Company

Product

Description

Indication

Status

Adaptimmune Therapeutics plc, of Oxfordshire, U.K.

ADP-A2M4

SPEAR T cells targeting MAGE-A4

Synovial sarcoma

Updated phase I data from 12 patients in expansion phase showed best overall response rate of 58%, disease control rate of 92% and stable disease

Adlai Nortye Ltd., of North Brunswick, N.J.

AN-0025

Oral EP4 antagonist

Locally advanced rectal cancer

Phase Ib results from 2 dose levels in combination with standard of care in patients where primary resection without chemoradiotherapy is unlikely to achieve clear margins showed complete clinical responses led to 5/25 patients being managed by watch-and-wait approach; in those who had surgery, 4/15 had partial clinical response with 12 having clear resection margins

Ayala Pharmaceuticals Inc., of Rehovot, Israel

AL-101

Small-molecule, gamma-secretase inhibitor

Adenoid cystic carcinoma

Preliminary data from Accuracy phase II trial in patients with recurrent/metastatic progressing disease and Notch activating mutations showed a 22% response rate (4 patients achieving partial response); 7 achieved stable disease; overall disease control rate of 61%

Basilea Pharmaceutica Ltd., of Basel, Switzerland

Derazantinib

Small-molecule pan-FGFR kinase inhibitor

Intrahepatic cholangiocarcinoma

Phase I/II data showed drug provided clinically meaningful antitumor activity in patients with FGFR2 gene fusions and in patients with FGFR2 gene mutations and amplifications; disease control rate was 67% for FGFR2 gene mutations or amplifications vs. 83% for FGFR2 gene fusions; median duration of disease control and median progression-free survival were similar at 8.6 months vs. 8.1 months and 6.7 months vs. 5.7 months, respectively

Beigene Ltd., of Beijing

Tislelizumab

Humanized IgG4 anti-PD-1 monoclonal antibody

Locally advanced or metastatic urothelial carcinoma

Data from 104 evaluable patients in phase II trial in Asian patients showed confirmed objective response rate of 23.1%, with 8 complete responses and 16 partial responses; median duration of response not reached; median progression-free and overall survival were 2.1 months and 9.8 months, respectively

Beigene Ltd., of Beijing

Pamiparib

PARP inhibitor

Locally advanced or metastatic solid tumors

Data from phase Ib trial in combination with low-dose temozolomide determine recommended phase II dose of 60 mg twice daily for 28 days; objective response rate was 19.3% (11 partial responses); disease control rate was 64.9%

Beigene Ltd., of Beijing

Pamiparib

PARP inhibitor

Advanced solid tumors

Updated data from phase Ia/Ib trial in Australia from 58 patients with ovarian and associated cancer showed 23 (39.7%) achieved confirmed objective response, with 4 complete responses (6.9%) and 19 partial responses (32.8%)

Beyondspring Inc., of New York

Plinabulin

Small molecule that activates GEF-H1

Stage IIb/IV non-small-cell lung cancer

Disclosed design for Dublin-3 phase III study, which will stratify by region (Asian/non-Asian) 554 patients with EGFR wild-type disease receiving second- or third-line docetaxel-plinabulin combination vs. docetaxel alone and will measure overall survival as primary endpoint

Bristol-Myers Squibb Co., of Princeton

Opdivo (nivolumab)

Anti-PD-1 antibody

Unresectable advanced or recurrent esophageal squamous cell carcinoma

Results from phase III Attraction-3 trial in patients refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drug showed 23% reduction in risk of death and 2.5-month improvement in median overall survival vs. chemotherapy

Cellectar Biosciences Inc., of Florham Park, N.J.

