AV-001 — Competitive Intelligence Brief

AV-001 (AV-001) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: PI3K inhibitor. Area: Oncology.

phase 2 PI3K inhibitor PI3K delta Oncology Small molecule

Target snapshot

AV-001 (AV-001) — Vasomune Therapeutics, Inc.. AV-001 is a small molecule that targets the PI3K pathway to modulate immune responses.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
AV-001 TARGET	AV-001	Vasomune Therapeutics, Inc.	phase 2	PI3K inhibitor	PI3K delta
GFH375	GFH375	Genfleet Therapeutics (Shanghai) Inc.	phase 3	PI3K delta inhibitor	PI3K delta
AD-221	AD-221	Addpharma Inc.	phase 3	PI3K delta inhibitor	PI3K delta
IPI-145	IPI-145	SecuraBio	phase 3	PI3K delta/gamma inhibitor	PI3K delta (PI3Kδ), PI3K gamma (PI3Kγ)
P-3073	P-3073	Polichem S.A.	phase 3	PI3K delta inhibitor	PI3K delta
TGR-1202	TGR-1202	Vanderbilt-Ingram Cancer Center	phase 3	PI3K delta inhibitor	PI3K delta
GDC 695	GDC 695	Balmoral Medical company	phase 3	PI3K delta inhibitor	PI3K delta (p110δ)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (PI3K inhibitor class)

1. Addpharma Inc. · 4 drugs in this class
2. AstraZeneca · 3 drugs in this class
3. Bayer · 3 drugs in this class
4. Ahn-Gook Pharmaceuticals Co.,Ltd · 2 drugs in this class
5. InventisBio Co., Ltd · 2 drugs in this class
6. Orient Pharma Co., Ltd. · 2 drugs in this class
7. Applied Biology, Inc. · 1 drug in this class
8. Angitia Incorporated Limited · 1 drug in this class
9. Aevi Genomic Medicine, LLC, a Cerecor company · 1 drug in this class
10. BPGbio · 1 drug in this class