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2022ASH Express; Kangfeng Biologics products were recognized as breakthrough devices by the FDA; Henlius is licensed by Yilian Biologics ADC platform

 Last Update: 2022-12-30
 Source: Internet
 Author: User

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Pharmacis Selection

ASH 2022: Ascentage Pharma announces latest data on APG-2575 for the treatment of CLL/SLL patients

Ascentage Pharma Group announced that APG-2575 alone or in combination with CALQUENCE (acalabrutinib) and rituximab in the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is initially available
.
As of December 5, 2022, a total of 164 patients
were enrolled in the study.
A total of 46 patients were enrolled in the APG-2575 monotherapy group, with a median age of 60.
5 years (41-80).

The rituximab combination group enrolled a total of 39 patients, with a median age of 64 years (34 to 75).

A total of 79 patients were enrolled in the acalabrutinib group, with a median age of 64 years (18-80).

Among the total population, 16 (9.
8%) were treatment-naïve patients, and a total of 19 (11.
6%) patients had been treated
with BTKi beforehand.
In the combined group (n=118), there were 25 cases with TP53 mutation and/or associated del (17p), and 34 cases with no mutation in IGHV
.
Median duration of treatment: 16.
5 (1-36) cycles of APG-2575 in the single-agent group, 11 (0-21) cycles in the rituximab combination group, and 11 (1-24) cycles
in the acalabrutinib combination group 。 In the single-agent group, the ORR of patients reached 67% (29/43), of which 67% (4/6) of patients who were refractory or intolerant to BTKi before; In the acalabrutinib combination group, the ORR of patients reached 98.
6% (72/73), including 98% (56/57) in relapsed/refractory population, 100% (16/16) in treatment-naïve population, and 88% (7/8) in patients refractory or intolerant to previous BTKi.
In the rituximab combination group, the ORR of patients reached 79% (27/34).

Common adverse events (AEs) of any grade include granulocytopenia, diarrhoea, and infection
.
Dose-limiting toxicity (DLT)
was not observed.
No drug interactions
were found in the combination therapy group.

ASH 2022: TD Biologics announces preliminary results from a first-of-its-kind PLK4 inhibitor for leukemia

TD Biologics presented preliminary results
from its first-of-its-kind monotherapy dose optimization study at the 64th American Society of Hematology (ASH) Annual Meeting in the first of its kind, the Polo-like kinase 4 (PLK4) inhibitor CFI-400945, in patients with advanced leukemia.
CFI-400945 is a first-of-its-kind oral PLK4 inhibitor, and preliminary data suggest that CFI-400945 has shown a tolerable safety profile and almost dose-linearly correlation of drug exposure
in cohorts of 32, 48, and 64 mg (N=12).
To date, no dose-limiting toxicity has been observed, indicating the need for further dose
optimization.
The adverse events (AEs) of CFI-400945 in this study were consistent
with those observed in previous studies in similar patient populations.
The main adverse events (of any grade) were haematologic, gastrointestinal, and metabolic/nutritional disturbances
.
The most obvious serious adverse event was febrile neutropenia
.
There were no treatment sudden adverse events that led to discontinuation
of the study drug.

Enterprise dynamics

Biosion and ImmunoGen have entered into a new anti-tumor ADC research collaboration

On December 14, Biosion announced a research collaboration with ImmunoGen to explore the development of
novel antibody-drug conjugates (ADCs) for the treatment of cancer.
In this joint study, Biosion will leverage its proprietary SynTracer high-throughput antibody endocytosis screening platform to discover hyperendocytic antibodies against mutually selected drug targets, and ImmunoGen will provide its proprietary "linker-toxin" technology to further build innovative ADC candidates
.
Founded in 2017, Biosion is committed to developing innovative therapies
using a proprietary antibody technology platform.
The company has an H³ (high-throughput, high-content, high-efficiency) antibody discovery platform, SynTracer high-throughput antibody endocytosis screening platform, and Flexibody bifunctional antibody technology platform, and has established a series of innovative drug
pipelines.

