NEWS

Rockville, MD., January 12, 2017 – OncoImmune, Inc. today announced that is has closed on a $15.0 million Series A round of fundraising led by 3E Bioventures Capital (“3E”). The new capital will be used primarily to develop a novel clinical stage asset targeting the CD24-Siglec pathway that regulates host inflammatory response to tissue injuries, which has broad implications in the pathogenesis of autoimmune diseases, cancer and graft-versus-host disease (GvHD). OncoImmune will continue clinical testing of its lead clinical product, CD24Fc, in a Phase II trial for the prevention of acute GvHD following myeloablative allogeneic hematopoietic stem cell transplant. CD24Fc has received orphan drug designation for GvHD in both the US and Europe. The funding will also support development of other immuno-oncology (IO) assets with a focus on solid tumor targeting monoclonal antibodies, cancer vaccines, and immunotherapy-related adverse eventsRead Press Release.

Rockville, MD., September 15, 2016 – OncoImmune, Inc. today announced that it has entered into an exclusive option and license agreement with Pfizer Inc. (NYSE: PFE) for ONC-392, a novel, differentiated preclinical anti-CTLA4 monoclonal antibody in a deal worth up to $250 million in upfront and potential milestone payments. Under the terms of the agreement, Pfizer plans to evaluate ONC-392 up until a certain agreed-upon time to determine whether it will exercise its option to exclusively license ONC-392 as well as any other OncoImmune anti-CTLA4 antibodies. If Pfizer exercises its option under the agreement, Pfizer would  be responsible for all development and potential commercialization of the program, and OncoImmune would be eligible to receive potential developmental and commercial milestone payments as well as royalties, tiered from mid-single up to low-double digits, on sales of any potential resulting products. Read Press Release.

Rockville, MD, February 26, 2016 – The U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for CD24Fc for use in the prophylactic treatment of acute GVHD. OncoImmune anticipates initiation of its Phase 2 clinical trial of CD24Fc in patients undergoing allogeneic myeloablative hematopoietic stem cell transplantation (HCT) in the second quarter of 2016. OncoImmune plans to conduct a randomized, placebo-controlled Phase IIa single dose escalation trial to evaluate the addition of CD24Fc to standard of care acute GVHD prophylaxis in cancer patients. After this initial dose finding trial, a phase IIb trial will be initiated to test the efficacy of the drug in reducing acute GVHD in the prophylactic setting.

Rockville, MD, October 8, 2015 – OncoImmune, Inc. today received a positive opinion from the EMA Committee for Orphan Medicinal Products (COMP) on the application for orphan drug designation of humanized fusion protein consisting of extracellular domain of CD24 linked to IgG1 Fc domain (CD24Fc) for the prevention of graft-versus-host disease.

Rockville, MD, June 9, 2015  OncoImmune, Inc. today was granted orphan-drug designation by the FDA for humanized fusion protein consisting of extracellular domain of CD24 linked to IgG1 Fc domain (CD24Fc) for the prevention of graft-versus-host disease.

Rockville, MD, May 21, 2015 – OncoImmune, Inc. today was granted orphan-drug designation by the FDA for the use of echinomycin in the treatment of acute myeloid leukemia (AML).

Rockville, MD, January 15, 2015 – OncoImmune, Inc. today completed its Phase I clinical study of CD24Fc in healthy human subjects. This was a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics of CD24Fc when administered intravenously. This study demonstrated that the single dose of CD24Fc up to 240 mg was generally well tolerated in healthy subjects. OncoImmune now intends to initiate a follow on study in the target indication population.

PUBLICATIONS

Kocak E, Lute K, Chang X, May KF, Jr., Exten KR, Zhang H, et al.
Combination therapy with anti-CTL antigen-4 and anti-4-1BB antibodies enhances cancer immunity and reduces autoimmunity.
Cancer Res. 2006;66(14):7276-84. Epub 2006/07/20. doi: 10.1158/0008-5472.CAN-05-2128. PubMed PMID: 16849577.

Lute KD, May KF, Lu P, Zhang H, Kocak E, Mosinger B, et al.
Human CTLA-4-knock-in mice unravel the quantitative link between tumor immunity and autoimmunity induced by anti-CTLA-4 antibodies.
Blood. 2005. PubMed PMID: 16037385.

May KF, Roychowdhury S, Bhatt D, Kocak E, Bai XF, Liu JQ, et al.
Anti-human CTLA-4 monoclonal antibody promotes T cell expansion and immunity in a hu-PBL-SCID model: a new method for preclinical screening of costimulatory monoclonal antibodies.
Blood. 2005;105:1114-20. PubMed PMID: 15486062.

