpha fusion receptor activates anti-tumor immunity" Poster Number: 1237 Session: Immuno-Engineering Date and Time: November 10, 2022 9:00 am – 9:00 pm The SITC abstracts have been published as a supplement in the Journal for ImmunoTherapy of Cancer (JITC), the society's global, open access, peer-reviewed journal. About Myeloid Therapeutics Myeloid Therapeutics is a clinical stage mRNA-immunotherapy company harnessing the power of myeloid cell biology to engineer new therapeutic alternatives for patients with cancer and autoimmune diseases. Integrating the fields of RNA biology, immunology, and medicine, the Company's proprietary platform provides clinical solutions that match therapeutic modalities to disease conditions, including use of autologous cell therapies, in vivo cell programming using mRNA, RNA-based gene-editing using RetroT™ and multi-targeted biologics. Myeloid is advancing a broad portfolio of clinical and preclinical candidates designed to enable full immune system responses. Myeloid has entered into strategic partnerships with Prime Medicine and Acuitas and is supported by well-known biotechnology investors. Myeloid is headquartered in Boston, MA.