These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
KalVista Pharmaceuticals is focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema, or HAE, and diabetic macular edema, or DME. KalVista is developing sebetralstat as an oral on-demand therapy for HAE attacks and is enrolling the Phase 3 KONFIDENT clinical trial. In addition, KalVista’s oral Factor XIIa inhibitor program "represents a new generation of therapies that may further improve treatment for people living with HAE," the company a. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.
Connect Biopharma is a U.S. and China-based clinical-stage biopharmaceutical company focused on treating inflammatory diseases with therapies derived from T cell research. The company’s lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha in development for the treatment of atopic dermatitis and asthma. The company’s second most advanced product candidate, CBP-307, is a modulator of S1P1 T cell receptor and is in development for the treatment of ulcerative colitis, or UC. The company’s third product candidate, CBP-174, is a peripherally acting antagonist of histamine receptor 3, in development for the treatment of pruritus associated with atopic dermatitis, or AD.
Cue Biopharma is developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body to treat cancer. CUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or “cues” to T cells.
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programed T cell therapies for the treatment of cancer. Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors.
Biohaven is focused on the discovery, development and commercialization of therapies for people with neurological and neuropsychiatric diseases, including rare disorders. The company is leveraging its drug development capabilities and proprietary platforms, including Kv7 ion channel modulation for epilepsy and neuronal hyperexcitability; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia and myostatin inhibition for neuromuscular diseases. Biohaven's portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain and CD-38 antibody recruiting, bispecific molecules for multiple myeloma.
Recent news on these stocks:
October 4
KalVista Pharmaceuticals announced that it has terminated the KOMPLETE phase 2 clinical trial for KVD824 for the prevention of attacks in people with hereditary angioedema. This decision was based on the observation of liver enzyme elevations in multiple patients in all treatment groups of the trial. No patients had concomitant elevation of bilirubin levels and all were asymptomatic. "The health and safety of participants in our clinical trials is of utmost importance to us," said Andrew Crockett, CEO of KalVista. "We made the difficult decision to terminate KOMPLETE because we concluded that the emerging safety profile of the current formulation will not meet our requirements for a best-in-class oral prophylactic therapy. This termination conserves our financial resources and allows us to focus on continuing to advance sebetralstat through the ongoing phase 3 program and towards a planned 2024 NDA filing, as well as on our emerging oral Factor XIIa inhibitor program as a potential once daily prophylactic therapy for people with HAE." The KOMPLETE trial is a phase 2 clinical trial evaluating KVD824, an investigational oral plasma kallikrein inhibitor designed for the prevention of attacks in adults living with HAE.
Connect Biopharma announced topline results for the primary analysis population of the pivotal trial of the company's lead candidate, CBP-201, in patients with moderate-to-severe atopic dermatitis in China. This multi-center, randomized, double-blind, parallel group, placebo-controlled trial is evaluating the efficacy and safety of CBP-201 as well as the potential for an extended CBP-201 dosing interval during the maintenance phase of treatment. The primary endpoint of IGA of 0 or 1 with at least 2 grades of reduction at Week 16 from baseline was significantly greater for the CBP-201 group with 30.3% of patients showing improvement compared to 7.5% for the placebo group. CBP-201 also met key secondary endpoints.
Cue Biopharma announced that the FDA has granted Fast Track designation to CUE-101, its lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics, for the treatment of patients with human papilloma virus - HPV16+ - recurrent/metastatic head and neck squamous cell carcinoma - R/M HNSCC - as a monotherapy and in combination with Keytruda, or pembrolizumab. Cue anticipates initiating a registrational trial for CUE-101 monotherapy by mid-2023. CUE-101 is currently being evaluated in a Phase 1b trial as a monotherapy for the treatment of second line and beyond patients with HPV16+ R/M HNSCC and as a first-line treatment in a Phase 1 dose escalation and expansion trial in combination with Keytruda for the same patient population.
Autolus Therapeutics has entered into an agreement with Bristol Myers Squibb (BMY). The agreement grants Bristol Myers Squibb access to incorporate Autolus' proprietary RQR8 safety switch into an initial set of selected cell therapy programs on a target-by-target basis for the treatment of cancer, with an option for Bristol Myers Squibb to incorporate the RQR8 safety switch in additional cell therapy programs beyond the initial set of selected programs. Safety switches are designed to allow the use of pharmacological agents to selectively eliminate a cell therapy in the event a patient experiences severe adverse side effects from the treatment. Autolus' proprietary RQR8 switch works by administration with the approved pharmaceutical antibody, rituximab. Under the terms of the agreement, Autolus will receive an upfront payment for access to the RQR8 safety switch for the initial set of cell therapy programs with the potential for near term option exercise fees and development milestone payments. In addition, Autolus would be entitled to receive royalties on net sales of all Bristol Myers Squibb cell therapy products that incorporate the RQR8 safety switch.
Biohaven launched as a new publicly traded company. As of today, Biohaven has officially begun operating as a separate independent entity as part of the acquisition agreement with Pfizer (PFE) in May 2022. The company, led by Vlad Coric, M.D. as Chairman and Chief Executive Officer, launched with approximately $257.8 million in cash at the distribution and no debt. Biohaven has a history of successful drug development and commercialization. The FDA filed and accepted for review Biohaven's New Drug Application submission for zavegepant nasal spray with a Prescription Drug User Fee Act goal date set for the first quarter of 2023. With the acquisition by Pfizer for a total consideration of approximately $13B including payoff of existing debt, Pfizer will now exclusively commercialize and develop the Biohaven CGRP franchise globally. Pfizer owns approximately 3% of the new spinoff company Biohaven.
About “Biotech Alert”
The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.
This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 15-plus million retail and financial professional investors through InvestingChannel's online financial news media ecosystem.
This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.
KalVista
-0.18 (-3.47%)
Connect Biopharma
-0.02 (-1.85%)
Cue Biopharma
-0.04 (-1.24%)
Autolus Therapeutics
+0.14 (+4.90%)
Biohaven
+0.11 (+0.90%)
Bristol Myers
-0.62 (-0.87%)
Pfizer
-0.7 (-1.59%)