SHANGHAI, Jan. 18, 2026 /PRNewswire/ — D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, today announcedSHANGHAI, Jan. 18, 2026 /PRNewswire/ — D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, today announced

D3 Bio Receives U.S. FDA Clearance for Two IND Applications, Enabling Phase 1 Trial of D3S‑003 and Phase 2 Combination Study of Elisrasib (D3S‑001) with D3S‑002

SHANGHAI, Jan. 18, 2026 /PRNewswire/ — D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications:

  • D3S‑003 — a KRAS G12D inhibitor — enabling the start of a Phase 1 first‑in‑human clinical trial.
  • A Phase 2 combination trial evaluating D3S‑001 (elisrasib), the Company’s next‑generation KRAS G12C inhibitor, in combination with D3S‑002, a selective oral ERK1/2 inhibitor.

D3S‑003 is an orally bioavailable, allele‑specific KRAS G12D inhibitor that targets both the GDP‑bound (OFF) and GTP‑bound (ON) conformations. Preclinical data demonstrate a differentiated, best‑in‑class profile with potent anti‑tumor activity, favorable drug‑like characteristics, and a promising safety margin. With FDA clearance received, D3 Bio will advance D3S‑003 into a Phase 1 first‑in‑human study in patients with advanced solid tumors harboring KRAS G12D mutations.

The newly cleared Phase 2 study will evaluate the combination of D3S‑001 and D3S‑002 in patients with KRAS G12C–mutant non‑small cell lung cancer (NSCLC) who have progressed on prior KRAS G12C‑targeted therapies. The trial, expected to begin in the first half of 2026, will investigate safety, pharmacokinetics, and early efficacy signals with the goal of establishing a rational combination strategy to address resistance and deliver more durable benefit in KRAS‑driven cancers.

“We are excited to receive FDA IND clearance for D3S‑003 and to advance a Phase 2 combination clinical trial of elisrasib and D3S‑002,” said George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. “With D3S‑003, we are bringing a differentiated KRAS G12D inhibitor into the clinic to address one of the most prevalent and challenging KRAS mutations. In parallel, the combination study of elisrasib and D3S‑002 pushes forward our next‑generation KRAS G12C strategy, particularly for patients who have progressed on prior KRAS G12C‑targeted therapies. Together, these milestones underline the momentum of our KRAS franchise and reinforce our commitment to delivering transformative therapies for patients with KRAS‑mutant cancers who urgently need new options.”

About Elisrasib (D3S-001)

Elisrasib is a next‑generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP‑bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

Key publications:

  • Cancer Discovery (2024) 14(9):1675–1698
  • Nature Medicine (2025) 31(8):2768–2777

About D3S‑002

D3S‑002 is a selective ERK1/2 inhibitor strategically designed for combination approaches, providing vertical MAPK‑pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.

Key publication:

  • Cancer Res 1 April 2023; 83 (7_Supplement): 5501.

About D3S‑003

D3S‑003 is a differentiated KRAS G12D inhibitor targeting both OFF and ON conformations to address one of the most common KRAS mutations. The program aims to broaden D3 Bio’s multi‑allele KRAS franchise and deliver new solutions for the heterogeneous and evolving landscape of KRAS‑driven cancers.

About D3 Bio

D3 Bio is a global biotechnology company focused on the discovery, development, and registration of novel oncology and immunology therapies with first‑ or best‑in‑class potential. Guided by deep clinical insight and biomarker‑driven strategies, the Company is advancing a pipeline of programs targeting key oncogenic drivers and immune pathways. D3 Bio owns global rights to all its programs.

For more information, please visit www.d3bio.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/d3-bio-receives-us-fda-clearance-for-two-ind-applications-enabling-phase-1-trial-of-d3s003-and-phase-2-combination-study-of-elisrasib-d3s001-with-d3s002-302664022.html

SOURCE D3 Bio

Market Opportunity
Ucan fix life in1day Logo
Ucan fix life in1day Price(1)
$0.009174
$0.009174$0.009174
+205.80%
USD
Ucan fix life in1day (1) Live Price Chart
Disclaimer: The articles reposted on this site are sourced from public platforms and are provided for informational purposes only. They do not necessarily reflect the views of MEXC. All rights remain with the original authors. If you believe any content infringes on third-party rights, please contact service@support.mexc.com for removal. MEXC makes no guarantees regarding the accuracy, completeness, or timeliness of the content and is not responsible for any actions taken based on the information provided. The content does not constitute financial, legal, or other professional advice, nor should it be considered a recommendation or endorsement by MEXC.

