PD-1

Mirati Therapeutics Presents Late-Breaking Results Evaluating Concurrent Adagrasib and Pembrolizumab in First-Line Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Monday, December 5, 2022

75 patients were enrolled and evaluable for safety with a median follow-up of 3.5 months (duration of treatment: 2 months).

Key Points: 
  • 75 patients were enrolled and evaluable for safety with a median follow-up of 3.5 months (duration of treatment: 2 months).
  • Treatment-related adverse events (TRAEs) were Grade 1-2 (39%), Grade 3 (40%) and Grade 4 (4%); there were no Grade 5 TRAEs observed.
  • TRAEs led to discontinuation of both adagrasib and pembrolizumab in 2 patients and only pembrolizumab in 2 patients; there were no patients who discontinued only adagrasib due to a TRAE.
  • This press release contains forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati").

AnaptysBio- and GSK-partnered immuno-oncology agent JEMPERLI (dostarlimab-gxly) meets primary endpoint in Phase 3 RUBY trial in primary advanced or recurrent endometrial cancer

Retrieved on: 
Friday, December 2, 2022

GSK expects to publish full results from the RUBY trial in a medical journal and present at an upcoming scientific meeting.

Key Points: 
  • GSK expects to publish full results from the RUBY trial in a medical journal and present at an upcoming scientific meeting.
  • RUBY is a two-part global, randomised, double-blind, multicentre study of patients with primary advanced or recurrent endometrial cancer.
  • RUBY is part of an international collaboration of European Network of Gynaecological Oncological Trial groups (ENGOT) and the GOG Foundation.
  • AnaptysBio is also developing imsidolimab, our anti-IL-36R antibody in Phase 3 for the treatment of generalized pustular psoriasis, or GPP.

EQS-News: Israeli Ministry Of Health Clears Way For Human Trials Of AllocetraTM, A Proprietary Off-the-Shelf Immunotherapy For Solid Tumors

Retrieved on: 
Thursday, December 1, 2022

Israeli Ministry Of Health Clears Way For Human Trials Of AllocetraTM, A Proprietary Off-the-Shelf Immunotherapy For Solid Tumors

Key Points: 
  • Israeli Ministry Of Health Clears Way For Human Trials Of AllocetraTM, A Proprietary Off-the-Shelf Immunotherapy For Solid Tumors
    The issuer is solely responsible for the content of this announcement.
  • The Israeli Ministry of Health (MOH) approved a Phase I/II trial of Enlivex Therapeutics Ltd.s (NASDAQ: ENLV) proprietary immunotherapy drug-candidate AllocetraTM.
  • Then, it can turn that macrophage into a pro-tumor ally that will suppress any immune response trying to kill the cancer.
  • The results of early-stage trials may differ significantly from the results of more developed, later-stage trials.

Wave of FDA Fast Track Designations Sparks Renewed Interest in Biotech Sector That's Heating Up

Retrieved on: 
Thursday, December 1, 2022

VANCOUVER, British Colombia , Dec. 1, 2022 /PRNewswire/ -- USA News Group  -  A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a designation is pelareorep from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) in combination with atezolizumab, an anti-PD-L1 checkpoint inhibitor from Roche Holding AG (OTCQX: RHHBY) for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). Among the small handful of other companies that recently received this distinction for their platforms have been Aravive, Inc. (NASDAQ: ARAV), Caribou Biosciences, Inc. (NASDAQ: CRBU), and Kintara Therapeutics, Inc. (NASDAQ: KTRA).

Key Points: 
  • The Fast Track process is designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.
  • Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan.
  • Drugs with Fast Track designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.
  • This represents the second FDA Fast Track designation in Oncolytics' history, with the first being for pelareorep in Metastatic Breast Cancer back in May 2017 .

Wave of FDA Fast Track Designations Sparks Renewed Interest in Biotech Sector That's Heating Up

Retrieved on: 
Thursday, December 1, 2022

VANCOUVER, British Colombia, Dec. 1, 2022 /PRNewswire/ -- USA News Group  -  A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a designation is pelareorep from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) in combination with atezolizumab, an anti-PD-L1 checkpoint inhibitor from Roche Holding AG (OTCQX: RHHBY) for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). Among the small handful of other companies that recently received this distinction for their platforms have been Aravive, Inc. (NASDAQ: ARAV), Caribou Biosciences, Inc. (NASDAQ: CRBU), and Kintara Therapeutics, Inc. (NASDAQ: KTRA).

Key Points: 
  • The Fast Track process is designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.
  • Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan.
  • Drugs with Fast Track designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.
  • This represents the second FDA Fast Track designation in Oncolytics' history, with the first being for pelareorep in Metastatic Breast Cancer back in May 2017 .

Hillstream BioPharma Announces Development of Proprietary Targeted Biologics, Knob Quatrabodies™ (HSB-1940) against PD-1, by combining Quatramers™ with OmniAb’s Picobodies™, via a Collaboration Agreement, against Novel, Unreachable and Undruggable

Retrieved on: 
Thursday, December 1, 2022

BRIDGEWATER, N.J., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream”, the “Company”) today announced the development of proprietary targeted biologics, Knob Quatrabodies™ (HSB-1940) against PD-1. Hillstream signed separate collaboration agreements with a subsidiary of OmniAb, Inc. (Nasdaq: OABI) (“OmniAb”) and with Minotaur Therapeutics, Inc. (“Minotaur”) to advance Picobodies against novel, unreachable and undruggable epitopes in high-value validated targets starting with PD-1.

