Gastroenterology | Phase I Developments

Partner International

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Emmaus Life Sciences Announces Engagement of Partner International to Lead Out-Licensing of Endari® for Diverticulosis

Lead Product(s): L-Glutamine

Therapeutic Area: Gastroenterology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Emmaus Life Sciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 16, 2020

Details:

Emmaus Life Sciences has engaged Partner International to lead the out-licensing activity for Emmaus’ prescription grade L-glutamine (PGLG) oral powder for use in the treatment of diverticulosis.

Pandion Therapeutics

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United States

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Pandion Therapeutics Raises $75 million IPO

Lead Product(s): PT101

Therapeutic Area: Gastroenterology Product Name: PT101

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $75.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 29, 2020

Details:

Funds will be used in company's lead asset, PT101, a combination of an interleukin-2 mutein effector module with a protein backbone, designed to selectively expand regulatory T cells systemically without activating proinflammatory cells.

Oppilan Pharma

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Oppilan Pharma Announces Positive Phase 1 Data for its Ulcerative Colitis Drug OPL-002

Lead Product(s): OPL-002

Therapeutic Area: Gastroenterology Product Name: OPL-002

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 23, 2020

Details:

In the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study, OPL-002 was well tolerated in a once-daily administration to healthy subjects for up to 28 days.

Assembly Biosciences

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Assembly Biosciences Regains Worldwide Rights to Microbiome Gastrointestinal Development Programs

Lead Product(s): ABI-M201

Therapeutic Area: Gastroenterology Product Name: ABI-M201

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: AbbVie Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Termination June 18, 2020

Details:

Assembly Biosciences will regain worldwide rights to all microbiome candidates subject to the collaboration, including ABI-M201 and ABI-M301.

Bacainn Therapeutics

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Bacainn Therapeutics Announces IND Clearance for BT051 and Initiation of Phase 1 Clinical Trial

Lead Product(s): BT051

Therapeutic Area: Gastroenterology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 10, 2020

Details:

The Phase 1 clinical trial is evaluating various dose levels of BT051 for safety, tolerability and pharmacokinetics in a double-blind, placebo-controlled study in healthy volunteers.

Vedanta Biosciences

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Vedanta Biosciences Announces Series C Financing and Data from Two Phase 1 Studies of VE202

Lead Product(s): VE202

Therapeutic Area: Gastroenterology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: JSR LIFE SCIENCES CORP

Deal Size: $71.1 million Upfront Cash: Undisclosed

Deal Type: Series C Financing June 09, 2020

Details:

Proceeds from the financing will supoorts company's ongoing effort in advancing Phase 1 studies in healthy volunteers of VE202, the Company’s orally-administered live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD).

Pandion Therapeutics

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Pandion Therapeutics Announces Issuance of U.S. Patent for Bifunctional Molecules Derived from TALON™ Platform

Lead Product(s): PT101

Therapeutic Area: Gastroenterology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2020

Details:

Patent protects foundational intellectual property and pioneering work on Pandion’s therapeutic autoimmune regulatory protein (TALON) drug design platform.

Applied Molecular Transport

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Inflammatory Disease Biotech Applied Molecular Transport Files for a $100 Million IPO

Lead Product(s): AMT-101

Therapeutic Area: Gastroenterology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: BofA Securities

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering May 18, 2020

Details:

The IPO will bankroll both Phase II trials for AMT-101 that they plan to begin this year, and a Phase I trial for AMT-126, an IL-22 agonist being developed for diseases that are related to barrier function.

Aerpio Pharmaceuticals

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Aerpio Announces Amended Licensing Deal with Gossamer Bio on its Inflammatory Bowel Disease Product Candidate GB004

Lead Product(s): GB004

Therapeutic Area: Gastroenterology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Gossamer Bio

Deal Size: $105.0 million Upfront Cash: $15.0 million

Deal Type: Licensing Agreement May 12, 2020

Details:

The renegotiated licensing deal is intended to place Gossamer Bio in a better position to progress GB004, and in addition, is designed to facilitate the further development of each company’s respective pipelines.

Assembly Biosciences

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Preclinical Data from Assembly Biosciences’ Microbiome Program in Ulcerative Colitis Featured in DDW 2020 Virtual Meeting Portal

Lead Product(s): ABI-M201

Therapeutic Area: Gastroenterology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2020

Details:

Assembly’s lead live biotherapeutic product candidate, ABI-M201, is being evaluated in a Phase 1b trial in patients with mildly to moderately active UC and ongoing treatment with mesalamine.

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Find Gastroenterology Drugs in Phase I Clinical Development

Phase I

Product Type

Companies

Partner International

Emmaus Life Sciences Announces Engagement of Partner International to Lead Out-Licensing of Endari® for Diverticulosis

Pandion Therapeutics

Pandion Therapeutics Raises $75 million IPO

Oppilan Pharma

Oppilan Pharma Announces Positive Phase 1 Data for its Ulcerative Colitis Drug OPL-002

Assembly Biosciences

Assembly Biosciences Regains Worldwide Rights to Microbiome Gastrointestinal Development Programs

Bacainn Therapeutics

Bacainn Therapeutics Announces IND Clearance for BT051 and Initiation of Phase 1 Clinical Trial

Vedanta Biosciences

Vedanta Biosciences Announces Series C Financing and Data from Two Phase 1 Studies of VE202

Pandion Therapeutics

Pandion Therapeutics Announces Issuance of U.S. Patent for Bifunctional Molecules Derived from TALON™ Platform

Applied Molecular Transport

Inflammatory Disease Biotech Applied Molecular Transport Files for a $100 Million IPO

Aerpio Pharmaceuticals

Aerpio Announces Amended Licensing Deal with Gossamer Bio on its Inflammatory Bowel Disease Product Candidate GB004

Assembly Biosciences

Preclinical Data from Assembly Biosciences’ Microbiome Program in Ulcerative Colitis Featured in DDW 2020 Virtual Meeting Portal