Latest news with #IgG4-related
USA Today
23-04-2025
- Health
- USA Today
She saw 26 doctors and had 37 procedures with no diagnosis in sight. Then, an answer.
She saw 26 doctors and had 37 procedures with no diagnosis in sight. Then, an answer. Show Caption Hide Caption How important is your family medical history? If you've been to a doctor before, you've probably been asked about your family medical history. How important is it actually? unbranded - Lifestyle Nika Beamon thought she was going to die. The former college athlete always played high-impact sports. Rugby, ice hockey, you name it. Always knocked down but toughing it out. By the time she was a senior at Boston College, though, toughing it out grew impossible. Waking up everyday was a struggle. Aches appeared out of nowhere, even when she wasn't exercising. She ran spontaneous fevers, like she was fighting an infection. Test after test – for mono, for anything – all failed to spit out a diagnosis. She had no family history of diseases; her brothers were perfectly healthy. But everyone agreed on one thing: Something was up. "I did not have any doctor who didn't think nothing was wrong," the now 52-year-old award-winning journalist says. "Everybody thought something was wrong. They just didn't know what it was." Fatigue and joint pain plagued her 20s. She suffered two strokes by the time she turned 35. Her lymph nodes swelled constantly, but biopsies showed no cancer. "I don't know who this is, but this doesn't seem like me," she adds. "I felt like I was aging rapidly. It was like, as if you went from 20 to 50 in a day." Beamon set out on a journey, and 26 doctors, 37 procedures and more than 17 years later, a rheumatologist finally cracked the confounding code: She had immune disorder IgG4-related disease, and all she needed was a blood test to confirm it. "There's no way I could have been to this many doctors and had this much blood drawn and nobody saw it," Beamon recalls. "(Her doctor) said, 'Well, they wouldn't be testing for it unless there was a reason.'" I got 14 tests done at this resort: I didn't need most of them. 'Most patients do well' IgG4-RD is an immune-mediated disorder. When someone has it, their immune system goes into overdrive, producing more antibodies (or immunoglobulins, hence the name) than necessary that disrupt typical organ function. "It's not cancers or anything," says Dr. Arezou Khosroshahi, associate professor at Emory University School of Medicine. "It's just that they are confused and they are reacting to something." The disease itself is not deadly, but left untreated, the antibodies can infiltrate different parts of the body like the pancreas, lung or liver. For example, if an accumulation of cells block the bile ducts, a patient can develop cirrhosis, or liver damage. The same pattern may pop up across different organs. Another wrinkle: Patients may be asymptomatic. If you catch it on time, a patient can live a normal life with regular follow-up appointments. But if someone's organ(s) already had severe dysfunction, you'll have to treat any associated consequential conditions, too. "I can't emphasize enough, this is very important, because people think, 'Oh, I've got a steroid and I feel much better, so I don't need treatment,' but then they come back two years later with significant damage. But in general, if this disease is diagnosed on time and treated, most patients do well." It's a challenging diagnosis, as the disease mimics other conditions. A majority of the time, if the cell accumulation turns into a mass, a doctor will do a biopsy to make sure it's not cancer. As more awareness of the disease grows, a radiologist might look at a CT scan and notice a similar pattern of inflammation or swelling across multiple organ systems that put IgG4-RD into a diagnosis differential. It mostly affects middle-aged and older men, though anyone can have it regardless of age, gender, race or ethnicity. Japanese gastroenterologists first recognized the condition in 2006, with Khosroshahi and colleagues at Massachusetts General Hospital identifying it in 2008. The disease was officially named in 2012 at the premier symposium focused on IgG4-RD. In case you need: Boost your immune system to fight germs 'You still have good days and bad days' Beamon takes medication and sees all kinds of doctors today to keep her organs in check. She started out with steroids to keep her inflammation down, but they're notorious for rough side effects, not meant to be taken long-term. IgG4-RD has been typically treated with a taper dose of a steroid like prednisone, followed by off-label immunosuppressive medications. The FDA recently approved new drug Uplizna to treat IgG4-RD, the first to treat the specific condition. It's a monoclonal antibody that targets certain B-cells to inhibit production of IgG4; in a clinical trial, it had an 87% reduction of flare-ups of the disease. "You still have good days and bad days, and that's the thing," Beamon says of how she currently lives with the disorder. "Depends on when you have a flare or the inflammation is high." She's coped well with a supportive online community, particularly after she began documenting her journey and writing a book: "Misdiagnosed: The Search for Dr. House." Beamon hopes anyone searching for a diagnosis advocates for themselves, keeps track of their medical records and brings loved ones to appointments with them. Don't think your doctor knows more about your body than you do, either. Still, she doesn't blame anyone for not figuring out her IgG4-RD sooner. "I found it when I found the right person who looked outside the box and said, 'forget what she looks like. Forget what they're telling you. Let me just look at what the documents tell me that she might have' and that's how we got there," she says. "But I don't think it was anybody's fault." Her biggest takeaway, though – apart from do not Google your symptoms too much, because every website will tell you you're dying – keep the faith. "There's always a doctor out there that can help you. You just have to find the right one."
