Aikido Pharma has secured an early investment in Convergent Therapeutics, Inc. Convergent Therapeutics, Inc. is a startup pharmaceutical company focused on developing next generation radiopharmaceutical therapy for prostate cancer and other applications. Its proprietary technology involves peptide receptor radionuclide therapy (“PRRT”) developed under the direction of Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine.
The cornerstone of Convergent’s PRRT technology is its proprietary drug, CONV 01-α, a monoclonal antibody conjugated with 225Ac, a radioactive alpha particle emitter. CONV 01-α was specifically designed to bind to the prostate-specific membrane antigen (“PSMA”). A key functional feature of CONV 01-α is that, once bound to PSMA, it internalizes itself and the receptor, delivering its powerful radioactive payload directly into prostate cancer cells. If FDA approved, CONV 01-α would be the first drug approved for an antibody to direct a radioisotope to prostate cancer, and the first drug approved for the use of 225Ac in cancer treatment.
Using CONV 01-α, Convergent has developed a dual PRRT therapy by adding a second molecule also containing a radioactive isotope. In this proprietary therapy, the second molecule has several key features:
- Like CONV 01-α, it binds specifically to the PSMA receptor on prostate cancer cells. But it binds to a different epitope of PSMA, allowing both drugs to bind PSMA simultaneously and noncompetitively.
- It has a different, non-overlapping biodistribution in the body than does CONV 01-α, reducing additive toxicity to healthy tissue when both drugs are administered.
- When both CONV 01-α and the second molecule are bound to PSMA, CONV 01-α still causes the internalization of the PSMA, so the radioactive payloads of both CONV 01-α and the second molecule are delivered into the cancer cells.
These key features allow for a more powerful treatment than using CONV 01-α alone, while minimizing double damage to healthy tissues. In fact, preliminary animal data indicate that the two molecules administered together act in a truly synergistic fashion, i.e., the effect of using both drugs together is significantly higher than the expected additive effects of using each separately.
Convergent is presently conducting several clinical trials in human prostate cancer patients to determine which of its proprietary treatment regimens will provide the greatest efficacy with the least toxicity. Convergent is well-advanced in human trials using both CONV 01-α alone and its dual PRRT technology to treat prostate cancer. Phase 2 CONV 01-α results are expected by Q2 2021. Convergent’s current and future clinical trials are described in more detail below:
CONV 01-α As A Single Therapy
Convergent is conducting two sets of clinical trials using CONV 01-α as a single agent treatment for prostate cancer:
- Convergent has completed a Phase 1a/2a Single Ascending Dose Trial of CONV 01-α. This trial has seen its last patient and the data is expected to be released by Q2 2021. Data from the first 27 of the total 31 patients shows substantial anti-tumor activity with minimal toxicity.
- In August of 2020, Convergent began a Phase 1b/2a trial to test the efficacy of multiple ascending doses of CONV 01-α.
CONV 01-α For Use in A Dual Therapy
The second molecule Convergent is testing for use with CONV 01-α in dual PPRT therapy is a small molecule designated PSMA I&T. It is routinely used clinically to perform imaging to show the presence and distribution of PSMA in a prostate cancer patient. Convergent is testing this small molecule in conjunction with either 177Lu, a beta particle emitter, or 225Ac, the same alpha emitter contained in CONV 01-α.
Convergent has approval to perform three human trials using CONV 01-α and PSMA I&T in a dual therapy, which are anticipated to begin in February of 2021:
(1) a Phase 1b/2a with the combination of CONV 01-α and PSMA I&T-β;
(2) a Phase 2b with the combination of PSMA I&T-β ± CONV 01-α, and
(3) a Phase 1b/2a trial with PSMA I&T-α ± CONV 01-α (i.e., both drugs with 225Ac, the α-particle emitter).
Another company is currently studying PSMA I&T-β, containing 177Lu, and has just completed a phase 3 trial in prostate cancer. Separately, Novartis is pursuing FDA approval for another 177Lu-small molecule drug for prostate cancer treatment, designated 177Lu-PSMA-617, which also binds PSMA. Novartis has recently completed a phase 3 registration trial for treatment of metastatic castration-resistant prostate cancer (mCRPC), which is a form of advanced prostate cancer. Like PSMA I&T-β, Novartis’s 177Lu-PSMA-617 may also be an excellent candidate for use with CONV 01-α in the proprietary dual PRRT therapy.
First in Class Operational Team
Philip Kantoff, MD CEO
Memorial Sloan Kettering Cancer Center (MSK)
- Chairman, Department of Medicine, 2015-present
- Grew faculty at MSK’s Department of Medicine by >200 (currently ~484 total) through recruitment of national and international clinical and research leaders in oncology
- Increased the annual research funding of the Department of Medicine to over $300 million dollars. An increase of 78% since starting in 2015
- Created and pushed forward research programs that have produced dozens of cancer related FDA drug approvals
- Steered the department through the COVID-19 crisis
Neil Bander, MD CSO / Founder
Weill Cornell Medicine
- Bernard and Josephine Chaus Professor of Urological Oncology and Director of Urological Oncology Research at Weill Cornell Medicine
- His team has the world’s largest experience in antibody discovery and clinical development in urological oncology.
- Developed the first monoclonal antibodies to prostate-specific membrane antigen (PSMA) that could successfully target prostate cancers in patients.
- Pioneered the clinical validation of PSMA and PSMA-Targeted Therapeutics (Radionuclides and Antibody-Drug Conjugates).
John Cullity, MD MBA CFO / CBO
- Managing Director at BioSynergy Partners, a life science advisory spun out of Torreya New York where he was CBO.
- Provides strategic advisory on M&A, partnering and financing to life-science companies worldwide.
- Chairman Race Oncology (RAC.ASX). Director of several life sciences start-ups.
- Oncology BD team leader and Head of Strategic Pricing at Sanofi, Health Economist at Schering Plough, Consultant at A.T. Kearney.
- Board certified internist: Royal College of Physicians, UK. Wharton MBA.