IND

Kezar Life Sciences Reports Third Quarter 2022 Financial Results and Provides Business Update

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Thursday, November 10, 2022

Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.

Key Points: 
  • Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.
  • Kezar presented positive complete results for the 37-week Phase 2 MISSION clinical trial at the American Society of Nephrologys (ASN) Kidney Week 2022 Annual Meeting.
  • General and administrative expenses for the third quarter of 2022 increased by $1.0 million to $5.0 million compared to $4.0 million in the third quarter of 2021.
  • Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing novel treatments for immune-mediated and oncologic disorders.

Artiva Biotherapeutics Presents Preclinical Data for AB-101, an Optimized Allogeneic NK Cell Therapy Candidate, at SITC 2022 Annual Meeting

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Thursday, November 10, 2022

The data were presented at the Society for Immunotherapy of Cancer (SITC) 37TH Annual Meeting in Boston.

Key Points: 
  • The data were presented at the Society for Immunotherapy of Cancer (SITC) 37TH Annual Meeting in Boston.
  • Artiva is also developing a combination therapy comprised of AB-101 and Affimed N.V.s Innate Cell Engager AFM13 for treatment of patients with relapsed/refractory CD30-positive lymphomas.
  • AB-101 is a cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers.
  • Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme Corp. and with Affimed GmbH.

Aulos Bioscience Presents Initial Data From First-in-Human Phase 1/2 Clinical Trial of Computationally Designed Antibody AU-007 at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting

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Thursday, November 10, 2022

AU-007 is a human monoclonal antibody computationally designed by Biolojic Design to harness the power of interleukin-2 (IL-2) and eradicate solid tumors.

Key Points: 
  • AU-007 is a human monoclonal antibody computationally designed by Biolojic Design to harness the power of interleukin-2 (IL-2) and eradicate solid tumors.
  • Data were presented in a poster presentation at the 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting in Boston, Massachusetts.
  • Initial pharmacokinetic data from the first three patients administered AU-007 as a monotherapy demonstrate characteristics similar to other IgG1 therapeutic human monoclonal antibodies.
  • AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2.

Medikine Presents Preliminary Results of a Single-Dose Phase 1 Healthy Subject Study of MDK-703, a Peptide-Based Mimetic of Interleukin-7 (IL-7)

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Thursday, November 10, 2022

A second poster presentation detailed preclinical results in peripheral blood monocytes (PBMCs) from healthy donors for MDK-1654, Medikines dual-acting agonist that incorporates both IL-7 and non-alpha IL-2/15 PEPTIKINES.

Key Points: 
  • A second poster presentation detailed preclinical results in peripheral blood monocytes (PBMCs) from healthy donors for MDK-1654, Medikines dual-acting agonist that incorporates both IL-7 and non-alpha IL-2/15 PEPTIKINES.
  • This is the first demonstration of a synthetic peptide with agonist activity for two clinically relevant cytokine receptors.
  • In addition to activating both the IL-2/15Rc and IL-7Rc signaling pathways, MDK-1654 expanded all memory T cells, including CD8 Tscm.
  • Medikines lead candidate, MDK-703, currently in a Phase 1 clinical trial in healthy volunteers, is an IL-7 PEPTIKINE fused to an immunoglobulin Fc-domain.

Ankyra Therapeutics Presents Positive Preclinical Data Supporting Advancement of ANK-101 into Clinical Studies for Treatment of Solid Tumors

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Thursday, November 10, 2022

IL-12 is a potent cytokine that can promote innate and adaptive anti-cancer immunity, but its clinical development has been limited by toxicity when delivered systemically.

Key Points: 
  • IL-12 is a potent cytokine that can promote innate and adaptive anti-cancer immunity, but its clinical development has been limited by toxicity when delivered systemically.
  • This is supported by our extensive preclinical work with ANK-101, where weve observed potent anti-tumor responses with good tolerability, and we look forward to its continued advancement towards clinical studies.
  • The data to be presented today are from several preclinical studies in mouse models and non-human primates (NHPs).
  • Ankyra Therapeutics is a biotechnology company developing a novel approach to treating cancer, designed to expand the therapeutic window of cytokine drugs.

