Kineta to Present at the H.C. Wainwright Bioconnect Virtual Conference

Kineta to Present at the H.C. Wainwright Bioconnect Virtual Conference

Kineta to Present at the H.C. Wainwright Bioconnect Virtual Conference

Seattle, WA — (January 11 , 2022) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today Kineta’s management team has been invited to participate at H.C. Wainwright Bioconnect Virtual Conference that is being held on January 10-13, 2022.  Shawn Iadonato, Kineta Chief Executive Officer, will present a corporate overview that will be available on-demand from January 10-13 to attendees registering via H.C. Wainwright at https://hcwevents.com/bioconnect/.

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Kineta is a clinical stage biotechnology company with a mission to develop next generation immunotherapies that transform patients’ lives.  We have leveraged our expertise in innate immunity to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy.  For more information on Kineta visit our website, www.kinetabio.com, and follow us on Twitter, LinkedIn and Facebook.


NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

 

Contact:
Jacques Bouchy
jbouchy@kineta.us
(206) 378-0400

Kineta Presented New Preclinical Data on its Anti-CD27 Agonist Antibody Program at the ESMO Immuno-oncology Congress 2021

Kineta Presented New Preclinical Data on its Anti-CD27 Agonist Antibody Program at the ESMO Immuno-oncology Congress 2021

Kineta Presented New Preclinical Data on its Anti-CD27 Agonist Antibody Program at the ESMO Immuno-oncology Congress 2021

Seattle, WA — (December 17, 2021) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today the presentation of new preclinical data on the company’s anti-CD27 agonist monoclonal antibody program at the virtual European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2021, that took place December 8-11, 2021.  Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented a poster revealing compelling in vitro data on the T cell activation and cytokine induction of Kineta’s lead anti-CD27 agonist antibodies.  Additionally, Dr. Guillaudeux presented new in vivo data demonstrating strong anti-tumor efficacy as a monotherapy in an MB49 tumor model.

“We are excited to see the robust preclinical data of our anti-CD27 agonist antibodies that was presented at ESMO” said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. “These data demonstrate the potential of our future lead anti-CD27 agonist antibodies as a monotherapy.   Additionally, we believe there are combinations with other immunotherapies that can provide strong synergistic efficacy and improve outcomes for patients with cancer.”

Key results from the ESMO poster presentation:

  • Evaluated 15 leads out of 147 fully human anti-CD27 monoclonal antibodies with unique sequences
  • Human T cell activation assay showed strong increased in proliferation and cytokine secretion for 3 mAbs
  • Surrogate in vivo model with anti-mouse CD27 agonist showed significant anti-tumor response
  • huCD27 transgenic mice will serve as our model for further in vivo studies to select our lead anti-CD27 agonist antibody

 

Presentation Details:

Title: Novel fully human agonist antibodies against the T-cell costimulatory receptor CD27 shape adaptive anti-tumor immunity
Date Presented:  December 8-11, 2021
Presenter:  Thierry Guillaudeux, PhD
Poster:  Click on the link below to view the poster:

CD27 Publications – Poster Presentation at ESMO 2021

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Anti-CD27 mAb program:  Kineta has developed a diverse set of anti-CD27 agonist antibodies. They are fully human monoclonal antibodies (mAbs) that demonstrate low nanomolar (nM) binding affinity to CD27 in humans. In preclinical studies, Kineta’s selected lead anti-CD27 agonist mAbs induce T cell proliferation and secretion of cytokines involved in T cell priming and recruitment, demonstrating the ability to potentiate new anti-tumor responses.  Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q1-Q2 2022.

Kineta is a clinical stage biotechnology company with a mission to develop next generation immunotherapies that transform patients’ lives.  We have leveraged our expertise in innate immunity to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy.  For more information on Kineta visit our website, www.kinetabio.com, and follow us on Twitter, LinkedIn and Facebook.


NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

 

Contact:
Jacques Bouchy
jbouchy@kineta.us
(206) 378-0400

Kineta Presents Phase 1/2 Clinical Trial Design of KVA12.1 at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

Kineta Presents Phase 1/2 Clinical Trial Design of KVA12.1 at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

Kineta Presents Phase 1/2 Clinical Trial Design of KVA12.1 at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

Anti-VISTA immunotherapy is being advanced in a range of solid tumors including non-small cell lung, colorectal, and ovarian cancers

Seattle, WA — (November 29, 2021) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today a presentation describing the Phase 1/2 trial design supporting KVA12.1 for the potential treatment of difficult-to-treat solid tumors at the Society for Immunotherapy of Cancer (SITC) 36th Anniversary Annual Meeting.  Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented a poster outlining the first-in-human clinical trial design KVA 12.1, a novel fully human anti-VISTA antibody, in monotherapy and in combination with an anti-PD1 antibody.

“Our fully human anti-VISTA antibody, KVA12.1,  which binds to a unique epitope has been optimized to reduce the potential risks of severe inflammation . It demonstrates excellent clinical characteristics including an extended pharmacokinetic (PK) profile” said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. “We are encouraged by the exceptional preclinical results of KVA12.1 and are eager to enter the clinic with KVA12.1 in the third quarter of 2022.”

The Phase 1/2 study will be a multicenter, open label, dose escalation and dose expansion study of intravenous infusion of KVA12.1 as a monotherapy and in combination with a fixed dose of an anti-PD1 antibody in patients with advanced refractory or metastatic solid tumors.

Study objectives detailed from the SITC poster presentation:

  • Primary objective: Evaluate the safety, tolerability, Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and Identify the Recommended Phase 2 Dose (RP2D) of VISTA-Mab when administered alone and in combination with an anti-PD1 antibody.
  • Secondary objectives: Further describe i) the PK of KVA12.1; ii) VISTA-Receptor Occupancy; and iii) the anti-tumor activity of KVA12.1 (alone and in combination).

Presentation Details:

Title: KVA 12.1 a novel fully human anti-VISTA antibody clinical trial design in monotherapy and in combination with an anti-PD1 antibody

Date Presented:  November 12-13, 2021
Presenter:  Thierry Guillaudeux, PhD

Poster:  Click on the link below to view the poster:

VISTA Publications – Poster Presentation at SITC 2021

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KVA12.1 is a fully human, optimized IgG1 monoclonal antibody (mAb) that was designed to bind to VISTA through a unique epitope. KVA12.1 drives strong antitumor immune cell activation:

  • Increases inflammatory monocyte differentiation and activation
  • Increases HLA-dependent T cell activation
  • Reduces MDSC-mediated T cell suppression

In preclinical models, KVA12.1 demonstrates strong single agent efficacy in poorly immunogenic “cold tumors” and complementary efficacy when dosed in combination with immune checkpoint inhibitors (ICIs) like PD-1 or CTLA-4. It is well-tolerated with no change in IL6 or TNFα levels, which are responsible for cytokine release syndrome (CRS), in toxicology studies.  KVA12.1 is being developed as an intravenous infusion.

KVA12.1 may be an effective immunotherapy for many types of cancer patients including non-small cell lung cancer (NSCLC), colorectal (CRC), renal cell carcinoma (RCC), head and neck squamous cell carcinoma (HNSCC), and ovarian (OC) cancers.

Kineta is a clinical stage biotechnology company with a mission to develop next generation immunotherapies that transform patients’ lives.  We have leveraged our expertise in innate immunity to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy.  For more information on Kineta visit our website, www.kinetabio.com, and follow us on Twitter, LinkedIn and Facebook.

 

NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

 

Contact:

Jacques Bouchy

jbouchy@kineta.us

(206) 378-0400

Kineta Presented Compelling Preclinical Data on its New CD27 Antibody Program at the 2021 SITC Annual Meeting

Kineta Presented Compelling Preclinical Data on its New CD27 Antibody Program at the 2021 SITC Annual Meeting

Kineta Presented Compelling Preclinical Data on its New CD27 Antibody Program at the 2021 SITC Annual Meeting

Seattle, WA — (November 16, 2021) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today the presentation of preclinical data on the company’s new anti-CD27 agonist monoclonal antibody program at the Society for Immunotherapy of Cancer (SITC) 36th Anniversary Annual Meeting, that took place November 10-14, 2021 in Washington D.C.  Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented a poster revealing new binding affinity and specificity data on the company’s CD27 monoclonal antibody drug candidates as well as potent agonistic activity on cellular and T cell activation assays.

