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CABA Hits New High, IMMP On Watch, SBPH Drops CATALYST

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Today's Daily Dose brings you news about Cabaletta Bio's Pemphigus Vulgaris drug candidate, DBV Technologies' stock offering, the progress of Immutep's pipeline and the decision of Spring Bank to halt the development of its HBV drug candidate.

Read on…

Cabaletta Bio Inc.'s (CABA) lead product candidate, DSG3-CAART, for the treatment of Pemphigus Vulgaris, has been granted Orphan Drug Designation by the FDA.

The FDA grants Orphan Drug Designation to drugs or biologics intended to treat or prevent rare diseases or conditions that affect fewer than 200,000 individuals in the United States. This designation qualifies Cabaletta for certain incentives, which may include a partial tax credit for clinical trial expenditures, waived user fees and potential eligibility for seven years of marketing exclusivity.

Pemphigus Vulgaris is a rare autoimmune disease that is characterized by blistering and erosion of the skin and mucous membranes. (Source: NIH).

The Company is preparing to initiate a phase I trial of DSG3-CAART in Pemphigus Vulgaris, and then report acute safety data from the first cohort of patients by the end of 2020.

CABA touched a new high of $19.63 in intraday trading on Wednesday, before closing at $18.67, up 13.43%.

DBV Technologies (DBVT) on Wednesday announced the launch of the proposed global offering of new ordinary shares, in the form of American Depositary Shares, in an aggregate amount of $125.0 million.

In addition, the Company intends to grant the underwriters a 30-day option to purchase additional ordinary shares, in the form of ADSs, in an aggregate amount of up to 15% of the total number of ordinary shares (including in the form of ADSs) proposed to be sold in the global offering.

As of December 31, 2019, the Company had cash and cash equivalents of €172.0 million.

The Company is developing Viaskin Peanut immunotherapy for the treatment of peanut-allergic children aged 4 to 11 years. The FDA decision on Viaskin Peanut is expected on August 5, 2020.

The FDA decision on Aimmune Therapeutics Inc.'s (AIMT) peanut allergy treatment Palforzia is due this month. If approved, Aimmune's Palforzia will be the first medicine for peanut allergy. Its market opportunity is estimated to be in excess of $1 billion peak sales in the U.S. alone, according to the Company.

DBVT closed Wednesday's trading at $11.33, up 1.16%. In after-hours, the stock fell 5.12% to $10.75.

Immutep Limited (IMMP), on Wednesday, provided an update on the progress of its pipeline.

A phase II study of Eftilagimod Alpha in combination with Merck's Keytruda in non-small cell lung carcinoma and head and neck carcinoma patients, dubbed TACTI-002, is underway. The preliminary overall response rate, or ORR, i.e, the proportion of patients in a trial whose tumor was destroyed or significantly reduced by the drug, was 41%.

More mature data from the TACTI-002 study is expected to be presented at the German Cancer Congress in mid-February 2020.

A phase IIb clinical trial of Eftilagimod alpha in combination with Paclitaxel in patients with metastatic breast cancer, dubbed, AIPAC, is ongoing. The first progression-free survival and overall response rate data read-out are expected in March.

A phase I clinical trial of Eftilagimod alpha in combination with Avelumab in patients with advanced solid malignancies, dubbed INSIGHT-004, is underway. One patient in Cohort 1 has experienced a partial response and another patient has been reported as having stable disease. More data from the study is expected to be reported in the first half of the calendar year 2020.

At December 31, 2019, the Company had a cash balance of $20.5 million.

IMMP closed Wednesday's trading at $2.40, up 20%.

Eli Lilly and Co.'s (LLY) New Drug Application for Selpercatinib for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer has been granted priority review by the FDA - with a decision expected in the third quarter of this year.

The New Drug Application is based on data from the LIBRETTO-001 Phase 1/2 trial of Selpercatinib in RET-altered lung and thyroid cancers.

LLY closed Wednesday's trading at $139.92, up 0.47%.

Spring Bank Pharmaceuticals Inc. (SBPH) plunged more than 20% on Wednesday on news of the Company pulling the plug on Inarigivir soproxil, which was in phase II development for the treatment of chronic hepatitis B virus.

The decision was taken based on the occurrence of unexpected serious adverse events, including one patient death, in a phase IIb trial, dubbed CATALYST.

While Spring Bank will not pursue further research and development efforts in the hepatitis B virus space, it will continue to focus on new treatments in the therapeutic fields of immuno-oncology and inflammation.

SBPH closed Wednesday's trading at $1.33, down 21.76%. In after-hours, the stock was down 5.26% to $1.26.

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