Recently, MBS314, an innovative tri-specific antibody product developed by Beijing Mabworks Biotech Company Limited (hereinafter referred to as “Mabworks”) in collaboration with Kangyuan Botron Biotechnology (Beijing) Limited, has obtained the Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration of the People’s Republic of China (SDA), which authorizes the conduct of Phase I/II clinical trial for the treatment of multiple myeloma. Myeloma. MBS314 is a new mechanism of tri-specific antibody targeting CD3/BCMA/GPRC5D for the treatment of multiple myeloma.MBS314 has a differentiated CD3 binding epitope, which is able to achieve low-affinity but long-lasting activation and killing effect with T-cells, with better safety; at the same time, it binds BCMA and GPRC5D with high affinity, which is able to overcome BCMA and GPRC5D tumor cell killing effect in the body of the patient. At the same time, the high affinity combination of BCMA and GPRC5D can overcome ...
Harbour BioMed’s Wholly-owned Subsidiary, Nona Biosciences, announced today that it has entered into an exclusive license agreement with Pfizer Inc. for the global clinical development and commercialization of Nona Biosciences’ MSLN-targeted antibody-drug conjugate (ADC), HBM9033. Under the terms of the agreement, Nona Biosciences will receive a total of up to $53 million in upfront and near-term payments, with the potential for additional payments of up to $1.05 billion upon achieving certain development and commercial milestones. Nona Biosciences is also eligible to receive tiered royalties on net sales ranging from high single digits to high teens. “We are delighted to collaborate with Pfizer, a company that is committed to developing high-impact medicines for people living with cancer,” said Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences. “This agreement represents a significant milestone in the advancement of our proprietary Harbour Mice® platform and the ADC ecosystem, affirming Nona’s robust capabilities and expertise ...
On December 15, 2023, BIO-THERA Bio-Pharmaceutical Co., Ltd. announced that it had received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, which approved the application for a Phase II/III clinical trial of the investigational drug BAT1308 injection in combination with platinum-containing chemotherapy for the first-line treatment of advanced or recurrent mismatch-modification-repaired protein-deficient (dMMR) endometrial cancer. BAT1308 is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA, which belongs to IgG4κ subtype and is expressed by Chinese hamster ovary cells.PD-1 is mainly expressed by activated T-lymphocytes, and is an inhibitory immune checkpoint.PD-L1 and PD-L2 are the two ligands of PD-1, and when PD-L1 or PD-L2 bind to PD-1, it can inhibit immune activation of T-cells through the downstream signaling pathway to inhibit immune activation of T cells. It has been found that a variety of tumor cells can express PD-L1 and PD-L2 and bind to PD-1 ...
Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
Boehringer Ingelheim and IBM have announced a partnership aimed at advancing generative artificial intelligence (AI) and foundation models for therapeutic antibody development. The collaboration agreement will see Boehringer use an IBM-developed, pre-trained AI model that will be “further fine-tuned” on the German drugmaker’s specific proprietary data to help accelerate the pace at which it can create new antibody therapeutics. The companies noted that, despite “major” technological advances, the discovery and development of therapeutic antibodies against diverse targets remains a “highly complex and time-consuming process”. IBM’s foundation model technologies, which have already shown success in generating biologics and small molecules with relevant target affinities, are used to design antibody candidates for specific disease targets. These are then screened with AI-enhanced simulation to select and refine the best binders for the target. Boehringer Ingelheim outlined that it will produce small quantities of the candidates that can be tested experimentally. Andrew Nixon, global ...
The shortage of Sanofi and AstraZeneca’s new respiratory syncytial virus (RSV) antibody Beyfortus continues to confound doctors and patients, with the Centers for Disease Control and Prevention (CDC) last week fast-tracking tens of thousands of extra doses into circulation to deal with a tough RSV season. Now, several Senate Democrats are pressing the drugmakers to get to the bottom of the issue. In a letter sent to the drugmakers Friday, Sen. Tammy Duckworth, D-Illinois, lamented that Sanofi and AZ “seem to have vastly underestimated” the amount of Beyfortus—also known nirsevimab—needed to protect young kids during this disease season. The partners’ immunization, approved back in July, has quickly run into supply problems, with the CDC last month issuing an advisory for doctors to prioritize available Beyfortus 100-mg doses for infants at the highest risk of severe RSV. At the time, Sanofi attributed the shortfall to “higher than anticipated demand,” which has ...
BioNTech has entered into an exclusive licensing and collaboration agreement with Biotheus to develop and commercialise its bispecific antibody candidate outside of China, with the deal potentially worth over $1bn. PM8002, which simultaneously targets PD-L1 and VEGF, is currently being evaluated in mid-stage studies in China as both a monotherapy and in combination with chemotherapy in patients with advanced solid tumours. The asset has already demonstrated a positive safety profile and encouraging anti-tumour activity “presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumour microenvironment,” the Chinese biotech said. Under the terms of the agreement, Biotheus will receive an upfront payment of $55m and will be eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1bn, as well as tiered royalties on potential future product sales. The transaction is expected to close in the fourth-quarter of this year subject to customary closing conditions. Xiaolin ...
Image Credit: Adobe Stock Images/huenstructurebio.com Daiichi Sankyo and Merck announced that they have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody-drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). Reportedly, the companies will jointly develop and potentially commercialize the candidates globally, except for Japan where Daiichi Sankyo will maintain exclusive rights. “The promising results from clinical trials of patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan continue to demonstrate the broad applicability of Daiichi Sankyo’s DXd ADC technology across multiple targets, with each of these medicines having the potential to change clinical practice as has been already seen with Enherti,” said Sunao Manabe, representative director, executive chairperson, CEO, Daiichi Sankyo Company, Limited. “As Daiichi Sankyo continues its transformation into a global oncology leader by increasingly building our infrastructure and talent, we recognize that a collaboration with Merck, a company ...
Almirall and EpimAb Biotherapeutics have announced a bispecific antibody partnership worth up to $210m. The agreement will give dermatology-focused Almirall a licence to utilise EpimAb’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to generate, develop and commercialise bispecific antibodies. Almirall will have exclusive global rights for any resulting products and, in exchange, EpimAb is eligible to receive milestone payments totalling up to $210m plus royalties on net sales. Karl Ziegelbauer, executive vice president, research and development, and chief scientific officer of Almirall, said the agreement was “an important step” towards the company’s ambition to develop new biologics in the dermatology field. EpimAb’s FIT-Ig platform generates bispecific antibodies using only the basic structural parts of monoclonal antibodies without adding any complex changes. The company has so far focused the technology within the oncology space and currently has five clinical-stage assets being evaluated for indications including non-small cell lung cancer (NSCLC), gastrointestinal cancer and multiple ...
Almirall has signed a licensing agreement with EpimAb Biotherapeutics to utilise the latter’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to develop up to three bispecific antibody targets. EpimAb is eligible for up to $210m (¥1.53bn) in milestone-based payments and net sale royalties. Almirall will hold exclusive global commercialisation rights over the therapies developed during the course of the partnership, based on a 12 October press release. EpimAb’s FIT-Ig platform rearranges the DNA sequences of two monoclonal antibodies to generate bispecific antibodies. “While we have made significant progress in utilizing our platform technology to develop a differentiated portfolio of bispecific antibodies in oncology, the potential of our platform in other areas such as immunology remains untapped,” said EpimAb’s CEOChengbin Wu in the press release. “We believe Almirall is the partner of choice for this endeavour and look forward to exploring the use of our novel bispecific platform to offer additional treatment options for ...
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