SNAPSHOT

Chinese biotech D3 Bio lands $108M to advance KRAS cancer drug into phase 3

D3 Bio secured $108M in Series B funding to launch global phase 3 trials of its lead KRAS G12C inhibitor, elisrasib, for solid tumors.

Why it matters: KRAS mutations are among the most common drivers of cancer. Advancing a next-gen inhibitor into late-stage trials could offer a new option for patients who don't respond to first-generation treatments.

Backstory: D3 Bio was launched in 2020 by AstraZeneca and BeiGene veteran Dr. George Chen with $200M in seed funding. The company focuses on precision oncology and immuno-oncology, targeting unmet needs using biomarker-driven approaches.

Big picture: The race to develop effective KRAS G12C therapies is heating up, with D3 Bio positioning elisrasib as a monotherapy and combo treatment for global regulatory approval.

Zoom in: Elisrasib targets KRAS G12C mutations, which are common in colorectal and non-small cell lung cancers (NSCLC). The drug showed “promising anti-tumor activity and favorable tolerability” in phase 1/2 trials in patients with advanced NSCLC resistant to existing KRAS treatments. The phase 3 trials will span the U.S., EU, and China and include combinations with Merck KGaA’s monoclonal antibody Erbitux or checkpoint inhibitors.

What's next: D3 Bio will initiate global phase 3 trials of elisrasib and is also advancing a pipeline of immuno-oncology assets, including ERK inhibitors and bispecific antibodies.

PRESENTED BY CN-BIO

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With global regulations moving towards phasing out animal testing in favour of new approach methodologies (NAMs) and widening awareness that Organ-on-a-chip outperforms traditional in vitro approaches, there’s no doubt the technology will become integral to drug discovery and development.

So, is it time to modernize your workflows? In this article, CN Bio outlines the key criteria for selecting the right solution—helping you onboard smoothly and realize benefits faster.

SNIPPETS

What’s happening in biotech today?

 🤖 AI aspirations: PsiThera, a spinout from Roivant Sciences, has raised $47.5 million in a Series A funding round to develop oral small-molecule drugs targeting tumor necrosis factor (TNF) for immune-related conditions. Leveraging a proprietary AI platform, PsiThera aims to replicate the efficacy of injectable biologics like Humira and Enbrel in pill form, potentially offering more accessible and cost-effective treatments. Backed by investors including Lightstone Ventures and Samsara BioCapital, PsiThera expects to name its lead drug candidate in 2026.

 🧠 Seizure silencer: EpilepsyGTx has raised $33 million in a Series A funding round to advance its lead gene therapy candidate, EPY201, into Phase 1/2a clinical trials for focal refractory epilepsy (FRE). EPY201 is an adeno-associated viral (AAV) gene therapy designed to reduce neuronal hyperexcitability through localized delivery to seizure-prone brain regions, potentially offering seizure freedom with a single minimally invasive treatment. FRE affects around 10 million people globally and resists conventional medication. The company aims to transform epilepsy treatment by avoiding invasive surgery and chronic drug use. Investors include XGEN Venture, the British Business Bank, and a global biopharma company.

💊 SERD adjuvant: Roche’s oral selective estrogen receptor degrader (SERD), giredestrant, demonstrated a 30% reduction in the risk of invasive disease recurrence or death in the Phase 3 lidERA trial for ER-positive, HER2-negative early-stage breast cancer. The study, involving 4,100 patients, showed 6.7% of giredestrant-treated participants experienced recurrence or death versus 9.4% in the control group. The drug also showed consistent efficacy across subgroups and was well tolerated, with manageable side effects. Roche plans to present the data to health authorities, positioning giredestrant as the first oral SERD to show significant benefit in adjuvant breast cancer treatment.

👶 Fertility boost: Igyxos Biotherapeutics has announced positive results from a Phase 1 multiple ascending dose trial of IGX12, its first-in-class monoclonal antibody for treating male and female infertility. In the randomized, placebo-controlled study involving 14 healthy male volunteers, IGX12 demonstrated a favorable safety profile with no serious adverse events and a pharmacokinetic profile supportive of monthly dosing. IGX12 enhances follicle-stimulating hormone (FSH) activity to support gametogenesis, aiming to improve ovarian stimulation in women and spermatogenesis in men with low sperm count. Building on earlier Phase 1 data in both sexes, Igyxos plans to initiate Phase 2 trials at European fertility centers in 2026.

🧠 EGFR smackdown: BlossomHill Therapeutics has raised $84 million in a Series B extension to accelerate development of its clinical-stage oncology pipeline, bringing total funding to $257 million. The financing will support the advancement of BH-30643, a first-in-class, CNS-active, macrocyclic OMNI-EGFRTM inhibitor for EGFR-mutant non-small cell lung cancer (NSCLC), and BH-30236, a novel macrocyclic CLK inhibitor targeting aberrant RNA splicing in relapsed or refractory AML and high-risk MDS. Preliminary trial data for BH-30643 shows activity against complex EGFR resistance mutations, while BH-30236 has entered combination testing with venetoclax. Clinical updates for both programs are expected in 2026, with strong backing from institutional investors.

SNAP AGAIN

Formation Bio launches Bleecker Bio with $605M Lynk immunology deal

Formation Bio has launched a new subsidiary, Bleecker Bio, and signed a licensing deal with Lynk Pharmaceuticals worth up to $605 million to develop a next-gen central nervous system (CNS)-penetrant TYK2 inhibitor for autoimmune and inflammatory diseases.

Why it matters: The deal expands Formation’s immunology portfolio and showcases its AI-driven drug development strategy, while giving Lynk a path to global exposure and revenue beyond China.

Backstory: Formation Bio, known for in-licensing or acquiring all of its drug candidates and then using AI to speed up drug development, raised $372M in 2024 and secured a $626M deal with Sanofi earlier in 2025. Lynk recently received FDA clearance for human trials of its TYK2 candidate.

Big picture: This partnership signals increasing biotech momentum toward AI-enhanced drug development and global collaboration, especially between Western and Chinese biotechs.

Zoom in: The asset, LNK01006, is an allosteric TYK2 inhibitor designed to target CNS immune pathways. Bleecker Bio gets global rights to LNK01006, excluding greater China. Lynk gains a minority stake in Bleecker, upfront cash, milestones, and royalties.

What's next: Formation Bio will initiate first-in-human trials for LNK01006 in the first half of 2026 under Bleecker Bio.

SPEED READ

More news

• The FDA has approved Waskyra, the first gene therapy for Wiskott-Aldrich syndrome, offering durable clinical benefits and a donor-free alternative for eligible patients lacking matched transplants.

• InduPro has partnered with Sanofi through a strategic equity investment and research collaboration to co-develop a preclinical bispecific PD-1 agonist targeting autoimmune and inflammatory diseases.

• Oxford BioTherapeutics has entered a multi-target collaboration with GSK to discover novel oncology targets using its OGAP-Verify platform, with potential milestone and royalty payments.

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• 🇺🇸 San Francisco, 10 January 2026 - Sachs Annual Oncology Innovation Forum

• 🇬🇧 London, 19 January 2026 - Bioseed

• 🇩🇪 Heidelberg, 4 February 2026- Life, the biomedical convention

• 🇦🇪 Dubai, 9-12 February 2026, WHX Dubai

• 🇩🇪 Göttingen, 19 February 2026 - Life Science Start-up Day

• 🇬🇧 London, 24-25 February 2026 - World ADC London 2026

• 🇳🇱 Amsterdam, 3-4 March 2026 - BioCapital

• 🇪🇸 Barcelona, 10-12 March 2026 - Bioprocessing Summit Europe

• 🇳🇱 Utrecht, 26 March 2026 - Innovation for Health

• 🇦🇹 Vienna, 27-30 March 2026 - BioProcess International