Company Product Description Indication Status
Phase I
Adamis Pharmaceuticals Corp., of San Diego Zimhi High-dose naloxone injection Healthy volunteers (eventually opioid overdose) Data published in The Journal of Opioid Management showed a 5-mg dose of Zimhi produced higher Cmax, area under the curve and half-life compared to the 2-mg dose of Evzio (naloxone, Kaleo Inc.)
Aileron Therapeutics Inc., of Watertown, Mass. ALRN-6924  Inhibits MDM2 and MDMX Chemotherapy-induced toxicity in patients with small-cell lung cancer  Enrolled first of approximately 8 patients in the expansion cohort; data from the dose-optimization part of the study expected in June 2020; data from the expansion cohort expected in the fourth quarter of 2020
Alucent Biomedical Inc., of Salt Lake City Natural vascular scaffolding Photoactivated protein Peripheral artery disease Enrolled the first 2 patients in the 15-patient Activate I study
Auris Medical Holding Ltd., of Hamilton, Bermuda AM-201  Structural analogue of histamine Antipsychotic-induced weight gain Weight gain was 2.8 kg for subjects taking the 30-mg dose of AM-201 and olanzapine compared to a 3.7-kg gain for subjects taking olanzapine alone (p<0.02)
Compugen Inc., of Holon, Israel COM-701 Anti-PVRIG antibody Advanced non-small-cell lung, ovarian, breast, endometrial and colorectal cancers Dosed first of approximately 20 patients in the expansion cohort testing the safety, tolerability and preliminary antitumor activity of the drug
Cytovation AS, of Bergen, Norway Cypep-1 Targets and lyses tumor cell membranes Advanced solid cancers Treated first of up to 21 patients in the study measuring the safety, efficacy and pharmacokinetics of the intratumoral injection
GT Biopharma Inc., of Los Angeles GTB-3550 Trispecific recombinant fusion protein conjugate composed of variable regions of heavy and light chains of anti-CD16 and anti-CD33 antibodies and modified form of IL-15 Acute myeloid leukemia or advanced systemic mastocytosis Treated second patient in the study
Macrogenics Inc., of Rockville, Md. Flotetuzumab  Bispecific CD123 x CD3 DART molecule Primary induction failure or early relapse acute myeloid leukemia Plans to expand ongoing study to up to 200 patients to be used for registration; primary endpoint is complete remission (CR) and CR with partial hematological recovery; secondary endpoints include durability of response and other supportive clinical endpoints
Mersana Therapeutics Inc., of Cambridge, Mass. XMT-1536 Antibody-drug conjugate targeting NaPi2b Ovarian cancer and non-small-cell lung adenocarcinoma In 20 evaluable patients, objective response rate was 35%, including 10% complete responses and 25% partial responses; 1 additional patient had an unconfirmed partial response with a confirmatory scan pending
Mina Therapeutics Ltd., of London MTL-CEBPA  Up-regulates CCAAT/enhancer binding protein alpha  Advanced hepatocellular carcinoma Data published in Clinical Cancer Research showed 1 of 24 evaluable patients had a partial response
Nascent Biotech Inc., of San Diego Pritumumab Vimentin modulator Brain cancer Trial set to begin, in conjunction with Hoag Family Cancer Institute, using design that allows treatment of variety of brain cancers, including gliomas and other primary brain tumors, brain metastases and leptomeningeal cancers
Transcenta Holding Ltd., of Suzhou, China MSB-2311 PD-L1-targeting antibody with pH-dependent and tumor recycling property Advanced solid tumors and select hematological malignancies Initial results suggest favorable safety profile across all doses; investigators report patients achieving durable responses that persisted, with 1 durable response beyond 12 months; at 20-mg dose, objective response rate was 33%; additional dose expansion with alternative dosing regimen at 10 mg/kg every 2 weeks is ongoing
Vir Biotechnology Inc., of San Francisco VIR-3434 Hepatitis B large envelope protein modulator Hepatitis B virus infection Trial initiated with design to progress from healthy volunteers to individuals with chronic infection in staggered, parallel fashion to generate early proof-of-concept data; results expected in 2021
Phase II
Auris Medical Holding Ltd., of Hamilton, Bermuda AM-125  Structural analogue of histamine Acute peripheral vertigo Resumed enrollment in study that was paused due to COVID-19; interim analysis expected in the third quarter of 2020
