IP Library › Granted Patent US 12697379
Granted Patent B2
US 12697379 · App. 17/261,975 · Granted Aug 4, 2026

Pegylated tetanus neurotoxins and treatment of hypotonia

Inventors: Thomas McLean (Melbourne, AU); Peter Smooker (Melbourne, AU); Luke Norbury (Melbourne, AU); Peter Coloe (Melbourne, AU); Russell Conduit (Melbourne, AU); Anthony Sasse (Kew, AU)
Assignee: Snoretox Pty Ltd
A61K39/08A61K47/60C07K14/33A61K2039/6037C12Y304/24068
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Quick Facts
Patent No.
US 12697379
App. No.
17/261,975
Granted
Aug 4, 2026
Kind
B2
Abstract

The invention relates to a composition comprising a first PEGylated tetanus neurotoxin (PEG-TeNT) comprising tetanus neurotoxin (TeNT) conjugated to polyethylene glycol (PEG) and a second TeNT. The invention also relates to various PEG-TeNTs. The invention also relates to a method of treating hypotonia using the composition or various PEG-TeNTs, and a kit comprising the composition or various PEG-TeNTs. In one embodiment, the hypotonia is obstructive sleep apnoea.

Claims (10)

1 . A method of treating hypotonia in a mammalian subject having pre-existing anti-tetanus neurotoxin (TeNT) antibodies due to prior exposure to TeNT or due to pre-immunization with tetanus toxoid, the method comprising administering to said subject a therapeutically effective amount of:

a first TeNT that is active and PEGylated (PEG-TeNT) comprising one or more surface serine-to-cysteine amino acid substitutions within the amino acid sequence of SEQ ID NO: 1, wherein the one or more substituted cysteines are conjugated to polyethylene glycol (PEG); and

a second TeNT that is an inactive TeNT consisting of SEQ ID NO: 1 carrying the R1225E and W1288A inactivating mutations, wherein the second inactive TeNT is not PEGylated.

2 . The method of claim 1 , wherein the PEG in the PEG-TeNT is of 2 kDa, 5 kDa, 10 kDa, or 20 kDa.

3 . The method of claim 1 , wherein the first PEG-TeNT comprises a PEGylated TeNT light chain (LC), a PEGylated TeNT heavy chain (HC), or a PEGylated TeNT fragment c (c).

4 . The method of claim 1 , wherein the first PEG-TeNT is PEG-TeNT-HC comprising a PEGylated heavy chain (HC), or is PEG-TeNT-LC-c comprising a PEGylated light chain (LC) and a PEGylated fragment c.

5 . The method of claim 1 , wherein the subject is administered: the first PEG-TeNT comprising PEGylated fragment c (PEG-TeNT-c) and the second TeNT until efficacy of the first PEG-TeNT decreases; then the first PEG-TeNT-HC comprising a PEGylated heavy chain (HC) and PEG-TeNT-LC-c comprising a PEGylated light chain (LC) and a PEGylated fragment c and the second TeNT until efficacy of the first PEG-TeNT decreases; and then the first PEG-TeNT comprising a PEGylated LC and a PEGylated HC (PEG-TeNT-LC-HC) and the second TeNT.

6 . The method of claim 1 , wherein the first PEG-TeNT's light chain (LC) is PEGylated and the first PEG-TeNT's heavy chain (HC) is PEGylated (PEG-TeNT-LC-HC), or the first PEG-TeNT's LC is PEGylated and the first PEG-TeNT's fragment c (c) is PEGylated (PEG-TeNT-LC-c).

7 . The method of claim 1 , wherein the second TeNT does not block release of inhibitory neurotransmitters.

8 . The method of claim 1 , wherein the second TeNT acts as a decoy for the anti-TeNT antibodies.