FDA Nod For BCRX - Decision In Japan, Europe Next, ENLV Soars On COVID Trial Data, STRO Abuzz

(RTTNews) - Today's Daily Dose brings you news about Johnson & Johnson submitting the first-ever drug for a mutation-specific lung cancer to the FDA, Sutro Biopharma's encouraging data from an ongoing dose-escalation phase I study of STRO-002 for patients with ovarian cancer, Enlivex' positive interim data of Allocetra in COVID-19 trial, and BioCryst's hereditary angioedema drug securing FDA nod.

1. FDA Approves BioCryst's HAE Drug - Japan & Europe Next?

The FDA has approved BioCryst Pharmaceuticals Inc.'s (BCRX) oral, once-daily ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.

Hereditary angioedema (HAE) is a rare disease characterized by unpredictable, potentially life-threatening recurrent swelling attacks most commonly affecting the extremities, face, abdomen, and larynx.

Currently, 7 products have secured FDA approval for preventing and treating HAE attacks and all these drugs are delivered intravenously or administered subcutaneously.

Berinert, Firazyr, Kalbitor and Ruconest are approved for treating HAE attacks while Cinryze, Haegarda, and Takhzyro are approved for preventing HAE attacks. (Source: US HAEA).

Orladeyo becomes the first oral treatment for preventing Hereditary Angioedema attacks. This drug is also under review in Japan and Europe, with a decision expected this month and March, respectively.

Physicians can begin writing prescriptions for Orladeyo immediately, with direct to patient shipments from Optime Care expected to begin by the end of this month, the company added. Optime Care is the exclusive specialty pharmacy provider for Orladeyo.

The company expects Orladeyo to achieve global peak sales of greater than $500 million.

BCRX closed Thursday's trading at $5.14, up 1.88%.

2. Enlivex Soars on Positive Interim Data from COVID-19 Trial

Enlivex Therapeutics Ltd.'s (ENLV) phase II clinical trial evaluating immunotherapy product candidate, Allocetra, in severe and critical COVID-19 patients has yielded positive interim results.

The interim clinical results relate to eight COVID-19 patients who were treated with Allocetra in the study, six of whom were in severe condition and two in critical condition.

According to the trial results, seven out of seven (100%) patients treated through November 26, 2020 had complete recovery from their respective severe/critical condition and were discharged from the hospital, after an average of 4.7 days following Allocetra administration. The eighth patient who enrolled in the phase II study in critical condition on November 27, 2020, has experienced a clinical improvement following treatment with Allocetra and is classified as moderate/severe condition on the date of this press release, noted the company.

Up to 24 patients are expected to be recruited in the study.

ENLV closed Thursday's trading at $11.40, up 37.85%.

3. First-ever Drug for a mutation-specific Lung Cancer submitted For FDA Review

Johnson & Johnson's (JNJ) subsidiary Janssen Pharma has submitted a Biologics License Application to the FDA seeking approval of Amivantamab for the treatment of mutation-specific non-small cell lung cancer.

Amivantamab is proposed for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

The application marks the first-ever regulatory submission for the treatment of patients with non-small cell lung cancer patients with EGFR exon 20 insertion mutations.

Although EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation, they are also often undetected. Patients with EGFR exon 20 insertion mutations have a median survival of less than 17 months, which is much shorter than patients with EGFR exon 19 deletions or L858R mutations, who have a median survival of 32-39 months, the company noted.

JNJ closed Thursday's trading at $149.00, up 0.58%.

4. Sutro Biopharma's Phase I Ovarian Cancer Trial Results Encouraging

Shares of Sutro Biopharma Inc. (STRO) were up over 23% in extended trading Thursday, following encouraging data from an ongoing dose-escalation phase I study of STRO-002 for patients with ovarian cancer.

Of the 31 heavily pretreated ovarian cancer patients tested with clinically active dose levels of 2.9 mg/kg of STRO-002 or higher, and who had post-baseline scans and were evaluable for *RECIST responses, 10 patients exhibited responses - with one patient achieving a complete response and 9 patients achieving a partial response. (*Response Evaluation Criteria In Solid Tumors, or RECIST is a standard way to measure how well a cancer patient responds to treatment - Source: National Cancer Institute).

At Week 12, the disease control was achieved by 23 patients (74%) and at Week 16, the disease control was achieved by 18 patients (58%).

The company is also exploring 4.3 and 5.2 mg/kg dose of STRO-002 in less heavily pre-treated patient population in the study.

Commenting on the study, Arturo Molina, Chief Medical Officer of Sutro Biopharma, said, "We are seeing improved outcomes in disease control and RECIST responses as the data matures and will continue to follow the patients who remain on study for further deepening of responses or clinical benefit."

STRO closed Thursday's trading at $17.00, up 3.98%. In after-hours, the stock was up another 20% at $20.40.

5. Stocks that Hit New Highs/Lows

Avid Bioservices Inc. (CDMO) closed at a 5-year high of $11.06, up 16.42%.

CRISPR Therapeutics AG (CRSP) closed at an all-time high of $140.46, up 6.78%.

OptimizeRx Corporation (OPRX) closed at an all-time high of $28.18, up 9.74%.

Histogen Inc. (HSTO) closed at an all-time low of $1.22, down 3.94%.

Progenity Inc. (PROG) closed at an all-time low of $3.26, down 0.61%.