Company Product Description Indication Status
Phase I
Aegis Life Inc., of San Diego Covigenix VAX-001 DNA vaccine  COVID-19  First participants dosed
Alzecure Pharma AB, of Stockholm ACD-856 Modulator of neurotrophin signaling Alzheimer's disease Showed a good pharmacokinetic profile with a significantly shorter human half-life than predecessor ACD-855, as well as a suitability for further clinical development
Erytech Pharma SA, of Lyon, France Eryaspase L-asparaginase encapsulated inside donor-derived red blood cells Pancreatic cancer No dose-limiting toxicity had been observed in the first cohort treated at a therapeutic dose of 75 U/kg; 2 of 3 patients treated had a partial response and significantly decreased levels of CA19-9
Humanigen Inc., of Burlingame, Calif. Lenzilumab Monoclonal antibody targeting granulocyte macrophage-colony stimulating factor Diffuse large B-cell lymphoma In combination with CAR T, demonstrated a 100% objective response rate and no severe cytokine release syndrome or severe neurotoxicity
Medivir AB, of Stockholm MIV-818 Prodrug converted to TRX-MP and its active metabolite troxacitabine triphosphate when taken up by liver cells Liver cancer Recommended dose for next phase determined
Transcenta Holding Ltd., of Suzhou, China TST-001 Second-generation recombinant humanized monoclonal antibody targeted CLDN18.2 Metastatic gastric cancer First patient dosed in combination with CAPOX regimen
Ziopharm Oncology Inc., of Boston CD19-specific Rapid Personalized Manufacturing CAR T  Genetically engineered T cells Advanced lymphoid malignancies First patient infused
Zyus Life Sciences Inc., of Saskatoon, Saskatchewan Trichomylin Fixed-dose cannabinoid Chronic pain Trial launched
Phase II
Bergenbio ASA, of Bergen, Norway Bemcentinib  AXL kinase inhibitor Hospitalized COVID-19 Completed 96% of the targeted enrollment of the BGBC020 study for a total of 115 patients; stopped enrollment at 50% of planned target enrollment of the investigator-sponsored ACCORD2–002 study due to a reduction in U.K. COVID-19 cases and to allow for prompt analysis; studies will be analyzed separately and together in a meta-analysis; initial results of the ACCORD2 study showed, at day 29, 1 death in 28 patients treated with bemcentinib plus standard of care (SoC) compared to 5 in 32 patients treated with SoC alone; in the BGBC020 study, mortality rate was 2 in 58 for bemcentinib plus SoC compared to 3 in 57 for SoC alone
Checkmate Pharmaceuticals Inc., of Cambridge, Mass. Vidutolimod (CMP-001) TLR9 agonist First-line relapsed or metastatic head and neck squamous cell carcinoma Started dosing of study testing vidutolimod plus Keytruda (pembrolizumab, Merck & Co. Inc.); primary endpoint is objective response rate; initial data for a subset of patients expected before the end of 2021; results expected in the second half of 2022
Lyndra Therapeutics Inc., of Watertown, Mass.  LYN-005 Extended-release capsule of the atypical antipsychotic risperidone Schizophrenia LYN-005 produced sustained therapeutic levels of risperidone over 1-week dosing intervals and reduced peak drug exposure compared to immediate release risperidone; plans to meet with FDA to discuss clinical path and pivotal clinical trial design
Mimedx Group Inc., of Marietta, Ga. Amniofix Micronized dehydrated human amnion chorion membrane Knee osteoarthritis All clinical effectiveness endpoint visits have been completed in the phase IIb study; data expected in the third quarter of 2021
Pharmabcine Inc., of Daejeon, South Korea Olinvacimab Monoclonal antibody targeting VEGFR2 Metastatic triple-negative breast cancer Plans to start a phase II study of olinvacimab plus Keytruda (pembrolizumab, Merck & Co. Inc.) in the first half of 2021 with Merck agreeing to provide the Keytruda; study will evaluate the clinical efficacy, safety, pharmacodynamics and the expression level of VEGFR-2 and PD-L1 after treatment with the combination
Sirnaomics Inc., of Gaithersburg, Md. STP-705 siRNA targeting TGF-βbeta and COX-2 expression Keloid scar prevention after keloidectomy  Started study testing multiple doses of STP-705; primary endpoint is the rate of recurrence at 3 months, 6 months and 12 months postsurgical excision
Todos Medical Ltd., of New York Tollovir (NLC-V-01) 3CL protease inhibitor Hospitalized COVID-19 Treated first 10 patients in the 77-patient study; primary endpoints are time to discharge from the hospital and time to clinical improvement based upon the National Early Warning Score 2 in Israel
Phase III
Karyopharm Therapeutics Inc., of Newton, Mass. Xpovio (selinexor) Selective inhibitor of nuclear export Unresectable dedifferentiated liposarcoma following progression on at least 2 prior therapies Data from the phase III portion of the Seal study published in Future Oncology showed pain scores worsened in the placebo arm compared to the Xpovio arm across all post-baseline visits, though some visits were not statistically significant; median time to next treatment was significantly longer in patients receiving Xpovio compared to those receiving placebo
Mimedx Group Inc., of Marietta, Ga. Amniofix Micronized dehydrated human amnion chorion membrane Plantar fasciitis and achilles tendonitis Last patients completed their last clinical visits in both phase III studies; data from both studies expected in the third quarter of 2021

Notes

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