August 2020: XEME Biopharma Holdings Inc.(“XBH”), previously known as Acqusalut, Inc., is a public company incorporated in the state of Florida. Through M&A process led by R2T Biopharma, Inc., XBH acquired 100% of XEME Biopharma, Inc. (“XEME”).
November 2019: 100% of XEME’s stock was acquired by R2T Biopharma Inc.(“R2T”), a company based in California. Under the new parent company “R2T Biopharma, Inc., XEME transferred operations to New Jersey and focused on re-implementing a cGMP Quality System to assure QC and QA for manufacturing and releasing clinical products. XEME plans to begin recruiting new patients in its Phase Ib clinical trial for CLL at Northwestern University and to eventually initiate trials in Follicular lymphoma and other solid tumors from Northwestern Cancer Center.
January 2018: XEME successfully completed the validation of all its quality control and manufacturing procedures at the new facility in Lombard, IL and has subsequently submitted a revised IND to the FDA. XEME hopes to re-start its clinical trial at Northwestern University in March-April 2018.
February 2017: XEME filed two non-provisional patents with the USPTO through their IP counsel, Banner and Witcoff Ltd. (Chicago) thereby enriching its IP portfolio.
February 2017: XEME was invited to present at the Keiretsu Mid-West Angel forum meeting in Cincinatti, OH on February 21, 2017 and is currently in the due diligence stage for potential investment by Keiretsu Angel members.
February 2017: XEME has launched efforts to validate its Quality Control / Quality Assurance and Manufacturing facilities at the new location in Lombard to cGMP standards and expects to re-start clinical trials later this year.
January 2017: XEME launched a web-based investment portal (invest.xemebiopharma.com) to raise capital via S.E.C. Regulation D, 506 c mechanism (for Accredited Investors using general solicitation).
June 2016: Dr. Larry Kwak, co-founder of XEME, was awarded the Ho-Am prize in Medicine, South Korea’s highest honor, for his work in immunotherapy.
May 2016: XEME and its parent company, TheraTest Laboratories Inc., consolidated operations at a newly constructed, 27,000-square-foot facility located in Lombard, IL (Chicago suburb).
May 2015: XEME participated in the American Society of Clinical Oncology annual meeting in Chicago. At its booth, XEME had the opportunity to meet with and discuss its clinical program and prior clinical data with several attendees.
December 2014: XEME received invitations to present at three prestigious Biotech science and investor conferences to be held in early 2015: the 7th Annual BIOTECH Showcase, January 12-14, 2015, San Francisco, CA; the 3rd Annual Cancer Bio-Partnering and Investment Forum, February 23, 2015, New York Academy of Sciences, NY; and the 8th European Life Sciences CEO Forum and Exhibition, March 3-4, 2015, Zurich, Switzerland.
July 2014: A Pilot Phase II clinical trial entitled “Oncoquest-L Vaccine in Patients with Previously Untreated Stage III and IV Asymptomatic, Non-Bulky Follicular Lymphoma” was opened at the Midwestern Regional Medical Center of the Cancer Treatment Centers of America, with Dr. Istvan Redei as Principal Investigator. The trial is designed to determine the clinical benefit of Oncoquest™-L in patients with follicular lymphoma whose immune system has not yet been compromised by disease and/or other treatments. Due to delays in patient accrual, this trial is also under consideration at MD Anderson Cancer Center in Houston, TX.
January 2014: XEME contracted with Theradex Inc., a clinical research organization specialized in oncology, to monitor an FDA approved pilot Phase II clinical trial in non-Hodgkin’s follicular lymphoma under IND 15639. Theradex will also provide the clinical database and act as FDA liaison for XEME on regulatory issues.
November 2013: A Phase Ib clinical trial of Oncoquest™-CLL was opened at the Lurie Cancer Center of Northwestern University, Chicago IL, with Dr. Shuo Ma as Principal Investigator. This clinical trial will assess safety and efficacy of Oncoquest™ vaccine in previously untreated patients with progressive hematologic tumors (CLL) who are in the “watchful waiting” stage. This trial was considered by FDA as "first-in-man".
July 2013: The US FDA-approved IND 15639 for a clinical trial of XEME’s Oncoquest™ vaccine in patients with chronic lymphocytic leukemia (CLL). The IND was designed to serve as a basis for clinical trial protocols using Oncoquest™ vaccine in other hematologic and solid tumor indications.
January 2013: XEME signed a Clinical Trial Agreement with the Cancer Treatment Centers of America to perform clinical trials at their hospitals. This large and prestigious hospital organization will help XEME to accelerate the clinical trial phase of Oncoquest™ vaccine toward product registration.
June 2012: With investments and administrative assistance from TheraTest, XEME completed the construction of a cGMP small volume manufacturing facility for production of autologous (personalized) therapeutic cancer vaccines using Aggregon® technology. The facility has the capacity to sustain the clinical trials program until registration trial(s) for marketing approval.
December 2011: XEME entered into a merger agreement with TheraTest Laboratories Inc., a profitable, established company with expertise in immunodiagnostic tests, in exchange for a negotiated percentage of TheraTest stock. XEME became a wholly owned subsidiary.
September 2011: XEME received a $400,000 investment from Dorel Nasui, President and CEO of American International Radio.
October 2010: XEME completed the negotiations with Oncothyreon Inc., the successor of Biomira Inc., for the exclusive use of the patents authored by XEME Founders while working at Biomira.
October 2008: XEME Biopharma received an SBIR grant from the US National Institutes of Health entitled "Therapeutic Cancer Vaccine for Non-Hodgkin’s Lymphoma."