text stringlengths 1 5.46k |
|---|
● Distribution: protein binding across species and concentration, red blood cell distribution, tissue distribution (optional) |
● Metabolism: in vitro stability in liver microsomes/hepatocytes across species, CYP phenotyping, metabolite ID with proposed biotransformation pathway, in vivo metabolite profiles |
● Excretion: definition of major clearance routes |
● Drug-Drug Interaction Potential: CYP inhibition (including TDI), CYP induction, interactions with transporters (inhibitor, substrate) |
● Human pharmacokinetics predictions, including DDI potential at projected efficacious exposures |
Toxicology |
● Single dose toxicity (optional) |
● Repeat dose toxicity in rodent and non-rodent |
● Genotoxicity package: In vitro mutagenicity, in vitro chromosomal aberration, in vivo micronucleus |
CMC reports and documents for an IND (small molecule) should cover, but not limited to, the following topics: |
CMC |
Drug Substance |
● Properties of the drug substance: Optical Isomerism, Physical State/Description, Melting Point, pKa, Solubility (specify conditions - temp./pH), Hygroscopicity, Polymorphism |
● Names and addresses of sites performing drug substance manufacture and testing (release and stability) |
● Drug substance batch records which should include any testing done in-process and at intermediates; ChemDraw file of synthetic scheme for GMP steps |
● Any reports or batch records for manufacture of starting materials and CoAs for the starting materials (these are informational only) |
● Documentation on how the GLP tox batch was manufactured (e.g., synthetic scheme or development report) so that a high-level comparison can be made with the GMP batch |
● Confirmation of structure: Information associated with Mass Spec, IR, NMR (H1 and C13), X-Ray, UV (including specta) |
● PGI assessment reports; Summaries of control strategies for Class 1-2 impurities from starting materials and GMP synthesis steps; Option 4 control strategies for Class 1-2 impurities; structures of any identified drug substance impurities if different from those specified in the drug substance |
● Specifications |
● Methods |
● Validation information - acceptance criteria, results, chromatogram overlays, linearity plots |
● CoAs / results for clinical and non-clinical lots |
● Justification for each specification |
● Reference Standard CoA or summary of results |
● If details are not provided in the batch records, documentation describing all components of the drug substance package |
● Stability Protocol(s) and details of study (e.g., packaging used for stability samples); Stability Data |
Drug Product |
● List of all the excipients used in the manufacture of the drug product; include quality of standard (e.g., USP/JP/Ph. Eu.), function and amount |
● High level description of the manufacturing process. |
● Names and addresses of sites performing drug product manufacture and testing (release and stability) |
● Excipient amounts for an exemplary batch of drug product |
● Detailed description of each step in the manufacturing process (including a flow diagram); diagram should include material inputs, process steps and process controls |
● A list of all the critical steps in the manufacturing process |
● Specification for each non-compendial excipient, if applicable. |
● Methods for evaluating each non-compendial excipient, if applicable |
● Method validation for each method for non-compendial excipient, if applicable |
● CoA for non-compendial excipient, if applicable |
● Attestation that there are not excipients of human or animal origin |
● Listing of any novel excipients |
● Drug Product Specifications |
● Drug Product Methods |
● Validation information - acceptance criteria, results, chromatogram overlays, linearity plots |
● CoAs / results for clinical and non-clinical lots |
● Characterization of impurities that are unique to the drug product; under what conditions are they formed |
● Justification for each specification |
● Reference Standard CoA or summary of results |
● If details are not provided in the batch records, documentation describing all components of the drug product package |
● Stability Protocol(s) and details of study (e.g., packaging used for stability samples); Stability Data |
Drug Product |
List of all the excipients used in the manufacture of the drug product; include quality of standard (e.g., USP/JP/Ph. Eu.), function and amount |
High level description of the manufacturing process. |
Names and addresses of sites performing drug product manufacture and testing (release and stability) |
Excipient amounts for an exemplary batch of drug product |
Detailed description of each step in the manufacturing process (including a flow diagram); diagram should include material inputs, process steps and process controls |
A list of all the critical steps in the manufacturing process |