Key Points: 
  • Targeting PD-1 is a step toward enabling Hillstream to enter the rapidly growing Immuno-oncology (IO) therapeutics market with additional IO targets after PD-L1.
  • Alternative species, particularly camelids and bovines, provide a paradigm for antigen recognition through novel domains which form the antigen binding site.
  • However, for camelids, heavy chain antibodies bind antigen with only a single heavy chain variable region, in the absence of light chains.
  • At ~4-6 kDa, these are three times smaller than a camelid nanobody, and are the smallest known antibody fragment.

Pyxis Oncology Announces FDA Clearance of Two IND Applications

Retrieved on: 
Thursday, December 1, 2022

CAMBRIDGE, Mass., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, announced today that it has received clearance for its two Investigational New Drug (IND) applications from the U.S. Food and Drug Administration (FDA) to initiate Phase 1 clinical trials. PYX-201, a novel antibody-drug conjugate (ADC) product candidate, will be investigated for the potential treatment of several solid tumors, including breast, head and neck, lung, and thyroid cancer. PYX-106, an immunotherapy product candidate, will be investigated for the potential treatment of solid tumors, including bladder, cholangio-carcinoma, colorectal, and kidney cancer.

Key Points: 
  • We are thrilled to receive two nearly simultaneous IND clearances from the FDA, representing a major moment as we transition to a clinical stage company demonstrating the operational prowess of our team, said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology.
  • Jay Feingold, M.D., Ph.D., Chief Medical Officer of Pyxis Oncology, added, "We are excited to advance multiple programs to the clinic.
  • Both product candidates could potentially be applied to a broad range of tumors and address a significant need in the community.
  • Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers.

Achilles Therapeutics to Present Early Proof of Concept of Safety and Clinical Activity of Clonal Neoantigen Reactive T Cells at the ESMO Immuno-Oncology Annual Congress 2022

Retrieved on: 
Wednesday, November 30, 2022

LONDON, Nov. 30, 2022 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies to treat solid tumors, today announced that an abstract highlighting updated interim results from the ongoing Phase I/IIa CHIRON and THETIS clinical trials evaluating clonal neoantigen-reactive T cells (cNeT) has been accepted for a poster presentation at the ESMO Immuno-Oncology Annual Congress (ESMO IO) taking place in Geneva, Switzerland from December 7-9, 2022. cNeT are the active component of the final, precision T cell product which target tumors through recognition of a patient’s clonal neoantigens present on all tumor cells.

Key Points: 
  • We believe this supports the potential for deep and durable clinical responses that can ultimately help extend overall survival, said Dr Karl Peggs, Chief Medical Officer of Achilles Therapeutics.
  • The encouraging safety and tolerability profile, coupled with reduced dose lymphodepletion and IL-2 continues to support expanded application to a broader patient population.
  • We look forward to sharing additional updated safety, activity, and translational science details at ESMO IO.
  • Safety and tolerability observations of cNeT compare favorably to standard tumor infiltrating lymphocytes (TIL) due to less IL-2 related toxicity.

Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010, an Allogeneic Anti-CD19 CAR-T Cell Therapy

Retrieved on: 
Tuesday, November 29, 2022

BERKELEY, CA, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted CB-010 Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed or refractory large B cell lymphoma (LBCL) and Fast Track designation for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, is being evaluated in the company’s ongoing ANTLER Phase 1 clinical trial in patients with r/r B-NHL, which can enroll three LBCL subtypes: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), and high-grade B cell lymphoma (HGBL). CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion.

Key Points: 
  • We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies.
  • Encouraging safety data and antitumor activity for CB-010 at dose level 1 (40x106 CAR-T cells) have been reported from the ANTLER trial .
  • CB-010 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations.
  • Caribou Biosciences and the Caribou logo are registered trademarks of Caribou Biosciences, Inc.

NETRIS Pharma Doses First Patient in Phase 2 Study of NP137 for Checkpoint Inhibitor Resistance

Retrieved on: 
Tuesday, November 29, 2022

The enrollment of the first patient in ImmunoNET is a new clinical milestone for NETRIS Pharma.

Key Points: 
  • The enrollment of the first patient in ImmunoNET is a new clinical milestone for NETRIS Pharma.
  • Based on a unique mode of action of NP137 and biomarker studies conducted in Phase 1, we believe we can enlarge the fraction of responding patients and potentially prevent resistance, said Patrick Mehlen, CEO of NETRIS Pharma.
  • ImmunoNET has been specifically designed by clinicians to provide new solutions for patients suffering from resistance to immune-checkpoint inhibitors.
  • NETRIS Pharma, a clinical-stage company designs and develops anti-cancer therapeutic molecules, particularly monoclonal antibodies, to block the interaction between dependence receptors and their ligands.