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𝐌𝐨𝐧𝐨𝐜𝐥𝐨𝐧𝐚𝐥 𝐀𝐧𝐭𝐢𝐛𝐨𝐝𝐲 𝐃𝐫𝐮𝐠𝐬 𝐚𝐧𝐝 𝐈𝐧𝐝𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐏𝐞𝐫𝐬𝐨𝐧𝐚𝐥𝐢𝐳𝐞𝐝 𝐲𝐨𝐮𝐫 𝐟𝐫𝐞𝐞 𝐜𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐡𝐞𝐫𝐞@https://lnkd.in/dcvXqwuS The field of Monoclonal Antibodies (MAbs) is experiencing rapid growth in the pharmaceutical industry, making it one of the most dynamic areas of new drug development. Over the next decade, we can expect a significant increase in the utilization and adoption of monoclonal antibody products. In recent years, several blockbuster products such as Rituxan, Remicade, Avastin, Humira, and Herceptin, have received approval and achieved blockbuster status. Furthermore, there are currently over 300 new drugs in clinical trials, indicating the ongoing innovation in this field. Both established biotechnology companies and emerging start-ups are actively involved in the development of monoclonal antibodies. This collaborative effort will contribute to the growing prominence of monoclonal antibody products in the coming years. MAbs are extremely selective for cancer cells because they attach to proteins on their surfaces & stimulate an immune reaction. Cancer mAbs may hold a significant position within the global mAbs market due to the growing global prevalence of cancer. Moreover, major pharmaceutical companies worldwide are making substantial investments in research and development related to cancer biologics, particularly MAbs. This is because MAbs offer efficiency and reduced toxicity compared to chemotherapy and other treatment modalities for various types of cancer, making them valuable in both the diagnosis and treatment of various cancer types. Human mAbs are preferred due to lower immunogenicity as compared to other mAb types such as murine, chimeric, and others. The first fully human mAb, Humira, was approved in 2002 with the help of phage display technology and the number of approved fully human mAbs has continued to rise ever since. A majority of the fully human mAbs are produced using transgenic mice, while some are produced by using phage display technology. Rising adoption of transgenic mice is favored by their ability to produce highly specific and affinity-matured antibodies, whereas demand for phage display technologies is supported by scalability, parallelization, and miniaturization attributes offered by the technique. Furthermore, fully human mAbs represent a promising option for treatment of severe, nonmalignant conditions, such as asthma, hypercholesterolemia, atopic dermatitis, and osteoporosis, which can significantly boost market growth. For instance, in December 2022, Aptar Pharma stated that its VP7 nasal multi-dose system will be used to deliver Hibiocy's Vaill Covitrap anti-CoV decongestant spray, which has been recently licensed by Thailand's Food & Drug Administration (FDA). 

😀 Biologics projected to keep gaining ground in cancer therapeutics market Analysts at GlobalData report that the oncology drug market is tilting toward biologics, and that the total market for these drugs will continue to grow rapidly, reaching $786 billion by 2029. This tremendous growth is largely due to biologics’ effectiveness in treating rare solid tumors, according to the report. In 1998, Rituximab, the first approved biologic drug, was introduced into the oncology market. Many more biologics have followed over the years, not only for cancer but for several other diseases as well. The total market value for biologics went from $124 billion in 2009 to $418 billion in 2022. Small molecules generated $354 billion last year, the GlobalData report found. This margin is forecast to expand over the years, with biologics expected to generate $786 billion and small molecules $548 billion in 2029. GlobalData reports that monoclonal antibodies alone are projected to account for more than 40% of the total 2029 biologics revenue. Jasper Morley, a drugs intelligence analyst at GlobalData, noted that within the solid tumor indication, the proportion of biologics drugs is already much higher than that of small molecules. The report shows that biologics currently account for 20% of all drugs, 51% of oncology drugs and 64% of oncology drugs targeted at solid tumors. Among the biologics topping the oncology market is Kite Pharma’s Yescarta, a CAR T cell therapy. Approved in 2017 as a treatment for non-Hodgkin lymphoma, Yescarta is predicted to generate sales of about $2.5 billion in 2029 alone. Morley attributes the success of biologics in the global market to their effectiveness against difficult rare cancers that small molecules cannot treat. Several tumors exhibit rare mutations that make it challenging for small molecules, which are limited in scope, to treat. Biologics, however, are designed to handle such peculiarities. Another driver of growth for the biologic oncology market is the increased incidence of cancer. According to a report from the International Agency for Research on Cancer, cancer cases rose from 18.1 million in 2018 to 19.3 million in 2020, with solid tumors such as breast cancer remaining the most common cancer type worldwide. There is an opportunity to use CAR T cell therapies potentially in areas outside of oncology, like autoimmune diseases, and if that happens, that will expand this market even further and further generate potential in this space. For example, the FDA announced the approval of Tezspire for the treatment of asthma in 2021. Last year, the regulator approved Novo Nordisk’s Tresiba biologic for diabetes, and this year, AbbVie’s oral biologic Rinvoq (upadacitinib) was approved for moderate to severely active Crohn’s disease.

