Alchem Laboratories

About

About Alchemab

Alchemlab is a biotech company focused on discovering and developing novel therapeutics for patients with hard-to-treat diseases by harnessing the power of naturally protective antibodies.

Our approach - Unique and Unbiased Approach

By mapping antibody repertoire differences between resilient and diseased individuals, we can identify protective antibodies conserved across patient populations, uncover the binding targets of the antibodies and subsequently develop therapeutic candidates that replicate the protective effect.

Convergent Protective Antibody Responses

Our highly differentiated drug discovery engine uses high-quality patient samples and a range of functional and advanced analytical techniques to evaluate convergent protective antibody responses in individuals that are susceptible but resilient to specific diseases.1)

About Alchem Laboratories (www.alchem.com) Alchem can be a value-creating partner for both established and start-up pharmaceutical companies by providing qualified infrastructure and trained personnel for all stages of drug development including design and synthesis of novel compounds, synthesis of analogs of lead compounds, process development and optimization, analytical method development and validation, stability studies for drugs and intermediates, cGMP manufacturing of APIs and products for clinical studies, and documentation for all stages of drug development.

Our partners and collaborators include the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), the National Institute of Standards and Technology (NIST), the U.S. Army Medical Research Acquisition Activity (USAMRAA), the U.S. Department of Agriculture (USDA), the Dr. Margarete Fischer-Bosch- Institute of Clinical Pharmacology (ICP), Gemphire Therapeutics, Inc. (NASDAQ: GEMP), Brickell Biotech, Inc., FLUCEL LLC, NanopharmaceuticsMRIGlobal, Pace Analytical Labs, Southern Research, and the University of Florida INNOVATE - Sid Martin Biotech 2)

Alchem Laboratories Team

James D. Talton, Ph.D., is Alchem's President and Chief Executive Officer. Prior to joining Alchem, Dr. James Talton served as the President and Chief Executive Officer of Nanotherapeutics, Inc for seventeen years.

Dr. Talton has developed multiple clinical-stage products as well as NanoFUSE® DBM, a sterile, FDA-cleared (K062459) easy-to-reconstitute bone graft. Leading multiple successful government programs, Dr. Talton has successfully won over $1 billion in contracts with government partners including NIH, DOD, and BARDA

Dr. Talton is an inventor on eleven U.S. patents and has authored several peer-reviewed publications and book chapters involved in drug delivery systems with a primary focus in drug analysis and controlled release formulations, pharmacokinetics, and pulmonary drug delivery. Dr. Talton received his B.S. and M.S. in Materials Science and Engineering and his Ph.D. in Pharmaceutical Sciences from the University of Florida.3)

Judy Talton, MS, ARNP, is the Chief Operating Officer at Alchem. Judy received her MS in Nursing in 2009 from University of Florida and is board certified in Acute Care and Family Practice. Prior to her medical career, Judy had positions in real estate, marketing, and management.

Judy Saxon is Alchem’s Chief Financial Officer. Mrs. Saxon has 30+ years of executive financial roles, providing management leadership to private companies and investment partnership groups, while specializing in funding and investor relations. She joined Alchem in 2001. In addition to her responsibilities at Alchem as its Chief Financial Officer, Mrs. Saxon provides executive guidance to Alchem’s management team and customers. Since 2001, her expertise has contributed towards the development and financial growth of Alchem’s organization. Mrs. Saxon earned her B.S. in Business Administration from the University of Florida, with majors in accounting and finance.

Otto Geoffroy, Ph.D. is Alchem's Director of Research. He is responsible for most laboratory-scale synthetic projects. He received his Ph.D. in organic chemistry from Tulane University in 1992. Following this he was an National Institutes of Health post-doctoral fellow in the Department of Pharmaceutical Sciences at the Medical University of South Carolina (1992-1994) and a post-doctoral fellow at the Hollings Cancer Center (1995-2000). Dr. Geoffroy joined Alchem in 2001 as a Senior Scientist and Group Leader. He was promoted to Director of Research in 2009.

Sergiy Denysenko, Ph.D. is Alchem's Director of Manufacturing. He oversees the scale-up laboratory and GMP manufacturing projects. Sergiy joined Alchem in 2001 as a Senior Research Scientist and was promoted to Principal Research Scientist in 2004 before becoming Director of Development in 2009. He received his Ph.D. in synthetic organic chemistry from Moscow State University in 1985. Following this he was Associate Professor at the Ukrainian State University of Chemical Technology (1985-1996) and a Postdoctoral Fellow and Senior Group Leader with Professor Alan Katritzky's research group at the University of Florida (1996-2001).

Vladimir Rudchenko, Ph.D. is Alchem's Technical Director.  His extensive background spans more than three decades in research and industry.  Dr. Rudchenko joined Alchem in 2001 and provides technical direction to both the Research and the Development groups. His academic credentials include D.Sc. in organic chemistry (Institute of Organic Chemistry, Academy of Sciences of the USSR, Moscow, 1986), Ph.D. in synthetic organic chemistry (Institute of Organic Chemistry, Academy of Sciences of the USSR, Moscow, 1977), and B.Sc. (with Distinction) in chemical engineering (Institute of Chemical Technology, Dnepropetrovsk, Ukraine, 1973). Dr. Rudchenko is an author of 13 patents and over 70 publications.

Jing Yang, Ph.D. is Alchem's Director of Quality Control. She received her undergraduate training in analytical chemistry at Shanghai University and a Ph.D in organometallic chemistry from the University of Florida. Joining Alchem in 1999 Dr. Yang was first responsible for API synthesis and process development and was promoted in 2001 to Group Leader for process development and GMP manufacturing of late-stage-experimental products. She was appointed to her current position in 2006.

  Ray Malloy, M.S. is Alchem's Acting Director of Quality Assurance. He completed his undergraduate and graduate studies (Masters of Science) at the University of South Florida, Tampa. He worked as an Environmental Scientist, being involved with analysis of water quality samples, pollution incident investigations, management of quality control database, and quality assurance review at the Environmental Protection Commission of Hillsborough County, Tampa, FL. Mr. Malloy joined Pharmos Corporation in 1994 as a Research Chemist. He was then involved with regulatory affairs and quality assurance issues as a consultant. He was in charge with cGMP manufacturing at Pharmos followed by Alchem twenty years ago and has directed Quality Assurance for over ten years.

Charles Alligood, A.S. is Alchem's Facilities Manager.  After serving four years in the United States Coast Guard, Mr. Alligood has overseen pharmaceutical R&D facilities since 1987 and has an extensive background in instrument maintenance and hazardous waste management. 4)

Kelly E. Gridley, PhD, RBP (ABSA), MT (ASCP), is Alchem's Director of Clinical Operations and QA. In her early career, she worked as a Medical Technologist in Clinical Microbiology at UF Health Shands Hospital. She received her Ph.D. from the University of Florida in Pharmacodynamics working with estrogen compounds as treatments for neurodegenerative diseases.

She is a former Dean at Santa Fe College, where she led the design and construction of the Santa Fe College Perry Center for Emerging Technologies, and served as Director for the Biotechnology, Biomedical Engineering Technology and Clinical Laboratory Science programs housed at the facility, playing a major role in Santa Fe’s successful move from a level I to a level II institution.

More recently, she served as the Biosafety Officer and Sr. Director of Environmental Health and Safety at Nanotherapeutics Advanced Development and Manufacturing facility, participating in the design, construction and commissioning of their BSL-3 manufacturing facility with responsibility for biosafety and environmental health and safety.

She is currently a Registered Biosafety Professional with ABSA International. Prior to joining Alchem, Dr. Gridley worked with a start-up focused on waste to fuel technology and drug development, performing risk assessments for drug compounds and facility site evaluations.5)

Steve Vasile, Ph.D. is Alchem’s Director of Discovery overseeing assay development and high throughput screening (HTS). He received his Ph.D. in biochemistry from the State University of New York at Buffalo’s Roswell Park Cancer Institute division in 1993.

Dr. Vasile has over 25 years of experience in the HTS field, with significant experience with multiple assay formats and with diverse screening laboratory instrumentation and automation. Dr. Vasile was recruited in 2018 from Sanford Burnham Prebys Medical Discovery Institute where he was Director of HTS for their Orlando, FL site.

Prior to SBP he was at Sugen Inc./Pharmacia/Pfizer. At Sugen his team helped to discover Sutent, an FDA-approved drug for renal cell carcinoma, Gleevec resistant GIST and advanced pancreatic neuroendocrine tumors.

