Today’s Daily Dose brings you news about Nektar’s collaboration with Merck; Pfizer initiating a refractory multiple myeloma study; Processa Pharma’s strategic financing; and vTv Therapeutics’ initiation of a phase 1 multiple ascending dose study of HPP737.
1. Nektar Teams Up With Merck
Nektar Therapeutics (NKTR) has entered into a clinical trial collaboration and supply agreement with Merck (MRK) for a Phase 2/3 study of Bempegaldesleukin in combination with KEYTRUDA for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck.
Bempegaldesleukin is Nektar’s drug candidate and is designed to stimulate the patient’s own immune system to fight cancer. KEYTRUDA is Merck’s approved blockbuster drug, which is approved for various cancers.
The study is planned to start in the second half of 2021.
Under the terms of the agreement, Nektar will conduct the Phase 2/3 study, which is expected to enroll 500 patients with metastatic or recurrent SCCHN with PD-L1 expressing tumors. The primary endpoints of the trial are overall response rate (ORR) and overall survival (OS); progression-free survival (PFS) is a secondary endpoint.
The company also inked a financing and co-development collaboration with SFJ Pharmaceuticals to support the development of Bempegaldesleukin. As part of the deal, Nektar is all set to receive up to $150 million to support the study and manage clinical trial operations.
NKTR closed Wednesday’s trading at $25.46, up 13.36%.
2. Pfizer Initiates Multiple Myeloma Trial
Pfizer Inc. (PFE) has initiated a pivotal phase II study of investigational drug Elranatamab in patients with relapsed/refractory multiple myeloma.
The study, dubbed MagnetisMM-3, is designed to enroll approximately 150 people with multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody.
The study’s estimated primary completion date is June 2022.
In other news, Pfizer and BioNTech SE (BNTX) announced an agreement with the European Commission to supply an additional 200 million doses of their COVID-19 vaccine COMIRNATY, also known as BNT162b2. The European Commission has the option to request supply of an additional 100 million doses.
Albert Bourla, Chairman and Chief Executive Officer of Pfizer said, “With this new agreement with the European Commission, we now expect to deliver enough doses to vaccinate at least 250 million Europeans before the end of the year.”
PFE closed Wednesday’s trading at $34.89, up 0.58%.
3. Processa Strengthens Balance Sheet
Shares of Processa Pharmaceuticals Inc. (PCSA) jumped more than 30%, following a $10.2 million strategic financing.
As part of the financing, the company sold 1.32 million shares through private investment in public equity (PIPE) financing at a price of $7.75 per share.
The financing attracted both institutional and accredited investors, noted the company. The closing of the private placement is expected to occur on or about February 23, 2021.
The company’s lead product candidate is oral PCS499, proposed for the treatment of Necrobiosis Lipoidica, under phase IIb trial. Another compound PCS6422 is under a phase Ib study in combination with capecitabine as first-line therapy for metastatic colorectal cancer. The company expects results from the interim analyses in the phase 1B PCS6422 study and the Phase 2B PCS499 study in the second half of this year.
PCSA closed Wednesday’s trading at $10.76, up 33.17%.
4. vTv Therapeutics On Track
vTv Therapeutics Inc. (VTVT) has initiated a phase 1 multiple ascending dose study of HPP737 in healthy adult volunteers.
HPP737 is a novel, potent, orally administered PDE4 inhibitor discovered by vTv Therapeutics. PDE4 has been demonstrated to be a validated therapeutic target for the treatment of a variety of disorders including psoriasis.
The phase I multiple ascending dose study is expected to be completed in Q2 2021.
Meanwhile, the company’s strategic partner, Newsoara Biopharma, has initiated a proof of concept phase II study of HPP737 in chronic obstructive pulmonary disease (COPD) in China. Newsoara is also initiating phase 2 studies with HPP737 in psoriasis and atopic dermatitis this year.
VTVT closed Wednesday’s trading at $2.84, up 6.77%.
5. Stocks That Gained/Lost The Most In A Day
Predictive Oncology Inc. (POAI) closed Wednesday’s (Feb.17, 2021) trading at $2.20, up 34.15%.
Shineco Inc. (TYHT) closed at $5.68, up 32.09%.
Check-Cap Ltd. (CHEK) closed at $2.33, up 29.44%.
Interpace Biosciences, Inc. (IDXG) closed at $4.44, down 23.97%.
AIkido Pharma Inc. (AIKI) closed at $1.68, down 21.13%.
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