Company Product Description Indication Status
Phase I
Atyr Pharma Inc., of San Diego ATYR-1923 Targets neuropilin-2 receptor Pulmonary sarcoidosis ATYR-1923 was safe and well-tolerated in 15 patients who have received at least one dose of the drug
Cstone Pharmaceuticals Ltd., of Suzhou, China CS-3005 Adenosine A2a receptor antagonist Advanced solid tumors Received approval from the HREC in Australia and acknowledgement from Australia's TGA on the trial
Gritstone Oncology Inc., of Emeryville, Calif. GRANITE Personalized immunotherapy of 20 tumor-specific neoantigens Advanced cancer In the GO-004 study, CD8+ T cells against multiple neoantigens were observed via IFN-g ELISpot in 4 patients; the T cells were able to produce IL-2 and Granzyme B
Gritstone Oncology Inc., of Emeryville, Calif. SLATE Off-the-shelf immunotherapy of 20 tumor-specific neoantigens Advanced cancer In the GO-005 study, therapy was well-tolerated with no dose-limiting toxicities observed in 3 patients across 2 dose levels
Helix Biopharma Corp., of Richmond Hill, Ontario L-DOS47 Urease  Previously treated patients with advanced pancreatic cancer Started enrollment in the study testing 3 doses of the drug plus doxorubicin in 9 total patients followed by a phase II study of 11 additional patients
Nordic Nanovector ASA, of Oslo, Norway Betalutin CD37-targeting radioimmunotherapy Relapsed/refractory diffuse large B-cell lymphoma No safety issues in the 3 completed cohorts; a reversible dose limiting toxicity experienced in 1 patient in the final dosing cohort; evidence of disease control in some patients; data to be presented in the first half of 2020
Soligenix Inc., of Princeton, N.J. Rivax Ricin toxin A-chain subunit vaccine Healthy adults (ricin toxin exposure) Started trial
Zhejiang Medicine Co. Ltd., of Shaoxing, China, and Ambrx Inc., of San Diego ARX-788  Antibody-drug conjugate targeting HER2 Pretreated metastatic HER2 positive breast cancer Overall response rates of 14%, 36%, 56% and 63% for doses of 0.88 mg/kg, 1.1 mg/kg, 1.3 mg/kg and 1.5 mg/kg, respectively
Phase II
Kazia Therapeutics Ltd., of Sydney GDC-0084 PI3K inhibitor  Glioblastoma Drug selected for the Global Coalition for Adaptive Research’s GBM AGILE study; patient recruitment of up to 200 patients in the GDC-0084 arm expected to begin in second or third quarter of 2020
PDS Biotechnology Corp., of Princeton, N.J. PDS-0101 T-cell activating platform targeting antigens in HPV-expressing cancers First-line recurrent or metastatic human papillomavirus-16 positive head and neck cancer Established an independent DMC and named principal investigator
Puma Biotechnology Inc., of Los Angeles Neratinib  Inhibitor of HER1, HER2 and HER4 HER2-mutant, hormone receptor-positive, metastatic breast cancer In the Summit basket study, neratinib plus trastuzumab and fulvestrant produced a confirmed objective response in 53% of the 17 evaluable patients, all of which were partial responses; median progression-free survival was 9.8 months
Transgene SA, of Strasbourg, France TG-4010 Modified vaccinia Ankara virus encoding MUC1 and IL-2  Non-small-cell lung cancer Quitting development after candidate missed primary endpoint (ORR) of trial evaluating its combination with chemotherapy and Opdivo (nivolumab, Bristol-Myers Squibb Co.) as first-line treatment for patients with advanced non-squamous NSCLC
Phase III
Medday Pharmaceuticals SAS, of Paris MD-1003 Formulation of high-dose pharmaceutical-grade biotin Primary and secondary progressive multiple sclerosis Last patient study visit occurred in the SPI2 study; top-line data expected by the end of the first quarter of 2020
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Monoclonal antibody targeting PD-1 First-line metastatic nonsquamous non-small-cell lung cancer with PD-L1 expression Exploratory analysis of the Keynote-042 study showed Keytruda reduced the risk of death by 58% in patients with any KRAS mutation and by 72% in patients with the KRAS G12C mutation compared to chemotherapy
Roche Holding AG, of Basel Switzerland Perjeta (pertuzumab) and Herceptin (trastuzumab) Monoclonal antibodies targeting HER2 HER2-positive early breast cancer Subcutanous fixed-dose combination (FDC) of the drug was noninferior for levels of Perjeta in the blood; 59.7% of patients receiving the FDC and 59.5% of patients treated with intravenous Perjeta and Herceptin achieved a total pathological complete response

Notes

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

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