Otto Geoffroy, Ph.D. is Alchem's Director of Research. He is responsible for most laboratory-scale synthetic projects. He received his Ph.D. in organic chemistry from Tulane University in 1992. Following this he was an NIH post-doctoral fellow in the Department of Pharmaceutical Sciences at the Medical University of South Carolina (1992-1994) and a post-doctoral fellow at the Hollings Cancer Center (1995-2000). Dr. Geoffroy joined Alchem in 2001 as a Senior Scientist and Group Leader. He was promoted to Director of Research in 2009.6)

Federal Contracts

2018 Theraputics

Alchem Laboratories Supporting Sixteen Active Clinical Programs and Awarded New DOD/NCI Contracts in 2018 - March 03, 2018

• Awarded a new DOD contract W81XWH-18-D-0028-to support the U.S. Army Medical Research Acquisition Activity with “Non-Personal Services for Experimental Therapeutics Medicinal Chemistry Tasks”

• Awarded two new five-year contracts in the second half of 2017 with the National Cancer Institute 

• Successfully conducted 140 cGMP batches to support over twenty different government and commercial projects

• Two different topical drug products manufactured in its new clinical manufacturing building to support Phase 1 and 2 clinical trials

• Products manufactured by Alchem over the last five years in 16 active clinical programs at the beginning of 2018

March 2, 2018 — Alchem Laboratories Corporation, a contract manufacturing organization located in Alachua, Florida dedicated to excellence in custom synthesis, today announced support of clinical programs and new DOD/NCI contracts for 2018. DOD contract W81XWH-18-D-0028-awarded in January supports the U.S. Army Medical Research Acquisition Activity with “Non-Personal Services for Experimental Therapeutics Medicinal Chemistry Tasks.” This contract was awarded to procure, synthesize, or purify potential antimalarial drug candidates for the Walter Reed Army Institute of Research. Alchem Laboratories was also awarded two new five-year contracts with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Contract HHSN261201700007I “Synthesis of Non-GMP Small Molecules” was awarded September 13, 2017 to synthesize, purify, characterize, and submit to the Drug Synthesis and Chemistry Branch (DSCB), Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), NCI, target compounds of high purities and small libraries of analogs of lead compounds. Contract HHSN261201700020C “Manufacture of Bulk Chemicals and Bulk Pharmaceutical Ingredients for Preclinical and Clinical Studies” was awarded July 31, 2017 to support DTP and NCI’s Experimental Therapeutics Program (NExT) to facilitate the transition of novel drug discoveries into clinical trials of new cancer therapeutic agents. These projects have been funded in whole or in part with Federal funds from NCI, NIH, Department of Health and Human Services, under Contract No. HHSN261201700007I (100% Federally funded up to $7,777,665.00) and Contract No. HHSN261201700020C (100% Federally funded up to $2,814,764.00).

“I am proud of the team and progress we have made over the past year. We have achieved critical milestones, with 140 cGMP batches successfully manufactured to support over twenty different government and commercial projects” said Jim Talton, President and CEO. “Twelve of 16 of the active clinical studies currently underway are led by the NCI, which Alchem has been supporting through multiple R&D contracts for over fifteen years. In 2018, we also will continue to work toward rolling scale-up of our GMP clinical manufacturing facility expansion, which is a cornerstone of our long-term strategy to support multiple development programs simultaneously through phase 2/3 clinical studies and commercial production” Talton stated.

January 20, 2018

Alchem awarded 5-year contract with U.S. Army Medical Research Acquisition Activity

January 20, 2018

Non-Personal Services for Experimental Therapeutics Medicinal Chemistry Tasks Solicitation Number: W81XWH-18-R-0012 Agency: Department of the Army Office: U.S. Army Medical Research Acquisition Activity Location: U.S. Army Medical Research Acquisition Activity

The Government requirement is for Non-Personal Services for Experimental Therapeutics Medicinal Chemistry Tasks for the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD. Service includes purification and characterization of organic compounds as needed. Reports resulting from the purification and characterization will be specified in individual task orders and will be provided to the WRAIR technical point of contact along with the purified or characterized material.

The contractor is responsible for shipping the compounds to the WRAIR and for mailing or e-mailing the reports resulting from procurement, synthesis, purification, and characterization to the point of contact specified in the task order. The contractor shall provide the manpower required to accomplish these tasks.7)

Federal Contract Summary 2021

Alchem has twenty four years of government contract experience with National Institutes of Health NIH, DOD, and BARDA. Alchem’s government contract experience has led to excellent CPARS ratings. Alchem is currently NCI’s main contractor for non-GMP and GMP API synthesis projects supporting NCI clinical trials.

