J&J reports results from antibody combo trial for MM patients
Johnson & Johnson (J&J) has reported new outcomes from the Phase II RedirecTT-1 trial of bispecific antibodies, Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv) for relapsed/refractory multiple myeloma (r/r MM).
The data showed a high overall response rate (ORR) with durability in those who have triple-class-exposed (TCE) RRMM with true extramedullary disease (EMD).
In the trial, which enrolled 90 subjects, the investigational combo resulted in an ORR of 78.9%, with over half of the subjects achieving a complete response or better, representing a significant improvement over the average ORR of less than 40% for this patient group.
Notably, responses were also found to be high among those previously treated with B-cell maturation antigen (BCMA) CAR-T or anti-FcRH5 bispecific antibodies.
According to the company, subjects in the trial showed deep and durable responses, with 66.2% remaining in response at the data cutoff and a median follow-up of 13.4 months.
At one year, 61% of subjects were progression-free and alive, and 74.5% were alive, with median overall survival not yet reached.
The combo was found to be consistent with prior reports of them as single agents.
Subjects had the option to switch to once-a-month dosing, which might have contributed to better tolerability.
The reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were found to be mostly low grade.
The study's findings were featured at the 2025 European Hematology Association Congress.
EMD represents a severe form of MM, where myeloma cells form tumours in soft tissues and organs.
Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter said: 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options.
'Our first-in-class bispecific antibodies, Talvey and Tecvayli, have transformed treatment for relapsed or refractory multiple myeloma.'
Recently, J&J reported that Tremfya decreased the symptoms and signs of active psoriatic arthritis (PsA) at 24 weeks in individuals against a placebo in the Phase IIIb APEX trial.
"J&J reports results from antibody combo trial for MM patients" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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Chicago Tribune
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Time Business News
a day ago
- Time Business News
TINs Under FATCA and CRS: The Global Net Closing on Financial Secrecy
VANCOUVER, Canada | A new financial reality is taking hold. In the shadows of the world's most secure bank vaults, in the ledgers of Caribbean trusts, and within the metadata of cryptocurrency exchanges, one number is changing everything: the Taxpayer Identification Number (TIN). Once an obscure tax filing tool, the TIN has become the spearhead of a global crackdown on financial secrecy, guided by the power of FATCA and the Common Reporting Standard (CRS). With over 120 countries now exchanging TIN-linked data across borders, the promise of anonymous wealth is vanishing fast. This comprehensive press release examines how TINs operate under FATCA and CRS, why they represent the new DNA of global finance, and how institutions—and individuals—are responding to the pressure of compliance in an increasingly transparent world. The TIN Revolution: From Local Filing Code to Global Financial Identifier A TIN, whether it's a U.S. Social Security Number (SSN), Canadian Social Insurance Number (SIN), UK Unique Taxpayer Reference (UTR), or Indian PAN, is now more than an administrative tag. It is a globally traceable identifier used to link people and entities to offshore accounts, hidden trusts, shell corporations, and undeclared investment income. TINs allow tax authorities to: These outcomes are made possible by two robust global systems: the U.S.-driven Foreign Account Tax Compliance Act (FATCA) and the OECD's Common Reporting Standard (CRS). FATCA and CRS: Two Forces, One Net FATCA – U.S. Power, Unilateral Reach The Foreign Account Tax Compliance Act (FATCA), enacted in 2010, requires foreign financial institutions (FFIs) to report information on U.S. persons to the Internal Revenue Service (IRS). Institutions that fail to comply are penalized with a 30% withholding tax on U.S.-source income. U.S. persons—including citizens, green card holders, and certain corporations—must provide a valid U.S. Taxpayer Identification Number (TIN) to banks abroad, or risk having their accounts closed or reported as non-compliant. CRS – OECD's Multilateral Masterstroke The Common Reporting Standard (CRS) is a global information exchange initiative introduced by the Organization for Economic Co-operation and Development (OECD) in 2014. It functions similarly to FATCA but is multilateral and reciprocal in nature. More than 120 jurisdictions, including most of Europe, Asia, and Latin America, now share information on foreign financial accounts held by individuals and entities. At the heart of CRS? The TIN. TINs: The Anchor of Automatic Exchange of Information (AEOI) Under FATCA and CRS, banks and financial institutions must report: Name Address Jurisdiction(s) of tax residence TIN(s) Date of birth Account number Balance or value Income generated (e.g., interest, dividends, proceeds from sale) If the TIN is missing, incorrect, or inconsistent with known residency information, the account may be reported to multiple tax authorities or flagged for audit. Case Study: The Dual Citizen Exposed by TIN Conflicts In 2023, a dual citizen of the United States and Australia opened investment accounts in Singapore using an Australian passport and declared only his Australian Tax Identification Number (TIN). However, the individual also held a U.S. Social Security number (SSN), and prior FATCA data had already flagged him in a separate filing. When Singapore's CRS data was cross-referenced with FATCA entries in the IRS's systems, the mismatch triggered an investigation. The individual was found to have underreported over $1.2 million in investment income over a five-year period and was fined heavily. The Death of Anonymous Offshore Banking In the past, an individual could hide assets offshore through: Shell companies with nominee directors Undisclosed trusts in Caribbean or Pacific jurisdictions Unregulated crypto wallets Anonymous bearer shares Tiered ownership across low-transparency countries Today, nearly all of these tactics have been rendered ineffective by FATCA and CRS due to one key requirement: the collection and reporting of TINs. Every shell company must now disclose its Ultimate Beneficial Owners (UBOs) along with their Tax Identification Numbers (TINs). Every trust must register the TINs of settlors, trustees, and beneficiaries. Every crypto platform subject to the OECD's new Crypto-Asset Reporting Framework (CARF) must collect and transmit users' Taxpayer Identification Numbers (TINs). TINs and the Machine: AI-Driven Financial Surveillance Tax agencies and compliance institutions now utilize artificial intelligence to analyze the massive flows of TIN-linked data they receive annually. These systems identify: Duplicate or fraudulent TINs TINs registered to deceased persons TINs linked to multiple high-risk jurisdictions TINs used in accounts with transactional patterns indicative of layering or structuring These alerts lead to proactive audits, coordinated international investigations, and often criminal referrals. Amicus Advisory: The New Landscape of Legal Identity Amicus International Consulting offers strategic compliance services to clients worldwide, ensuring lawful restructuring in light of TIN-related risk. Services include: Global TIN consistency audits for individuals and businesses Rectification of mismatched, outdated, or invalid TIN records Advising on CRS/FATCA-compliant structuring of trusts, entities, and second residencies Guidance on voluntary disclosure to minimize penalties TIN-aligned offshore compliance strategies that preserve financial privacy without breaching the law 'Most exposure is unintentional,' says one employee of Amicus. 'We help clients rebuild their financial footprint around clarity and legality, not secrecy.' Case Study: Offshore Property Flagged by TIN Records In 2024, a British entrepreneur's offshore property in Portugal was flagged by HMRC after a Portuguese financial institution submitted a CRS report, which listed the entrepreneur's UK Taxpayer Identification Number (TIN). The individual had never declared the property on their UK tax filings. Using the TIN as the anchor, HMRC accessed transaction history, title records, and even a renovation loan registered to the same TIN, resulting in a full tax reassessment and retroactive penalties. CRS + FATCA + CARF: The Total Transparency Framework TINs are now central not only to FATCA and CRS, but also to the OECD's new Crypto-Asset Reporting Framework (CARF), which takes effect as of January 2025. Under CARF, TINs are required for: Crypto wallet openings Tokenized asset purchases Staking and lending platforms DeFi (decentralized finance) protocols, if jurisdictionally covered The scope of TIN-linked tracking is now: REGIME SCOPE WHO REPORTS USE OF TIN FATCA U.S. Persons Foreign Banks Required for ID and enforcement CRS Global Participants Local Banks Matches with home tax returns CARF Crypto Platforms Exchanges and Wallets Connects users to tax obligations TINs and Risk Ratings: Why Institutions Monitor the Numbers Financial institutions now integrate TIN data into their client risk rating systems. For example: Clients with TINs from high-risk or sanctioned countries receive enhanced due diligence Clients with multiple TINs must explain overlapping residencies Clients with unrecognized or expired TINs may be denied account access This impacts not only account approvals but also transaction clearance times, credit issuance, and internal reporting to regulators. Legal and Financial Consequences of TIN Mismanagement Misuse, non-disclosure, or manipulation of TINs can lead to: Civil penalties of up to 300% of the tax owed Criminal prosecution for tax evasion or fraud Confiscation of assets linked to undeclared income Cross-border arrests and extradition (in extreme cases) Blocklisting of associated corporate or personal accounts Case Study: The TIN That Triggered a Tax Rebellion A South African executive's TIN, linked to a Panama-based trust, was disclosed in a 2023 CRS exchange. While the executive believed the structure was legally opaque, the TIN used during trust setup provided a direct link to his residency and triggered a significant investigation. Ultimately, the executive entered into a public settlement and became a case study for the risks associated with financial opacity. Amicus Case File: TIN Reconciliation to Avoid Disclosure Fallout A Canadian Israeli entrepreneur approached Amicus after receiving FATCA inquiries linked to a dormant U.S. LLC. Amicus performed a TIN alignment and voluntarily disclosed the entity under Canada's tax amnesty program. Outcome: Avoided criminal charges Paid penalties at a reduced rate Cleared the way for future CRS-compliant investment structures The Path Forward: Strategic Transparency with Legal Shielding True privacy no longer lies in secrecy, but in lawful clarity. TINs will continue to expand their reach as: Biometric TINs are adopted in high-fraud countries are adopted in high-fraud countries Digital wallets become tied to tax identifiers become tied to tax identifiers Residency and citizenship-by-investment programs adopt stricter TIN checks adopt stricter TIN checks TIN-based sanctions systems link individuals to national enforcement regimes Amicus continues to serve clients facing this new paradigm, not to avoid transparency, but to master it strategically and lawfully. 📞 Contact Information Phone: +1 (604) 200-5402 Email: info@ Website: Follow Us: 🔗 LinkedIn 🔗 Twitter/X 🔗 Facebook 🔗 Instagram About Amicus International Consulting Amicus International Consulting provides strategic legal and financial restructuring services for global citizens, corporate entities, and high-net-worth individuals navigating the complexities of FATCA, CRS, CARF, and global transparency regulations. Amicus offers lawful pathways for protecting assets, ensuring compliance, and preserving cross-border mobility. TIME BUSINESS NEWS