Infections and Infectious Diseases | IND Enabling Drugs

Aptorum

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Hong Kong

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Aptorum Group Announces Further Positive Data on ALS-4 against MRSA Wound Infection and MRSA Bacteraemia against Linezolid and Vancomycin Re...

Lead Product(s): ALS-4

Therapeutic Area: Infections and Infectious Diseases Product Name: ALS-4

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 01, 2020

Details:

Two sets of positive data showing both significant in vivo activities of its lead compound ALS-4 against Methicillin-Resistant Staphylococcus aureus in wound infected and bacteraemia mouse models, respectively when compared to prevailing antibiotics.

FSD Pharma

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CANADA Canada

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FSD Pharma Announces Phase 2 Clinical Trial IND Filing With The FDA to Treat Patients With COVID-19

Lead Product(s): Palmitoylethanolamide

Therapeutic Area: Infections and Infectious Diseases Product Name: FSD201

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 31, 2020

Details:

The FSD201 COVID-19 Trial will be a multicenter study that assesses the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care compared to SOC alone in hospitalized patients with COVID-19 disease.

Mapp Biopharmaceutical

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United States

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Avid Bioservices Selected by Mapp Biopharmaceutical, Inc. for Clinical Development of Novel Human Monoclonal Antiviral Antibody

Lead Product(s): Human monoclonal antiviral antibody

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Avid Bioservices

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership August 26, 2020

Details:

Mapp Biopharmaceutical has contracted Avid to provide process transfer, scale-up and clinical manufacturing services to support one of its development programs for a novel antiviral drug candidate. Avid and Mapp will immediately commence the initial phase of the project.

HiFiBiO Therapeutics

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United States

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HiFiBiO Therapeutics Submits IND Application for Fully Human SARS-CoV-2 Neutralizing Antibody for the Treatment of COVID-19 Patients

Lead Product(s): HFB30132A

Therapeutic Area: Infections and Infectious Diseases Product Name: HFB30132A

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 26, 2020

Details:

The highly differentiated antibody, HFB30132A, has been rapidly identified, engineered, and evaluated in multiple preclinical studies. A Phase I single-IV administration ascending dose study will assess the safety, tolerability, and pharmacokinetics of HFB30132A.

RNAimmune

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United States

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RNAimmune Closed Seed Funding of $2.35m for Development of mRNA Therapeutics and Vaccines

Lead Product(s): RV1730

Therapeutic Area: Infections and Infectious Diseases Product Name: RV1730

Highest Development Status: IND Enabling Product Type: Vaccine

Partner/Sponsor/Collaborator: Terra Magnum Capital Partners

Deal Size: $2.3 million Upfront Cash: Undisclosed

Deal Type: Financing August 24, 2020

Details:

The Company will use the proceeds to advance its Covid-19 vaccine (RV1730) program and neoantigen-based cancer vaccine programs.

Elicio Therapeutics

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United States

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Elicio’s Lymph Node Targeting Covid-19 Vaccine Candidate Induces Up To 25-Fold More T Cells Over Benchmark Vaccines

Lead Product(s): ELI-005

Therapeutic Area: Infections and Infectious Diseases Product Name: ELI-005

Highest Development Status: IND Enabling Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 19, 2020

Details:

ELI-005 is made of two components: ELI-004, an Amphiphile adjuvant with a hydrophobic albumin-binding lipid linked to a hydrophilic immune stimulating CpG DNA oligonucleotide (AMP-CpG), and a COVID-19 Spike protein receptor binding domain.

Kimera Labs

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United States

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Kimera® Labs Files First FDA Investigational New Drug (IND) Application Using XoGlo® for Treatment of ARDS Secondary to COVID-19

Lead Product(s): Mesenchymal Stem Cell- Derived Exosomes

Therapeutic Area: Infections and Infectious Diseases Product Name: XoGlo

Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 18, 2020

Details:

Kimera® Labs has filed an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class XoGlo® isolated placental mesenchymal stem cell-based exosomes.

Tlc Therapeutics

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United States

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TLC Submits Investigational New Drug (IND) Application for TLC19 Inhalable Liposomal Hydroxychloroquine for COVID-19

Lead Product(s): Hydroxychloroquine Sulphate

Therapeutic Area: Infections and Infectious Diseases Product Name: TLC19

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 14, 2020

Details:

TLC19 utilizes TLC’s existing proprietary liposome technology to encapsulate ~1/100 of the oral HCQ dose into an inhalable formulation for direct deposit into the airways and lungs.

MicuRx Pharmaceuticals

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United States

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MicuRx Announces CARB-X US$7.78 Million Financing for Development of MRX-8

Lead Product(s): MRX-8

Therapeutic Area: Infections and Infectious Diseases Product Name: MRX-8

Highest Development Status: IND Enabling Product Type: Peptide

Partner/Sponsor/Collaborator: CARB-X

Deal Size: $8.0 million Upfront Cash: Undisclosed

Deal Type: Financing August 13, 2020

Details:

The nondilutive financing is intended for a Phase 1 clinical trial and related R&D activities of its new antimicrobial agent MRX-8. Previously, CARB-X has funded investigational new drug (IND) enabling studies for MRX-8 in the US.

TFF Pharmaceuticals

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United States

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Union Therapeutics Option Agreement to Acquire Worldwide Exclusive License for Covid-19 Technologies Developed By TFF Pharmaceuticals

Lead Product(s): Niclosamide

Therapeutic Area: Infections and Infectious Diseases Product Name: UNI911

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Union Therapeutics

Deal Size: $210.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 13, 2020

Details:

UNION therapeutics completed an agreement with TFF Pharmaceuticals to acquire an option to obtain a worldwide exclusive license for the use of their Thin Film Freezing technology in combination with niclosamide to focus on treatments for COVID-19.

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Find FDA Investigational New Drug (IND) Submissions for Infections and Infectious Diseases

IND Enabling

Product Type

Companies

Aptorum

Aptorum Group Announces Further Positive Data on ALS-4 against MRSA Wound Infection and MRSA Bacteraemia against Linezolid and Vancomycin Re...

FSD Pharma

FSD Pharma Announces Phase 2 Clinical Trial IND Filing With The FDA to Treat Patients With COVID-19

Mapp Biopharmaceutical

Avid Bioservices Selected by Mapp Biopharmaceutical, Inc. for Clinical Development of Novel Human Monoclonal Antiviral Antibody

HiFiBiO Therapeutics

HiFiBiO Therapeutics Submits IND Application for Fully Human SARS-CoV-2 Neutralizing Antibody for the Treatment of COVID-19 Patients

RNAimmune

RNAimmune Closed Seed Funding of $2.35m for Development of mRNA Therapeutics and Vaccines

Elicio Therapeutics

Elicio’s Lymph Node Targeting Covid-19 Vaccine Candidate Induces Up To 25-Fold More T Cells Over Benchmark Vaccines

Kimera Labs

Kimera® Labs Files First FDA Investigational New Drug (IND) Application Using XoGlo® for Treatment of ARDS Secondary to COVID-19

Tlc Therapeutics

TLC Submits Investigational New Drug (IND) Application for TLC19 Inhalable Liposomal Hydroxychloroquine for COVID-19

MicuRx Pharmaceuticals

MicuRx Announces CARB-X US$7.78 Million Financing for Development of MRX-8

TFF Pharmaceuticals

Union Therapeutics Option Agreement to Acquire Worldwide Exclusive License for Covid-19 Technologies Developed By TFF Pharmaceuticals