HHSN261201600066C “Non-GMP Synthesis of Compounds for Drug Development” 5-year contract with NCI National Cancer Institute (9/19/16-9/19/21)

HHSN261201700007I “Synthesis of Non-GMP Small Molecules” 5-year IDIQ contract with National Cancer Institute NCI (9/18/17-9/17/22)

HHSN261201700020C “Manufacture of Bulk Chemicals and Bulk Pharmaceutical Ingredients for Preclinical and Clinical Studies” 5-year contract with National Cancer Institute NCI (9/1/17-8/31/22)

W81XWH18D0028 “Experimental Therapeutics Drug Development” 5-year IDIQ contract with the Army (1/18/18-1/18/23)

75N95019D00028 “CRO Support for NCATS Medicinal Chemistry for Lead Optimization” 5-year IDIQ contract with NCATS-NIDA National Institute of Allergy and Infectious Diseases (9/26/19-9/25/24)

75N98019D00057 “Drug Formulation and Manufacturing Contract” 5-year IDIQ contract with National Institutes of Health NIH (9/27/19-9/26/24)

19-05 (TRE) “Prophylactic and Therapeutic cMCM Libraries, Mid to Late Pipeline Development” with JPEO-CBRND MCS under OTA W15QKN1691002 to ATI

75N93021D00002 “Preclinical Services for HIV Therapeutics” 7-year IDIQ contract with NIAID National Institute of Allergy and Infectious Diseases (10/15/20-10/14/27)

Task Area A: In Vitro Testing and Screening Resource for Therapeutics

Task Area B: Synthesis of Therapeutic Agents for Treatment of Infectious Diseases

Task Area E: Formulation Development and Manufacture of Clinical Dosage Forms

Alchem Partners

Alchem can be a value-creating partner for both established and start-up pharmaceutical companies, as well as government programs. Our current partners and collaborators include:

National Cancer Institute (NCI) / National Institutes of Health (NIH) National Institute of Standards and Technology (NIST) U.S. Army Medical Research Acquisition Activity (USAMRAA) / Department of Defense (DoD) U.S. Department of Agriculture (USDA) Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (ICP) Gemphire Therapeutics, Inc. (NASDAQ: GEMP) Cerenis Therapeutics Holding SA (CEREN.PA) Brickell Biotech, Inc. FLUCEL LLC Nanopharmaceutics  MRIGlobal Pace Analytical Labs Southern Research UF Innovate / Sid Martin Biotech 8)

Capabilities

Alchem can be a value-creating partner for both established and start-up pharmaceutical companies by providing custom synthesis services.

  • New synthetic routes for known compounds
  • Synthesis of novel compounds
  • Scale-up (gram to kilogram quantities)
  • Chemical process development
  • Specialty chemicals

Alchem has produced over 10,000 novel compounds. Our expertise includes, but is not limited to:

  • Fatty acid analogs
  • Terpinoids
  • Chiral compoounds and building blocks
  • Complex heterocycles
  • Heterocyclic moiety containing drugs
  • Cyclodextrin complexes
  • Labeled compounds
  • Prodrugs and chemical drug delivery systems
  • Small Peptides (<6 AAs)
  • Natural and Modified Amino acid derivatives
  • Nucleosides

  Chemical Reactions Performed at ALCHEM (including but not limited to)

  • Acylation
  • Addition
  • Alkylation
  • Amination
  • Arylation
  • Chiral resolution
  • Condensation
  • Coupling Reactions
  • Cyclization
  • Decarboxylation
  • Dehydration
  • Diazotization
  • Dehydrogenation
  • Esterification
  • Halogenation
  • Hydrogenation
  • Hydrolysis
  • Hydroxylation
  • Nitration
  • Nitrosation
  • Oxidation
  • Organometallic
  • Quaternization
  • Reduction
  • Rearrangement
  • Sulfonation
  • Thioalkylation 9)

COVID-19 Contracts

Dedicated to excellence in custom synthesis

13305 Rachael Boulevard Alachua, FL, 32615 United States - 386-418-1650

info@alchem.com Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial

February 11, 2022 / James Talton

Abstract

Objective We assessed whether famotidine improved inflammation and symptomatic recovery in outpatients with mild to moderate COVID-19.

Design Randomised, double-blind, placebo-controlled, fully remote, phase 2 clinical trial (NCT04724720) enrolling symptomatic unvaccinated adult outpatients with confirmed COVID-19 between January 2021 and April 2021 from two US centres. Patients self-administered 80 mg famotidine (n=28) or placebo (n=27) orally three times a day for 14 consecutive days. Endpoints were time to (primary) or rate of (secondary) symptom resolution, and resolution of inflammation (exploratory).