𝐋𝐞𝐠𝐨𝐂𝐡𝐞𝐦 𝐁𝐢𝐨𝐬𝐜𝐢𝐞𝐧𝐜𝐞𝐬 𝐄𝐧𝐭𝐞𝐫𝐬 𝐖𝐨𝐫𝐥𝐝𝐰𝐢𝐝𝐞 𝐋𝐢𝐜𝐞𝐧𝐬𝐢𝐧𝐠 𝐀𝐠𝐫𝐞𝐞𝐦𝐞𝐧𝐭 𝐰𝐢𝐭𝐡 𝐆𝐥𝐲𝐜𝐨𝐭𝐨𝐩𝐞 𝐟𝐨𝐫 𝐀𝐧𝐭𝐢𝐛𝐨𝐝𝐲 𝐃𝐫𝐮𝐠 𝐂𝐨𝐧𝐣𝐮𝐠𝐚𝐭𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 LegoChem Biosciences Inc. (LCB) LegoChem Biosciences and Glycotope GmbH (Glycotope)Glycotope GmbH have entered into an exclusive worldwide licensing agreement to develop an antibody drug conjugate (ADC) by combining LCB’s proprietary ADC technology with one of Glycotope’s investigational antibodies, building on a 2022 collaboration and license agreement. Under the licensing agreement, LCB has exclusive rights to develop and commercialize the selected antibody as an ADC. Glycotope will receive an upfront payment and is eligible for milestone payments and royalties on net sales worldwide from LCB. Specific financial terms have not been disclosed. “With the licensing of the antibody for ADC development, we are expanding the number of ADCs under development, demonstrating our commitment to maximizing the value of our ADC technology,” said Dr. Yong-Zu Kim Yong Kim, CEO & President of LCB. “We look forward to advancing the program to the clinical stage.” “We are excited by the collaboration with LCB on this ADC program,” added Henner Kollenberg Henner Kollenberg, CEO of Glycotope. “Our antibody platform based on glyco-epitopes (GlycoTargets) is expanding, and it's great to see another antibody being developed in a therapeutic setting.” “We believe this antibody has excellent potential for treating several solid tumor indications with high medical need. The continued progress of our collaboration with LCB highlights the importance of tumor-associated glycosylation in cancer treatment,” said Patrik Kehler Patrik Kehler, CSO of Glycotope. ADCs are a type of targeted cancer medicine that delivers chemotherapy to cancer cells via a monoclonal antibody. LCB’s ADC platform overcomes limitations with improved properties: site-specific stable bioconjugation, cancer-selective linker activation, and cancer-selective activation of a potent payload. Glycotope’s antibodies target tumor-associated carbohydrate structures or glyco-epitopes (GlycoTargets), enabling a broad indication range, long-term treatment potential, and reduced on-target/off-tumor toxicity, key elements of potent therapies. Glycotope’s antibodies provide a tailored therapy format for many patients. #treatment #antibody #healthcare #patient #cancer #therapeutic #pharmaceutical #agreement #partnership

