The Nasdaq Biotech Index added 4 % during April 2021

Monthly market moves of selected competitors compared to NASDAQ Biotechnology Index (NBI).

Nektar Therapeutics

Nektarannounced it will present its financial results for the 1Q 2021 on May 6, 2021.

Xencor

Xencor presented new data from multiple preclinical studies for XmAb bispecific antibody and its preclinical IL-12-Fc cytokine program at AACR. Xencor’s IL-12-Fc cytokine program is based on the clinical-stage biopharma company’s earlier work with IL-15-Fc cytokines in oncology, where the reduction in potency led to improved pharmacodynamics,pharmacokineticsandtolerabilityin preclinical studies.

ADC Therapeutics

FDA approved Zynlonta (loncastuximabtesirine-lpyl) for treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Zynlonta is the first and only CD19-targeted ADC as a single-agent treatment. It demonstrated 48.3% ORR, 24.1% complete response rate and durable responses in heavily pretreated patients in pivotal LOTIS-2 trial.

Immunogen

IMGN presented a poster highlighting preclinical data for its novel ADAM9-targeting ADC, IMGC936, which is being investigated in multiple solid tumor types, at AACR.IMGC936 showed compelling anti-tumor activity against multiple patient-derived xenograft models with clinically relevant levels of ADAM9 and was well-tolerated across all models tested.

Mersana Therapeutics

Mersana presented preclinical data from XMT-1660, a B7-H4-targeted Dolasynthen ADC, and XMT-2056, an Immunosynthen-based STING-agonist ADC at AACR. The data demonstrate that XMT-2056 is highly differentiated from other innate immune activating approaches and has the anti-tumor activity and tolerability to support continued development of this novel STING-agonist ADC candidate. Additionally, data of XMT-1660 outperformed other B7-H4 ADCs in vivo. 

Seattle Genetics

SGEN announced that FDA accepted for Priority Review the BLA seeking accelerated approval for tisotumabvedotin for treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. FDA set a target action date of Oct 10, 2021. Separately, Seagen and Astellas announced that FDA filed two sBLA submissions for Padcev for review. The applications were granted Priority Review, with a target action date of August 17.

Allogene Therapeutics

Allogene announced that FDA has cleared an IND application to study ALLO-605 for the treatment of patients with relapsed or refractory multiple myeloma. ALLO-605 is an allogeneic CAR T therapy targeting BCMA. Phase 1 will evaluate escalating doses of ALLO-605 beginning in mid-2021.

Autolus Therapeutics

Autolus has received innovative licensing and access pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency for AUTO4 being studied in a Phase 1 study in TRBC1 positive PTCL.

Bellicum Pharmaceuticals

The short interest of Bellicum increased in April by 23% to 1,060,000 on April 15, compared to 863,000 on March 15.

Mustang Bio

Mustang participated in Chardan’s 5th Annual Genetic Medicines Manufacturing Summit.

Arcus Biosciences

Arcus presented PFS and OS data in patients with advanced metastatic CRC from ARC-3 study at AACR. Phase 1/1b results for the etrumadenant combination demonstrated a 4.2 month PFS, approximately double the 2 months reported for current standard of care therapies in ≥3L mCRC.

Immutep

Immutep announced its lead product IMP321, a soluble LAG-3 protein, has received Fast Track designation in 1st line recurrent or metastatic HNSCC from FDA. Fast Track has been granted for the program for 1st line treatment of recurrent or metastatic HNSCC. The ORR reported at SITC was approximately 36% for 28 patients receiving IMP321 in combination with Keytruda.

NorthWest Biotherapeutics

The short interest of NW Bio increased in April by 13% to 18,982,800 on April 15, compared to 16,756,000 on March 31.

Clovis Oncology

Clovis presented Phase 1 data from studies exploring Rubraca in combination with Xtandi for the treatment of advanced PCA and Rubraca monotherapy in advanced solid tumors in Japanese patients (RUCA-J) during AACR. The safety profile was consistent with that associated with each drug as a monotherapy, with no clinically significant drug-drug interactions observed with the combination. These data support further study of the combination in this patient population and the Phase 3 CASPAR study.