Pipeline Report: July 2022 | Articles

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PC14586 Shows Preliminary Activity, Safety in p53 Y220C–Mutant Solid Tumors

July 28th 2022

The first-in-class p53 reactivator, PC14586, induced a response in approximately 1 of 4 patients with advanced solid tumors harboring p53 Y220C mutations and showcased an acceptable safety profile consisting primarily of grade 1 and 2 events.

Low-Dose Belantamab Mafodotin/Nirogacestat Demonstrates Encouraging Clinical Activity in R/R Myeloma

July 27th 2022

Nirogacestat plus belantamab mafodotin induced promising responses with manageable safety for patients with relapsed/refractory multiple myeloma.

Belantamab Mafodotin/Pembrolizumab Combo Elicits Favorable ORR in Heavily Pretreated Multiple Myeloma

July 26th 2022

The addition of pembrolizumab to belantamab mafodotin resulted in a higher overall response rate in patients with relapsed/refractory multiple myeloma than what has been observed with the antibody-drug conjugate alone, according to results from the phase 1/2 DREAMM-4 trial.

Bomedemstat Demonstrates Early Promise in Advanced Myelofibrosis

July 26th 2022

Single-agent bomedemstat was found to improve symptom scores, bone marrow fibrosis, spleen volumes, and anemia in patients with advanced myelofibrosis, according to findings from the phase 1/2 IMG-7289-CTP-102 trial (NCT03136185) presented during the 2022 EHA Congress.

Selinexor/Ruxolitinib Combo Shows Early Activity, Tolerability in Treatment-Naïve Myelofibrosis

July 25th 2022

A combination comprised of selinexor (Xpovio) and ruxolitinib (Jakafi) induced rapid spleen responses at week 12 and showcased a manageable toxicity profile in patients with treatment-naïve myelofibrosis.

FDA Grants Orphan Drug Designation to DSP-0390 for Brain Cancer

July 22nd 2022

The FDA has granted an orphan drug designation to DSP-0390 for the treatment of brain cancer.

Eltanexor Gets FDA Fast Track Status and Orphan Medicinal Product Designation in Europe for MDS

July 21st 2022

Eltanexor has been granted a fast track designation from the FDA and an orphan medicinal product designation from the European Commission for use as a potential therapeutic option in patients with myelodysplastic syndromes.

FDA Grants Fast Track and Rare Pediatric Disease Designations to WU-CART-007 in R/R T-ALL and LBL

July 21st 2022

The FDA has granted fast track and rare pediatric disease designations to the CAR T-cell therapy WU-CART-007 for the treatment of patients with relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.

FDA Grants Orphan Drug Designation to NT-I7 for Glioblastoma Multiforme

July 15th 2022

The FDA has granted an orphan drug designation to NT-I7 for the treatment of patients with glioblastoma multiforme.

Pirtobrutinib Demonstrates Encouraging Efficacy, Favorable Safety in Previously Treated CLL/SLL

July 14th 2022

Pirtobrutinib continued to produce promising responses in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, irrespective of BTK C481 mutation status, reason for prior BTK inhibitor discontinuation, or other classes of previous therapy received.

FDA Grants Orphan Drug, Fast Track Designations to CV-01 in Recurrent Glioblastoma

July 13th 2022

CV-01, Alpheus Medical’s novel sonodynamic therapy delivery platform, has received orphan drug and fast track designations from the FDA for the treatment of patients with recurrent glioblastoma.

Ibrutinib/Obinutuzumab Combo Elicits Durable Responses in Relapsed/Refractory CLL

July 13th 2022

Findings from a phase 1b trial showed that the addition of obinutuzumab to ibrutinib produced a complete response rate that compared favorably with what has historically been observed with ibrutinib monotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

FOR46 Shows Early Antitumor Activity in Metastatic Castration-Resistant Prostate Cancer

July 12th 2022

The CD46-targeted antibody-drug conjugate FOR46 demonstrated encouraging evidence of antitumor activity in patients with metastatic castration-resistant prostate cancer with a safety profile that proved to be similar to other monomethyl auristatin E–based ADCs, according to data from a phase 1a/1b trial.

Anbalcabtagene Autoleucel Elicits Meaningful Responses in Relapsed/Refractory LBCL

July 8th 2022

The CAR T-cell therapy anbalcabtagene autoleucel generated strong overall response rates in patients with relapsed/refractory large B-cell lymphoma.

FDA Grants Orphan Drug Designation to PBI-200 for NTRK Fusion–Positive Solid Tumors

July 7th 2022

The FDA has granted an orphan drug designation to PBI-200 for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors.

FDA Grants Fast Track Designation to Belzupacap Sarotalocan for Non–Muscle Invasive Bladder Cancer

July 7th 2022

The FDA has granted a fast track designation to belzupacap sarotalocan for the treatment of patients with non–muscle invasive bladder cancer, representing the first virus-like drug conjugate candidate therapy from Aura Biosciences, Inc., the drug developer.