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Details:
Kappaproct (cobitolimod) is a Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Details:
Kappaproct (cobitolimod) is a Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2023
Details:
Under the agreement, Viatris will register and commercialize Kappaproct (cobitolimod), a TLR9 agonist being evaluated in phase III as a novel treatment for moderate to severe ulcerative colitis, in Japan.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Viatris
Deal Size: $50 million Upfront Cash: $10 million
Deal Type: Licensing Agreement May 31, 2023
Details:
Kappaproct (cobitolimod) is a Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2023
Details:
Kappaproct (cobitolimod) is a Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2023
Details:
Patients responding to Kappaproct (cobitolimod) in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo once every three weeks.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2023
Details:
The phase III program for Kappaproct (cobitolimod) in moderate to severe left-sided ulcerative colitis consists of two sequential global induction studies and a year long maintenance study, with patients that have responded to cobitolimod as induction therapy.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2022
Details:
Kappaproct (Cobitolimod) is a topically administered, DNA-based oligonucleotide that activates Toll-like receptor 9 (TLR9), and previous research has shown clinical efficacy in patients with moderate-to-severe ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2022
Details:
The study will evaluate the efficacy and safety of first-in-class TLR9 agonist cobitolimod for treatment patients with moderate to severe left-sided ulcerative colitis. The phase III program will form the basis for marketing approval of cobitolimod in ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2021
Details:
The patent provides additional protection for the use of certain dosage regimens of cobitolimod for treating chronic active ulcerative colitis in patients that are not responding or are intolerant to anti-inflammatory therapy.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2021
Details:
The phase III study CONCLUDE with cobitolimod is a randomised, double-blind, placebo-controlled, clinical study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2021
Details:
The study will include at least 6 patients with moderate to severe ulcerative colitis treated with doses of 500 mg of cobitolimod administered rectally.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2021
Details:
The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2021
Details:
InDex’s Kappaproct is a synthetic oligonucleotides that function as immunomodulatory agents by targeting Toll-like receptor 9 (TLR9). DIMS mimic bacterial DNA, without being harmful, and stimulate immune cells to produce beneficial cytokines.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021
Details:
CONCLUDE is a randomised, double-blind, placebo-controlled, global phase III study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: InDex Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 30, 2021
Details:
The study met the primary endpoint and cobitolimod demonstrated an outstanding combination of efficacy and safety.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
The CONDUCT study met the primary endpoint with 21.4% of patients in clinical remission at week 6 in the highest dose group receiving 250 mg x 2 cobitolimod, compared with 6.8% of patients in the placebo group.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Kappaproct
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
Company has received positive responses from FDA and EMA regarding phase III development of the company's TLR9 agonist cobitolimod, for the treatment of moderate to severe ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
Details:
The grant will be used for a preclinical project to evaluate selected compounds from InDex's DIMS platform in inflammatory disease models outside the field of inflammatory bowel disease.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Vinnova
Deal Size: $0.1 million Upfront Cash: Undisclosed
Deal Type: Funding March 31, 2020
Details:
The paper shows that the Toll-like receptor 9 (TLR9) agonist cobitolimod can modulate the immune system in ulcerative colitis by balancing the mucosal Th17/Treg cell response.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2020
Details:
The Phase IIb dose optimisation study CONDUCT, is evaluating the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe ulcerative colitis.
Lead Product(s): Cobitolimod
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2020
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