PD-1

Tempest Announces Publication of Positive Data from Phase 1 Trial of TPST-1120 in Patients with Advanced Solid Tumors in Journal of Cancer Research Communications

Retrieved on: 
Thursday, April 4, 2024

These earlier Phase 1 data complement the positive Phase 1b/2 data reported in October 2023 from a global randomized study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, which showed clinical superiority of the TPST-1120 arm across multiple study endpoints and relevant biomarker-defined patient subpopulations.

Key Points: 
  • These earlier Phase 1 data complement the positive Phase 1b/2 data reported in October 2023 from a global randomized study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, which showed clinical superiority of the TPST-1120 arm across multiple study endpoints and relevant biomarker-defined patient subpopulations.
  • “In this Phase 1 study of TPST-1120, we saw the first evidence of anti-tumor activity in multiple cancer types, affirming our belief that PPARα inhibition is an exciting and novel approach for cancer treatment,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest.
  • “These early-phase data are supported by the positive top line results of the ongoing randomized Phase 1b/2 trial in first-line HCC.
  • We believe there is tremendous potential for TPST-1120 to make a meaningful impact for patients and we look forward to providing updated data this year.”

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

Retrieved on: 
Thursday, April 4, 2024

This three-arm trial had earlier shown that 50% of PTG-007-treated patients in combination with rituximab were still in remission after 24 months.

Key Points: 
  • This three-arm trial had earlier shown that 50% of PTG-007-treated patients in combination with rituximab were still in remission after 24 months.
  • PolTREG CEO Piotr Trzonkowski, who co-authored the peer-reviewed study, said: “This peer-reviewed scientific publication adds to our growing excitement about the potential of polyclonal Treg therapies.
  • We have treated over 100 patients with our cell therapy at our facility over the last 17 years.
  • Having a biomarker of efficacy, like PD-1+ T-cells, could facilitate doctors’ ability to monitor their patients’ responses to therapy.

Xilio Therapeutics Announces Pipeline and Business Updates and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024

WALTHAM, Mass., April 01, 2024 (GLOBE NEWSWIRE) --  Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced pipeline progress and business updates and reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Xilio today reaffirmed plans to:
    Select a recommended Phase 2 dose for XTX101 in combination with atezolizumab in the second quarter of 2024.
  • In March 2024, Xilio and Gilead Sciences, Inc. (Gilead) announced an exclusive license agreement for Xilio’s tumor-activated IL-12 program, including XTX301.
  • Xilio will also be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.
  • Net Loss: Net loss was $17.7 million for the quarter ended December 31, 2023, compared to $22.5 million for the quarter ended December 31, 2022.

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, March 29, 2024

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

Mural Oncology Announces Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024

WALTHAM, Mass. and DUBLIN, Ireland, March 26, 2024 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, today announced its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update.

Key Points: 
  • “We have made significant progress since becoming an independent company during the fourth quarter of 2023.
  • Financial Results for the Quarter Ended December 31, 2023
    Cash Position: As of December 31, 2023, cash and cash equivalents were $270.9 million.
  • G&A Expenses: General and administrative expenses were $16.3 million for the fourth quarter of 2023, including $9.7 million in non-cash, share-based compensation expenses.
  • Furthermore, the company’s 2023 financial results reflect carve-out financials until the date of the spin out.

Calliditas receives notice of allowance for United States patent application covering setanaxib in cancer treatment

Retrieved on: 
Monday, April 8, 2024

STOCKHOLM, April 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.

Key Points: 
  • STOCKHOLM, April 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.
  • 16/760,910 entitled "Use of NOX Inhibitors for Treatment of Cancer".
  • This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • Calliditas has corresponding applications in several additional territories around the world, including a pending patent application in Europe.

Calliditas receives notice of allowance for United States patent application covering setanaxib in cancer treatment

Retrieved on: 
Monday, April 8, 2024

STOCKHOLM, April 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.

Key Points: 
  • STOCKHOLM, April 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.
  • 16/760,910 entitled "Use of NOX Inhibitors for Treatment of Cancer".
  • This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • Calliditas has corresponding applications in several additional territories around the world, including a pending patent application in Europe.

BeyondSpring Announces First Patient Dosed with Pembrolizumab, Plinabulin Plus Etoposide/Platinum in a Phase 2 Investigator-initiated Study of First-Line Extensive-Stage Small-Cell Lung Cancer

Retrieved on: 
Monday, March 25, 2024

This Phase 2 trial will evaluate the efficacy and safety of Pembrolizumab, Plinabulin plus EP in 1L ES-SCLC.

Key Points: 
  • This Phase 2 trial will evaluate the efficacy and safety of Pembrolizumab, Plinabulin plus EP in 1L ES-SCLC.
  • KEYNOTE-604 study revealed that 12-month PFS rate in patients with pembrolizumab plus EP is 13.6% vs. 3.1% with placebo plus EP.
  • Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell Lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial.
  • An Open-Label, Single-Arm, Phase II Study of Pembrolizumab, Plinabulin Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer.

Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 21, 2024

REDWOOD CITY, Calif., March 21, 2024 (GLOBE NEWSWIRE) --  Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • –   Cash balance of $128.6 million as of December 31, 2023, anticipated to fund key milestones through late 2025
    REDWOOD CITY, Calif., March 21, 2024 (GLOBE NEWSWIRE) --  Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • “We made substantial progress advancing our two proprietary clinical-stage development programs in 2023,” said Randall Schatzman, Ph.D., Chief Executive Officer.
  • “We have now administered BDC-1001, which we have renamed trastuzumab imbotolimod, to patients in all five of the Phase 2 cohorts.
  • BDC-3042 also continues to advance, and has now entered the fourth dose escalation cohort without a dose-limiting toxicity.

Compass Therapeutics Reports 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024

Ended 2023 with $152 million in cash and marketable securities, which is expected to provide cash runway into mid-year 2026.

Key Points: 
  • Ended 2023 with $152 million in cash and marketable securities, which is expected to provide cash runway into mid-year 2026.
  • BOSTON, March 21, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported full 2023 financial results and provided business update.
  • The increase was primarily attributable to higher stock compensation expense of $1.0 million offset by lower insurance costs of $0.3 million.
  • During 2023, the Company decreased its cash position by $34.1 million, primarily from $40.6 million of net cash used in operating activities.