LPS

Apexigen Announces Positive Interim Results from Phase 2 Trial Evaluating its CD40 Antibody, Sotigalimab, in Combination with Doxorubicin in Patients with Liposarcoma

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Monday, November 14, 2022

SAN CARLOS, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Apexigen, Inc. (NASDAQ: APGN) a clinical-stage company focused on developing innovative antibody-based therapeutics for the treatment of cancer with a focus on immuno-oncology, today announced topline data from an ongoing Phase 2 investigator sponsored trial in collaboration with Columbia University, evaluating sotigalimab, Apexigen’s agonist antibody targeting CD40, in combination with standard of care doxorubicin (dox), in patients with advanced soft tissue sarcoma (STS). In the subgroup of patients with liposarcoma (LPS), the second most common STS, treatment with sotigalimab combined with dox resulted in a median progression-free survival (mPFS) of 12.45 months relative to the historically observed mPFS of less than 5 months in patients treated with dox monotherapy.

Key Points: 
  • In contrast, results from the ongoing Phase 2 trial showed the subgroup of patients with LPS treated with sotigalimab in combination with dox achieved a mPFS more than double than historically seen with dox alone.
  • This impressive increase in PFS is an improvement of clinical benefit that builds on the standard of care treatment of this disease.
  • Further, these results could inform a potential Phase 3 registration-enabling study for patients with LPS in the first-line setting.
  • Results support the initiation of an expansion cohort with an additional 10 patients to inform a potential phase 3 registration-enabling trial in first-line LPS patients.

EpiEndo commences Phase 2a trial for EP395 in COPD patients

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Monday, November 14, 2022

EpiEndo Pharmaceuticals (EpiEndo), the clinical-stage biopharmaceutical company developing therapeutics for chronic inflammatory diseases, has received regulatory approval to commence a Phase 2a clinical trial with lead molecule EP395 in COPD (Chronic Obstructive Pulmonary Disease) patients.

Key Points: 
  • EpiEndo Pharmaceuticals (EpiEndo), the clinical-stage biopharmaceutical company developing therapeutics for chronic inflammatory diseases, has received regulatory approval to commence a Phase 2a clinical trial with lead molecule EP395 in COPD (Chronic Obstructive Pulmonary Disease) patients.
  • EP395 is an orally available macrolide or Barriolide, with reduced antimicrobial resistance potential, which aims to address the unmet medical need for a treatment for COPD.
  • The study will assess the safety and tolerability of EP395 in COPD patients, as well as assessing the effect of EP395 on inflammatory and potential barrier enhancing biomarkers in the lung.
  • The results of the study are expected in H2 2023 and will provide key data on EP395 in a COPD population.

OncoResponse Announces Preclinical Data Highlighting OR2805 Discovery from Elite Responder Platform and OR502 anti-LILRB2 Antibody at SITC 2022

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Friday, November 11, 2022

SEATTLE, Nov. 11, 2022 /PRNewswire/ -- OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Responders, today announced preclinical data on immuno-oncology candidates OR2805 and OR502 presented at the Society for Immunotherapy of Cancer's (SITC) 37th Annual Meeting.

Key Points: 
  • OR2805 is a fully human monoclonal antibody identified from an Elite Responder using OncoResponse's proprietary B-cell discovery platform.
  • "Our data presented at SITC highlight the ability of OR2805 and OR502 to modulate inhibitory macrophages in the tumor microenvironment and induce anti-tumor immune activity.
  • The OncoResponse posters presented at SITC are accessible on the Publications & Presentations page of the OncoResponse website.
  • OR2805 is a fully human antibody discovered using B cells derived from an Elite Responder to checkpoint inhibitor (CPI) therapy.

Rain Therapeutics Reports Third Quarter 2022 Financial Results and Highlights Recent Progress

Retrieved on: 
Thursday, November 10, 2022

We plan to initiate the MANTRA-4 trial next quarter and remain very excited about this second tumor agnostic basket strategy.

Key Points: 
  • We plan to initiate the MANTRA-4 trial next quarter and remain very excited about this second tumor agnostic basket strategy.
  • As of September 30, 2022, Rain had $90.7 million in cash, cash equivalents and short-term investments as compared to $140.2 million at December 31, 2021.
  • As of September 30, 2022, Rain had approximately 26.6 million shares of common stock outstanding.
  • The management of Rain Therapeutics will host a conference call and webcast for the investment community today, November 10, 2022 at 2:00 pm PT (5:00 pm ET).

Cummins is Awarded Major Defense Contract for Power Generation Equipment

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Monday, November 7, 2022

LTPS is a modernization program managed by the Product Lead, Large Power Systems (LPS), that will provide more mobile, reliable, and logistically supportable tactical electric power sources for the DoD's 21st century digitized forces.

Key Points: 
  • LTPS is a modernization program managed by the Product Lead, Large Power Systems (LPS), that will provide more mobile, reliable, and logistically supportable tactical electric power sources for the DoD's 21st century digitized forces.
  • It is in direct reflection of our teams persistence in innovation: to create the most reliable and logistically supportable power sources for the future of digitized forces, stated Doreen Swanson, Director of Government and Military Business for Cummins Power Generation.
  • To learn more about Cummins defense solutions in power generation, marine, or land support, please visit www.cummins.com .
  • Cummins Inc., a global power leader, is a corporation of complementary business units that design, manufacture, distribute and service a broad portfolio of power solutions.

Rain Therapeutics Provides Interim Analysis of Phase 2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors (MANTRA-2)

Retrieved on: 
Friday, November 4, 2022

NEWARK, Calif., Nov. 04, 2022 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead clinical candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, today announced preliminary data in the multicenter, single arm, open-label, Phase 2 basket trial evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor, for the treatment of MDM2-amplified advanced solid tumors.

Key Points: 
  • We are encouraged by the preliminary observations from the MANTRA-2 trial, said Avanish Vellanki, co-founder and chief executive officer of Rain.
  • In addition, anti-tumor activity was observed in patients with genetic co-alterations, and in tumors with MDM2 copy number above 8.
  • Hence, we plan to revise the protocol to include patients tested locally for MDM2 copy number of 8 and greater.
  • Rain has completed enrollment in a Phase 3 trial of milademetan (MANTRA) in patients with LPS, and is evaluating milademetan in a Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2).

Topcon Set to Feature Latest Technologies at Bauma in Munich

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Thursday, October 20, 2022

Topcon Positioning Systems will showcase the latest in technologies for the key areas of earthmoving, road building and paving, building construction and surveying at Bauma 2022 in Munich.

Key Points: 
  • Topcon Positioning Systems will showcase the latest in technologies for the key areas of earthmoving, road building and paving, building construction and surveying at Bauma 2022 in Munich.
  • The Topcon earthmoving portfolio includes solutions to help contractors plan, execute and profit through greater efficiency and productivity.
  • MC-Mobile allows contractors to seamlessly move from layout, to design, to the machine utilizing the same hardware and software solutions.
  • The latest Topcon technologies in construction surveying and geopositioning technologies will be available at the show.

EpiEndo commences LPS challenge trial for lead candidate EP395

Retrieved on: 
Wednesday, August 31, 2022

EpiEndo Pharmaceuticals (EpiEndo), the clinical-stage biopharmaceutical company developing disease-modifying therapeutics for chronic respiratory disorders, has received regulatory and ethics approval to commence a Lipopolysaccharide (LPS) challenge clinical trial with lead molecule EP395.

Key Points: 
  • EpiEndo Pharmaceuticals (EpiEndo), the clinical-stage biopharmaceutical company developing disease-modifying therapeutics for chronic respiratory disorders, has received regulatory and ethics approval to commence a Lipopolysaccharide (LPS) challenge clinical trial with lead molecule EP395.
  • The study will be conducted in up to 48 healthy adults at the Hannover Medical School in Germany.
  • This proof of pharmacology study is designed to assess the effect of repeat oral doses of EP395 on inflammation in the lung induced by inhaled LPS.
  • EpiEndos lead drug candidate, EP395, aims to be the first on-market oral macrolide which avoids bacterial resistance, is barrier strengthening and anti-inflammatory for the treatment of COPD.

Rain Therapeutics Reports Second Quarter 2022 Financial Results and Highlights Recent Progress

Retrieved on: 
Thursday, August 4, 2022

NEWARK, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) --  Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, today reported financial results for the second quarter and six months ended June 30, 2022, along with an update on the Company’s key developments, business operations and upcoming milestones.

Key Points: 
  • As of June 30, 2022, Rain had $105.7 million in cash, cash equivalents and short-term investments.
  • Rain anticipates that its quarter-end cash position will provide runway into mid-2024 and therefore believes the milademetan program is well-funded.
  • As of June 30, 2022, Rain had approximately 26.5 million shares of common stock outstanding.
  • The management of Rain Therapeutics will host a conference call and webcast for the investment community today, August 4, 2022 at 2:00 pm PT (5:00 pm ET).

Rain Therapeutics Announces Completion of Enrollment in Phase 3 MANTRA Trial for Milademetan in Liposarcoma

Retrieved on: 
Thursday, August 4, 2022

NEWARK, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics, today announced completion of enrollment in its Phase 3 MANTRA randomized, global, registrational trial of its lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53. The trial targeted an enrollment of 160 patients and completed enrollment five months ahead of schedule with 175 patients.

Key Points: 
  • The trial targeted an enrollment of 160 patients and completed enrollment five months ahead of schedule with 175 patients.
  • MANTRA is an event-driven trial with progression-free survival (PFS) as the primary endpoint, which will be analyzed upon reaching 105 events.
  • The MANTRA trial is powered to show a doubling of PFS versus the standard of care.
  • Milademetan is being evaluated in an ongoing Phase 3 clinical trial in patients with LPS (MANTRA), as well as a Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2).