UK MHRA approved Anktiva plus BCG for BCG-unresponsive NMIBC in situ

CLINICAL AND REGULATORY 

UK MHRA approved Anktiva plus BCG for BCG-unresponsive NMIBC in situ 

This is the first marketing approval outside the US for this novel lymphocyte-stimulating agent. Anktiva is a first-in-class IL-15 agonist that activates and proliferates NK cells and CD4+ and CD8+ T cells. It is designed to restore immune competence by reversing lymphopenia, a condition in which cancer and conventional therapies, such as chemotherapy, radiation and checkpoint inhibitors, reduce the number and function of immune cells. Restoring immune function is essential for immunosurveillance, immunogenic cell death, and sustained tumor control. The BioShield platform’s effectiveness can be monitored using a routine complete blood count. Anktiva was designated a Breakthrough Therapy by the FDA and received approval from both the FDA and MHRA based on its safety and efficacy outcomes of complete response and duration of response. In a single-arm, multicenter trial, 77 evaluable patients received Anktiva with BCG for up to 37 months. As of the November 2023 data cutoff, the duration of complete response for some patients exceeded 47 months and remains ongoing. These extended duration of complete responses beyond 24 months with ANKTIVA and BCG surpasses the benchmark for meaningful clinical results set by experts from the International Bladder Cancer Group. ImmunityBio has also submitted regulatory applications to EMA to expand the availability of ANKTIVA across Europe.

Medicenna strengthens IP portfolio with five patents granted for its IL-2 and IL-4 superkines

Medicenna Therapeutics, a clinical-stage immunotherapy company developing novel Superkines for oncology and autoimmune diseases, announced grant of five patents covering the company’s IL-2 and IL-4 Superkine platforms. These patents strengthen Medicenna’s IP position across key markets and further support the company’s lead clinical and preclinical programs. The newly granted patents cover composition, formulation, combination, use, and therapeutic applications of IL-2 and IL-4 Superkines. Newly granted patents span major markets, with anticipated expiration dates ranging from 2033 to 2040 depending on the specific case and local rules, without accounting for any potential extensions. The patents include IL-2 superagonists in combination with anti-PD-1 antibodies, and Partial agonists and antagonists of IL-2. 

DEALS AND FINANCING 

Nektar announced closing of $115 million public offering 

Nektar Therapeutics announced the closing of its underwritten public offering of $115 million of shares of its common stock. Nektar sold 4,893,618 shares of common stock in the offering, which includes 638,298 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The shares of common stock were sold at a public offering price of $23.50 per share. The gross proceeds to Nektar from the offering were approximately $115 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the securities sold in this offering were offered by Nektar. Nektar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, clinical development and manufacturing costs to support the advancement of its drug candidates, as well as other general corporate purposes.