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GMDA On Track, GNFT Soars, HTBX Sparkles, LLY's Neutralizing Antibody Therapies Get FDA Nod

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Today's Daily Dose brings you news about KalVista's hereditary angioedema trial results, Heat Biologics' encouraging data from its phase II trial of HS-110 in non-small cell lung cancer, Gamida's presentation of full efficacy and safety results of Omidubicel in patients with hematologic malignancies and Neovasc regaining Nasdaq compliance.

Read on…

1. Gamida's Presentation At TCT Meetings Catches Eyes

Shares of Gamida Cell Ltd. (GMDA) were up over 60% at $16 in extended trading Tuesday, following the presentation of full efficacy and safety results of the company's phase III clinical trial of Omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant at the 2021 TCT Meetings.

Omidubicel resulted in faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital, all of which are meaningful results and represent potentially important advancements in care when considering the patient experience following transplant, according to the company.

Last May, Gamida Cell reported that the study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient's recovery from a bone marrow transplant. Results reported last October showed that the Omidubicel phase III study achieved its secondary endpoints of platelet engraftment, infections, and hospitalizations.

A Biologics License Application for Omidubicel is expected to be submitted in the second half of this year.

GMDA closed Tuesday's trading at $9.89, down 2.37%. In after-hours, the stock was up 67.85% at $16.60.

2. GENFIT's PBC Study Results Published in the Journal of Hepatology

GENFIT (GNFT) on Tuesday after the bell announced that the positive results from its phase II clinical trial evaluating Elafibranor in patients with Primary Biliary Cholangitis (PBC) with incomplete response to ursodeoxycholic acid (UDCA) have been published in the Journal of Hepatology.

The positive results from the phase II PBC trial were reported in 2018, with Elafibranor showing a clinically relevant improvement on the primary and composite biochemical endpoints providing early confirmation of efficacy, a positive trend on pruritus improvement, while maintaining a favorable tolerability profile.
Primary biliary cholangitis (PBC) is a chronic, autoimmune disease in which bile ducts in the liver are gradually destroyed.

Elafibranor is currently under a phase III trial in Primary Biliary Cholangitis, dubbed ELATIVE, with results expected by early 2023.

GNFT closed Tuesday's trading at $5.20, down 0.76%. In after-hours, the stock was up 150% at $13.

3. Heat Biologics Lighting Up The Market

Heat Biologics Inc.'s (HTBX) phase II trial of HS-110, in combination with Bristol-Myers Squibb's (BMS) OPDIVO in advanced non-small cell lung cancer has yielded positive results.

HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients' immune system against multiple cancer testis antigens to elicit a diverse and robust immune response against tumor cells.

The study includes two cohorts - Cohort A comprised of previously treated, checkpoint inhibitor naïve patients with advanced NSCLC and Cohort B comprised of patients who had previously been treated with a checkpoint inhibitor and whose disease had subsequently progressed.

In Cohort A, HS-110, in combination with Opdivo resulted in a median progression free survival (PFS) of 1.8 months and a median overall survival (OS) of 24.6 months was observed with a median follow-up time of 19.4 months. The one-year survival rate of Cohort A is 61.7%.

According to published data, the median OS data was 12.2 months and the 1-year survival rate was 50.7% in previously treated, advanced NSCLC patients who received Opdivo as a single agent.

In Cohort B, a median PFS of 2.8 months and median OS of 11.9 months were observed with a median follow-up time of 11.9 months. According to published data from other studies, the median OS ranges from 6.8 to 9.0 months for previously treated, advanced NSCLC patients.

The company is currently evaluating possible Phase 3 registration pathways for HS-110 in combination with a checkpoint inhibitor and intends to review these plans with the FDA as well as potential partners.

HTBX closed Tuesday's trading at $12.54, up 49.82%.

4. KalVista Soars As Hereditary Angioedema Study Hits Goals

Shares of KalVista Pharmaceuticals Inc. (KALV) jumped more than 100% on Tuesday, following positive topline data from a phase II clinical trial of KVD900 as an oral on-demand treatment for hereditary angioedema (HAE) attacks.

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.

The trial included 53 type 1 and type 2 HAE patients who had three attacks in 90 days prior to enrollment. The use of rescue medication was significantly reduced in the KVD900-treated patients. Only 15% of the KVD900 treated attacks required rescue medication compared to 30% in the placebo. KVD900 achieved an onset of symptom relief as early as 1.6 hours compared to 9 hours for attacks treated with placebo.

No serious adverse events were reported in the trial and no patients withdrew due to adverse events.

There are already 8 FDA-approved drugs for preventing or treating HAE attacks, including the recently approved BioCryst Pharmaceuticals Inc.'s (BCRX) Orladeyo.

Berinert, Firazyr, Kalbitor and Ruconest are approved for treating HAE attacks while Orladeyo, Cinryze, Haegarda, and Takhzyro are approved for preventing HAE attacks.
KalVista Pharma's KVD900 is being developed for the treatment of HAE attacks.

KALV closed Tuesday's trading at $33.50, up 114.61%.

5. Lilly's neutralizing antibody therapies For COVID-19 Gets Emergency Nod

Eli Lilly and Co.'s (LLY) combination of neutralizing antibody therapies Bamlanivimab (LY-CoV555) 700 mg and Etesevimab (LY-CoV016) 1400 mg together has been authorized for emergency use by the FDA for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19.

Bamlanivimab and Etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, the company noted.

LLY closed Tuesday's trading at $201.71, down 1.97%.
6. Neovasc Regains Minimum Bid Price Compliance

Neovasc Inc. (NVCN) has regained compliance with the Nasdaq's minimum bid price requirement.

However, the company is still not in compliance with the minimum market value requirement of $35 million set forth in Nasdaq Rules. There is time until June 8, 2021 to regain such compliance.

Reducer, the company's medical device for the treatment of refractory angina, is CE-marked in the European Union.

NVCN closed Tuesday's trading at $2.29, up 52.67%.

7. Some Stocks That Gained/Lost The Most In A Day

PDS Biotechnology Corporation (PDSB) closed Tuesday's trading at $6.81, up 53.38%.

Iterum Therapeutics plc (ITRM) closed at $2.27, up 47.40%.

Veru Inc. (VERU) closed at $19.27, up 38.43%.

Aeterna Zentaris Inc. (AEZS) closed at $2.20, down 34.13%.

Ekso Bionics Holdings, Inc. (EKSO) closed at $10.18, down 22.11%.

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