NantKwest Stock Goes North, QURE's HOPE-B Trial On Hold, EU Greenlights First COVID-19 Vaccine

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Today's Daily Dose brings you news about NantKwest's non-muscle invasive bladder cancer trial results and the company's proposed merger with privately-held ImmunityBio; Agios' sale of oncology portfolio to Servier for $1.8 billion upfront; the clinical hold on uniQure's hemophilia B gene therapy program due to safety concerns; ChemoCentryx' ACCOLADE trial results; and the first COVID-19 vaccine authorized in the EU.

Read on…

1. Agios Sells Oncology Portfolio for $1.8 Bln Upfront

Agios Pharmaceuticals Inc. (AGIO) is all set to sell its commercial, clinical and research-stage oncology portfolio to Servier, an independent global pharmaceutical company, for up to $2.0 billion in cash.

The cash consideration includes $1.8 billion in upfront payment and $200 million in a potential future milestone payment for Vorasidenib, as well as 5% royalties on U.S. net sales of TIBSOVO.

Vorasidenib is Agios' investigational drug which is currently being studied in the registration-enabling phase III study in patients with IDH-mutant low-grade glioma, dubbed INDIGO.

Tibsovo is Agios' marketed medicine, which is approved for the treatment of patients with acute myeloid leukemia who have an IDH1 mutation.

The transaction is expected to close in the second quarter of 2021.

AGIO closed Monday's trading at $42.62, up 28.33%.

.2. Astellas Terminates LACEWING Trial

An independent Data Monitoring Committee has recommended termination of Astellas Pharma Inc.'s (ALPMY.OB) phase III trial of XOSPATA plus Azacitidine in newly diagnosed FLT3 mutation-positive acute myeloid leukemia patients who were ineligible for intensive induction chemotherapy.

The trial, dubbed LACEWING, did not meet its primary endpoint of overall survival at a planned interim analysis of the trial.

Acute myeloid leukemia, a cancer of the blood and bone marrow, is one of the most common types of leukemia in adults. It has the lowest survival rate of all types of leukemia. Approximately one-third of people with AML have a FLT3 mutation.

ALPMY.OB closed Monday's trading at $14.83, up 0.20%.

3. ChemoCentryx Fails To Win ACCOLADE

Shares of ChemoCentryx Inc. (CCXI) were down over 7% at $55 in after-hours trading Monday, following topline data from its phase II trial of Avacopan in C3 Glomerulopathy, dubbed ACCOLADE.

C3 Glomerulopathy is a very rare kidney disease characterized by an abundance of a protein called C3 in the renal glomeruli. Some of the signs and symptoms of the disease include blood in the urine, which is called hematuria; dark foamy urine, which signifies the presence of protein or 'proteinuria'; swelling or 'edema', initially of the legs although any part of the body can be affected; and high blood pressure.(Source: NORD).

In the ACCOLADE clinical study, although the chosen primary (but unvalidated) C3G histologic index for disease activity endpoint was not entirely informative, there was a significant improvement in renal function with Avacopan in C3G.

Avacopan therapy was associated with a rapid reduction in proteinuria. At week 16, there was a 35% mean decrease in proteinuria with Avacopan versus a 1% decrease in the placebo group and at the end of 26 weeks, proteinuria reduced by 26% in the Avacopan group compared to s 14% in the placebo group.

Avacopan also appeared safe and well-tolerated in patients with C3G, added the company.

CCXI closed Monday's trading at $59.73, down 1.58%.

4. FDA Places uniQure's Hemophilia B Gene Therapy Program under Clinical Hold

The FDA has slapped a clinical hold on uniQure N.V.'s (QURE) hemophilia B gene therapy program due to safety concerns.

The hemophilia B gene therapy program placed under hold includes a pivotal phase III trial of Etranacogene Dezaparvovec , an investigational adeno-associated virus five (AAV5)-based gene therapy, for the treatment of patients with severe and moderately severe hemophilia B, dubbed HOPE-B. The HOPE-B trial has enrolled 54 patients.

One of the patients in the HOPE-B trial treated with Etranacogene Dezaparvovec in October 2019 has developed hepatocellular carcinoma (HCC), a form of liver cancer. The patient has multiple risk factors associated with HCC, including a twenty-five-year history of hepatitis C (HCV), hepatitis B virus (HBV), evidence of non-alcoholic fatty liver disease and advanced age. Chronic infections with hepatitis B and C have been associated with approximately 80% of HCC cases, noted the company.

No other cases of HCC have been reported in uniQure clinical trials conducted in more than 100 patients in hemophilia B and other indications, with some patients dosed more than 10 years ago, added the company.

QURE closed Monday's trading at $38.51, down 16.19%.

5. NantKwest Stock Goes North on Double dose of Good News

Shares of NantKwest Inc. (NK) jumped more than 56% on Monday, following a double dose of good news.

The company's phase II/III trial evaluating a combination of Anktiva plus Bacillus Calmette-Guerin or BCG, the most common intravesical immunotherapy in non-muscle invasive bladder cancer in high risk carcinoma in situ (CIS) disease, dubbed QUILT 3.032, met the primary endpoint, with 51 out of 71 evaluable patients (72%) having a complete response (at any time). The data also showed that there was a 59% probability of these patients maintaining a complete response for at least 12 months.

The QUILT 3.032 is studying Anktiva in combination with BCG in patients with BCG-unresponsive non-muscle invasive bladder cancer. Another study, dubbed QUILT 2.005, is investigating use of Anktiva in combination with BCG for patients with BCG-naïve non-muscle invasive bladder cancer.

A Biologics License Application for Anktiva is expected to be filed in the second half of 2021 following a meeting with the FDA.

In other news, NantKwest has entered into an agreement to merge with ImmunityBio, a privately-held immunotherapy company, in a stock-for-stock transaction. The combination will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.

The transaction is expected to close in the first half of 2021, following which the combined company will assume the name ImmunityBio and continue to be listed on the NASDAQ exchange. However, the combined company ticker symbol is expected to be changed to IBRX.

Upon completion of the transaction, on a fully diluted basis, ImmunityBio shareholders will own approximately 72% of the combined company and NantKwest shareholders will own approximately 28% of the combined company, on a fully diluted basis.

NK closed Monday's trading at $16.02, up 56.14%.

6. EU Greenlights First COVID-19 Vaccine

BioNTech (BNTX) and Pfizer Inc.'s (PFE) COVID-19 vaccine has been granted conditional marketing authorisation in the European Union to prevent coronavirus infection in people of age 16 years and older.

The vaccine, which will go by the name Comirnaty, is given as two injections into the arm, at least 21 days apart.

In a trial that involved around 44,000 people, there was a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine compared with people who received a dummy injection. The most common side effects with Comirnaty were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever.

Comirnaty, also known as BNT162b2, has been authorized for use in more than 40 countries worldwide, including all 27 EU member states.

In the U.S., the FDA issued emergency use authorization for the vaccine on December 11, 2020.

BNTX closed Monday's trading at $106.46, up 2.13%.

7. Stocks hitting New Highs/Lows

Editas Medicine Inc. (EDIT) closed Monday's trading at a new high of $83.66, up 29.89%.

Intellia Therapeutics Inc. (NTLA) closed at a new high of $62.73, up 13.21%.

ClearPoint Neuro Inc. (CLPT) closed at a new high of $13.80, up 6.15%.

Virios Therapeutics, LLC (VIRI) closed at a new low of $9.80, down 5.77%.

Histogen Inc. (HSTO) closed at a new low of $1.13, down 7.38%.

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