Specification for each non-compendial excipient, if applicable. |
Methods for evaluating each non-compendial excipient, if applicable |
Method validation for each method for non-compendial excipient, if applicable |
CoA for non-compendial excipient, if applicable |
Attestation that there are not excipients of human or animal origin |
Listing of any novel excipients |
Drug Product Specifications |
Drug Product Methods |
Validation information - acceptance criteria, results, chromatogram overlays, linearity plots |
CoAs / results for clinical and non-clinical lots |
Characterization of impurities that are unique to the drug product; under what conditions are they formed |
Justification for each specification |
Reference Standard CoA or summary of results |
If details are not provided in the batch records, documentation describing all components of the drug product package |
Stability Protocol(s) and details of study (e.g., packaging used for stability samples); Stability Data |
Schedule 9.5 |
Public Announcements |
[See attached.] |
AbbVie Launches Strategic Collaboration with HotSpot Therapeutics to Further Expand Immunology Pipeline |
- Collaboration leverages HotSpot's Smart AllosteryTM drug discovery platform for the development of the first and only small molecule IRF5 (interferon regulatory factor 5) inhibitor for the potential treatment of autoimmune diseases |
- HotSpot to receive an upfront cash payment of $40 million with potential for further milestones and royalties |
NORTH CHICAGO, Ill. and BOSTON, Mass., December [XX], 2022 AbbVie (NYSE: ABBV) and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, today announced an exclusive worldwide collaboration... |
"This collaboration with HotSpot has the potential to deliver an entirely new target class of modulators to patients with serious autoimmune diseases, such as systemic lupus erythematosus, and will help to further strengthen our robust immunology pipeline," said Jonathon Sedgwick, Ph.D., vice president and global head ... |
IRF5 is a transcription factor that acts as a key regulator of certain types of immune responses, and its dysregulation is strongly implicated in several poorly treated autoimmune disorders. Efforts to modulate IRF5 using conventional small molecule approaches have been unsuccessful because IRF5 lacks a traditional act... |
"Today's agreement with AbbVie underscores our significant progress in rapidly building a substantial pipeline of novel allosteric small molecule therapeutic candidates for the treatment of autoimmune diseases and cancer," said Jonathan Montagu, Co-Founder and Chief Executive Officer of HotSpot Therapeutics. "We look f... |
Under the terms of the agreement, HotSpot will receive an upfront cash payment of $40 million and may be eligible to receive up to $295 million in option fees and research and development milestones, with potential for further commercial milestones as well as tiered royalties on global net sales. Should AbbVie exercise... |
About AbbVie |
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterolog... |
About HotSpot Therapeutics, Inc. |
HotSpot Therapeutics, Inc. is pioneering a new class of allosteric drugs that target certain naturally occurring pockets on proteins called "natural hotspots." These pockets are decisive in controlling a protein's cellular function and have significant potential for new drug discovery by enabling the systematic design ... |
Forward-Looking Statements |
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions th... |
Contacts: AbbVie: Global Media Frank Benenati (847) 938-8745 amber.landis@abbvie.com |
Investors Liz Shea (847) 935-2211 liz.shea@abbvie.com |
Contacts: HotSpot: Investor & Media Contact Natalie Wildenradt nwildenradt@hotspotthera.com |
Global Media Sunny Uberoi (917) 747 2018 sunny@hotspotthera.com |
Schedule 10.2 |
Disclosures to Additional Representations and Warranties of HotSpot |
"Scheduled Third Party Agreement" means the Collaboration and Materials Transfer Agreement between Macroceutics, Inc. and Nurix, Inc., dated September 17, 2015, as amended and restated on November 8, 2016. |
"Scheduled Litigation" means that certain litigation between HotSpot and Nurix Therapeutics, Inc. as commenced by HotSpot on July 13, 2022 in the U.S. District Court for the Northern District of California. |
"Project DELs" has the meaning provided in the Scheduled Third Party Agreement. |
"Scheduled Deliverables" means Deliverables, Nurix Materials, Reports, Project DELs, Technology, or Nurix Confidential Information, each as defined in the Scheduled Third Party Agreement. |
"Scheduled Third Party" means Nurix, Inc. |
"Scheduled Third Party Exclusive Field" means Nurix Exclusive Field as defined in the Scheduled Third Party Agreement. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.