Search Results for “ breast cancer” – Page 22 – media

Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
- Source: drugdu
- 150
- March 5, 2024
AstraZeneca’s “CD19/CD3 dual antibody” receives clinical approval in China

According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia. AZD0486 (TNB-486) is a new, fully human CD19xCD3 IgG4 bispecific antibody, originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for US$1.265 billion and also obtained its clinical-stage drug TNB-486. According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal “OncLive” in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs. Currently, AZD0486 has entered the Phase ...
- Source: drugdu
- 98
- March 2, 2024
Gilead signs antibody deal with Biocytogen amid ADC buzz

Biocytogen Pharmaceuticals shared plans for its new antibody evaluation and option agreement with Gilead Sciences. In the deal, Gilead will gain access to Biocytogen’s fully human antibody library. The agreement gives Gilead a three-year nomination period to choose its targets of interest and assess the selected antibodies, with the option of acquiring selected antibodies for worldwide therapeutic development. Biocytogen owns four genetically engineered RenMice platforms for the discovery of multiple antibody types. This includes bispecific antibody-drug conjugates (ADC), TCR-mimic antibodies and more. As of June 2023, the China-based company was part of 50 therapeutic antibody and multiple clinical asset co-development, out-licensing and transfer agreements. Earlier this year, Biocytogen partnered with Radiance Biopharma to share its bispecific ADC expertise. The company also signed deals with Ona Therapeutics in December 2023 and Myricx Bio in September 2023 to develop ADCs. This correlates with an uptick in high-value deals recently seen in the ...
- Source: drugdu
- 86
- February 21, 2024
Yet another clinical hold for Gilead’s magrolimab trials

Gilead Sciences had paused enrolment in the magrolimab solid tumour trials, with the FDA requesting a partial clinical hold on these studies. Earlier this month, the US regulatory agency placed a full clinical hold on all the clinical trials of magrolimab for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). “Gilead will likely decide to deprioritise the magrolimab programme entirely,” said Sakis Paliouras, associate director for oncology research and analysis at GlobalData. Adding: “it is less likely, but still possible, that the company will come back from the clinical hold and continue the programme.” The latest partial clinical hold affects the Phase II trials of magrolimabin multiple solid tumour conditions such as head and neck squamous cell carcinoma (NCT04854499), triple-negative breast cancer (NCT04958785), and colorectal cancer (NCT05330429). In addition to Gilead-sponsored trials, the partial clinical also applies to Investigator Sponsored Studies with magrolimab in solid tumours. Paliouras said the blood ...
- Source: drugdu
- 155
- February 21, 2024
Telix to acquire QSAM Biosciences for $123.1m

Australia-based global biopharmaceutical company Telix Pharmaceuticals has agreed to acquire US-based QSAM Biosciences for $123.1m.The deal comes after the companies signed a conditional non-binding term sheet for the prospective acquisition.Telix will also acquire QSAM’s lead investigational drug, Samarium-153-DOTMP (153Sm-DOTMP), a new kit-based bone-seeking targeted radiopharmaceutical candidate. The acquisition terms include an upfront payment of $33.1m (A$50.8m), payable as 4,369,914 ordinary shares of Telix.The deal also comprises contingent value rights that could see additional payments of $90m on meeting clinical and commercial milestones. These payments may be made in cash and/or shares.QSAM focuses on the development of therapeutic radiopharmaceuticals for primary and metastatic bone cancer. Its 153Sm-DOTMP for bone cancer has applications in pain management and therapy for bone metastases and osteosarcoma, including for paediatric patients.It complements Telix’s focus on oncology therapies and has shown promising safety, efficacy and commercial potential in early trials. The drug also has an improved safety ...
- Source: drugdu
- 99
- February 8, 2024
CSPC Pharmaceutical Group’s SYS6002’s first human study unveiled at ASCO-GU

From January 25th to 27th local time, the 2024 American Society of Clinical Oncology Urogenital Oncology Branch (ASCO-GU) annual meeting was grandly held in San Francisco. ASCO GU is an academic event in the field of urogenital tumors. The conference will showcase the most innovative scientific progress in this field and discuss the future treatment directions of urogenital tumors. The first human study of SYS6002, a collaboration between CSPC and Fudan University Cancer Hospital’s Professor Ye Dingwei’s team and Professor Zhang Jian’s team – “Evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6002 in patients with advanced solid tumors “An open, single-arm, multi-center phase I clinical trial” – phased research results were presented at the conference in the form of a poster (number B622). Research methods This study is a single-arm, open, multi-center phase I study. Aims to evaluate the safety, tolerability and PK characteristics of SYS6002 in ...
- Source: drugdu
- 135
- February 5, 2024
Daiichi Sankyo again dials up Enhertu sales forecast, advances 2nd AstraZeneca-partnered ADC

AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma has again increased its sales projection for the HER2-directed antibody-drug conjugate. But this time, the rosier outlook reflects developments outside the U.S. Daiichi now expects Enhertu sales to come in at 383.9 billion Japanese yen (about $2.6 billion) for the 12 months ending March 31. The number includes profits from regions where AstraZeneca books Enhertu sales. Daiichi had already once dialed up its Enhertu forecast for its current fiscal year. The drugmaker’s projection was originally 320 billion yen back in April 2023, then Daiichi raised it to 381.7 billion yen in October. Despite rolling out the higher global forecast, Daichii actually reduced Enhertu’s 12-month sales estimate in the U.S. by $30 million to $1.58 billion. For the first nine months of the company’s fiscal year, Enhertu generated $1.14 billion in the U.S., an increase of ...
- Source: drugdu
- 131
- February 2, 2024
FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo’s Enhertu for HER2+ Solid Tumors

Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 Enhertu is a HER2-directed antibody-drug conjugate (ADC) with approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction (GEJ) adenocarcinoma. “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. ...
- Source: https://www.pharmexec.com/authors/pharmaceutical-executive-editorial-staff
- 139
- January 31, 2024
Gilead’s Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC

January 23, 2024 Pharmaceutical Executive Editorial Staff The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.Image credit: Dr_Microbe | stock.adobe.com Data from the Phase III EVOKE-01 trial (NCT05089734) show that Gilead Sciences, Inc’s Trodelvy (sacituzumab govitecan-hziy) did not achieve the primary endpoint of overall survival (OS) in patients with previously treated, metastatic non-small cell lung cancer (NSCLC).EVOKE-01 was comparing Trodelvy with docetaxel for the treatment of patients with metastatic or advanced NSCLC who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Gilead Sciences Chief Medical Officer Merdad Parsey, MD, PhD, in a press release. “Treating metastatic NSCLC that has progressed on or ...
- Source: drugdu
- 90
- January 25, 2024
RecA protein skips “unwinding” step in DNA repair

Researchers from Tokyo Metropolitan University have been studying DNA repair by homologous recombination, where the RecA protein repairs breaks in double-stranded DNA by incorporating a dangling single-strand end into intact double strands, and repairing the break based on the undamaged sequence. They discovered that RecA finds where to put the single strand into the double helix without unwinding it by even a single turn. Their findings promise new directions in cancer research. Homologous recombination (HR) is a ubiquitous biochemical process shared across all living things, including animals, plants, fungi, and bacteria. As we go about our daily lives, our DNA is subjected to all kinds of environmental and internal stress, some of which can lead to breakage of both strands in the double helix. This can be disastrous, and lead to imminent cell death. Luckily, processes like HR are continuously repairing this damage. During HR, one of the two exposed ...
- Source: drugdu
- 183
- January 23, 2024

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