Triumvira Immunologics Demonstrates Strength of Preclinical Research Pipeline for Gastric and Colorectal Cancers in Three Posters at SITC 2022

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Thursday, November 10, 2022

Data was shared in three posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in-person in Boston.

Key Points: 
  • Data was shared in three posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in-person in Boston.
  • The data showed that CLDN18.2-TAC T and GUCY2C-TAC T could be an effective treatment for hard to treat solid tumors."
  • Triumvira announced updated data on its novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) for the treatment of gastric cancer.
  • The data continue to demonstrate that CLDN18.2-TAC T effectively eliminates CLDN18.2-expressing gastric cancer cells in vitro and in vivo.

Corbus Presents Latest Preclinical Data for CRB-601 at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

Retrieved on: 
Thursday, November 10, 2022

NORWOOD, Mass., Nov. 10, 2022 /PRNewswire/ -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an oncology company, is presenting new preclinical data for CRB-601 today in a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Boston.

Key Points: 
  • NORWOOD, Mass., Nov. 10, 2022 /PRNewswire/ -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an oncology company, is presenting new preclinical data for CRB-601 today in a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Boston.
  • The latest preclinical data demonstrate significant tumor growth inhibition by CRB-601 as a single agent and in combination with anti-PD-1 treatment in the syngeneic murine tumor models MC38 and EMT6.
  • CRB-601 is the only anti-v8 targeting agent known to demonstrate such an effect in these models to date.
  • The anti-tumor effects in the immune excluded EMT6 model correlated with changes in the immune cell populations in the tumor microenvironment.

Myeloid Therapeutics Presents Update On Myeloid Cell Programming Technologies, Including Non-Human Primate Proof-Of-Concept Data Delivering in vivo mRNA TROP-2 Targeting CAR (MT-302) at Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

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Thursday, November 10, 2022

CAMBRIDGE, Mass., Nov. 10, 2022 /PRNewswire/ -- Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company, today presented multiple posters on its therapeutics platforms, ATAK™ CAR receptors and in vivo mRNA programming, at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, being held in Boston, MA, November 8-12, 2022.  

Key Points: 
  • We are planning to advance this program into the clinic and expect to file an IND in 2023."
  • Myeloid's adaptations of mRNA for the myeloid compartment have enabled the evolution to deliver these receptors directly to the patient without any ex-vivo cell engineering.
  • Myeloid's novel in vivo engineering platform specifically targets and activates myeloid cells to elicit broader anti-tumor adaptive immunity.
  • Myeloid has entered into strategic partnerships with Prime Medicine and Acuitas and is supported by well-known biotechnology investors.

MindMed Reports Third Quarter 2022 Financial Results and Business Highlights

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Thursday, November 10, 2022

NEW YORK, Nov. 10, 2022 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today reported its financial results for the quarter ended September 30, 2022.

Key Points: 
  • Additionally, we continue our efforts to bring MM-402 into human clinical studies," said Robert Barrow, Chief Executive Officer and Director of MindMed.
  • In August 2022, the Company initiated patient dosing in the Phase 2b dose-optimization study of MM-120 for the treatment of GAD.
  • Cash Balance.As of September 30, 2022, MindMed had cash and cash equivalents totaling $154.5 million compared to $133.5 million as of December 31, 2021.
  • MindMed management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company's third quarter 2022 financial results.

Baudax Bio Reports Third Quarter 2022 Financial Results and Business Highlights

Retrieved on: 
Tuesday, November 8, 2022

MALVERN, Pa., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today reported financial results for the three and nine months ended September 30, 2022, updated the status of the neuromuscular blocking (NMB) agent development program, provided key metrics around the ongoing commercialization of ANJESO (meloxicam) injection, and provided an overview of other corporate and financial developments.

Key Points: 
  • Baudax Bio expects to complete nonclinical studies and manufacturing data required to support the IND for BX3000 in the first half of 2023.
  • In August 2022, Baudax Bio announced that the United States Patent and Trademark Office (USPTO) had provided a Notice of Allowance for patent application No.
  • As of September 30, 2022, Baudax Bio had cash and cash equivalents of $5.6 million.
  • These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.