CLR-131

Small-molecule phospholipid-drug conjugate

Diffuse large B-cell lymphoma

Data from DLBCL cohort in phase II Clover study showed durable responses, including 33% overall response rate, 16.6% complete response rate and 50% clinical benefit rate; CLR-131 showed activity against both germinal center and activated DLBCL

Checkpoint Therapeutics Inc., of New York

Cosibelimab

Anti-PD-L1 antibody

Squamous cell carcinoma and non-small-cell lung cancer

Phase I data showed 50% objective response rate in CSCC patients (1 complete response and 6 partial responses) and 40% ORR in NSCLC patients (10 partial responses)

Cstone Pharmaceuticals Co. Ltd., of Suzhou, China

CS-1001

Anti-PD-L1 antibody

Advanced solid tumors or lymphoma

Data from phase Ib Gemstone-101 trial showed combination with CF chemotherapy showed objective response rate of 77.8% in first-line esophageal squamous cell carcinoma, with disease control rate of 88.9%; in combination with XELOX chemo in first-line gastric cancer/gastroesophageal junction cancer, ORR was 62.1% and DCR was 82.8%; in unresectable cholangiocarcinoma/gallbladder cancer, ORR was 10.3% and DCR was 37.9%; in microsatellite instability-high/deficient mismatch repair tumors, ORR was 38.1% and DCR was 57.1%

Debiopharm SA, of Lausanne, Switzerland

Debio-1143

Antagonist of IAPs (inhibitor of apoptosis proteins)

High-risk, locally advanced squamous cell carcinoma of the head and neck

Data from phase II study in combination with chemoradiotherapy (CRT) showed statistically significant improvement in primary endpoint of locoregional control rate (21% improvement at 18 months after CRT vs. control arm) and progression-free survival benefit vs. control arm after 2-year follow-up period

Deciphera Pharmaceuticals Inc., of Waltham, Mass.

Ripretinib

Inhibits KIT and PDGFRalpha mutated kinases

Advanced gastrointestinal stromal tumors

Results from pivotal phase III Invictus study showed reduction in risk of disease progression or death by 85% vs. placebo, with median progression-free survival of 6.3 months vs. 1 month for placebo (p<0.0001); 8 patients (9.4%) had confirmed objective response vs. none in placebo arm, and median duration of response had not been reached by cut-off date; median overall survival was 15.1 months vs. 6.6 months for placebo (nominal p=0.0004)

Elevar Therapeutics Inc., of Salt Lake City

Rivoceranib (apatinib)

Small-molecule angiogenesis inhibitor

Gastric or gastroesophageal junction cancer

Data from phase III Angel study in combination with best supportive care in patients who have failed at least 2 lines of therapy showed median overall survival of full intent-to-treat population (third- and fourth-line patients) was 5.8 months vs. 5.1 months for placebo (p=0.485), missing statistical significance; however, median OS in fourth-line was 6.3 months vs. 4.7 months for placebo (p=0.0195); median progression-free survival in full population was 2.8 months vs. 1.8 months (p<0.0001), while median PFS in fourth-line was 3.5 months vs. 1.7 months (p<0.0001)

Evgen Pharma plc, of London

SFX-01

Targets STAT3 signaling

ER-positive, metastatic breast cancer

Data showed phase II Stem trial met primary endpoints, demonstrating drug is well-tolerated with no safety concerns; in combination with endocrine therapy, SFX-01 showed both antitumor activity and prolonged disease stabilization in heavily pretreated patients progressing on endocrine therapy at trial entry

Faron Pharmaceuticals Oy, of Turku, Finland

Clevegen

Immunotherapy targeting Clever-1 positive tumor-associated macrophages

Metastatic or inoperable solid tumors

Data from phase I/II Matins study showed good tolerability across all dosing levels; antitumor activity showed by trial's first long-lasting partial responder, a heavily pretreated metastatic colorectal cancer patient whose tumor had been classified as microsatellite instability-low and tumor mutation burden, and who had previously been treated with 6 prior therapies