Siglec-G-CD24 axis controls the severity of graft-versus-host disease in mice. 
Toubai T, Hou G, Mathewson N, Liu C, Wang Y, Oravecz-Wilson K, et al.
Blood. 2014;123(22):3512-23.

Siglec-G/10 in self-nonself discrimination of innate and adaptive immunity.
Chen GY, Brown NK, Zheng P, Liu Y.
Glycobiology. 2014 Sep;24(9):800-6. doi: 10.1093/glycob/cwu068. Epub 2014 Jul 4.

A hypermorphic SP1-binding CD24 variant associates with risk and progression of multiple sclerosis.

Lizhong Wang, Runhua Liu, Dongling Li, Shili Lin, Xianfeng Fang, et al.
Am J Transl Res. 2012; 4(3): 347–356. 

Sialoside-based pattern recognitions discriminating infections from tissue injuries.
Liu Y, Chen GY, Zheng P.
Curr Opin Immunol. 2011 Feb;23(1):41-5. doi: 10.1016/j.coi.2010.10.004. Epub 2011 Jan 3.

Amelioration of sepsis by inhibiting sialidase-mediated disruption of the CD24-SiglecG interaction.

Chen GY, Chen X, King S, Cavassani KA, Cheng J, Zheng X, Cao H, Yu H, et al.
Nat Biotechnol. 2011 May;29(5):428-35. 

Targeting HIF1α eliminates cancer stem cells in hematological malignancies.
Wang Y, Liu Y, Malek SN, Zheng P, Liu Y.
Cell Stem Cell. 2011 Apr 8;8(4):399-411. doi: 10.1016/j.stem.2011.02.006.

CD24 and Siglec-10 Selectively Repress Tissue Damage-Induced Immune Responses.
Chen GY, Tang J, Zheng P, Liu Y.
Science. 2009;323:1722-5. 

CD24-Siglec G/10 discriminates danger- from pathogen-associated molecular patterns.
Liu Y, Chen GY, Zheng P.
Trends Immunol. 2009 Dec;30(12):557-61. doi: 10.1016/j.it.2009.09.006. Epub 2009 Sep 26.

A dinucleotide deletion in CD24 confers protection against autoimmune diseases.
Wang L, Lin S, Rammohan KW, Liu Z, Liu JQ, Liu RH, Guinther N, et al.
PLoS Genet. 2007 Apr 6;3(4):e49. 

CD24 is a genetic modifier for risk and progression of multiple sclerosis.
Zhou Q, Rammohan K, Lin S, Robinson N, Li O, Liu X, Bai XF, Yin L, et al.
Proc Natl Acad Sci U S A. 2003 Dec 9;100(25):15041-6.

GRANTS

OncoImmune, Inc. has successfully applied for a number of NIH grants that helped development of its lead products.

Funding Agency/Year
Grant Number
Title
NIH 2015 R43 AI108115-02 Targeting endogenous sialidases for treatment of endotoxic shock
NIH 2014 R01 NS080821-02 CD24 Targeting for Multiple Sclerosis: a First-In-Human Phase I Study
NIH 2014 R43 AI108115-01 Targeting endogenous sialidases for treatment of endotoxic shock
NIH 2013 R01 NS080821-01 CD24 Targeting for Multiple Sclerosis: a First-In-Human Phase I Study
NIH 2011 R43 AI092874-01 Novel Therapeutics for Sepsis
NIH 2011 R43 AR061252-01 Targeting host response to DAMP for therapy of Rheumatoid Arthritis
NIH 2010 R44 NS041692-06 CD24 as Therapeutic Target for Multiple Sclerosis-phase II Competing Renewal
NIH 2009 R44 NS041692-05 CD24 as Therapeutic Target for Multiple Sclerosis-phase II Competing Renewal
NIH 2008 R44 NS041692-04 CD24 as Therapeutic Target for Multiple Sclerosis-phase II Competing Renewal
NIH 2005 R44 NS041692-03 CD24 as therapeutic target for multiple sclerosis-phase2
NIH 2004 R44 NS041692-02 CD24 as therapeutic target for multiple sclerosis-phase2
NIH 2001 R43 NS041692-01 CD24 as a therapeutic target for Multiple Sclerosis
NIH 2003 R41 CA101611-01 S6K and mTOR as targets for tuberous sclerosis
NIH 2003 R43 NS045401-01 Endothelial Cells as Gene Vehicles for MS Therapy
NIH 2002 R43 CA094537-01 GDP-bound Ras mutant RasN17N69 as a therapeutic agent
NIH 2001 R41 CA093107-01 Human gene knock-in mice and anti-cancer antibodies
NIH 2001 R41 CA093204-01 Wild type Ras as cancer therapeutic agent

For more information visit: http://grantome.com

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