Category: 3. Business

As treatment approaches in multiple myeloma continue to advance, new areas of controversy arise, leading to undefined expectations within clinical practice, according to Ajai Chari, MD.

Accordingly, experts gathered at the inaugural Bridging the Gaps in Leukemia, Lymphoma, and Multiple Myeloma Conference to identify current controversies or challenges in the field and come to a consensus about the optimal approaches to myeloma management. An overview of these findings was published in a manuscript after the meeting.

“There’s a joke in that if you ask myeloma doctors for an opinion, you’ll get 6 answers. This [meeting] shows that there’s a lot of complexity and evolving data [in the multiple myeloma space],” Ajai Chari, MD, explained in an interview with OncLive®.

During the interview, Chari detailed the importance of publishing this manuscript; the limitations to current risk stratification approaches in smoldering multiple myeloma; ongoing challenges regarding determination of the optimal timing for treatment initiation; and what the potential FDA approval of daratumumab (Darzalex) could mean for this patient population.

Chari is director of the Multiple Myeloma Program and a professor of medicine in the School of Medicine at the University of California, San Francisco.

OncLive: What is the importance of publishing this manuscript from the Bridging the Gaps in Leukemia, Lymphoma, and Multiple Myeloma?

Chari: The purpose of this manuscript is to put a bunch of experts in the room and see how people think, where we agree, and where the areas of controversy are that we need to work on. It’s really for people who may not be doing this day in and day out, [in which we] take a little look under the hood, [so to speak].

How is risk stratification approached for smoldering multiple myeloma? Are there any limitations to current models?

Conventionally, risk stratification for smoldering has been based on static models. For example, how much M-spike [is present]? What’s the light chain? What’s the bone marrow burden? What are the immunoglobulin levels? The limitation there is that the date of diagnosis of smoldering myeloma is typically the date of the marrow, but somebody could have been smoldering prior to the marrow for anywhere from a month or 2 years. When you try to figure out who’s going to progress in the short term, that’s a big confounding variable. Although we need static models, because they’re convenient, we need more dynamic models, which tell us how the tumor is evolving. Are the protein levels going up? Is the hemoglobin drifting down? Are the bone lesions evolving? Those are where the field needs to go. Also, incorporating genetics, immune markers, and genomic markers. We haven’t gotten there yet, and that’s the struggle of serious stratification.

What are some key considerations when deciding on an optimal time to initiate therapy and treatment strategies in smoldering multiple myeloma?

The struggle with treating patients with smoldering myeloma is that they are essentially healthy people. They don’t have active myeloma. [The important questions are:] how do you not over-treat these patients with potentially toxic therapies that could cause adverse effects to help the individuals? Also, how do we not under-treat these patients? If we have amazing therapies that can help prevent symptoms and the onset of myeloma, shouldn’t we be doing that? That’s the tightrope that we have to walk in figuring out what the right time to initiate is. That’s where the risk stratification can help us make that decision.

What would the FDA approval of daratumumab mean for this space?

[Data from] the [phase 3] AQUILA study [NCT03301220] published in The New England Journal of Medicine showed, in a randomized fashion, that observation vs treatment with daratumumab…led to improved response, including progression-free survival and, surprisingly, overall survival. We just heard that the European Medical Association voted favorably on it; if that’s FDA approved, we could give patients with smoldering myeloma a relatively well-tolerated therapy, [particularly those who] we are concerned about progressing.

[Nevertheless], I’m most excited [to potentially use daratumumab plus lenalidomide [Revlimid], bortezomib [Velcade], and dexamethasone [Dara-VRd] for older patients who have smoldering myeloma and may have a high risk of progression. [These patients likely] would not be excited about having to receive a multidrug therapy in the future. [Therefore], it’s very reasonable to consider this

[Daratumumab] is a monoclonal antibody to help prevent the development of myeloma and potentially confer those clinical benefits. The challenge is that the study included 3 years of therapy, and that’s a [relatively] long period. Where I struggled more is with the younger patients; where they are now, they could easily tolerate multidrug therapy. However, do we need to commit everybody to 3 years of preventative therapy? This is another tightrope we have to walk.

