RCC

Tempest Reports New Preclinical Data for TPST-1120 in RCC at the AACR Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024

These new data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO 2022.

Key Points: 
  • These new data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO 2022.
  • “Preclinical data presented at AACR further demonstrate that TPST-1120 has the potential to positively transform the tumor microenvironment and expand the activity of anti-tumor immunity in kidney cancer,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest.
  • In preclinical models of renal cell carcinoma (RCC), treatment with TPST-1120 reduced tumor growth by 52%-56% as monotherapy.
  • Additional improvement in anti-cancer activity was demonstrated in combination treatment with standard first-line RCC cabozantinib or anti-PD1 therapy, where tumor inhibition was 81% and 74%, respectively.

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

Retrieved on: 
Sunday, April 7, 2024

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

Xilio Therapeutics Announces $11.3 Million Private Placement Equity Financing

Retrieved on: 
Thursday, March 28, 2024

WALTHAM, Mass., March 28, 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 that it has entered into a securities purchase agreement with certain existing accredited investors, including Bain Capital Life Sciences and Rock Springs Capital, to issue and sell an aggregate of 1,953,125 shares of Xilio common stock at a price of $0.64 per share and prefunded warrants to purchase up to an aggregate of 15,627,441 shares of Xilio common stock at a purchase price of $0.6399 per prefunded warrant share, through a private investment in public equity financing. The prefunded warrants will have an exercise price of $0.0001 per share of common stock, be immediately exercisable and remain exercisable until exercised in full. Xilio anticipates receiving aggregate gross proceeds from the private placement of approximately $11.3 million, before deducting placement agent fees and expenses payable by the company. The private placement is expected to close on April 2, 2024, subject to the satisfaction of customary closing conditions. Xilio expects to use the proceeds from the private placement to fund working capital and other general corporate purposes.

Key Points: 
  • Xilio anticipates receiving aggregate gross proceeds from the private placement of approximately $11.3 million, before deducting placement agent fees and expenses payable by the company.
  • The private placement is expected to close on April 2, 2024, subject to the satisfaction of customary closing conditions.
  • Xilio expects to use the proceeds from the private placement to fund working capital and other general corporate purposes.
  • Prior to the potential transition fee, Xilio is eligible to receive up to a total of $29.0 million in additional equity investments and a development milestone payment.

Calibre Enters Pre-Commissioning and Commissioning Contract with Reliable Controls Corporation and Executes A Gold Prepayment

Retrieved on: 
Thursday, March 28, 2024

Darren Hall, President and Chief Executive Officer of Calibre, stated: “With construction at Valentine 61% complete I remain confident in our ability to deliver first gold during H1, 2025.

Key Points: 
  • Darren Hall, President and Chief Executive Officer of Calibre, stated: “With construction at Valentine 61% complete I remain confident in our ability to deliver first gold during H1, 2025.
  • To further derisk delivery, I am pleased to announce that we have secured RCC, a team of highly experienced commissioning experts to lead pre-commissioning and commissioning of the process plant.
  • Calibre is required to deliver Asahi 2,300 ounces of gold per month over a twelve-month period, beginning in May 2024, such ounces determined based on gold forward curve prices averaging $2,239 per ounce.
  • Approximately 2,233 ounces per month will be credited against the prepayment and Calibre will receive a cash payment for the balance.

Synthekine Presents Positive Initial Results from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, for Treatment of Advanced Solid Tumors

Retrieved on: 
Tuesday, April 9, 2024

Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.

Key Points: 
  • Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.
  • The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.
  • In the results presented, which included 47 patients treated in Phase 1a dose escalation, STK-012 monotherapy demonstrated a favorable safety, efficacy, pharmacokinetic and pharmacodynamic profile.
  • The poster, titled “Initial results from a Phase 1a/1b study of STK-012, a first-in-class α/β IL-2 receptor biased partial agonist in advanced solid tumors (NCT05098132),” will be presented today at AACR from 9 am to 12:30 pm PT.

Trevi Therapeutics Announces Abstract Presentation at the American Thoracic Society 2024 International Conference

Retrieved on: 
Tuesday, April 9, 2024

NEW HAVEN, Conn., April 9, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that data from the Phase 2 CANAL trial will be presented at the American Thoracic Society (ATS) 2024 International Conference being held in San Diego, CA, from May 17-22. The presentation will take place on May 19th.

Key Points: 
  • NEW HAVEN, Conn., April 9, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that data from the Phase 2 CANAL trial will be presented at the American Thoracic Society (ATS) 2024 International Conference being held in San Diego, CA, from May 17-22.
  • The presentation will take place on May 19th.
  • Presenter: Jacky Smith, MB, ChB, FRCP, PhD, Professor of Respiratory Medicine at the University of Manchester, and an Honorary Consultant at Manchester University NHS Foundation Trust.
  • Director of the NIHR Manchester Clinical Research Facility, Respiratory Theme Lead in the NIHR Manchester Biomedical Research Centre and an NIHR Senior Investigator.

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 19, 2024

BURLINGAME, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2023.
  • We have several exciting opportunities in immunology, including plans for a randomized, placebo controlled clinical trial of soquelitinib in atopic dermatitis.
  • Mr. Arcara previously served as senior vice president, head global marketing & portfolio and strategy for the innovative medicines and biosimilars business at Teva Pharmaceuticals.
  • ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2023 financial results.

Allogene Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 14, 2024

These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.

Key Points: 
  • These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.
  • Research and development expenses were $54.7 million for the fourth quarter of 2023, which includes $7.0 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.2 million for the fourth quarter of 2023, which includes $8.2 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.

SillaJen Submits CSR to the US FDA for REN026 Study in Patients with RCC

Retrieved on: 
Wednesday, March 27, 2024

SillaJen, Inc. (KOSDAQ: 215600) has submitted CSR to the US FDA on 06 Feb 2024 for REN026, a phase 1b/2a dose escalation and safety/efficacy evaluation study of Pexa-Vec in combination with cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC).

Key Points: 
  • SillaJen, Inc. (KOSDAQ: 215600) has submitted CSR to the US FDA on 06 Feb 2024 for REN026, a phase 1b/2a dose escalation and safety/efficacy evaluation study of Pexa-Vec in combination with cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC).
  • In 2017, SillaJen began a collaboration agreement with Regeneron for the clinical study of Pexa-Vec in combination with cemiplimab in patients with RCC.
  • The study was conducted in four study arms (A to D) to assess the safety and efficacy of the Pexa-Vec in combination with cemiplimab.
  • Given the typically lower response rates in patients with more prior extensive treatments, the results are considered highly encouraging.

Trevi Therapeutics to Participate in Upcoming April Events

Retrieved on: 
Thursday, April 4, 2024

NEW HAVEN, Conn., April 4, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that senior management will attend and participate in the following events in April.

Key Points: 
  • NEW HAVEN, Conn., April 4, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that senior management will attend and participate in the following events in April.
  • A live webcast of the 23rd Annual Needham Virtual Healthcare Conference fireside chat will be accessible from the 'Investors & News' section on the Company's website at www.TreviTherapeutics.com .
  • An archived replay of the webcast will also be available for 30 days on the Company's website following the event.