“We are highly encouraged with the compelling preclinical data demonstrated with Kineta’s new CD27 monoclonal antibodies” said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. “CD27 is a promising cancer immunotherapy approach that can mobilize new specific tumor antigen specific T cells to drive a potent anti-tumor response with single agent efficacy as well as synergistic effects with other immune checkpoint inhibitors.

Kineta has developed a diverse set of anti-CD27 agonist antibodies. They are fully human monoclonal antibodies (mAbs) that demonstrate low nanomolar (nM) binding affinity to CD27 in humans. In preclinical studies, Kineta’s selected lead anti-CD27 agonist mAbs induce T cell proliferation and secretion of cytokines involved in T cell priming and recruitment, demonstrating the ability to potentiate new anti-tumor responses.  Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q1-Q2 2022.

Key results from the SITC poster presentation:

  • 147 fully human anti-CD27 monoclonal antibodies with unique sequences were generated
  • Anti-CD27 agonist assay showed strong agonist activity for 8 pre-selected anti-CD27 antibodies
  • Human T cell activation assay data for 5 mAbs showed increased proliferation and cytokine secretion
  • Further in vitro and in vivo developments are on-going to select our lead anti-CD27 agonist antibody

Presentation Details:

Title: A promising cancer immunotherapy target: Novel agonistic human antibodies against the human T-cell costimulatory receptor CD27
Date Presented:  November 12-13, 2021
Presenter:  Thierry Guillaudeux, PhD
Poster:  Click on the link below to view the poster:

CD27 Publications – Poster Presentation at SITC 2021

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Kineta is a clinical stage biotechnology company with a mission to develop next generation immunotherapies that transform patients’ lives.  We have leveraged our expertise in innate immunity to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy.  For more information on Kineta visit our website, www.kinetabio.com, and follow us on Twitter, LinkedIn and Facebook.

 

NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Contact:

Jacques Bouchy
jbouchy@kineta.us
(206) 378-0400

Kineta Presents Preclinical Data on its New CD27 Program at the AACR Conference on Tumor Immunology and Immunotherapy

Kineta Presents Preclinical Data on its New CD27 Program at the AACR Conference on Tumor Immunology and Immunotherapy

Kineta Presents Preclinical Data on its New CD27 Program at the AACR Conference on Tumor Immunology and Immunotherapy

Kineta expands the company’s immuno-oncology pipeline with the addition of a new monoclonal antibody program targeting CD27

Seattle, WA — (October 7, 2021) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today the presentation of preclinical data on the company’s new immuno-oncology program targeting CD27 at the American Association for Cancer Research Virtual Conference on Tumor Immunology and Immunotherapy.   Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented a poster detailing new preclinical data on the company’s lead anti-CD27 agonist antibodies.

CD27 is a member of the TNF receptor superfamily and plays a critical role in T-cell activation by providing a co-stimulatory signal together with its ligand CD70.  CD27 is highly expressed on naïve T cells and also provides a co-stimulatory signal for NK cell activation.  A major challenge in cancer immunotherapy is T cell “exhaustion”.  Anti-cancer T cells, through repeated stimulation, begin to lose their cancer-fighting effector functions.  Once a T cell is exhausted, further stimulation becomes ineffective.  CD27 agonist immunotherapy may reprogram the immune system to generate new and more diverse populations of anticancer “memory” T cells from naïve T cells to elicit a strong anti-tumor response.

“This is a significant milestone for Kineta as we expand our pipeline with another exciting immuno-oncology antibody program,” said Shawn Iadonato, PhD, Chief Executive Officer of Kineta. “Our immuno-oncology strategy is to develop differentiated immunotherapies to address key mechanisms of cancer resistance including immunosuppression, exhausted T cells, and lack of tumor antigens.  CD27 is a promising immunotherapy target to address exhausted T cells and restore anti-tumor T cell function”.