Results Of 55 patients in the intention-to-treat group (median age 35 years (IQR: 20); 35 women (64%); 18 African American (33%); 14 Hispanic (26%)), 52 (95%) completed the trial, submitting 1358 electronic symptom surveys. Time to symptom resolution was not statistically improved (p=0.4). Rate of symptom resolution was improved for patients taking famotidine (p<0.0001). Estimated 50% reduction of overall baseline symptom scores were achieved at 8.2 days (95% CI: 7 to 9.8 days) for famotidine and 11.4 days (95% CI: 10.3 to 12.6 days) for placebo treated patients. Differences were independent of patient sex, race or ethnicity. Five self-limiting adverse events occurred (famotidine, n=2 (40%); placebo, n=3 (60%)). On day 7, fewer patients on famotidine had detectable interferon alpha plasma levels (p=0.04). Plasma immunoglobulin type G levels to SARS-CoV-2 nucleocapsid core protein were similar between both arms.

Conclusions Famotidine was safe and well tolerated in outpatients with mild to moderate COVID-19. Famotidine led to earlier resolution of symptoms and inflammation without reducing anti-SARS-CoV-2 immunity. Additional randomised trials are required. 0 Likes Image analysis of topical drug uptake in tissue after ablative fractional laser treatment

December 02, 2021 / James Talton

Visualizing and Quantifying Drug Distribution in Tissue VI, part of SPIE BiOS, https://spie.org/bo105

11938-8

Image analysis of topical drug uptake in tissue after ablative fractional laser treatment

Author(s): Haley L. Marks, Massachusetts General Hospital (United States); Sarfaraz A. Quadri, Massachusetts General Hospital (United States), Northeastern Univ. (United States); Joshua Glahn, Michael Wang-Evers, Massachusetts General Hospital (United States); James Talton, Alchem Lab. Corp. (United States); Dieter Manstein, Massachusetts General Hospital (United States)

Ablative fractional laser (AFL) treatment prior to application of a topical drug enhances drug uptake and the resultant coagulation zone (CZ) surrounding each fractional photothermal injury may provide a reservoir for sustained drug release. In this work, we evaluate how morphological changes in the skin after AFL affect the uptake of an intrinsically fluorescent topical antibiotic.

Brightfield images of NBTC stained histopathological slides were evaluated using a deep learning approach for semantic segmentation of fractional laser patterns for automatic assessment of laser hole diameter and CZ morphology. Last, collagen denaturation and drug uptake were quantified via polarization and fluorescence microscopy, respectively.10)

Different UK Alchem??

Alex Leech - CEO - Alex joined Alchemab as founding CEO in 2019, bringing extensive biotechnology and pharmaceutical leadership experience. He is a serial biotechnology CEO and in 2016 he led the sale of European dermatology company Creabilis Therapeutics. Alex is an experienced company builder, a Venture Partner at SV Health Investors and a non executive Director of Zarodex Therapeutics.

Jane Osbourn - CSO - Former VP of R&D at MedImmune (Astrazeneca), former Chair of the BIA. OBE for services to drug discovery & development and Lifetime Achievement Award from Scrip.

Olivia Cavlan - Head of Business & Operations - Olivia is an experienced biotech leader, former McKinsey and QuantumBlack Partner focused on biopharmaceutical analytics and private equity, and previously an academic clinician specialised in paediatric infectious diseases.

Gavin Kilpatrick - Head of Neuroscience and Academic Liaison - 30 years’ experience of drug discovery and development in biotechnology and pharmaceutical sectors. Senior management positions at GSK, CeNeS, Roche and Takeda.11)

Deep sequencing of B cell receptor repertoires from COVID-19 patients reveals strong convergent immune signatures

Jacob D. Galson, Sebastian Schaetzle, Rachael J. M. Bashford-Rogers, Matthew I. J. Raybould, Aleksandr Kovaltsuk, Gavin J. Kilpatrick, Ralph Minter, Donna K. Finch, Jorge Dias, Louisa James, Gavin Thomas, Wing-Yiu Jason Lee, Jason Betley, Olivia Cavlan, Alex Leech, View ORCID ProfileCharlotte M. Deane, Joan Seoane, Carlos Caldas, Dan Pennington, Paul Pfeffer, Jane Osbourn doi: https://doi.org/10.1101/2020.05.20.106294 12)

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