AstraZeneca and Presage Biosciences collaborates for a “Remarkable Intratumoral Evaluation of 3 Novel Drugs (done concurrently)”: A Ground-breaking Tumor microenvironment analysis in HNSCC Antitumor efficacy in PCT models doesn't translate faithfully to patient outcomes– a fundamental problem in cancer drug development! To address this inconsistency, Presage Biosciences have developed a technology platform called CIVO (Comparative In Vivo Oncology), which enables simultaneous assessment of up to eight drugs or drug combinations within a single solid tumor in vivo. On April, 2024, Astra Zeneca in collaboration with Presage Biosciences initiated a Phase 0 trial. (Phase O studies can help identify, early in the process, promising candidates for continued development and eliminate those lacking promise). Key facts: 🚩 The purpose of this trial was to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, and sabestomig within the tumor microenvironment (TME) of HNSCC tumor when administered intratumorally in microdose quantities via the CIVO device (Based on Presage’s CIVO Platform). 🚩 AstraZeneca (AZ) is developing 3 bispecific novel monoclonal antibodies: rilvegostomig, volrustomig, and sabestomig designed to stimulate antitumor immunity. 🚩 Using Presage’s CIVO device, AZ will get to evaluate the intratumoral activity of all these 3 drugs simultaneously, by injecting their microdoses, that too, in a single patient tumor, while the tumor is still in the patient, in its native environment! 🚩 Pembrolizumab will also be injected in a single patient tumor to see how it compares with the other 3 AZ’s novel drugs. Why is this process unique?  Because microdoses of the novel drugs are injected directly in the tumor (thereby maintaining the tumor microenvironment), the results produced would be more promising than systemically administering the evaluated drug. All this while Presages CIVO platform tracks the drug exposure intratumorally and provides quantitative analysis on distinct cell populations within the intact TME.    Implications for Drug Developers  This trial represents a significant opportunity for drug developers to gain insights into tumor and microenvironment responses to multiple drug combinations. The data obtained could revolutionize the strategies for developing more effective treatments for HNSCC and potentially other cancers. Are you looking to stay ahead in oncology drug development? Contact us to learn how our market research and consultancy services can help you leverage the latest advancements, like the CIVO platform, to accelerate your drug development process and optimize your clinical trial outcomes. Email us at support@mellalta.com #Oncology #CancerResearch #HNSCC #DrugDevelopment #Pharma #Biotech #Innovation #ClinicalTrials #Phase0 #CIVOPlatform #PresageBiosciences #AstraZeneca #Consulting #MarketResearch

Johnson & Johnson announced today it has entered into a definitive agreement to acquire Ambrx Biopharma, a clinical-stage biopharmaceutical company with a proprietary synthetic biology technology platform to design and develop next-generation antibody drug conjugates (ADCs), in an all-cash merger transaction for a total equity value of approximately $2.0 billion, or $1.9 billion net of estimated cash acquired. Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety of its candidate therapeutics in multiple cancer indications, including ARX517, its proprietary ADC targeting PSMA for metastatic castration-resistant prostate cancer (mCRPC); ARX788, its proprietary ADC targeting human epidermal growth factor receptor 2 (HER2) for metastatic HER2+ breast cancer; and ARX305, its proprietary ADC targeting CD-70 for renal cell carcinoma. “Ambrx’s ADC technology offers unique advantages in the conjugation of stable antibodies and cytotoxic linker payloads, which results in engineered ADCs that effectively kill cancer cells and limit toxicities,” said Yusri Elsayed, MD, MHSc,PhD, Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “The results seen to date with ARX517 in mCRPC are promising and represent a potential first- and best-in-class targeted therapy for the treatment of this aggressive disease. In addition, Ambrx’s pipeline and ADC platform present exciting future opportunities to deliver enhanced, precision biologics as we look to transform the treatment of cancer and improve patients’ lives.” “With a median overall survival of less than two years and novel hormonal therapies moving earlier in the disease, significant unmet need remains in the treatment of mCRPC,” said Margaret Yu, M.D., Prostate Cancer Disease Area Leader, Johnson & Johnson Innovative Medicine. “We see a unique opportunity to harness the potential of this innovative ADC platform, and with our deep understanding of prostate cancer, deliver a targeted PSMA therapeutic for addressing the growing needs of the more than 185,000 patients living with metastatic castration-resistant disease today.” Ambrx was spun out of The Scripps Research Institute in 2003. The company pioneered the expanded genetic code technology platform for incorporation of synthetic amino acid (SAA) into proteins at any selected site using industry standard cell lines. SAAs allow engineered precision biologics with site-specific, homogenous and stable conjugation, overcoming limitations of traditional conjugation technologies. #ADC #prostatecancer #mCRPC #renalcellcarcinoma #breastcancer #Ambrx #JohnsonandJohnson 👉 Media Center (jnj.com)

