Optimus

Immutep Announces Completion of the Safety Lead-In and Opening of the Randomized Phase II of the AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer

Retrieved on: 
Monday, November 6, 2023
ASX, MHC, IDMC, Data monitoring committee, Optimus, Paclitaxel, Autoimmune disease, Safety, IMM, Cancer, Patient, Toxicity, Pharmaceutical industry

SYDNEY, AUSTRALIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the open-label safety lead-in of its integrated AIPAC-003 Phase II/III trial evaluating for the very first time 90mg of eftilagimod alpha (efti) in combination with paclitaxel has been completed with no safety or tolerability issues.

Key Points: 
  • The IDMC recommended proceeding to the randomised Phase II portion of the trial.
  • The randomised (1:1) Phase II portion of the study will now open to include up to 58 evaluable patients with metastatic breast cancer receiving either 30mg efti or 90mg efti to determine the optimal biological dose.
  • Importantly the determination of the optimal biological dose is relevant for the whole efti program across all disease indications.
  • The integrated Phase II/III AIPAC-003 trial is evaluating efti, Immutep’s soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with standard-of-care paclitaxel for the treatment of metastatic hormone receptor positive (HR+), HER2-negative or HER2-low breast cancer and triple-negative breast cancer.

Insider information: Faron Initiates Phase 2 Part of BEXMAB Study of Bexmarilimab in HMA-failed MDS

Retrieved on: 
Monday, November 6, 2023
Principal, Patient, FDA, Helsinki University Central Hospital, Standard of care, AIM, Food, Trial of the century, MDS, Nasdaq First North, Associate professor, Bone marrow, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Syndrome, HMA, Quality of life, Optimus, Majesty of the Seas, RDE, Faron Pharmaceuticals, Immunotherapy, ORR, SOC, Safety, Pharmaceutical industry, Vaccine, Dietary supplement, Fårö

TURKU, Finland and BOSTON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces that based on guidance from the U.S. Food and Drug Administration (FDA), hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndromes (MDS) has been selected as the initial indication to advance to Phase 2 in the BEXMAB study investigating bexmarilimab in combination with standard of care (SoC).

Key Points: 
  • The BEXMAB study is a multicenter study, taking place in Finland and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with SoC in patients with aggressive myeloid leukemias.
  • The Phase 2 part of the BEXMAB trial will enroll a total of 32 patients with HMA-failed MDS.
  • Patients will be randomized 1:1 between the selected recommended doses for expansion (RDE) of 3 mg/kg or 6 mg/kg bexmarilimab before moving into a Phase 2/3 extension of the study.
  • Post selection of final dosing Faron intends to discuss a potential registrational study plan with the FDA.

Electrify Expo Takes Over Famed F1 Track at Circuit of the Americas for a Weekend Full of Electric Fun Including Tesla, BMW, Ford and 100+ Leading Electric Brands

Retrieved on: 
Wednesday, November 1, 2023
EV, Ford, SUV, Food, Electrification, Circuit of the Americas, GT, Tesla, X & Y, Austin Energy, Optimus, RTR, Growth, Plug, Mustang, BMW, Super73, Volvo, Music, Model, Optimus (robot), Tesla Model 3, Volkswagen, Circuit, Amusement park, Rail transport, Porsche, Polestar, Axios

Attendees will ride, drive and demo the world's leading electric cars and trucks alongside electric motorcycles, e-bikes, e-scooters, e-skateboards and more.

Key Points: 
  • Attendees will ride, drive and demo the world's leading electric cars and trucks alongside electric motorcycles, e-bikes, e-scooters, e-skateboards and more.
  • According to Axios , electric vehicles accounted for 9.3% of monthly new vehicle registrations in the Austin area in January 2023 - up 7% from the previous year.
  • The weekend will feature entertainment, including all types of thrilling demo courses, huge kids zones, music, displays and food.
  • Volkswagen makes its Electrify Expo return with the highly-anticipated ID.Buzz and ID.4 along with other automakers like BMW, Polestar, Porsche and many more.

Inside information: Faron Announces Positive BEXMAB Study Update in Relapsed/Refractory AML and HMA-Refractory MDS Patients

Retrieved on: 
Wednesday, October 11, 2023
Majesty of the Seas, Nasdaq First North, Faron Pharmaceuticals, Quality of life, Optimus, Capillary leak syndrome, Standard of care, ORR, AML, EST, Webcast, Acute myeloid leukemia, IR, Bone marrow, Hemophagocytic lymphohistiocytosis, AIM, HMA, Syndrome, Cryptogenic organizing pneumonia, SOC, MDS, Prognosis, Patient, Phase II, Pharmaceutical industry, Online shopping, Fårö

TURKU, Finland and BOSTON, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces updated data from the Phase 1/2 BEXMAB study investigating bexmarilimab in combination with standard of care (SoC) in relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients having failed hypomethylating agents (HMAs).

Key Points: 
  • The most recent data includes read outs from a total of 22 patients (r/r AML with 12 patients, MDS frontline and MDS HMA-failed patients with five patients each) who have completed at least two or more treatment cycles.
  • Eight of 11 patients achieved complete remission in the bone marrow with or without blood count recovery.
  • The highest single indication-specific ORR was observed among HMA-failed MDS patients (4 out of 5 patients; 80%).
  • Faron plans to increase the number of US clinical sites from two to five sites to accelerate study recruitment.

Electrify Expo Prepares For A Massive Festival In Miami As Exhibitor Participation Spikes

Retrieved on: 
Tuesday, October 10, 2023
Mustang, Ford, X & Y, Volkswagen, Optimus, Mitsubishi Group, Optimus (robot), RTR, Tesla, Music, EVS, EV, Sunshine State, Plug, Model, Volvo, Tesla Model 3, GT, SUV, Action Pack (TV programming block), Amusement park, Nightclub, Rail transport, Porsche

Attendees at Electrify Expo will ride, drive and demo the world's leading electric cars and trucks alongside electric motorcycles, e-bikes, e-scooters, e-skateboards and more.

Key Points: 
  • Attendees at Electrify Expo will ride, drive and demo the world's leading electric cars and trucks alongside electric motorcycles, e-bikes, e-scooters, e-skateboards and more.
  • “We’re headed back to Miami for our third year but this will be our biggest festival yet in the Sunshine State,” said BJ Birtwell, CEO and founder of Electrify Expo.
  • “Miami is one of the top regions in the country for EV adoption so our festival fits right in with their desire to go electric.
  • Electrify Expo is driving directly to the southern EV hub for consumers to experience the exhilarating feeling of going electric.

Airobotics Optimus 1-EX Drone Receives Historic U.S. FAA Type Certification; Using ParaZero SafeAir Safety System

Retrieved on: 
Friday, September 8, 2023
ASTM, NAS, OOP, Aircraft, Public key certificate, National Airspace System, Certification, FAA, Organization, Optimus, Growth, Environment, 3D printing

Tel Aviv, Israel, Sept. 08, 2023 (GLOBE NEWSWIRE) --  ParaZero Technologies Ltd. (Nasdaq: PRZO) (“ParaZero”), an aerospace company focused on drone safety systems for commercial drones and urban air mobility aircraft, announced today that the U.S. Federal Aviation Administration (FAA) has granted the Airobotics Optimus-1EX system an airworthiness Type Certification, a historic milestone that will streamline continuous operational approvals for broad flight operations, including fully autonomous missions, operations over people, and beyond visual line of sight operations.  Airobotics is a subsidiary of Ondas Holdings Inc. (Nasdaq: ONDS), a leading provider of private industrial wireless networks, commercial drones and automated data solutions. The certification verifies the compliance of the aircraft's design with the required FAA airworthiness standards, ensuring safe operations within the National Airspace System (NAS).

Key Points: 
  • The certification verifies the compliance of the aircraft's design with the required FAA airworthiness standards, ensuring safe operations within the National Airspace System (NAS).
  • The Airobotics Optimus-1EX system is equipped with a customized safety system from ParaZero, which was developed in collaboration with Airobotics.
  • ParaZero's ASTM F3322-18 compliant parachute-based smart parachute system facilitated the expedition of certain regulatory processes, including FAA operational flight waivers and streamlined demonstrated flight hours throughout the Type Certification process.
  • Drone flights can be tasked to carry specific sensors, enabling each drone within the fleet to execute diverse tasks.

Sungage Financial Is Now Available on the Enerflo Solar Platform

Retrieved on: 
Tuesday, August 15, 2023
Learning, Partnership, Optimus, Love, Automation, Renewable energy

BOSTON, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Enerflo and Sungage Financial have partnered to provide solar installers access to Sungage financing within Lendflo, Enerflo’s integrated financing suite, giving homeowners an easier, faster way to switch to solar.

Key Points: 
  • BOSTON, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Enerflo and Sungage Financial have partnered to provide solar installers access to Sungage financing within Lendflo, Enerflo’s integrated financing suite, giving homeowners an easier, faster way to switch to solar.
  • "We’re pleased to partner with Sungage Financial and offer their competitive financing options to our solar installer customers,” said Enerflo Co-Founder Pat Bennett.
  • Our mission is to help solar installers deploy more solar, and, by integrating with Sungage, they can achieve just that.” Sungage Financial is just as excited about the partnership as Enerflo.
  • "We’re thrilled that the Sungage integration with Enerflo is now live,” said Sungage Financial CEO Michael Gilroy.

SEC Charges Twice-Convicted Fraudster Eliyahu Weinstein and Five Others with $38 Million Ponzi-Like Scheme to Defraud Investors

Retrieved on: 
Wednesday, July 19, 2023
Charles Ponzi, Sale, Complaint, District court, Optimus, Investment, Anderson, Hattab, FBI, Security (finance), Fraud, Cryptocurrency

The SEC alleges that, beginning in or around November 2021, Weinstein, Bromberg, and Wittels raised money from investors for purported deals through Optimus Investments Inc. while concealing Weinstein’s identity, criminal history, and involvement from investors.

Key Points: 
  • The SEC alleges that, beginning in or around November 2021, Weinstein, Bromberg, and Wittels raised money from investors for purported deals through Optimus Investments Inc. while concealing Weinstein’s identity, criminal history, and involvement from investors.
  • Hattab provided substantial assistance to the other defendants in carrying out the scheme.
  • The SEC alleges that, collectively, the defendants’ fraudulent scheme raised at least $38 million from at least 150 investors.
  • The SEC appreciates the assistance of the U.S. Attorney’s Office for the District of New Jersey and the FBI.

Genmab and AbbVie Announce Positive Topline Results from Phase 1/2 EPCORE™ NHL-1 Trial Evaluating Epcoritamab (DuoBody® CD3xCD20) in Patients with Relapsed/Refractory Follicular Lymphoma (FL)

Retrieved on: 
Tuesday, June 27, 2023
IRC, Follicular lymphoma, CRS, Lymphoid leukemia, DOR, ABBV, Lymphoma, NHL, Optimus, Cytokine release syndrome, Patient, AbbVie, Risk, FDA, NYSE, ORR, Food, Pharmaceutical industry, Genmab

The study cohort includes 128 adult patients with relapsed/refractory follicular lymphoma (FL) who received at least two prior lines of systemic therapy.

Key Points: 
  • The study cohort includes 128 adult patients with relapsed/refractory follicular lymphoma (FL) who received at least two prior lines of systemic therapy.
  • 70.3 percent of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent.
  • Based on the topline results, the companies will engage with global regulatory authorities to determine next steps.
  • Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

Genmab and AbbVie Announce Positive Topline Results from Phase 1/2 EPCORE™ NHL-1 Trial Evaluating Epcoritamab (DuoBody® CD3xCD20) in Patients with Relapsed/Refractory Follicular Lymphoma (FL)

Retrieved on: 
Tuesday, June 27, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, IRC, Follicular lymphoma, CRS, Lymphoid leukemia, DOR, ABBV, Optimus, Cytokine release syndrome, Patient, AbbVie, Risk, NYSE, ORR, Food, Pharmaceutical industry, Genmab

Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced topline results from the follicular lymphoma (FL) cohort of the phase 1/2 EPCORE™ NHL-1 clinical trial evaluating epcoritamab (DuoBody® CD3xCD20), an investigational T-cell engaging bispecific antibody administered subcutaneously.

Key Points: 
  • Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced topline results from the follicular lymphoma (FL) cohort of the phase 1/2 EPCORE™ NHL-1 clinical trial evaluating epcoritamab (DuoBody® CD3xCD20), an investigational T-cell engaging bispecific antibody administered subcutaneously.
  • The study cohort includes 128 adult patients with relapsed/refractory follicular lymphoma (FL) who received at least two prior lines of systemic therapy.
  • Based on the topline results, the companies will engage with global regulatory authorities to determine next steps.
  • Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.