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Monday, June 15, 2020

Bellicum Pharma on go with mid-stage study of BPX-603 for HER2+ solid tumors

The FDA has cleared Bellicum Pharmaceuticals’ (NASDAQ:BLCM) investigational new drug application (IND) for BPX-603.
BPX-603 is a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2).
The company plans to initiate Phase 1/2 trial later this year.
BPX-603 is the company’s first dual-switch GoCAR-T product, which incorporates both the company’s iMC activation and CaspaCIDe safety switch technologies.
https://seekingalpha.com/news/3582963-bellicum-pharma-on-go-mid-stage-study-of-bpxminus-603-for-her2-solid-tumors

Cue Biopharma’s lead drug shows encouraging action in cancer study

Thinly traded Cue Biopharma (NASDAQ:CUE) is up 3% premarket on light volume on the heels of updated data from a Phase 1 clinical trial evaluating lead candidate CUE-101 for the second-line treatment of patients with HPV-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
As of June 15, 13 patients have been enrolled, most receiving multiple cycles of therapy. Six remain on study for the ongoing data presentation.
Drug exposure in line with preclinical projections and is dose-proportional. Comparable exposures observed upon repeated administration.
Pharmacodynamic data showed selective expansion of targeted T cells in the peripheral blood of several participants in cohorts 2 and 3.
Preliminary radiographic evidence showed CUE-101 to be clinically active.
The company says it appears to have an “attractive” therapeutic window.
On the safety front, most treatment-related adverse events have been mild or moderate with no discontinuations. There was one severe adverse event (anemia and fatigue) that was possibly treatment-related. The patient had an underlying condition and remains on study. The anemia was resolved following a blood transfusion.
CUE-101, a member of the CUE-100 series, is a fusion protein designed to selectively activate tumor-specific T cells to fight HPV-driven cancers.
https://seekingalpha.com/news/3582965-cue-biopharmas-lead-drug-shows-encouraging-action-in-cancer-study

Progenity sets IPO terms

Progenity (PROG) has filed a prospectus for its IPO of ~6.7M common shares at $14 – 16 per share. Gross proceeds should be ~$100M (midpoint).
The molecular testing services provider’s lineup consists of a non-invasive prenatal test for fetal chromosomal disorders, an expanded carrier screen (preconception or early in pregnancy) for genetic diseases, a hereditary cancer screen, a prenatal test for monogenic disease and a portfolio of anatomic and molecular pathology tests.
Selected competitors: LabCorp (NYSE:LH), Quest Diagnostics (NYSE:DGX), Natera (NASDAQ:NTRA), Myriad Genetics (NASDAQ:MYGN), Invitae (NYSE:NVTA)
https://seekingalpha.com/news/3582973-progenity-sets-ipo-terms

Magenta teams up with Beam Therapeutics in blood disorders

Magenta Therapeutics (NASDAQ:MGTA) inks a non-exclusive research and clinical collaboration agreement with Beam Therapeutics (NASDAQ:BEAM) to evaluate its antibody-drug conjugate (ADC) MGTA-117 for conditioning sickle cell disease and beta-thalassemia patients receiving the latter’s base editing therapies.
Conditioning is done to prepare a patient receiving edited cells that need to engraft in the bone marrow to be effective. Currently, this is done via chemotherapy or radiation, both of which are associated with significant toxicities.
MGTA-117 targets only hematopoietic stem and progenitor cells while sparing immune cells, potentially capable of clearing space in bone marrow to support long-term engraftment and rapid recovery.
Under the terms of the partnership, Beam will fund study costs related to its base editors when combined with MGTA-117 and Magenta will be responsible for all other development costs related to the ADC. Each company will retain all commercial rights to their respective candidates and technologies.
https://seekingalpha.com/news/3582874-magenta-teams-up-beam-therapeutics-in-blood-disorders

Forma Therapeutics sets IPO terms

Forma Therapeutics (FMTX) has filed a preliminary prospectus for its IPO of 11,764,706 common shares at $16-18 per share. Gross proceeds (midpoint) should be ~$200M.
https://seekingalpha.com/news/3582875-forma-therapeutics-sets-ipo-terms

Repare Therapeutics sets terms for IPO

Repare Therapeutics (RPTX) has filed a preliminary prospectus for its IPO of 7,352,941 common shares at $16-18 per share. Gross proceeds (midpoint) should be ~$125M.
https://seekingalpha.com/news/3582876-repare-therapeutics-sets-terms-for-ipo

vTv Therapeutics’ TTP399 successful in mid-stage type 1 diabetes study

VTv Therapeutics (NASDAQ:VTVT) is up 45% premarket on the heels of results from the Phase 2 Simplici-T1 study evaluating TTP399 as an adjunct to insulin therapy in adults with type 1 diabetes.
The results demonstrate that TTP399, a once-a-day pill, reduces HbA1c and improves time in range, without increasing hypoglycemia or any signal for adverse events including diabetic ketoacidosis.
Patients randomized to TTP399 achieved better glycemic control (improved HbA1c) while reducing insulin dose (0.41%, p=0.01) as compared to placebo-treated group, where reduction in insulin dose was associated with a worsening in HbA1c.
https://seekingalpha.com/news/3582879-vtv-therapeutics-ttp399-successful-in-mid-stage-type-1-diabetes-study