You May Also Like

Crucial Fed Rate Cut: October Probability Surges to 94%

Crucial Fed Rate Cut: October Probability Surges to 94%

BitcoinWorld Crucial Fed Rate Cut: October Probability Surges to 94% The financial world is buzzing with a significant development: the probability of a Fed rate cut in October has just seen a dramatic increase. This isn’t just a minor shift; it’s a monumental change that could ripple through global markets, including the dynamic cryptocurrency space. For anyone tracking economic indicators and their impact on investments, this update from the U.S. interest rate futures market is absolutely crucial. What Just Happened? Unpacking the FOMC Statement’s Impact Following the latest Federal Open Market Committee (FOMC) statement, market sentiment has decisively shifted. Before the announcement, the U.S. interest rate futures market had priced in a 71.6% chance of an October rate cut. However, after the statement, this figure surged to an astounding 94%. This jump indicates that traders and analysts are now overwhelmingly confident that the Federal Reserve will lower interest rates next month. Such a high probability suggests a strong consensus emerging from the Fed’s latest communications and economic outlook. A Fed rate cut typically means cheaper borrowing costs for businesses and consumers, which can stimulate economic activity. But what does this really signify for investors, especially those in the digital asset realm? Why is a Fed Rate Cut So Significant for Markets? When the Federal Reserve adjusts interest rates, it sends powerful signals across the entire financial ecosystem. A rate cut generally implies a more accommodative monetary policy, often enacted to boost economic growth or combat deflationary pressures. Impact on Traditional Markets: Stocks: Lower interest rates can make borrowing cheaper for companies, potentially boosting earnings and making stocks more attractive compared to bonds. Bonds: Existing bonds with higher yields might become more valuable, but new bonds will likely offer lower returns. Dollar Strength: A rate cut can weaken the U.S. dollar, making exports cheaper and potentially benefiting multinational corporations. Potential for Cryptocurrency Markets: The cryptocurrency market, while often seen as uncorrelated, can still react significantly to macro-economic shifts. A Fed rate cut could be interpreted as: Increased Risk Appetite: With traditional investments offering lower returns, investors might seek higher-yielding or more volatile assets like cryptocurrencies. Inflation Hedge Narrative: If rate cuts are perceived as a precursor to inflation, assets like Bitcoin, often dubbed “digital gold,” could gain traction as an inflation hedge. Liquidity Influx: A more accommodative monetary environment generally means more liquidity in the financial system, some of which could flow into digital assets. Looking Ahead: What Could This Mean for Your Portfolio? While the 94% probability for a Fed rate cut in October is compelling, it’s essential to consider the nuances. Market probabilities can shift, and the Fed’s ultimate decision will depend on incoming economic data. Actionable Insights: Stay Informed: Continue to monitor economic reports, inflation data, and future Fed statements. Diversify: A diversified portfolio can help mitigate risks associated with sudden market shifts. Assess Risk Tolerance: Understand how a potential rate cut might affect your specific investments and adjust your strategy accordingly. This increased likelihood of a Fed rate cut presents both opportunities and challenges. It underscores the interconnectedness of traditional finance and the emerging digital asset space. Investors should remain vigilant and prepared for potential volatility. The financial landscape is always evolving, and the significant surge in the probability of an October Fed rate cut is a clear signal of impending change. From stimulating economic growth to potentially fueling interest in digital assets, the implications are vast. Staying informed and strategically positioned will be key as we approach this crucial decision point. The market is now almost certain of a rate cut, and understanding its potential ripple effects is paramount for every investor. Frequently Asked Questions (FAQs) Q1: What is the Federal Open Market Committee (FOMC)? A1: The FOMC is the monetary policymaking body of the Federal Reserve System. It sets the federal funds rate, which influences other interest rates and economic conditions. Q2: How does a Fed rate cut impact the U.S. dollar? A2: A rate cut typically makes the U.S. dollar less attractive to foreign investors seeking higher returns, potentially leading to a weakening of the dollar against other currencies. Q3: Why might a Fed rate cut be good for cryptocurrency? A3: Lower interest rates can reduce the appeal of traditional investments, encouraging investors to seek higher returns in alternative assets like cryptocurrencies. It can also be seen as a sign of increased liquidity or potential inflation, benefiting assets like Bitcoin. Q4: Is a 94% probability a guarantee of a rate cut? A4: While a 94% probability is very high, it is not a guarantee. Market probabilities reflect current sentiment and data, but the Federal Reserve’s final decision will depend on all available economic information leading up to their meeting. Q5: What should investors do in response to this news? A5: Investors should stay informed about economic developments, review their portfolio diversification, and assess their risk tolerance. Consider how potential changes in interest rates might affect different asset classes and adjust strategies as needed. Did you find this analysis helpful? Share this article with your network to keep others informed about the potential impact of the upcoming Fed rate cut and its implications for the financial markets! To learn more about the latest crypto market trends, explore our article on key developments shaping Bitcoin price action. This post Crucial Fed Rate Cut: October Probability Surges to 94% first appeared on BitcoinWorld.
Share
Coinstats2025/09/18 02:25
Jett Nisay, endorser of Marcos impeach complaint, is a public works contractor

Jett Nisay, endorser of Marcos impeach complaint, is a public works contractor

Nisay is also among the 215 lawmakers who backed Vice President Sara Duterte's impeachment in 2025
Share
Rappler2026/01/19 11:06
Trump's Greenland Acquisition Odds Swell On Crypto Prediction Market In 2026 As Dispute Grows Into Potential US-EU Flashpoint

Trump's Greenland Acquisition Odds Swell On Crypto Prediction Market In 2026 As Dispute Grows Into Potential US-EU Flashpoint

The odds that the U.S. takes control of Greenland have spiked on prediction markets since the year began as President Donald Trump intensifies push to annex the
Share
Coinstats2026/01/19 11:06