Rakovina Therapeutics Announces Strategic Pivot to AI Company Leveraging Deep Docking AI Drug Discovery Platform VANCOUVER, British Columbia, March 27, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV), (“Rakovina” or the “Company”), a biopharmaceutical company dedicated to improving the lives of cancer patients through the development of novel DNA-damage response inhibitor therapeutics, is pleased to announce a strategic evolution in its business model that will place the Company at the forefront of artificial intelligence-driven (AI) precision medicine for cancer drug development research. The Company has entered into a collaboration agreement (“Agreement”) with Dr. Artem Cherkasov granting Rakovina exclusive access to the proprietary Deep Docking (trademarked) AI Platform for DNA-damage response targets. Dr. Cherkasov is a professor at the University of British Columbia (UBC) and a senior scientist at the Vancouver Prostate Centre and was appointed to the Company’s scientific advisory board in November 2023. Using the Deep Docking platform powered by advanced AI algorithms, Rakovina can quickly analyze billions of molecular structures to evaluate their potential as targeted cancer drugs. The company then validates the activity using its established R&D infrastructure. This approach is innovative to developing new drug therapies that target DNA-damage response-related vulnerabilities that are common in many types of cancer. “This strategic change of business for us is a significant step forward in Rakovina’s mission,” said Executive Chair Jeffrey Bacha. “The Deep Docking AI Platform will rapidly screen billions of drug candidates against validated DNA-damage response targets, predicting safety, efficacy and pharmaceutical properties. We then validate their activity in our confirmatory assays and advance the most promising drug candidates through human clinical trials and pharmaceutical partnerships.” “Under the leadership of Rakovina’s Chief Scientific Officer Dr. Mads Daugaard, we are honoured to leverage the expertise of Dr. Cherkasov and the research infrastructure already established in collaboration with UBC. We look forward to sharing additional details with our shareholders on our upcoming conference call,” added Bacha. Founded in 2021, Rakovina’s mission has always been to transform and prolong the lives of individuals battling cancer. The DNA-damage response is a crucial mechanism for maintaining genomic integrity, and defects in these pathways contribute to the development and progression of many cancers. Rakovina recognizes the urgency of addressing this issue and is committed to developing targeted therapies to overcome resistance to conventional treatments. Rakovina Strategic Information Conference Call The Rakovina leadership team and members of the scientific team will be hosting a conference call to provide additional information about the company's new strategic direction and industry insights.

Elpiscience Biopharmaceuticals and Astellas Pharma Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager Shanghai and Suzhou, TOKYO, December 28, 2023 - Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., “Elpiscience”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced a research collaboration and license agreement for novel bispecific macrophage engagers, ES019 and another program. The two companies will collaboratively conduct early-stage research for these two programs. Elpiscience will also grant Astellas the right to add up to two additional programs to be included in the collaboration. If Astellas exercises its option, Elpiscience will grant Astellas the exclusive right to further research, develop, manufacture and commercialize the products for each program.  Elpiscience is a privately held, clinical-stage biopharmaceutical company dedicated to developing next-generation immuno-oncology therapies for cancer patients worldwide. Their Bispecific Macrophage Engager Platform (BiME®) is anti-tumor associated antigen (TAA) and anti-signal-regulatory protein α (SIRPα) bispecific antibody-based platform to activate Tumor Associated Macrophage (TAM) phagocytosis killing towards specific TAA expressing tumor cells. BiME® shows highly potent phagocytosis due to engagement of the Fc receptor on TAM and the tumor cells via TAA and SIRPα, and blockade of CD47-SIRPα “don’t eat me” signaling1. This platform is utilized for ES019, an anti-PD-L1/SIRPα bispecific antibody. https://lnkd.in/ehWJrpRR

HighField Biopharmaceuticals, will present positive clinical and preclinical data of HFK1, a drug encapsulated immunoliposome for treatment of solid tumors, at the American Society of Clinical Oncology annual meeting May 31 – June 4, in Chicago, IL. The poster titled “The design, preclinical study and Phase 1 dose escalation of a HER2 targeted immunoliposome (HF-K1) for HER2 low solid tumor treatment,” will be presented Saturday, June 1st from 9am-12pm CDT. The poster presentation describes preliminary findings from the company’s Phase 1a study of HFK1 for HER2 low expression cancers. The first patient dosed suffers from lung metastasis of a rare HER2 low cancer. The patient has been treated with HFK1 for more than five months with no dose-limiting toxicity and stable disease. The clinical and preclinical data, which will be presented by HighField CEO and Scientific Founder Yuhong Xu, Ph.D., also includes study results comparing HFK1 to other antibody drug conjugates (ADCs) and PEGylated liposomal doxorubicin (PLD). The findings demonstrate HFK1 improves significantly on the safety and efficacy of ADCs and PLD. In particular, HFK1 exceeded ADCs in expanding the drug therapeutic window and reducing tumor growth. “We look forward to sharing the encouraging data of our HFK1 studies at ASCO,” said Dr. Xu. “They confirm our confidence that our unique drug encapsulated immunoliposomes will offer a new alternative for targeting HER2 low cancers with lower off-target toxicities and wider therapeutic windows.” HighField’s Phase 1 open-label clinical trial is enrolling patients who have advanced refractory solid tumors with HER2 low expression. The Phase 1a dose escalation portion will be followed by a Phase 1b dose expansion phase. Both the Phase 1a and 1b studies will assess the safety and preliminary efficacy of HFK1. For more information visit NCT05861895 on clinicaltrials.gov. HighField’s immunoliposomes represent a new generation of targeted chemotherapy drugs following the success of antibody drug conjugates (ADCs). Due to their unique features, HighField’s immunoliposomes may offer better safety with greater efficacy in treatment of a broad range of solid tumor types. For more information visit: highfield.bio #cancerresearch #adc #antibodydrugconjugates #biopharma #ASCO24 https://lnkd.in/g9U_-hug