Reference

Chari A, Bal S, Ailawadhi S, et al. Expert Perspectives on Current Challenges and Emerging Approaches for Multiple Myeloma: Narrative Review of an Inaugural Bridging the Gaps in Leukemia, Lymphoma, and Multiple Myeloma. Clin Lymphoma Myeloma Leuk. Published online March 11, 2025. doi:10.1016/j.clml.2025.03.008

Dear faculty and staff,

The next Circles of Excellence, on Aug. 7, will focus on how to increase your email marketing response rates and better understand your target audience.

Discover 5 strategies to increase your email marketing response rates

Ready to boost your email engagement? In this virtual presentation led by Strategic Marketing and Communications, we’ll explore five proven strategies to increase response rates in your email marketing and communications.

Backed by real-life examples and UIC-specific data, this session will highlight actionable tactics you can start using right away — including A/B testing, audience segmentation, personalized messaging and data-driven decision-making — all within UIC’s official Emma Email Marketing platform.

When:
1-2:30 p.m. Thursday, Aug. 7

Where:
Virtual via Zoom
Advance registration is required.

Who should attend:
Anyone who creates and sends email marketing campaigns using UIC’s Emma email marketing platform.

For questions or more information, please email smcs@uic.edu.

Together, let’s continue to elevate the transformational story of UIC, where access is broad and excellence thrives.

Gratefully,
Chandra Harris-McCray, PhD
Vice Chancellor for Strategic Marketing and Communications

For more information, please contact:
Strategic Marketing and Communications
smcs@uic.edu

Routine echocardiographic surveillance in adults with muscular dystrophy may uncover early signs of left ventricular systolic dysfunction (LVSD) and prompt timely intervention, but physical limitations can make consistent monitoring a challenge. Artificial intelligence (AI)–based electrocardiogram interpretation (AI-ECG) could offer a noninvasive, accessible alternative to routine echocardiography, according to findings published in the Journal of the American Society of Echocardiography.¹

“Our findings have potential implications for clinical practice. Current guidelines recommend routine echocardiographic monitoring for muscular dystrophy patients, typically on an annual or biannual basis,” the authors wrote. “However, obtaining high-quality echocardiographic images can be challenging due to patient-specific factors such as scoliosis and muscle weakness. Our findings suggest that AI-ECG could serve as a complementary screening tool, potentially allowing for more flexible and patient-friendly monitoring strategies.”

Cardiac complications are substantial contributors to mortality in muscular dystrophies, including Duchenne muscular dystrophy (DMD), in which up to 70% of patients experience LVSD.² Despite the recommendations for regular electrocardiography, capturing high-quality echocardiographic images can be challenging for patients with muscular dystrophy due to scoliosis, muscle weakness, immobility, and other physical limitations, the authors noted.¹

“Given these limitations and the current pressure on echocardiography availability in our health care systems, alternative methods for LVSD risk stratification are urgently needed,” the authors wrote. “[AI] applied to [AI-ECG] has shown promise for predicting LVSD in various populations. An ECG is widely accessible, cost-effective, and quick to perform (also in immobile populations), with the potential for home monitoring applications.”

The researchers identified patients with DMD, Becker muscular dystrophy, limb-girdle muscular dystrophy, or myotonic dystrophy who were 16 years or older and underwent an ECG and transthoracic echocardiogram within 90 days of each other at the University Medical Center Utrecht hospital in the Netherlands between 2007 and 2023. The data pool also included female carriers of DMD or BMD, who are also at a higher risk of cardiac complications.

A convolutional neural network was first trained using a derivation cohort of 53,874 ECG-echocardiogram pairs from 30,978 patients without muscular dystrophy to detect LVSD, then it was tested on a set of 390 ECG-echo pairs from 390 patients with muscular dystrophy. The researchers used a Cox proportional hazards model to determine the predictive value of AI-ECG for new-onset LVSD.

Follow-up echocardiography was available for 177 patients without LVSD at baseline. At a median follow-up of 4.8 (IQR, 2.6-8.6) years, LVSD occurred in 92 (52%) patients. LVSD prevalence ranged from 13.4% in patients with myotonic dystrophy to 81.3% in patients with DMD. No BMD female carriers showed LVSD, but 17.4% of DMD carriers had LVSD.

In the validation set, the model achieved an area under the receiving operator curve (AUROC) of 0.86 (95% CI, 0.85-0.88), sensitivity of 0.90 (95% CI, 0.88-0.92), and specificity of 0.58 (95% CI, 0.56-0.60). In the muscular dystrophy test set, the model demonstrated an AUROC of 0.83 (95% CI, 0.79-0.87), sensitivity of 0.87 (95% CI, 0.81–0.93), and specificity of 0.58 (95% CI, 0.52-0.63). The negative predictive value was 0.91 (95% CI, 0.86-0.95), and the positive predictive value was 0.49 (95% CI, 0.43-0.53).

The model overall showed an AUROC of 0.72 (95% CI, 0.66-0.78) for predicting new-onset LVSD, and the AI-ECG probability was a significant predictor of LVSD occurrence.

Despite the model’s potential, the authors cautioned that timely diagnosis of LVSD and initiation of cardioprotective treatment are crucial. Therefore, AI-ECG must be evaluated in a structured clinical framework to ensure that it improves established monitoring methods rather than replaces them. The clinical utility, cost-effectiveness, and optimal integration of AI-ECG into current care standards must also be determined through prospective studies and cluster randomized trials, they added. Their study was also limited by its single-center nature and reliance on routine clinical interpretation of echocardiograms.

“This study demonstrates that AI-ECG can accurately detect and predict LVSD in muscular dystrophy patients, offering a non-invasive, widely accessible, and applicable tool for cardiac risk stratification,” the authors concluded. “The ability to detect and predict LVSD may enable more personalized follow-up strategies, reducing reliance on echocardiography. Future research should focus on external validation and pediatric application.”

References

1. Arends BKO, Zwetsloot PM, Heeres PS, et al. Left ventricular systolic dysfunction screening in muscular dystrophies using deep learning-based electrocardiogram interpretation. J Electrocardiol. Published online June 12, 2025. doi:10.1016/j.jelectrocard.2025.154048

2. Verhaert D, Richards K, Rafael-Fortney JA, Raman SV. Cardiac involvement in patients with muscular dystrophies: magnetic resonance imaging phenotype and genotypic considerations. Circ Cardiovasc Imaging. 2011;4(1):67-76. doi:10.1161/CIRCIMAGING.110.960740

BEIJING, June 30, 2025 (GLOBE NEWSWIRE) — TIAN RUIXIANG Holdings Ltd (Nasdaq: TIRX) (the “Company” or “TRX”), a China-based insurance broker, today announced it has completed the acquisition of 100% of issued and outstanding shares of Ucare Inc. (“Ucare”), the sole operator of China’s only cloud-based AI-driven hospital and health insurance risk management platform. The all-stock transaction, valued at US$150 million, marks a major milestone in TRX’s strategy to expand into in-hospital distribution channels and capture new growth opportunities within the health insurance sector.

As part of the closing, TRX has issued 101,486,575 Class A ordinary shares, each with a par value of US$0.025. Powered by the largest hospital database and a cloud-based generative AI platform, Ucare develops innovative healthcare solutions that help providers, payers, and institutions reduce fraud, abuse, waste, and administrative costs. Following the acquisition, Ucare will harness TRX’s robust platform, capital resources, and strategic relationships to advance R&D, embed cutting-edge generative AI into clinical pathways, and broaden its reach from healthcare providers to insurance partners.

Leveraging Ucare’s existing relationships with over 4,000 hospitals and leading AI analytics, TRX will expand business channels and build unique health insurance service offerings. Ucare’s generative AI platform will be integrated into TRX’s underwriting and claims processing health insurance workflows to reduce fraud, streamline operations, and improve pricing precision.

Ms. Sheng Xu, Director, Chairwoman and Chief Executive Officer of TRX, stated, “We are thrilled to officially welcome Ucare to the TRX family. This acquisition places us at the intersection of healthcare and insurance, unlocking data-driven insights that will transform how health insurance is designed, sold, and serviced. In the coming months, we are focused on expediting Ucare’s growth by building on the success it’s already achieved, while designing differentiated offerings that align with evolving patient needs and national healthcare priorities. Our long-term goal is to create a seamless insurance-hospital ecosystem that enhances transparency, efficiency, and accessibility for all stakeholders.”

Mr. Wei Zhu, Chief Executive Officer of Ucare, added, “Joining TRX opens an exciting new chapter for Ucare’s mission to reshape hospital and health insurance risk management in China. With TRX’s resources, we are well-positioned to accelerate our platform deployment and deepen integration with insurance services. Together, we will lead the next wave of innovation in medical cost containment and health insurance.”

About TIAN RUIXIANG Holdings Ltd
TIAN RUIXIANG Holdings Ltd, headquartered in Beijing, China, is an insurance broker operating in China through its China-based variable interest entity. It distributes a wide range of insurance products, which are categorized into two major groups: (1) property and casualty insurance, such as commercial property insurance, liability insurance, accidental insurance, and automobile insurance; and (2) other types of insurance, such as health insurance, life insurance, and other miscellaneous insurance.

About Ucare Inc.
Ucare Inc. develops innovative healthcare solutions that enable providers, payers, and institutions to reduce fraud, abuse, waste, and administrative costs. Powered by the largest hospital database, Ucare’s cloud-based generative AI platform continuously refines disease models by integrating real-world data, the latest medical guidelines, and real-time intelligence. Ucare’s vision is to ease the burden on patients, expand coverage, and ultimately improve access to healthcare for everyone.

Forward-Looking Statements
Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review risk factors that may affect its future results in the Company’s registration statement and in its other filings with the U.S. Securities and Exchange Commission.

For investor and media enquiries, please contact:
TIAN RUIXIANG Holdings Ltd
Investor Relations Department
Email: ir@tianrx.com

Water Tower Research
Feifei Shen
Email: feifei@watertowerresearch.com

Treatment with the combination of the first-in-class Bicycle drug conjugate (BDC) zelenectide pevedotin (BT8009) and pembrolizumab (Keytruda) was safe and generated antitumor activity in patients with previously untreated, cisplatin-ineligible, locally advanced or metastatic urothelial carcinoma, according to data from the phase 1/2 Duravelo-1 trial (NCT04561362).

Findings presented at the 2025 ASCO Annual Meeting showed that at a median follow-up of 7.1 months (range, 1.0-13.2), evaluable patients treated with the combination (n = 20) achieved an overall response rate (ORR) of 65.0% (95% CI, 40.8%-84.6%), comprising a complete response rate of 25.0% and a partial response rate of 40.0%. The stable disease rate was 25.0%, and the disease control rate (DCR) was 90.0%. Duration of response (DOR) data were not mature.

Regarding safety, any-grade treatment-emergent adverse effects (TEAEs) occurred in all patients (n = 22), and 72.7% experienced grade 3 or higher TEAEs. Treatment-related AEs (TRAEs) of any grade were reported in all patients, including 68.2% who had grade 3 or higher TRAEs. Any-grade and grade 3 or higher zelenectide pevedotin–related TRAEs occurred at rates of 90.9% and 59.1%, respectively. These rates were 95.5% and 50.0%, respectively, for pembrolizumab.

Serious AEs were reported in 54.5% of patients, including 50.0% who had grade 3 or higher serious AEs. TEAEs led to dose reductions and dose discontinuations of zelenectide pevedotin in 50.0% and 4.5% of patients, respectively. These rates were 0% and 9.1%, respectively, for pembrolizumab.

“These data support a randomized, multicenter, open-label, phase 2/3 trial [NCT06225596] of zelenectide pevedotin as monotherapy and in combination with pembrolizumab vs chemotherapy in patients with locally advanced/metastatic urothelial cancer,” lead study author Patrizia Giannatempo, MD, of Fondazione IRCCS – Istituto Nazionale dei Tumori in Milan, Italy, and colleagues wrote in a poster presentation of the data.

Zelenectide Pevedotin and Duravelo-1 Background

Zelenectide pevedotin features a highly selective Nectin-4–targeting bicyclic peptide that is conjugated to a monomethyl auristatin E payload via a cleavable link. Bicycle molecules have the manufacturing and pharmacokinetic properties of small molecules with the high binding specificity of a biologic agent.

Duravelo-1 enrolled adult patients with locally advanced or metastatic urothelial carcinoma who were ineligible for cisplatin per Galsky criteria and were naive to systemic therapy in the advanced setting. Patients needed to meet at least 1 of the following criteria to be deemed ineligible for cisplatin:

• a creatinine clearance of 30 to 59 mL per minute
• hearing loss of at least 25 decibels at 2 contiguous frequencies
• New York Heart Association heart failure of class III or higher
• an ECOG performance status of 2, with a hemoglobin level of at least 10 g/dL, a creatinine clearance of at least 50 mL per minute, and no NYHA class III heart failure

The study evaluated zelenectide pevedotin as monotherapy and in combination with pembrolizumab. For the combination, zelenectide pevedotin was given at 5 mg/m² on days 1, 8, and 15 of each 21-day cycle, and pembrolizumab was administered at 200 mg on day 1 of each cycle.

The trial’s primary end point was investigator-assessed ORR per RECIST 1.1 criteria. Safety, DOR, and DCR were secondary end points.

As of the January 3, 2025, data cutoff, patients in the combination cohort (n = 22) had a median age of 77 years (range, 61-85). The majority were male (68.2%) and White (81.8%). Patients had an ECOG performance status of 0 (22.7%), 1 (31.8%), or 2 (45.5%). Baseline creatinine clearance was below 60 mL per minute for 54.5% of patients.

Additional Safety Findings

Grade 4 TRAEs of hypomagnesemia and neutropenia were each reported in 1 patient. No grade 5 TRAEs occurred.

The most common TRAEs reported in at least 20% of patients given the combination included asthenia (any-grade, 63.6%; grade ≥3, 9.1%), anemia (59.1%; 0%), diarrhea (50.0%; 9.1%), decreased appetite (40.9%; 4.5%), increased aspartate aminotransferase levels (36.4%; 4.5%), nausea (36.4%; 4.5%), rash (31.8%; 4.5%), increased alanine aminotransferase levels (27.3%; 13.6%), neutropenia (27.3%; 13.6%), pruritus (27.3%; 0%), alopecia (22.7%; 0%), hyperglycemia (22.7%; 0%), and vomiting (22.7%; 4.5%).

Reference

Giannatempo P, Galsky M, Duran I, et al. Phase 1/2 Duravelo-1 study: Preliminary results of nectin-4–targeting zelenectide pevedotin (BT8009) plus pembrolizumab in previously untreated, cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. J Clin Oncol. 2025;43(suppl 16):4567. doi:10.1200/JCO.2025.43.16_suppl.4567

• Contribution highlights leadership’s understanding of the importance AI will play in drug discovery

WARREN, N.J., June 30, 2025 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN) today announced that founder and Chief Executive Officer, Ryan Saadi, M.D., M.P.H., has personally contributed $500,000 towards the build-out and first-year operating costs of Tevogen’s new corporate headquarters in Warren, New Jersey.

“This contribution is about belief in Tevogen’s mission, in the remarkable people who bring that mission to life, and in the future we are building together,” said Dr. Saadi. “Our purpose is more than a business plan; it is a shared promise to patients, to one another, and to the society we serve. I am grateful for how far we have come and confident in the road ahead.”

As previously announced, the new facility more than doubles Tevogen’s previous footprint and centralizes cross-functional teams, including research, regulatory affairs, and the expanding Tevogen.AI initiative, under one roof. Dedicated collaboration spaces will support data scientists and engineers as they unlock the full potential of Tevogen’s proprietary PredicTcell™ and AdapTcell™ AI platforms.

“This personal investment by our CEO underscores the conviction of Tevogen’s leadership in our long-term vision of accessible, affordable cell therapies,” added Kirti Desai, Chief Financial Officer. “We expect it to enable us to scale efficiently while maintaining our commitment to capital discipline.”

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications

T: 1 877 TEVOGEN, Ext 701

Communications@Tevogen.com

Ress Life Investments
Nybrogade 12
DK-1203 Copenhagen K
Denmark
CVR nr. 33593163
www.resslifeinvestments.com

To: Nasdaq Copenhagen
Date: 30 June 2025

Corporate Announcement 22/2025

Ress Life Investments A/S publishes Net Asset Value (NAV).

Ress Life Investments A/S publishes the Net Asset Value (NAV) per share as of 16 June 2025.

NAV per share in USD: 2615.44

The performance during the first half of June is -0.07% in USD. The year-to-date net performance is 0.78 % in USD.

Assets under management (AUM) are 257.8 million USD.    

The NAV per share in EUR is published on the website of Nasdaq Copenhagen under the section AIF Companies and Funds, where the bid and ask prices are published. The daily NAV in EUR is calculated as the most recently published NAV in USD divided by the European Central Bank’s EUR/USD reference rate on the relevant day.

Questions related to this announcement can be made to the company’s AIF-manager, Resscapital AB.

Contact person:
Gustaf Hagerud
gustaf.hagerud@resscapital.com
Tel + 46 8 545 282 27