Biolinerx Ltd., of Tel Aviv, Israel BL-8040 (motixafortide) CXCR4 antagonist Pancreatic cancer Previously reported data from first cohort (n=37) and first 22 participants in second cohort, all with metastatic disease, in ongoing Combat/Keynote-202 combination trial with pembrolizumab (Keytruda, Merck and Co. Inc.) and chemotherapy published in Nature Medicine 
Ironwood Pharmaceuticals Inc., of Boston, and Abbvie Inc., of North Chicago MD-7246 (linaclotide, oral delayed-release) Natriuretic peptide receptor C agonist Irritable bowel syndrome with diarrhea Trial in adults with abdominal pain associated with disease missed primary endpoints of change from baseline in abdominal pain at its worst each week and overall abdominal pain response, and all secondary endpoints; companies halting development
Novartis AG, of Basel, Switzerland Ofatumumab B-lymphocyte antigen CD20 inhibitor Relapsing multiple sclerosis  Analysis from Aplios trial (n=284) showed treatment with study drug led to rapid and sustained depletion of CD20+ B and T cells in participants, including memory B cells, naïve B cells and subset of T cells known to exhibit activated phenotype; CD3+ T cells that do not express CD20 receptor were largely unaffected
NS Pharma Inc., wholly owned subsidiary of Nippon Shinyaku Co. Ltd., of Kyoto, Japan Viltolarsen DMD gene modulator Duchenne muscular dystrophy Findings from trial in 16 people with DMD, published in JAMA Neurology, showed statistically significant increases in mean dystrophin expression (40 mg/kg/wk: p<0.001; 80 mg/kg/wk p=0.012), with mean dystrophin levels of 5.7% and 5.9% observed in comparison to mean baseline levels of 0.3% and 0.6% in 40-mg/kg/wk and 80-mg/kg/wk groups, respectively; 14 (88%) reached dystrophin levels greater than 3%
Zynerba Pharmaceuticals Inc., of Devon, Pa. Zygel (ZYN-002, cannabidiol transdermal gel) Cannabinoid CB2 receptor modulator Autism spectrum disorder Bright trial achieved statistically significant (<0.0001 to 0.0002) improvement from baseline in all 5 subscales of aberrant behavior checklist; participants achieved mean improvement of 46% at week 14 from baseline score of 40.8, measured by PRAS-ASD (p<0.0001); 57% of participants assessed as “very much improved” or “much improved” at week 14, measured by CGI-I
Phase III
Genentech Inc., unit of Roche Holding AG, of Basel, Switzerland Lucentis (ranibizumab) VEGF-A inhibitor Wet age-related macular degeneration Archway trial of port delivery system, refilled with study drug every 6 months, met primary endpoint by showing noninferior and equivalent efficacy vs. standard-of-care monthly eye injections
Novartis AG, of Basel, Switzerland Ofatumumab B-lymphocyte antigen CD20 inhibitor Relapsing multiple sclerosis  Data from Asclepios I and II trials (n=1,882) showed that greater proportion of those treated with study drug vs. teriflunomide (Aubagio, Sanofi SA) achieved no evidence of disease activity, or NEDA-3, in year 1 (47% vs. 24.5%; p<0.001) and year 2 (87.8% vs. 48.2%; p<0.001); data published in European Journal of Neurology 
Novartis AG, of Basel, Switzerland Kisqali (ribociclib) Cyclin-dependent kinase-4/6 inhibitor Metastatic breast cancer Subgroup analysis of Monaleesa-3 (M3) and -7 (M7) trials in women with HR+/HER2- advanced or metastatic disease showed study drug plus endocrine therapy extended life vs. endocrine therapy alone for those with liver metastases; for M3 in postmenopausal women, median overall survival (OS) was 36.1 for Kisqali plus fulvestrant vs. 24.1 months for fulvestrant alone; for M7 in premenopausal women, median OS was not evaluable for Kisqali plus NSAI and goserelin vs. 33.6 months for NSAI plus goserelin 
Novartis AG, of Basel, Switzerland Kisqali (ribociclib) Cyclin-dependent kinase-4/6 inhibitor Metastatic breast cancer Updated data from single-arm phase IIIb Compleement-1 trial (n=3,246) evaluating study drug plus letrozole in first-line setting in expanded population resembling real-world practice showed median time to progression of 27.1 months and overall response rate of 43.6% 
Radius Health Inc., of Waltham, Mass., and Teijin Pharma Ltd., of Tokyo Abaloparatide-SC Parathyroid hormone receptor 1 agonist Osteoporosis Study in Japan that included men and women with osteoporosis at high risk for fracture achieved efficacy endpoint of increased lumbar spine bone mineral density at 18 months

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments