Spacecraft

EQS-News: Heidelberg Pharma granted orphan drug designation by FDA for its proprietary ATAC candidate HDP-101

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Wednesday, April 10, 2024
ODD, Diagnosis, RRMM, BCMA, Patient, Multiple myeloma, Spacecraft, Amanitin, AACR, Antibody, Safety, HPHA, FDA, B-cell maturation antigen, ATAC, Food, Pharmaceutical industry

Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.

Key Points: 
  • Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.
  • Heidelberg Pharma is investigating the candidate in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted that our proprietary ATAC candidate HDP-101 has been granted Orphan Drug Designation by the FDA, providing further validation of its potential benefit as a therapeutic for patients with multiple myeloma.
  • The designation provides significant incentives to promote the development of the drug including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

EQS-News: ERFOLGE VON DEFENCE BEI SEINEM ACCUTOX®-ARM(TM)-VAKZIN ZUR KREBSBEKÄMPFUNG FÜHREN ZUR ENTWICKLUNG EINES WIRKUNGSVOLLEN ARM-002(TM)-KREBSIMPFSTOFFS DER ZWEITEN GENERATION

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Wednesday, April 10, 2024
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Bei Tests als therapeutisches Vakzin bei einem Melanom-Modell führte ARM-002TM in Kombination mit dem Immuncheckpoint-Inhibitor Anti-PD1 in 80 % der Fälle zu einer vollständigen Reaktion.

Key Points: 
  • Bei Tests als therapeutisches Vakzin bei einem Melanom-Modell führte ARM-002TM in Kombination mit dem Immuncheckpoint-Inhibitor Anti-PD1 in 80 % der Fälle zu einer vollständigen Reaktion.
  • Darüber hinaus können entwickelte Immunzellen zu einem lang anhaltenden immunologischen Gedächtnis führen, das Patienten vor späteren Krebsrückfällen schützen kann.
  • Defence hat sich dafür entschieden, seinen AccuTOX®-Leitkandidaten zu testen, um einen Krebsimpfstoff der zweiten Generation zu entwickeln, da dieser bei einer intratumoralen Verabreichung in geringeren Dosierungen nachweislich die Antigenpräsentation in Krebszellen verbessert.
  • Der Kern der Defence Therapeutics-Plattform besteht in der ACCUM®-Technologie, die einen präzisen Transport von Impfantigenen oder ADCs in intakter Form zu den Zielzellen ermöglicht.

EQS-News: Heidelberg Pharma to host R&D Webinar following novel data presented at AACR

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Wednesday, April 10, 2024
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Ladenburg, Germany, 5 April 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that it will be hosting an R&D Webinar on 23 April 2024 at 16.00 CEST/15.00 BST, for investors, analysts and media.

Key Points: 
  • Ladenburg, Germany, 5 April 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that it will be hosting an R&D Webinar on 23 April 2024 at 16.00 CEST/15.00 BST, for investors, analysts and media.
  • The event will provide information on Heidelberg Pharma’s lead clinical ATAC product candidate HDP-101 targeting relapsed and refractory multiple myeloma as well as its proprietary ADC toolbox and therapeutic product pipeline.
  • Attendees will have the opportunity to participate in a live Q&A session at the end of the presentation or submit questions in advance of the event.
  • For further information on the R&D webinar, or to register your interest, please contact Optimum Strategic Communications at [email protected] or register using the link below:

EQS-News: Heidelberg Pharma announces financial figures and reports on successful business performance in 2023

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Wednesday, April 10, 2024
Malignancy, Spanish mythology, State university system, Patient, Sale, Renal cell carcinoma, Clinical trial, Neoplasm, Therapy, Depreciation, HPHA, USD, Marketing, GLP, Health, Research, ATACS, EPO, Immune system, ADC, BLA, ATAC, Food, Biologics license application, Disease, Magenta, Multiple myeloma, AACR, GCC, Annual report, FDA, Diagnosis, EUR, Supervisory board, Accounting, PET, EDT, Spacecraft, Amanitin, European Patent Convention, Patent, Eli Lilly and Company, Binghamton University, Pharmaceutical industry

Minority interest in Emergence sold: In summer 2023, Heidelberg Pharma sold its minority interest in Emergence Therapeutics AG, Duisburg, Germany, (Emergence).

Key Points: 
  • Minority interest in Emergence sold: In summer 2023, Heidelberg Pharma sold its minority interest in Emergence Therapeutics AG, Duisburg, Germany, (Emergence).
  • As a result, Heidelberg Pharma lost sales revenue in the low single-digit millions for the 2023 financial year.
  • In April 2023, Heidelberg Pharma signed a termination agreement with Magenta under which all licensed ATAC rights and some Magenta patents were assumed by Heidelberg Pharma.
  • The Heidelberg Pharma Group includes two entities, Heidelberg Pharma AG and Heidelberg Pharma Research GmbH.

EQS-News: Heidelberg Pharma announces progress into Cohort 6 with its proprietary ATAC candidate HDP-101 in Phase I/IIa multiple myeloma study

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Wednesday, April 10, 2024
Multiple myeloma, Bone marrow, Cohort, Infection, Incidence, BCMA, Patient, Plasma cell, Mortality, B cell, Spacecraft, AACR, Annual report, Antibody, The Annual Report, Safety, Pharmacokinetics, HPHA, FDA, ATAC, Food, Pharmaceutical industry

Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body.

Key Points: 
  • Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body.
  • Plasma cells are a type of blood cell that makes antibodies to fight infection, created by bone marrow.
  • Heidelberg Pharma’s Phase I/IIa clinical study is an ongoing, non-randomised, open label study which is actively enrolling patients with relapsed or refractory multiple myeloma or other plasma cell disorders expressing BCMA.
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, said: “Our proprietary ATAC candidate HDP-101 is showing exciting potential for treating multiple myeloma.

EQS-News: Andera Partners’ portfolio company Tubulis closes upsized €128 Million Series B2 to accelerate the development of its ADC Pipeline

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Wednesday, April 10, 2024
Translocase, Partner, 5T4, Growth, Science, Patient, Doctor of Philosophy, Spacecraft, Andera-ye Olya, AACR, ADC, Annual general meeting, Fine chemical

Tubulis is developing a pipeline of uniquely matched antibody drug conjugates (ADCs) with an indication-tailored targeting molecule and payload combination to develop novel ADCs with superior properties.

Key Points: 
  • Tubulis is developing a pipeline of uniquely matched antibody drug conjugates (ADCs) with an indication-tailored targeting molecule and payload combination to develop novel ADCs with superior properties.
  • The proceeds of the Series B2 will primarily support progress in Tubulis’ pipeline of next-generation ADCs toward clinical evaluation and help achieve clinical proof-of-concept for lead candidates, TUB-040 and TUB-030.
  • The company expects to start its first Phase 1/2a clinical trial, including dose escalation and dose optimization cohorts in 2024.
  • “This substantial financing from a syndicate of global specialist biotech investors recognizes Tubulis’ unique position in the ADC space.

EQS-News: Heidelberg Pharma announces receipt of non-refundable upfront cash payment following the successful closing of its royalty purchase agreement with HealthCare Royalty

Retrieved on: 
Wednesday, April 10, 2024
Diagnosis, Telix, Biologics license application, PET, Research, Sale, Multiple myeloma, Spacecraft, HPHA, ADC, USD, Positron emission tomography, Pharmaceutical industry

Ladenburg, Germany, 19 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the formal closing of the royalty purchase agreement with HealthCare Royalty (HCRx) for Zircaix®, signed earlier this month.

Key Points: 
  • Ladenburg, Germany, 19 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the formal closing of the royalty purchase agreement with HealthCare Royalty (HCRx) for Zircaix®, signed earlier this month.
  • Dr. George Badescu, Chief Business Officer at Heidelberg Pharma, said: “The funding from the royalty purchase agreement with HealthCare Royalty is enabling us to further advance Heidelberg Pharma’s leading expertise in the field of ADC research and development.
  • The upfront payment strengthens the Company’s liquidity, and along with future anticipated payments, should extend our cash runway.
  • The funds will be used to advance the expansion of our ADC pipeline including our preclinical projects HDP-102, HDP-103 and HDP-201.”

Investing in the Electric Aircraft Revolution

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Wednesday, April 3, 2024
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According to research from MarketsandMarket s, the Electric Aircraft Market is set to achieve unprecedented growth, projecting a remarkable worth of $37.2 billion by 2030.

Key Points: 
  • According to research from MarketsandMarket s, the Electric Aircraft Market is set to achieve unprecedented growth, projecting a remarkable worth of $37.2 billion by 2030.
  • KULR Technology Group, Inc. (NYSE American: KULR), betting on the electrification of everything, will play a key role in the safety of the electric aircraft future.
  • From startups like Eviation with their Alice aircraft to major players like Airbus and their E-Fan X project, the race is on to develop viable electric planes.
  • Some smaller electric aircraft are already taking to the skies for test flights ."

BriaCell Showcases Data Demonstrating Unmatched Progression-Free Survival (PFS) and Clinical Efficacy in Antibody-Drug Conjugate (ADC) Resistant and Central Nervous System (CNS) Metastatic Breast Cancer at the 2024 AACR

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Tuesday, April 9, 2024
HER2, ILD, CPI, Survival, Progression-free survival, Central nervous system, Patient, CNS, History, Death, Eribulin, Spacecraft, MD, CBR, TPC, EMBRACE, Life, BCT, AACR, TSX, Therapy, Breast cancer, Safety, Poster, CMO, PFS, ADC, PD-1, Pharmaceutical industry

“ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.

Key Points: 
  • “ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.
  • To our knowledge, there are no effective treatment options in this patient population for whom the progression-free survival prognosis is only a few weeks.
  • BriaCell will be monitoring ADC resistant patients in its ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer.
  • Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study.

GigaDevice Launches GD32F5 Series Cortex®-M33 Core MCUs for High-Performance Applications

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Tuesday, April 9, 2024
ECC, GD32, GigaDevice, RWW, SRAM, DSP, OTA, SDRAM, IAR, IEC61508, Communication, SDIO, PLC, GUI, MCU, Software, Power management, OTG, Spacecraft, PWM, Update, Flash, Programmable logic controller, Sensor, Ecosystem, The, Automotive engineering, FMEDA, KEIL, Video game

The GD32F5 series high-performance MCUs offer significantly expanded storage space, excellent processing efficiency, and a wide array of interface options.

Key Points: 
  • The GD32F5 series high-performance MCUs offer significantly expanded storage space, excellent processing efficiency, and a wide array of interface options.
  • The GD32F5 series high-performance MCUs adopt the Arm® Cortex® -M33 core with a maximum operating frequency of 200MHz and a working performance of up to 3.31 CoreMark®/MHz.
  • The GD32F5 series high-performance MCUs are equipped with up to 7.5MB on-chip Flash and 1MB SRAM.
  • GigaDevice provides the new high-performance GD32F5 series MCU with free development environment GD32 IDE, debugging and download tool GD-LINK, and the programming tool GD32 All-In-One Programmer.