Elpiscience Biopharma Ltd.

“Bispecific Antibodies Sales Surpassed USD 8 Billion In 2023 With More Than 50% YOY Growth” Bispecific antibodies represent a cutting edge class of therapeutic agents at the forefront of revolutionizing modern medicine. These molecules, engineered to bind simultaneously to two different targets, offer a unique and potent approach to treating a variety of diseases, particularly cancer. With their ability to harness the body's immune system to precisely target tumor cells while sparing healthy tissue, bispecific antibodies have garnered significant attention in both clinical and commercial markets across the globe. Clinically, bispecific antibodies clench immense promise as a cornerstone of precision medicine, offering targeted therapy tailored to individual patients' molecular pro By engaging immune effector cells, such as T cells or natural killer (NK) cells, bispecific antibodies orchestrate precise and potent immune responses against cancer cells, leading to tumor regression and improved patient outcomes. The versatility of bispecific antibodies allows for the development of therapies targeting various tumor antigens and immune cell populations, spanning a broad range of cancers and other ailments. Download Research: Besides that, the commercial market for bispecific antibodies is experiencing rapid growth, driven by the increasing demand for innovative and effective therapies across diverse therapeutic areas. The approval and commercial success of several bispecific antibodies, such as blinatumomab for acute lymphoblastic leukemia (ALL) and catumaxomab for malignant ascites, have validated the therapeutic potential of this class of molecules and spurred further investment and development. Pharmaceutical companies, biotechnology firms, and academic institutions are actively pursuing bispecific antibody programs, capitalizing on advancements in antibody engineering technology and strategic collaborations to accelerate the translation of promising candidates into clinical market. Several key factors driving the clinical and commercial success of bispecific antibodies include rise in cancer incidences, augmenting research and development, involvements of various stakeholders from the pharma and biotech company along with fostering research collaborations and investments in the realm. For instance, in December 2023, a research collaboration and license agreement are signed by Elpiscience and Astellas for the novel bispecific macrophage engager, ES019, and other programs. For these two programs, both the companies will work together to conduct early-stage research. In addition to cancer malignancies, other disorders like autoimmune diseases, infectious diseases, and neurological disorders are also being researched in the sphere. Their adaptable mode of action and capacity to interact with various targets render them appealing options for tackling unfulfilled medical requirements in various therapeutic domains. For instance, in a study conducted by researchers at The University of Texas MD Anderson Cancer Center, in 2023, developed fully human bispecific antibodies that bind to two different epitopes of the receptor binding domain (RBD) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein and neutralize a wide range of variants including the Omicron variant. One of the key prime movers which aid to expand the market of bispecific antibodies is the bestow from regulatory agencies and augmenting approval to novel and innovative bispecific antibodies. For instance, in August 2023, European Commission (EC) has approved TALVEY (talquetamab) for use as a monotherapy in treating adult patients with relapsed and refractory multiple myeloma (RRMM). Talquetamab is a bispecific antibody that engages T cells specifically by binding to CD3, which is present on the surface of T cells, and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target that is expressed on the surface of hard keratinized tissues and multiple myeloma cells. Looking ahead, the commercial market for bispecific antibodies holds immense potential for growth and expansion. Continued research, clinical development, and regulatory approvals will be instrumental in unlocking the full therapeutic potential of bispecific antibodies and addressing unmet medical needs across diverse patient populations. With their transformative impact on patient care and the potential to reshape the treatment landscape, bispecific antibodies are poised to play a pivotal role in advancing the future of medicine and improving outcomes for patients worldwide.

Astellas continued to expand in one of its key focus areas of immuno-oncology via a deal with Elpiscience Biopharma focused on bispecific macrophage engagers. The agreement, announced Thursday, includes Elpiscience’s anti-PD-L1/SIRPα bispecific antibody ES019.The preclinical therapy - based on Elpiscience’s bispecific macrophage engager (BiME) technology - is designed to reactivate macrophages and T-cells to kill cancer cells. ES019 targets SIRPα​ to block the “don’t eat me” signal, whilst activating the “eat me” signal via Fc engagement, leading to PD-L1 dependent specific phagocytosis of tumour cells​.Along with ES019, Astellas will gain a licence to another undisclosed bispecific macrophage engager, with the companies working together on early-stage research for the two programmes. The Japanese drugmaker also has the right to add up to two additional programmes to the collaboration.Under the agreed terms, Elpiscience will receive up to $37 million, including an upfront payment and licence option fees, and is eligible for research funding from Astellas. If the Japanese firm exercises its option, Elpiscience is eligible for over $1.7 billion in milestone payments, as well as single-digit to lower double-digit percent sales royalties.Astellas has been steadily building out its oncology pipeline, with Issei Tsukamoto, global head of business development, calling it a “hot area” for the company earlier this year in an interview with FirstWord. The Japanese firm has inked a number of cancer-focused deals in 2023, including with Cullgen, Phanes Therapeutics, Poseida Therapeutics, Propella Therapeutics and Sony.