Shanghai Pharmaceutical and Hong Kong Science and Technology Parks (HKSTP) are launching a biomedical co-incubation programme

Shanghai Pharmaceutical, Shanghai Biomedical Frontier Industry Innovation Center and Hong Kong Science and Technology Parks Corporation announced that they will jointly launch a biomedical co-incubation programme in Hong Kong Science and Technology Park to accelerate the incubation of biomedical start-ups and the transformation
of innovative technologies.
It is learnt that the Co-Incubation Programme will attract the world's top biomedical start-ups to set up in Hong Kong, and assist them to enter the Guangdong-Hong Kong-Macao Greater Bay Area and even the Yangtze River Delta region led by Shanghai, strengthen the construction of scientific research and innovation platforms in the two places, and jointly promote the development of
biomedicine in China.
Under the scheme, HKSTP will set up 14,000 square feet of co-working space at the Hong Kong Science Park for participating start-ups, who will also have access to various resources and support services
under the Biomedical Technology Incubation Programme (Incu-Bio).
At the same time, the Shanghai Pharmaceutical and Frontier Innovation Center will also provide guidance and support services for these enterprises, including laboratory space and office facilities, professional technology platform and clinical R&D resources, commercialization services, marketing development, etc
.
The Shanghai Pharmaceutical and Frontier Industry Innovation Center also has the opportunity to further support the development of
enterprises through capital investment or cultivation of investment into equity.

Henlius has been licensed to the Yilian Biologics ADC platform to develop products for two specific targets

Henlius announces a strategic partnership with Suzhou Yilian Biopharmaceutical Co.
, Ltd.
to obtain exclusive licenses and sub-licensing rights
for the global development, production and commercialization of ADC products based on the Yilian Biologics antibody drug conjugate (ADC) technology platform for two designated targets 。 Focusing on the development of internationally competitive conjugate drugs, Elilink Biologics has developed the latest generation of Tumor with independent intellectual property rights Microenviroment Activable LINker (TMALIN) new ADC technology can expand the therapeutic window of ADC drugs and improve the therapeutic effect of ADC drugs in solid tumors, in order to bring better treatment options
to cancer patients around the world.
The YL201 and YL202 projects in the Yilian Biologics pipeline have obtained implied approval for clinical trials in China and the United States and entered the clinical phase I research stage
.
Henlius is committed to providing affordable high-quality biological drugs to patients around the world, covering oncology, autoimmune diseases, ophthalmic diseases and other fields, and has launched 5 products in China, 1 product in the international market, 15 indications approved, and 4 marketing registration applications accepted by the China Food and Drug Administration
.

Instrument news

The Cryofocus RDN System was recognized as a breakthrough device by the FDA

Kangfeng Biotechnology (Shanghai) Co.
, Ltd.
announced that it has independently developed its self-developed cryoablation to remove the renal artery sympathetic nervous system (Cryofocus RDN).
System) has received breakthrough device designation from the US FDA, and the system is mainly suitable for patients
with refractory hypertension.
As the world's first cryoablation to remove the sympathetic nervous system of the renal artery, Kangfeng Biotech Cryofocus RDN The system has previously passed the review of China's NMPA special examination procedure for innovative medical devices, and has independent intellectual property rights
in the world.
As early as 2015, Professor Ge Junbo, academician of the Chinese Academy of Sciences and Zhongshan Hospital affiliated to Fudan University, led a team to complete the world's first deep and low temperature Cryofocus RDN Systematic in vivo surgery marks another major progress
in the original of domestic cardiovascular devices.
The product can cover the effective ablation depth, and has the advantages of 360° circular ablation, complete nerve damage, precise ablation position, and small endothelial damage, bringing new hope
to hypertensive patients.

Lifetech IBS Absorbable Coronary Stent Phase II clinical trial in China completed enrollment

Yuanxin Technology (Shenzhen) Co.
, Ltd.
, a subsidiary of Lifetech Holdings, announced that its self-developed innovative product IBS Absorbable Drug-Eluting Coronary Stent System (hereinafter referred to as "IBS Coronary Stent") has successfully completed the enrollment of all subjects in a prospective, multicenter, randomized controlled phase II clinical trial in China
.
Independently developed by Lifetech Technology, IBS coronary stent is the world's first fully degradable iron-based absorbable coronary stent
.
Its matrix is processed from high-purity nitriding iron pipe with high strength and plasticity, and the total wall thickness of the bracket rod is only 70μm, and the support force is strong
.
IBS coronary stent begins to degrade 3-6 months after implantation, enters the end of degradation in about 2 years, and is finally absorbed by human tissue, thereby effectively avoiding a series of long-term prognostic problems
that may be caused by the implantation of permanent metal stents.

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