OncoOne’s Post

a. Lepu Biopharma Co., Ltd has announced that its drug candidate MRG003 received the FDA’s Breakthrough Therapy Designation for treating recurrent or metastatic nasopharyngeal cancer, marking significant progress in the drug’s development and potential market opportunities. The designation will expedite MRG003’s development process and review, highlighting the FDA’s acknowledgment of its promising clinical data. This achievement underscores the company’s strides towards internationalization and its commitment to providing new treatment options. b. Biocytogen has entered into an option and license agreement for a potential first-in-class B7H3/PTK7 BsADC program with IDEAYA Biosciences. The agreement grants IDEAYA an option for an exclusive worldwide license from Biocytogen for a potential first-in-class B7H3/PTK7 topo-I-payload BsADC program. Source: offcial annoucement by Lepu, Biocytogen & IDEAYA Contact AsymBio for comprehensive ADC solutions! https://www.asymbio.com/ #ADC #CDMO #BsADC #licensing #FDA #BTD #cancer #treatment

If you haven’t been to the #ELAINEStudies website lately, now is the time to take another look. We have transformed the site into a dynamic educational resource for patients—with new interactive content, video assets, ELAINE-3 study details, and more. Visit the site: https://lnkd.in/euVcnsAX The #ELAINEStudies are evaluating an investigational oral drug, lasofoxifene, in women and men with locally advanced or metastatic estrogen receptor-positive/human epidermal growth factor 2-negative (ER+/HER2-) breast cancer expressing an estrogen receptor 1 (ESR1) mutation. ELAINE-1 and ELAINE-2 are active with enrollment complete. Enrollment is currently open for ELAINE-3, a large, randomized, phase 3 study with clinical trial sites across the United States, Europe, Asia-Pacific, Israel, and Canada.

Trial costs can cascade due to even the most common hurdles. According to the NIH, a phase III study could have up to 120 protocol deviations. With an average cost between $25,000 - $55,000 per deviation, reducing deviations can have both fiscal rewards and a strong impact on the efficacy of your study. Learn how Longboat reduced deviations by over 20% in a Phase III breast cancer trial across 188 trial sites.  

Trial costs can cascade due to even the most common hurdles. According to the NIH, a phase III study could have up to 120 protocol deviations. With an average cost between $25,000 - $55,000 per deviation, reducing deviations can have both fiscal rewards and a strong impact on the efficacy of your study. Learn how Longboat reduced deviations by over 20% in a Phase III breast cancer trial across 188 trial sites.  

Zai Lab's partners Pfizer and Genmab jointly announced that the US FDA has approved their supplementary Biologics License Application (sBLA) for TIVDAK(®). This sets the stage for its use in the treatment of patients who are suffering from recurrent or metastatic cervical cancer, whose condition has progressed during or after chemotherapy. There's a considerable unmet need for cervical cancer treatment. The disease - recurrent and/or metastatic cervical cancer - is extremely destructive and often incurable; statistics show that up to 15% of adult cervical cancer patients experience metastasis at diagnosis, and for those diagnosed early and treated, as many as 61%(v) suffer recurrences. #QMportfolio #QMhealthcare #ZaiLab #Pfizer #Genmab #FDA #TIVDAKApproval #CervicalCancerTreatment

As of February 2024, 12 antibody–drug conjugates (ADCs) have received FDA approval, and over 100 ADCs are undergoing clinical trials or pre-clinical development at various stages. ADCs are transforming cancer treatment by combining humanized monoclonal antibodies with potent cytotoxic drugs. Sino Biological contributes to advancements in the ADC field by offering recombinant targets like FRα, Nectin-4, TROP-2, and Tissue factor, alongside the established ones such as CD22 and HER2 and their respective antibodies. Learn more: https://ow.ly/yTbb50QFMqc #ADCTherapy #ADCs #CancerResearch

The results are in: The more sites engaged with the resources in Advarra's Longboat technology, the better their overall performance. Sites using Advarra’s system made fewer mistakes and had fewer queries and protocol deviations, ensuring important patient data could be included in the final study analysis. Learn how Longboat reduced deviations by over 20% in a Phase III breast cancer trial across 188 trial sites.

This piece by Ned Pagliarulo in BioPharma Dive is a great primer on our recently announced collaboration with ARTBIO and the excitement surrounding #radiopharmaceuticals overall. As Ned writes, “The radiopharma field is booming, drawing substantial investment from large companies and venture capital firms eager to capitalize on the drugs’ potential to balance cancer-killing potency with better safety.” The Helicon-enabled radioligand therapies we will co-develop will benefit from the hyper-tunability of Helicons, to control the drugs’ distribution and half-life, and from the uniqueness of lead-212, one of the most promising isotopes for radiopharmaceutical use. Check out this photo of our teams together kicking off our partnership, and read the story here: https://bit.ly/3KN2zm5 #radioligandtherapy #cancer #oncology #peptides #Helicons #patients  

Mestag Therapeutics is going to bring their novel fibroblast-immune interactions program to the upcoming AACR 2024 conference (April 5-10) in San Diego. M300, which is a bispecific antibody designed to conditionally induce the formation of Tertiary Lymphoid Structures (TLS) for solid tumor treatment, has been listed in the Late-Breaking Research Poster session. According to them, TLSs are aggregates of immune cells that form in tumor tissue as part of our bodies’ natural anti-cancer mechanisms, and drive powerful immune responses by recruiting, educating, and activating new anti-tumor T and B-cells. Check link for more detail: https://lnkd.in/gArpUa2p Additionally, the 2024 Annual Conference of our society, featuring numerous novel modalities of biologics, will convene in Cambridge, MA, USA on Saturday, May 11, 2024. Registration for the conference is now open via the following link. https://lnkd.in/ecmFPA4v #antibodydiscovery #antibodydrugconjugates #oncology #annualmeeting #annualconference #aacr

𝗧𝗵𝗲 𝗣𝗵𝗮𝗿𝗺𝗮 𝗡𝗲𝘄𝘀 𝟮𝟬𝟮𝟰 Decoding the News: Key Insights from the News Article ⬇ Below are the links to the respective news articles: 1. Sanofi, AstraZeneca Get FDA Approval of New Manufacturing Line to Bolster US Supply of RSV Antibody https://lnkd.in/gtAf8k-C 2. ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial https://lnkd.in/gdT388dH 3. A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology https://lnkd.in/gkBSM3Fh 4. Novo Nordisk's latest RNA deal involves $530M biobucks to sing in Korro's opera https://lnkd.in/gM86SGmw 5. Capricor sells Europe rights to DMD therapy for $35M as FDA application approaches https://lnkd.in/gxWFTxKY P.S. Comment below with the latest pharma/biotech news you came across. #pharma #cdmo #biotech