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SHANGHAI, Jan. 14, 2024 /PRNewswire/ -- Hope Medicine Inc. ('HopeMed'), a clinical-stage innovative biopharmaceutical company, announced recently that the company has completed a Phase Ib study, "An Open-Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period". This study is led by Professor Rodney Sinclair and included 12 male and 4 female patients in Australia with androgenic alopecia (AGA). HMI-115 demonstrated positive efficacy results. It is also safe and well-tolerated. Specifically, in the 12 male patients at the end of the trial, the mean non-vellus target area hair count (TAHC) increased by 14 hairs/cm2, compared to that of the baseline. This increase is statistically significant indicating an apparent confidence of treatment effect. "The positive outcome of this trial is very encouraging," said Professor Rui-Ping Xiao, founder of Hope Medicine, "this study is the first ever to show that prolactin receptor blockade can promote hair growth in patients with androgenic alopecia and may provide a novel therapeutic approach." "Encouraged by the success of this proof-of-concept trial," said Nathan Chen, CEO, "Hope Medicine has commenced recruitment for a Phase II study of AGA in China with 180 patients. We aim to achieve full PoC by the end of 2024." About Androgenic Alopecia Androgenetic Alopecia is the most common type of hair loss and affects up to 70% of men and 40% of women. While male and female pattern hair loss is commonly believed to be due to a combination of genetics and the male hormone dihydrotestosterone, the detailed mechanism remains unclear. Our data points to a role of prolactin/prolactin-receptors signaling in the disorder. About Hope Medicine Hope Medicine Inc. is a science-driven clinical-stage biopharmaceutical company with research laboratories and offices in Beijing, Shanghai, and Nanjing, China. HopeMed is established on the in-depth expertise in translational medicine and decades of research of Professor Rui-Ping Xiao's laboratory at the College of Future Technology of Peking University. Based on excellent scientific research and to improve the quality of life, HopeMed is committed to the research, development, and commercialization of first-in-class medicines for common and major diseases that threaten human health. The company finalized a Round B financing in May 2021 following a worldwide exclusive license agreement with Bayer AG on the development and commercialization of HMI-115. Besides HMI-115, HopeMed also established a diversified pipeline with internal R&D based on Professor Xiao's breakthrough research at the Institute of Molecular Medicine (IMM) at Peking University via a joint research lab. As a result, HopeMed brought in MG53 from Peking University, which is a protein with a new target. Preclinical studies have shown that this protein has a promising therapeutic effect on indications such as acute myocardial infarction. Forward-Looking Statements This press release contains forward-looking statements that are primarily based on the current outlook, expectations, estimates, and projections of the company's management team. When using "anticipate," "believe," "may," "design," "effect," "assess," "expect," "predict," "target," "aim," "purpose" and any other similar words and expressions, in references to the company, the intention of the statement is forward-looking. Forward-looking statements are subject to risks and uncertainties, many of which are difficult to predict and often beyond the company's control, which could cause actual results to differ from the forward-looking statements. The company undertakes no public announcement obligation to update or revise any forward-looking statement. CONTACT: Amber Chen, pr@hopemedinc.com SOURCE Hope Medicine Inc.

Chime Biologics to support the late-stage clinical study and to provide global commercial manufacturing services for Hope Medicine's first-in-class monoclonal antibody drug, HMI-115. The first-in-class mAb will benefit endometriosis and androgenetic alopecia patients. SHANGHAI, Oct. 26, 2023 /PRNewswire/ -- Chime Biologics, a leading CDMO that enables its partners' success in biologics, and Hope Medicine Inc. (HopeMed), a science-driven, patient-centric, clinical-stage biotech company, announced on September 28 that the companies are collaborating to develop and manufacture the first-in-class monoclonal antibody drug HMI-115. Under the terms of the agreement, Chime Biologics will provide one-stop-shop CMC solution for Hope Medicine's HMI-115 monoclonal antibody from technology transfer, process optimization, scale-up, clinical phase III GMP production, process characterization, process validation, BLA filing support, to commercial manufacturing. Hope Medicine will leverage Chime Biologics' extensive experience in 2000L cGMP manufacturing, late-stage CMC development and BLA filings to jointly accelerate HMI-115 mAb development and manufacturing for speedy clinical advancement of targeting endometriosis and androgenetic alopecia, benefiting more female patients and alopecia patients. Dr. Damian Tu, President of Hope Medicine, said, "HMI-115 is Hope Medicine's most critical and advanced clinical antibody drug asset. We are very pleased to enter this strategic collaboration with Chime Biologics, a leading CDMO service company with strong experience in late stage biologics development, manufacturing, and regulatory support, as well as with strong customer-centric culture and mindset. With the help from Chime Biologics, I am confident that we will be able to launch HMI-115 mAb in a fast pace and benefit patients that are suffering from EM and AGA. Hope Medicine's vision is to bring more first-in-class drugs and highly differentiated products to the world, especially to China. We look forward to more collaborations with Chime Biologics!" Dr. Jimmy Wei, President of Chime Biologics, said, "We are pleased to be a strategic partner of Hope Medicine. We are fully committed to driving the commercialization of HMI-115 mAb for the treatment of endometriosis and androgenetic alopecia to ensure the successful launch of this novel antibody drug. Currently, Chime Biologics has completed several late-stage CMC projects and is also in the process of commercial manufacturing for several post-market drugs. We are proud to empower our global partners to deliver clinical value for the benefit of patients." About HMI-115 HMI-115 is a first-in-class monoclonal antibody drug that Hope Medicine owns the global rights. In April 2019, Hope Medicine and Bayer AG signed an exclusive global license agreement for the development and commercialization of HMI-115, a monoclonal antibody targeting the prolactin receptor (PRLR), for multiple indications globally. Potential indications for the antibody include Endometriosis (EM), Androgenic Alopecia (AGA), and other chronic diseases. In 2021, Hope Medicine received approval from the FDA and EMA to conduct MRCT Phase II clinical trials for the treatment of endometriosis Hope Medicine has now completed patient enrollment and dosing at all clinical trial centers in the US and Europe. In November 2022, HMI-115 received clinical trial approval from the NMPA, and is currently conducting MRCT Phase II clinical trial in China for the treatment of endometriosis. In March 2023, Hope Medicine announced that HMI-115 received approval for a Phase II clinical trial in China for the treatment of androgenetic alopecia. About Endometriosis Endometriosis is a chronic estrogen-dependent gynecological disease defined by the presence of endometrium-like tissue outside the uterus, which induces a chronic inflammatory reaction. The endometrium is a layer of mucous tissue, which lines the uterus cavity and undergoes hormone-dependent changes during the menstrual cycle. Endometriosis is a common disease among women of reproductive age. The prevalence is estimated to be up to 10% in women of childbearing age worldwide. Lower abdominal and pelvic pain, cramping menstrual pains (dysmenorrhea), painful sexual intercourse (dyspareunia) and infertility are well recognized symptoms of endometriosis. It has been reported that Asian women have a higher endometriosis prevalence in comparison to Caucasians and African Americans. A recent study found the prevalence to be higher among Filipino, Indian, Japanese and Korean women (15.7%) when comparing to Caucasian women (5.8%). Endometriosis is typically associated with a lower quality of life and significant physical, sexual, psychological and social impact. The cause of endometriosis is not entirely clear, and there is no cure for endometriosis. Typically, there are two types of interventions: treatment of pain and treatment of endometriosis-associated infertility. About Androgenic Alopecia Androgenetic Alopecia is the most common type of hair loss and affects up to 70% of men and 40% of women. While male and female pattern hair loss is commonly believed to be due to a combination of genetics and the male hormone dihydrotestosterone, the detailed mechanism remains unclear. Data published by a Bayer team as well as data generated jointly point to a yet hardly recognized role of prolactin/prolactin-receptors signaling in the disorder. About Hope Medicine Hope Medicine (HopeMed) is a science-driven, patient-centric, clinical-stage biotech company with research and development bases in major innovation hubs in China. The company was established on the foundation of deep understanding of disease biology and translational medicine, and decades of scientific research in the laboratory of the founder, Professor Rui-Ping Xiao, at Peking University. With a management team of highly accomplished industry veterans combining entrepreneurship and global pharma experience, HopeMed is committed to the discovery, development, and commercialization of innovative, safe, effective, affordable medicines for large, underserved patient populations. Strategically, we are building a robust pipeline in the field of endocrine, cardiovascular and metabolic diseases, with a special focus on women's health, through internal R&D capabilities, access to external technology platforms to enable a variety of molecular modalities, as well as in-license of complementary and differentiated assets to address unmet medical needs. For more information, please visit . About Chime Biologics Chime Biologics is a leading CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners' success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health. For more information, please visit . SOURCE Chime Biologics

- X213 shown to be safe and effective, demonstrating complete suppression of lactation in study participants BERKELEY, Calif., April 24, 2017 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery and development of therapeutic antibodies, today announced that it has achieved positive Phase 2 proof-of-concept results for X213 in physiological hyperprolactinemia (HPRL). X213 is a monoclonal antibody that neutralizes prolactin action.  “This proof-of-concept study was an important milestone in demonstrating the potential efficacy of this novel antibody. We believe that X213 could be a treatment option for a wide range of patients with hyperprolactinemia including prolactinoma and anti-psychotic induced HPRL as the signs and symptoms are similar irrespective of the etiology,” said Jim Neal, Chief Executive Officer of XOMA. “Consistent with our business strategy, we intend to maximize the value of X213 for shareholders by seeking a license partner for the program.” The Phase 2 study was a multi-center, open-labelled, randomized, single-dose, controlled trial of intravenously administered X213 in women who wished to suppress lactation immediately post-partum. The results of the study indicate that X213, when given as a single 700mg intravenous infusion during the first day post-partum, was effective in suppressing milk secretion, as well as breast engorgement and pain in 100 percent of the treated women. In addition, none of the treated women experienced rebound breast symptomatology during the 21-day study period. While the study was not intended, or powered to show statistical significance, it demonstrated that X213 was: safe and well tolerated; caused no significant adverse events (SAEs); showed favorable pharmacokinetics with a terminal half-life of two weeks and; demonstrated target (prolactin receptor) engagement and mechanism of action confirmation by serum prolactin profiling. “The findings from this proof-of-concept study are encouraging and confirm that X213 inhibits prolactin signaling and thus, may be effective in blocking effects of symptomatic hyperprolactinemia,” said Dr. Shlomo Melmed, endocrinologist, Dean of the Medical Faculty and Professor of Medicine, Cedars-Sinai Medical Center, Los Angeles. “New classes of drugs such as X213 may offer benefit to the up to 20 percent of patients who do not respond to, or are intolerant of, current standard of care involving dopamine agonist medications.” Prolactin is a multifunctional hormone that is primarily secreted by the pituitary and whose best-known functions are related to lactation and reproduction. In pregnant women, excess prolactin secretion (hyperprolactinemia) occurs to enhance breast development and to induce lactation postpartum. Commonly encountered etiologies of hyperprolactinemia include prolactinoma, medication effect, kidney failure, cystic or granulomatous pituitary lesions, and disorders which interfere with hypothalamic inhibition of prolactin release. Prolactinomas, benign tumors of the pituitary gland, hypersecrete prolactin with significant medical consequences, particularly hypogonadism, infertility and osteoporosis. About X213 X213 (formerly LFA 102) is a first-in-class allosteric inhibitor of prolactin action. It is a humanized IgG1-Kappa monoclonal antibody that binds to the extracellular domain of the human prolactin receptor with high affinity at an allosteric site. The antibody has been shown to inhibit prolactin-mediated signaling, and it is potent and similarly active against animal and human prolactin receptors. The Phase 2 study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of X213 in post-partum women. The study was conducted at multiple medical centers in Spain. About XOMA Corporation XOMA has an extensive portfolio of products, programs, and technologies that are the subject of licenses the Company has in place with other biotech and pharmaceutical companies.  Many of these licenses are the result of the Company's pioneering efforts in the discovery and development of antibody therapeutics. There are more than 20 such programs that are fully funded by partners and could produce milestone payments and royalty payments in the future. In order to maximize its value in a licensing transaction, XOMA continues to invest in X358, an allosteric monoclonal antibody that reduces insulin receptor activity, as the antibody could have a major impact on the treatment of hyperinsulinism. For more information, visit . Forward-Looking Statements Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding: X213 as a potential treatment option for patients with hyperprolactinemia including prolactinoma and anti-psychotic induced HPRL; XOMA's portfolio of partnered programs and licensed technologies; XOMA's intent to license X213 and X358; and statements that otherwise relate to future periods. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.Investor contact: Luke Heagle Pure Communications +1 910-726-1372 lheagle@purecommunications.com Media contact: Colin Sanford Pure Communications +1 415-946-1094 csanford@purecommunications.com