Stating the obvious – Antibody Drug Conjugates (ADCs) are a dynamic area in oncology. After a bustling 2023, the positive momentum continues strong into 2024. Here are the latest ADC updates for June. If you're working on ADCs, you'll definitely want to scroll down!   Clinical Updates 🔬 FDA Partial Clinical Hold on BioNTech's ADC: FDA places a partial clinical hold on BioNTech SE's Phase 1 trial of BNT326 for advanced NSCLC and breast cancer. 🔬 Day One Biopharma Expansion: Day One Biopharmaceuticals expands its pipeline to ADCs with MabCare for MTX-13, a first-in-class ADC targeting PTK7 for solid tumors 🔬 Tubulis Trial Initiation: Tubulis GmbH doses the first patient in its Phase I/IIa trial for ADC candidate TUB-040 targeting ovarian cancer and lung adenocarcinoma. 🔬 IDEAYA Biosciences Trial: IDEAYA Biosciences announces the first patient dosed in a Phase 1 trial evaluating the combination of IDE397 and Trodelvy® for MTAP-deletion bladder cancer. Regulatory Updates 📝 BioNTech and DualityBio Fast Track: BioNTech SE and Duality Biologics receive FDA Fast Track designation for their ADC candidate BNT324/DB-1311 in prostate cancer. 📝 Tubulis FDA Fast Track: Tubulis GmbH receives FDA Fast Track designation for its ADC candidate TUB-040 for platinum-resistant ovarian cancer. 📝 FDA Response to Patritumab BLA: The FDA issues a complete response letter to the BLA submission for Merck's Patritumab Deruxtecan due to inspection findings at a third-party manufacturer. Conference Updates 📅 Innovent at ESMO: Innovent Biologics announces an oral presentation at the ESMO GI Cancers Congress 2024 on clinical data of IBI-345, an anti-CLDN18.2 ADC for advanced gastric and gastroesophageal junction adenocarcinoma. Deals/Investment Update 💼 Veranova Investment: Veranova announces a new investment to expand its ADC and highly potent API capabilities at its Devens, MA facility. 💼 Pyxis Oncology Grants: Pyxis Oncology reported inducement grants under Nasdaq Listing Rule 5635(c)(4). The company anticipates releasing data for its ADC asset, PYX-201, by the end of 2024 💼 Daiichi Sankyo and Seagen Arbitration: The arbitration dispute between Daiichi Sankyo US and Seagen ends with Seagen paying ~$47 million in attorneys' fees and costs plus interest. 💼 EISAI Solo Development in ADC: The collaboration between Eisai US and Bristol Myers Squibb for the Farletuzumab Ecteribulin (FZEC) ADC has been terminated. EISAI plans to refund $200 million to BMS. 💼 ABL Bio 2.0 strategy: ABL Bio Inc. announces its plans to invest 400 billion KRW (310 million USD) for the development of bispecific antibody ADC. 💼 Redmile Group Investment: Redmile Group purchases $2.25 million worth of ADC Therapeutics shares. Follow us for timely updates and expert insights. Stay informed, stay competitive! #ADC #oncology #news #competitiveintelligence #phenomiqs #pharmaceutical

Zumutor Biologics Inc "Zumutor", a Boston based biopharmaceutical company focused on developing unique novel therapeutics in immuno-oncology (I-O) announces that the US Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for the novel drug ZM008 to initiate a Phase 1, first-in-human, clinical study for the treatment of multiple solid cancers. ZM008 is a human IgG1 monoclonal antibody against LLT1 (CLEC2D), which disrupts the interaction of LLT1-CD161 between human immune cells and Tumor cells resulting in antitumor effects of ZM008 in monotherapy. The disruption of LLT1-CD161 interaction with ZM008 leads to reversal from "cold" or less immune responsive Tumor Microenvironment (TME) to "hot" highly immune responsive TME – the Holy Grail of I-O mechanisms. https://lnkd.in/deNZc4AK