Five Prime Therapeutics Inc., of South San Francisco

FPA-150

Fully human, afucosylated monoclonal antibody targeting B7-H4

Advanced solid tumors

Updated phase Ia/Ib data from monotherapy portion in B7-H4-positive ovarian cancer showed 2 patients had confirmed partial response, 10 with stable disease remained on therapy as of Aug. 9, 2019, and increased tumor infiltration of T cells and NK cells observed in patients with PR or SD; in combination portion with Keytruda (pembrolizumab, Merck & Co. Inc.), combo was well-tolerated in first 4 patients

Hutchison China Meditech Ltd., of London

Surufatinib

Inhibits VEGFR and FGFR

Non-pancreatic neuroendocrine tumors

Phase III Sanet-ep study achieved primary endpoint, reducing risk of progression or death by 67%; median progression-free survival was 9.2 months for surufatinib vs. 3.8 months for placebo (p<0.0001); NDA in China expected to be filed by year-end

Imugene Ltd., of Sydney

HER-Vaxx

Cancer vaccine

Gastric cancer

Results from phase Ib trial in patients whose cancers overexpress HER2 showed 100% objective response in 3 patients receiving optimal dose of 50 mcg; in 5 of 11 evaluable patients, tumor reduction was associated with high HER2-specific antibody levels

Imugene Ltd., of Sydney

HER-Vaxx

Cancer vaccine

Cancer

Preclinical data showed combining HER2 vaccines with PD-1 vaccines reduced cancer growth in a number of standard models

Innate Pharma SA, of Marseille, France

IPH-5401

Anti-C5aR antibody

Advanced solid tumors

Preliminary data from phase I Stellar-001 trial in combination with Imfinzi (durvalumab, Astrazeneca plc) showed, of 12 evaluable patients, 1 confirmed partial response in hepatocellular carcinoma patient with prior progression after Opdivo (nivolumab, Bristol-Myers Squibb Co.) and 1 prolonged stable disease in non-small-cell lung cancer patient with prior progression after Opdivo

Innate Pharma SA, of Marseille, France

Monalizumab

Checkpoint inhibitor targeting NKG2A receptors

Recurrent and/or metastatic squamous cell carcinoma of the head and neck

Data from first expansion cohort in phase II study testing combination with cetuximab showed median overall survival of 8.5 months, with median follow-up of 17 months; 12-month OS rate was 44% (60% in I-O-pretreated patients and 32% in I-O-naïve); response rate was 27.5% (36% and 17% in I-O-naïve and pretreated, respectively

Stemline Therapeutics Inc., of New York

Felezonexor (SL-801)

Oral, small molecule that reversibly inhibits Exportin-1

Advanced solid tumors

Updated phase I data showed partial response achieved with single-agent in fourth-line patient with KRAS-positive, microsatellite stable colorectal cancer; stable disease in 12 patients, with 11 of those third-line or greater; 5 patients had SD for 4 and 11 months, including 1 patient with basal cell carcinoma with SD for about 11 months

Transgene SA, of Paris

TG4-001

Vaccine targeting human papillomavirus E6 and E7

HPV-16-positive recurrent or metastatic malignancies, including oropharyngeal cancers

Data from phase Ib trial in combination with Bavencio (avelumab, Merck KGaA) showed 3 of 6 patients treated at higher dose had durable partial responses; T-cell responses against the HPV-16 E6 and E7 antigens were detected in patients' blood at day 43; no dose-limiting toxicity observed

Tyme Technologies Inc., of New York

SM-88 (racemetyrosine)

Oral therapy designed to use modified tyrosine derivative to interrupt metabolic processes of cancer cells

Non-metastatic, biochemical-recurrent prostate cancer

Phase II study showed efficacy and safety for patients where sparing testosterone is important and also showed reduction of circulating tumor cells; from initial diagnoses of PSA rise, 100% of patients (23/23) remained free of metastatic progression and 87% (20/23) have maintained radiographic progression-free survival with median duration of 6.5 months since starting treatment

Notes

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