Associated Press
17-03-2025
- Business
- Associated Press
Zenas BioPharma Appoints Lisa von Moltke, M.D., as Head of Research and Development and Chief Medical Officer
–Dr. von Moltke brings over 30 years of deep drug development experience and a proven track record of clinical and regulatory success at both large and emerging global biopharmaceutical companies– WALTHAM, Mass., March 17, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. ('Zenas' or the 'Company') (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today announced the appointment of Lisa von Moltke, M.D., as its Head of Research and Development and Chief Medical Officer (CMO). Dr. von Moltke brings over 30 years of U.S. and international drug development experience spanning multiple therapeutic areas, including autoimmune diseases, early- and late-stage clinical development, and commercialization at both large and smaller emerging growth companies. 'I am delighted to welcome Lisa to the Zenas leadership team as we advance obexelimab through Phase 2 and Phase 3 clinical trials in an effort to meaningfully impact the lives of patients with autoimmune diseases, including IgG4-related disease, multiple sclerosis, and systemic lupus erythematosus,' said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. 'Zenas will benefit from Lisa's proven leadership and extensive drug development experience, including her successful track record of moving multiple products through development and global regulatory approvals.' 'It is an exciting time to join Zenas, as we approach multiple meaningful clinical trial results, and I am eager to help the company achieve its objectives and bring obexelimab to patients with autoimmune diseases throughout the world,' said Dr. von Moltke. 'I believe obexelimab's unique ability to inhibit the activity of B cells without depleting them, along with its demonstrated clinical activity and self-administered, subcutaneous injection regimen, represent a compelling profile and opportunity to potentially address the challenges that still exist in treating patients with chronic autoimmune diseases, including IgG4-related disease, multiple sclerosis, and systemic lupus erythematosus.' Dr. von Moltke most recently served as CMO at Seres Therapeutics with functional oversight of clinical development, sciences and operations, and regulatory and medical affairs. Prior to Seres, Dr. von Moltke served in roles of increasing responsibility at Alkermes, Inc., culminating as Senior Vice President and Head of Clinical Development. Before joining Alkermes, Dr. von Moltke was Vice President, Clinical and Exploratory Pharmacology at Sanofi/Genzyme Corporation, where she also served as U.S. Head Clinical & Exploratory Pharmacology Sciences (CEP) and Early Development and later as Head of CEP for Japan and China. Earlier in her career, Dr. von Moltke was Head, Translational Medicine at Millennium: The Takeda Oncology Company. Dr. von Moltke was a practicing physician and completed a fellowship in clinical pharmacology at Tufts University School of Medicine and had an academic career in pharmacology and developmental therapeutics that spanned fifteen years. She has also served as President of the American College of Clinical Pharmacology and as Editor-in-Chief of The Journal of Clinical Pharmacology. Dr. von Moltke earned a B.A. at Wellesley College and an M.D. from Michigan State University, College of Human Medicine, and she is a current member of the Board of Directors at Cara Therapeutics, Inc. About Zenas BioPharma, Inc. Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas' lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab's unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit and follow us on LinkedIn. Forward looking statements This press release contains 'forward-looking statements' which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning Zenas's plans, objectives, expectations and intentions; advancing our clinical trials with obexelimab and the expected results from the phase 3 INDIGO trial, the MoonStone trial and the SunStone trial; and obexelimab's potential benefits and opportunity to potentially address the challenges that still exist in treating patients with chronic autoimmune diseases, including IgG4-RD, MS and SLE. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company's actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company's limited operating history, incurrence of substantial losses since the Company's inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company's need for substantial additional financing to achieve the Company's goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company's current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company's product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company's current indications; the Company's ability to realize the benefits of the Company's current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company's ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company's dependence on the services of the Company's senior management and other clinical and scientific personnel, and the Company's ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company's ability to grow the Company's organization, and manage the Company's growth and expansion of the Company's operations; risks related to the manufacturing of the Company's product candidates, which is complex, and the risk that the Company's third-party manufacturers may encounter difficulties in production; the Company's ability to obtain and maintain sufficient intellectual property protection for the Company's product candidates or any future product candidates the Company may develop; the Company's reliance on third parties to conduct the Company's preclinical studies and clinical trials; the Company's compliance with the Company's obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company's product candidates; risks related to the operations of the Company's suppliers, many of which are located outside of the United States, including the Company's current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section 'Risk Factors' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company's control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. The Zenas BioPharma word mark, logo mark, and the 'lightning bolt' design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. Investor Contact: Matthew Osborne Media Contact:
