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SELLAS Life Sciences Receives FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Provides Updated Data for Phase 2a Study of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia Patients

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화요일, 1월 9, 2024

Venetoclax, Patient, CRC, MRD, EFS, MD, OS, Acute myeloid leukemia, SLS, COVID, PD, Standard of care, Azacitidine, Food, COVID 19, Disease, Safety, Doctor of Science, Sepsis, Fast Track, FDA, AML, Treatment, CDK9, Pharmaceutical industry

NEW YORK, Jan. 09, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009 (formerly GFH009), its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.

Key Points:

The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.
Importantly, as of the last follow-up, eight of the nine patients enrolled in the 45 mg cohort were alive.
The first patient enrolled in the study achieved a complete response (CR) and continues on study in the seventh month with full peripheral blood recovery.
Eight patients (89%) remain alive (one patient succumbed to sepsis having previously contracted COVID 19) and six continue treatment.

Razer Pioneers the Future of Gaming at CES 2024 With Multiple Product Announcements and Razer Blade 14 Pre-order Now Live

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화요일, 1월 9, 2024

(CES 2024) – Razer™, the leading global lifestyle brand for gamers, once again redefines the future of gaming with its latest showcase at CES 2024.

Key Points:

(CES 2024) – Razer™, the leading global lifestyle brand for gamers, once again redefines the future of gaming with its latest showcase at CES 2024.
Razer Sensa blurs the lines between physical reality and the virtual world via the Project Esther concept display at CES 2024.
The new Blade 14, Blade 16, and Blade 18 deliver unparalleled performance and innovative display technology.
At 0.71” thin and 4.05 light, the Razer Blade 14 melds power and portability for gamers on the go.

Affimed Provides Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer

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월요일, 1월 8, 2024

PRS, Cancer, CMO, Patient, NSCLC

Initial data as presented on December 11, 2023, showed 1 confirmed PR as well as 1 unconfirmed CR, and 2 unconfirmed PRs.

Key Points:

Initial data as presented on December 11, 2023, showed 1 confirmed PR as well as 1 unconfirmed CR, and 2 unconfirmed PRs.
Based on the promising response data from the EGFRwt NSCLC cohort, Affimed will expand enrollment to 40 patients.
Additionally, the Company reported that enrollment of the EGFRmut NSCLC cohort is ongoing.
“There is a significant unmet need for these patients who have exhausted all previous lines of therapy and did not respond to any therapies, including PD-1/PD-L1 treatment.

Syros Highlights Anticipated 2024 Milestones to Deliver on the Value of Tamibarotene

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월요일, 1월 8, 2024

Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, RARA, Aplastic anemia, Bone marrow, New Drug Application, Syros, Azacitidine, Venetoclax, Patient, Acute myeloid leukemia, AML, Pharmaceutical industry

Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today highlighted anticipated 2024 milestones to deliver on the value of tamibarotene.

Key Points:

Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today highlighted anticipated 2024 milestones to deliver on the value of tamibarotene.
In addition, we closed an approximately $45.0 million equity financing, providing us additional capital to advance the development of tamibarotene.
By the middle of the fourth quarter of 2024, we expect to report pivotal data from the SELECT-MDS-1 Phase 3 clinical trial.
Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed unfit AML patients with RARA overexpression.

Jasper Therapeutics Highlights Recent Accomplishments and Key Upcoming Milestones

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금요일, 1월 5, 2024

REDWOOD CITY, Calif., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), as well as lower to intermediate risk myelodysplastic syndromes (LR-MDS) and novel stem cell transplant conditioning regimens, today announced its recent accomplishments, including the authorization by the European Medicines Agency (EMA) of the Company’s Clinical Trial Applications (CTA) for its Phase 1b/2a trials of briquilimab in CIndU and CSU, and outlined its corporate priorities and anticipated milestones for 2024. Called SPOTLIGHT – “Study (Phase 1b/2a) Of subcuTaneous brIquilimab in patients diaGnosed with cHronic inducible urTicaria” – the CIndU study will evaluate single doses of subcutaneous briquilimab in adult patients with cold urticaria or symptomatic dermographism.

Key Points:

“2023 was a strategically important year for Jasper,” said Ronald Martell, President and Chief Executive Officer of Jasper.
“We secured IND clearance and CTA authorization for the Phase 1b/2a BEACON study of briquilimab in CSU and successfully dosed the first patient.
Our achievements in 2023 set the stage for a transformational year ahead with multiple key clinical milestones on the horizon across multiple indications.
Strengthened the organization with key leadership appointments including Thomas Wiggans as Chairperson of the Board of Directors, Scott Brun, M.D.

Compass Therapeutics Provides Corporate Update

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금요일, 1월 5, 2024

As previously disclosed, effective January 9, 2024, Vered Bisker-Leib, PhD, Compass President and COO, will lead Compass as Compass Chief Executive Officer and join the Compass board of directors.

Key Points:

As previously disclosed, effective January 9, 2024, Vered Bisker-Leib, PhD, Compass President and COO, will lead Compass as Compass Chief Executive Officer and join the Compass board of directors.
Effective January 9, 2024, Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and Chief Executive Officer will transition to President of Research and Development and be appointed Vice Chair of the Compass board of directors.
BOSTON, Jan. 05, 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 a business update.
Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and current Chief Executive Officer will transition to President of Research and Development and assume the role of Vice Chair of the Compass board of directors.

Crane Company Announces Acquisition of Vian Enterprises, Inc.

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수요일, 1월 3, 2024

Chemicals, Plastics, Other Energy, Technology, Aerospace, Manufacturing, Other Technology, Energy, CFO, Acquisition, Crane Holdings, Growth

Crane Company (“Crane,” NYSE: CR) today announced that it has acquired Vian Enterprises, Inc. (“Vian”) for approximately $103 million on a cash free and debt free basis.

Key Points:

Crane Company (“Crane,” NYSE: CR) today announced that it has acquired Vian Enterprises, Inc. (“Vian”) for approximately $103 million on a cash free and debt free basis.
Through August 2023, we estimate that Vian had trailing 12-month sales of approximately $33 million and adjusted EBITDA of approximately $8 million, with an order backlog exceeding $100 million.
Crane financed the acquisition primarily with proceeds from its revolving credit facility.
Vian, along with the other acquisitions that we continue to pursue, meets our clearly defined strict financial and strategic acquisition criteria.”
Mr. Mitchell concluded: “I would like to personally thank Chris and Elizabeth Vian and the Vian family for entrusting Crane as the stewards of this great business moving forward.

OPENLANE Launches Visual Boost AI™ to Pinpoint Vehicle Damage

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수요일, 1월 3, 2024

Partnership, KAR, AI, Artificial intelligence, EVP, Inspection

CARMEL, Ind., Jan. 3, 2024 /PRNewswire/ -- OPENLANE, Inc. (NYSE: KAR), a leading operator of digital marketplaces for wholesale used vehicles, announces the launch of Visual Boost AI™, new damage detection overlays for every dealer-consigned vehicle in OPENLANE's US marketplace. The AI-powered technology supplements vehicle inspection data by prominently highlighting detected exterior damage directly on photos within the condition report (CR), making it faster and easier for interested buyers to accurately locate and assess potential defects before making a purchase decision.

Key Points:

Now available on all dealer-consigned vehicles in OPENLANE's US marketplace, Visual Boost AI leverages artificial intelligence and computer vision technology to provide a virtual overlay of any exterior damage detected.
"OPENLANE's Visual Boost AI really improves the quality of the inspections, giving me 60%-70% extra confidence about the major damage on the vehicle," said Rami Mourtaja, general manager of R B Morgan Co in Houston, Texas.
Innovated in partnership with Click-Ins Visual Intelligence platform for vehicle inspections, Visual Boost AI expands the company's portfolio of mobile-based artificial intelligence capabilities for damage detection and vehicle inspections.
OPENLANE's network of independent vehicle inspectors scan the vehicle using their smartphone camera as part of their regular inspection process.

SELLAS Provides Corporate Updates and Highlights Key Upcoming Milestones

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수요일, 1월 3, 2024

NEW YORK, Jan. 03, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today provided a business update and will host a corporate webinar at 8:30 am ET.

Key Points:

“2023 was a very productive year for SELLAS,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
Dr. Stergiou continued: “We hope to build on this excellent progress and look forward to multiple clinical milestones that have the potential to create significant value for our shareholders.
Meaningful cell killing activity, defined as ≥50% reduction in blasts in the bone marrow, was observed at several dose levels.
This study is fully funded by the Company’s partner for SLS009, GenFleet Therapeutics (Shanghai), Inc. and is being conducted in China.

Kronos Bio Announces Pipeline Update and p300 KAT Inhibitor Development Candidate

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월요일, 12월 18, 2023

SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced an update on its pipeline. After a review of data from the phase 1b portion of its phase 1b/2 trial of lanraplenib in combination with gilteritinib in FLT3-mutated relapsed/refractory acute myeloid leukemia (AML), the Company has decided not to proceed to phase 2. The Company is open to further development of lanraplenib, a SYK inhibitor, with a partner.

Key Points:

The Company is open to further development of lanraplenib, a SYK inhibitor, with a partner.
Kronos Bio also announced the designation of a new development candidate, KB-9558, which targets the lysine acetyltransferase (KAT) domain of p300, a critical node of the IRF4 transcription regulatory network (TRN).
“Kronos Bio was founded with a clear vision: to tackle the challenge of deregulated transcription, a hallmark of cancer,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio.
We look forward to continuing to work with the Kronos Bio team to bring KB-9558 to patients.”
“We believe that KB-9558 is positively differentiated from compounds targeting other p300 domains,” said Christopher Dinsmore, Ph.D., chief scientific officer of Kronos Bio.