Pipeline

Novelwise is advancing a pipeline of Specific HDAC inhibitors

Program	Discovery	Preclinical	Phase I	Phase Ib/Expansion	Phase II	Phase III
HDAC8 inhibitors (NBM-BMX)
Metastatic Uveal Melanoma	Discovery Preclinical Phase I Phase Ib/Expansion Phase II Phase III
Glioblastoma	Discovery Preclinical Phase I Phase Ib/Expansion Phase II Phase III
Hepatocellular Carcinoma：Investigator-Initiated Trial	Discovery Preclinical Phase I Phase Ib/Expansion Phase II Phase III
Mesothelioma：Investigator-Initiated Trial	Discovery Preclinical Phase I Phase Ib/Expansion Phase II Phase III
HDAC11 Inhibitors	Discovery Preclinical Phase I Phase Ib/Expansion Phase II Phase III

NBM-BMX – Mechanism of Action

NBM-BMX: Specific HDAC8 Inhibitor

Oral, small-molecule epigenetic therapy
Selectively targets HDAC8, reducing toxicity vs. first-gen HDAC inhibitors

Dual action

Tumor growth inhibition (cell cycle arrest, apoptosis)• Anti-angiogenesis (blocking VEGF signaling) Demonstrated efficacy in glioblastoma & uveal melanoma preclinical models
NBM-BMX is being investigated as a potential therapy for patients with advanced solid tumors, glioblastoma, and metastatic uveal melanoma in ongoing Phase 1b/2 clinical trials.
NBM-BMX has demonstrated selective inhibition of HDAC8 with dual anti-cancer activity, blocking tumor growth and angiogenesis.

The clinical program include:

NBM-BMX-001/002: Phase 1 studies in advanced solid tumors (completed)
NBM-BMX-003 (TW): Phase 1b/2 trial in glioblastoma
NBM-BMX-004 (US): Phase 1b/2 trial in metastatic uveal melanoma

Novelwise has submitted an application to the U.S. FDA for Orphan Drug Designation of NBM-BMX in uveal melanoma, marking an important step toward bringing new treatment options for patients with rare and hard-to-treat cancers.

Metastatic Uveal Melanoma

NBM-BMX: Metastatic Uveal Melanoma (Phase 1b/2)

Glioblastoma

NBM-BMX: Glioblastoma (TW, Phase 1b/Expansion → Phase 2)

Mesothelioma and Hepatocellular Carcinoma｜Novelwise

Investigator-Initiated Trial

Hepatocellular Carcinoma：Investigator-Initiated Trial

Mesothelioma：Investigator-Initiated Trial

Expanded Access

Novelwise Pharmaceutical is committed to carefully considering access to our investigational medicines through expanded access.

Expanded Access Policy

At NovelWise Pharmaceutical Corporation, we are committed to discovering and developing innovative therapies that have the potential to fundamentally improve the way patients are treated.
Our core philosophy is to identify and advance validated molecular targets or therapeutic approaches that show meaningful clinical potential but remain underexplored.
NovelWise aims to advance these innovative therapies through to clinical Proof-of-Concept and ultimately redefine standards of care for patients with serious diseases.

Our ultimate goal is to provide access to these therapies through marketing authorization. However, before our product candidates might be available through these means, NovelWise Pharmaceutical is committed to carefully considering access to our investigational medicines through expanded access.

There is no guarantee that every request will be fulfilled; however, each request will be given careful consideration by NovelWise Pharmaceutical whose decisions are final.

Please see more about NovelWise Pharmaceutical’s Expanded Access programs.

Criteria for Expanded Access Requests

General Criteria:
To be eligible for consideration under Expanded Access, patients should:

Suffer from a serious or life-threatening disease or condition.
Have received appropriate standard treatments without success, and have no comparable or satisfactory alternative therapy available.
Be ineligible for participation in an ongoing clinical study of the investigational medicine, including due to geographic limitations.

For Treating Physicians
Requests for Expanded Access must be submitted by a qualified treating physician who:

Is appropriately licensed and authorized to administer investigational drugs; and
Agrees in writing to comply with:

All applicable country-specific legal and regulatory requirements governing the use of investigational products under Expanded Access; and
NovelWise requirements regarding medical criteria, safety reporting, drug handling and accountability, ongoing data collection, and protection of intellectual property.

For Patients

If you are a patient seeking information about access to an investigational medicine, please discuss this option directly with your treating physician.
Information about NovelWise’s ongoing or recruiting clinical trials can be found on www.clinicaltrials.gov by searching “NovelWise Pharmaceutical”.

Submitting a Request

Physicians requesting Expanded Access for their patients should submit a written request to:
expandedaccess@novelwisepharma.com

NovelWise will make best effort to acknowledge receipt of each request within five (5) business days.
Any Expanded Access or early-access programs provided by NovelWise will comply with all applicable laws and regulations in the respective country.

NovelWise may update or revise this Expanded Access Policy at any time.
Any modifications will be reflected on this webpage upon implementation.