Key results from the AACR poster presentation include the following:

  • 147 fully human monoclonal anti-CD27 antibodies with unique sequences were generated
  • Kineta’s anti-CD27 antibodies are highly specific and cross-react with cyno-CD27
  • Anti-CD27 agonist assay showed particularly strong induction for eight of the anti-CD27 antibodies
  • Human peripheral blood T cell activation assay showed increased proliferation and cytokine secretion

“We are encouraged with the results of our anti-CD27 antibodies as they performed exceedingly well across multiple preclinical experiments”, said Thierry Guillaudeux, PhD, SVP Immuno-oncology at Kineta. “We are currently in lead selection and will nominate a clinical candidate to advance into IND-enabling studies in 2022.”

Presentation Details:

Title: A promising cancer immunotherapy target:  Novel fully human agonist antibodies against the human T-cell costimulatory receptor CD27
Date Presented:  October 5-6, 2021
Presenter:  Thierry Guillaudeux, PhD
Poster:  Click on the link below to view the poster:
Kineta CD27 Poster Presentation at AACR Conference on Tumor Immunology and Immunotherapy

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Kineta is a clinical stage biotechnology company with a mission to develop next generation immunotherapies that transform patients’ lives.  We have leveraged our expertise in innate immunity to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy.  For more information on Kineta visit our website, www.kinetabio.com, and follow us on Twitter, LinkedIn and Facebook.

NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Contact:

Jacques Bouchy
jbouchy@kineta.us
(206) 378-0400

Kineta Announces Poster Presentation at the 2021 American Association for Cancer Research Conference on Tumor Immunology and Immunotherapy

Kineta Announces Poster Presentation at the 2021 American Association for Cancer Research Conference on Tumor Immunology and Immunotherapy

Kineta Announces Poster Presentation at the 2021 American Association for Cancer Research Conference on Tumor Immunology and Immunotherapy

Seattle, WA — (September 28, 2021) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today that it will present a poster on the company’s new anti-CD27 agonist antibody program at the American Association for Cancer Research (AACR) Virtual Special Conference: Tumor Immunology and Immunotherapy, to be held on October 5-6, 2021.

Title: A promising cancer immunotherapy target:  Novel fully human agonist antibodies against the human T-cell costimulatory receptor CD27
Date Poster Available:  October 5, 2021

 

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Kineta is a clinical stage biotechnology company with a mission to develop next generation immunotherapies that transform patients’ lives.  We have leveraged our expertise in innate immunity to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy.  For more information on Kineta visit our website, www.kinetabio.com, and follow us on Twitter, LinkedIn and Facebook.


NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Contact:

Jacques Bouchy
jbouchy@kineta.us
(206) 378-0400

Kineta Announces Participation at H.C. Wainwright 23rd Annual Global Investment Conference

Kineta Announces Participation at H.C. Wainwright 23rd Annual Global Investment Conference

Kineta Announces Participation at H.C. Wainwright 23rd Annual Global Investment Conference

Seattle, WA — (August 30, 2021) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today that the company will participate in the H.C. Wainwright 23rd Annual Global Investment Conference taking place virtually from September 13-15, 2021.  Shawn Iadonato, PhD, Chief Executive Officer of Kineta will present a corporate overview, that will be viewable online. Members of the management team will also be available for virtual meetings with institutional investors throughout the course of the conference.  For more information on the conference or to register, visit: HCW Events.

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Kineta is a clinical stage biotechnology company with a mission to develop next generation immunotherapies that transform patients’ lives.  We have leveraged our expertise in innate immunity to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy.  For more information on Kineta visit our website, www.kinetabio.com, and follow us on Twitter, LinkedIn and Facebook.

NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s and Kineta Chronic Pain, LLC’s (KCP) plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s and KCP’s businesses which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and neither Kineta nor KCP undertake any obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.


NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Contact:
Jacques Bouchy
jbouchy@kineta.us
(206) 378-0400

Kineta Announces Patent Issuance of U.S. Patent for Composition of Matter of KCP506

Kineta Announces Patent Issuance of U.S. Patent for Composition of Matter of KCP506

Kineta Announces Patent Issuance for U.S. Patent Covering Composition of Matter of KCP506, a Novel Non-opioid Therapy for Chronic Pain

Seattle, WA — (August 10, 2021) Kineta Inc, through its subsidiary Kineta Chronic Pain LLC, announced today that the company has received Patent No. 11,014,970 for Modifications and Uses of Conotoxin Peptides from the U.S. Patent and Trademark Office (“USPTO”) related to KCP506, the company’s novel non-opioid therapy in development to treat chronic neuropathic pain. Among other claims, the patent covers the composition of matter of KCP506.

“The allowance of this patent in the U.S. substantially strengthens our intellectual property position, an important milestone for KCP506’s development and potential commercialization,” said Kineta Eric Tarcha, PhD., EVP Research and Development at Kineta. “With a significant need for an effective therapy to treat chronic neuropathic pain, KCP506 has the potential to provide a non-opioid treatment option with a novel drug mechanism relative to conventional pain therapies.”

A Notice of Allowance is issued after the USPTO makes a determination that a patent should be granted from an application. The patent will have a term that expires no earlier than 2035.

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KCP506 may potentially be an effective treatment for many types of chronic neuropathic pain including radiculopathy, chemotherapy-induced peripheral neuropathy, and diabetic neuropathy. The global neuropathic pain market was $6.3 billion in 2019 and is expected to reach to $9.9 billion by 2027.

Kineta, Inc. is a clinical stage biotechnology company committed to developing disruptive life science technologies that address unmet patient needs.  We have leveraged our expertise in immunology to advance a focused pipeline of investigational drugs in oncology and neuroscience.  We actively collaborate with a broad array of private, government and industry partners to advance our innovative products.  For more information on Kineta visit our website, www.kinetabio.com, follow us on Twitter at @kinetabio, LinkedIn and Like us on facebook.com/KinetaBio.


NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s and Kineta Chronic Pain, LLC’s (KCP) plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s and KCP’s businesses which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and neither Kineta nor KCP undertake any obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

 

Contact:
Jacques Bouchy
jbouchy@kineta.us
(206) 378-0400

Kineta Announces Successful Completion of Pre-IND Meeting with the FDA for KVA12.1

Kineta Announces Successful Completion of Pre-IND Meeting with the FDA for KVA12.1

Kineta Announces Successful Completion of Pre-IND Meeting with the FDA for KVA12.1

Phase 1/2 clinical studies of the company’s anti-VISTA antibody to commence in mid-2022

Seattle, WA — (July 27, 2021) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plan for KVA12.1.  Kineta has gained alignment with FDA on the initial Phase 1/2 clinical trial of the safety and efficacy of Kineta’s KVA12.1 as a single agent and in combination with pembrolizumab in patients with unresectable or metastatic solid tumors.

“We greatly appreciate the FDA’s guidance as we prepare to advance our novel anti-VISTA immunotherapy into the clinic next year”, said Shawn Iadonato, PhD, Chief Executive Officer of Kineta.  “The successful completion of this engagement with the FDA is an important milestone that provides regulatory clarity for KVA12.1 and confidence with the planned development program for this novel anti-cancer immunotherapy.

A pre-IND meeting provides an opportunity for an open communication between a drug development company and the FDA to discuss the IND development plan and to obtain the agency’s guidance for clinical studies of the company’s new drug candidate. The FDA reviewed the IND enabling preclinical data, manufacturing plan and phase 1/2 clinical study protocol synopsis for KVA12.1, provided guidance and addressed Kineta’s questions on the development plan.  Kineta plans to initiate the Phase 1/2 first-in-human clinical studies in mid-2022.

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Kineta, Inc. is a clinical stage biotechnology company committed to developing disruptive life science technologies that address unmet patient needs.  We have leveraged our expertise in immunology to advance a focused pipeline of investigational drugs in oncology and neuroscience.  We actively collaborate with a broad array of private, government and industry partners to advance our innovative products.  For more information on Kineta visit our website, www.kinetabio.com, follow us on Twitter at @kinetabio, LinkedIn and Like us on facebook.com/KinetaBio.


NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

 

Contact
Jacques Bouchy
jbouchy@kineta.us
(206) 378-0400