SHANGHAI & SUZHOU, China & GERMANTOWN, Md.--(BUSINESS WIRE)-- Elpiscience Biopharmaceuticals, Inc. (“Elpiscience”), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, presented studies for its innovative immunotherapeutic molecules at the SITC 2023 Annual Meeting, including KG2A/NKG2C dual-targeting antibody ES015-2, a high affinity LILRB1 specific blocking antibody ES008-a, and the first-in-class anti-CD39/TGF-βRII bifunctional fusion protein ES014. Study Highlights: Title: Selective delivery of TGFβ “trap” to CD39-expressing immune and stroma cells reshapes tumor microenvironment and rejuvenates antitumor immunity Abstract Number: 453 CD39-Adenosine and TGFβ are two key immune suppressive pathways within the tumor microenvironment (TME). TGFβ, in contrast to its biphasic effects on tumor cells, acts on stromal cells and immune cells in the TME, which commonly express high levels of CD39, to promote tumor progression. CD39-targeted TGFβ “trap” is thus more likely to effectively inhibit tumor progression. Our study showed that ES014, a bifunctional antibody–ligand trap which comprises an antibody targeting CD39 fused to a TGFβ receptor II ectodomain, can inhibit TGFβ activity and lead to cancer killing in ex vivo models. A phase I clinical study is ongoing to primarily investigate the safety, tolerability, and preliminary clinical activity of ES014 in patients with advanced solid tumors. Highlights: ES014 binds and neutralizes both CD39 and TGFβ. ES014 promoted killing of tumors from NSCLC patients in ex vivo MPE model. ES014 inhibits Treg differentiation and TGFβ-induced CD39 expression on T cells. ES014 promotes T cell survival. Title: ES015-2, a first-in-class NKG2A and NKG2C dual-targeting antibody, demonstrated potent anti-tumor immune response Abstract Number: 498 The inhibitory receptor NKG2A and the activating receptor NKG2C modulate the function of NK and CD8 T cells by recognizing the same ligand HLA-E. NKG2A is selectively expressed on lymphocytes with cytolytic function, and the NKG2C “engager” has the potential to generate a strong antitumor response against various tumors. Inhibiting NKG2A and HLA-E alone was not as effective as had been expected in both mouse tumor models and in clinical trials. Our NKG2A/NKG2C dual targeting antibody ES015-2 can inhibit NKG2A function yet promoting NKG2C action, leading to superior anti-tumor response. Highlights: ES015-2 is a NKG2A/NKG2C dual targeting antibody. ES015-2 can completely block the interaction of NKG2A/CD94 with HLA-E, thereby inhibits HLA-E-induced NKG2A inhibitory signaling. Ligation of ES015-2 effectively potentiates the activation of NKG2C+ NK cells and T cells. Title: ES008-a, a high affinity LILRB1 specific blocking antibody activates multiple immune cells to fight cancers Abstract Number: 510 LILRB1 is the most broadly expressed member of LILRB family on various immune cells. Blocking LILRB1 augments macrophage phagocytosis of tumor cells, restores cytotoxic function of NK cells, and enhances tumor cell killing by effector CD8+ T cells. The high affinity LILRB1 specific blocking antibody ES008-a can activate multiple immune cells to fight cancers. Highlights: ES008-a is a high affinity LILRB1-specific blocker that can completely block HLA-G/LILRB1 and HLA-A2/LILRB1 interactions. ES008-a promotes NK cell-mediated destruction of tumor cells. ES008-a synergizes with CD47/SIRPα inhibitors in enhancing macrophage phagocytosis of tumor cells. About Elpiscience Elpiscience is a clinical-stage biopharmaceutical company dedicated to developing life-changing immuno-oncology therapies for cancer patients worldwide. The company’s innovative approach is focused on removing immunosuppressive factors in the tumor microenvironment, by targeting the adenosine pathway and myeloid checkpoints. A pipeline of novel molecules has been developed using its proprietary platforms including a powerful Bispecific Macrophage Engager (BiME®) technology that connects and activates macrophages for solid tumor killing without causing cytokine storms. For more information, please visit: View source version on businesswire.com: Contacts BD inquiries: BD@elpiscience.com Media inquiries: PR@elpiscience.com Source: Elpiscience Biopharmaceuticals, Inc. View this news release online at: