HiFiBiO Therapeutics的动态

???????????????????? ???????????????? ?????????? ?????? ???????????????????? ???????????????????????? ???????? ???????? ?????????????????????????? ????????@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).?

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.

Dren Bio, Inc., a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune, and other serious diseases, today announced that it has entered into a strategic collaboration with Novartis Pharma AG, a subsidiary of Novartis AG. The collaboration will focus on the discovery and development of therapeutic bispecific antibodies for cancer using Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform. “Our agreement with Dren Bio is a promising opportunity to discover novel bispecific antibody therapies for cancer, building on our longstanding expertise in immuno-oncology science at Novartis,” said Shiva Malek, Ph.D., Global Head of Oncology for Biomedical Research at Novartis. ? “We’re excited to collaborate to bring forward new therapeutic options for patients living with cancer, complementing our strategic efforts across a wide range of modalities, including targeted therapies, biologics, radioligand therapies and CAR-Ts.” “We are thrilled to establish this new collaboration with Novartis, a global leader in oncology,” said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. “Combining the proven capabilities of Novartis in oncology drug development with Dren Bio’s novel platform could enable the advancement of important new therapies for patients.” Amit Mehta, Ph.D., Chief Operating Officer and Chief Business Officer of Dren Bio, added “Dren Bio’s Targeted Myeloid Engager and Phagocytosis Platform is designed to deplete various disease-causing agents and has led to a rich and diverse pipeline. This collaboration will benefit from Novartis' impressive track record of developing novel medicines and help further expand the reach of our platform.” Under the terms of the agreement, Dren Bio will receive a total upfront consideration of $150 million from Novartis, which includes a $25 million equity investment in the Company. Dren Bio is also eligible to receive up to $2.85 billion in additional cash payments upon achieving certain preclinical, clinical, regulatory, and commercial milestones, as well as tiered royalties on future net sales of any commercialized products resulting from the collaboration. Dren Bio and Novartis will collaborate to advance selected targeted myeloid engager programs in oncology through clinical candidate selection, at which point Novartis will assume full responsibility for all remaining development, manufacturing, regulatory, and commercialization activities. The agreement is subject to customary closing conditions including regulatory clearance. #Oncology #ImmunoOncology #TargetedMyeloidEngager? #Collaboration #DrenBio #Novartis #ReimagineMedicine

Jingrui pharma's brain penetrable BET inhibitor JRD-018 is approved by the U.S. FDA for clinical investigation on April 24, 2024 JINGRUI pharma, a small molecule anti-tumor drug discovery company, has announced that its BET inhibitor JRD-018 has gained Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for treatment of advanced malignancies. The drug is designed to be taken once a day orally. This is the first IND approval Jingrui Biopharma has obtained in its three years since its establishment. Jingrui will commence Phase I clinical trial and will recruit patients to determine the safety, tolerability and pharmacokinetics of JRD-018, and obtain preliminary anti-tumor activity of the drug in patients with advanced solid tumors, hematologic malignancies, brain-metastasized or primary brain tumors. JRD-018 targets the bromodomain and extra-terminal domain (BET) family of proteins, whose bromodomains (BRDs) are characterized with a conserved sequence of 110 amino acids that form a hydrophobic binding pocket for acetylated lysine residues on histones and other proteins. As a BET inhibitor, JRD-018 effectively inhibits the expression of c-Myc and inhibits tumor growth. c-Myc is considered to be a classic oncogene but has been difficult to be therapeutically targeted for a long time due to its lack of suitable drug-binding structure. JRD-018 showed good anti-tumor activities in glioma, small cell lung cancer, non-small cell lung cancer, myeloid monocytic leukemia and breast cancer in monotherapy. The blood brain barrier (BBB) has always posed big challenge for the industry for drug delivery to the brain. We foresee that with the improvement of drug delivery to the brain, the survival rate of patients with brain tumors or brain-metastasized tumors will drastically improve. So far, while there are a number of BETi in clinical trials worldwide, very few have been reported BBB-permeable and capable of treating brain tumors.?Therefore, the significance of JRD-018 development cannot be overstated. "We are very grateful to all the staff and shareholders of Jingrui for their continuous innovation, hard work and full support! The IND approval of JRD-018 in the United States is an important milestone in the company's development.” Dr. Mark Han, Founder and CEO of Jingrui Pharma, said, "We will continue to work hard and leverage our unique strength to provide patients and doctors with newer, safer and more effective treatments as fast as we can.”

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 [email protected] #Oncology #CancerResearch #HNSCC #DrugDevelopment #Pharma #Biotech #Innovation #ClinicalTrials #Phase0 #CIVOPlatform #PresageBiosciences #AstraZeneca #Consulting #MarketResearch

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

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

[Clinical Trials] 09/13 Atea Pharmaceuticals, Inc' phase 3 SunRISE-3 Trial Fails Primary Goal, Bemnifosbuvir Does Not Significantly Reduce COVID-19 Hospitalization or Death Rate same day : ( ↑ NASDAQ: AVIR | +0.68% ) 09/13 VICO Therapeutics B.V. Reports 28% Reduction in CSF Mutant HTT in phase 1/2a Trial of VO659 for Huntington's Disease 09/13 CureVac Reveals phase 1 CVGBM Cancer Vaccine Study Results Showing T-cell Responses in 77% of Evaluable Patients Post Chemo-Radiation Therapy same day : ( ↑ NASDAQ: CVAC | +2.1% ) 09/12 Neurocrine Biosciences Halts Development of Luvadaxistat After phase 2 Clinical Study Fails to Meet Primary Endpoint in Treating Schizophrenia same day : ( ↑ NASDAQ: NBIX | +0.82% ) [Deals] 09/13 Marengo Therapeutics and Gilead Sciences Collaborate on Clinical Study for Metastatic Breast Cancer Treatment same day : ( ↓ NASDAQ: GILD | -0.3% ) 09/12 Navamedic ASA and Alex Therapeutics partner to launch medication management app for Parkinson's patients in Nordic countries 09/12 Nona Biosciences and Umoja Biopharma partner to develop new CAR-T cell therapies using HCAb and VivoVec technologies 09/12 Kazia Therapeutics Limited Acquires Rights for PI3K Inhibitor Drug Therapies from QIMR Berghofer Medical Research Institute same day : ( ↓ NASDAQ: KZIA | -5.41% ) [Venture Capital] 09/13 ONL Therapeutics raises $65M for further development of ONL1204 Ophthalmic Solution, enters phase 2 trials for geographic atrophy treatment 09/12 Vironexis Biotherapeutics Emerges from Stealth with $26M Seed Funding to Unveil Groundbreaking AAV-Delivered Cancer Immunotherapy Platform [Regulatory] 09/13 GSK's Blenrep combined with bortezomib and dexamethasone for relapsed or refractory multiple myeloma receives Breakthrough Therapy Designation in China following DREAMM-7 trial results 09/13 Senhwa Biosciences, Inc.' Silmitasertib receives rare pediatric disease designation by FDA for neuroblastoma treatment 09/12 Janssen-cilag International Nv submits application to European Medicines Agency for nipocalimab, a treatment for myasthenia gravis, following phase 3 Vivacity-MG3 study results 09/12 FDA approves Genentech's Tecentriq Hybreza, a subcutaneous Anti-PD-(L)1 cancer therapy reducing treatment time and demonstrating comparable effectiveness 09/12 China's NMPA approves Keymed Biosciences' drug Stapokibart for moderate-to-severe atopic dermatitis treatment based on phase III trial results View the full newsletter contents for free via the link in the comments.

Canadian immunotherapy company Synthekine has announced a global partnership with?Sanofi?to develop IL-10 receptor agonists for inflammatory diseases. Under the deal, Sanofi and Synthekine will work together to research cytokine therapies up to a predefined point in preclinical development. After that, Sanofi will be solely responsible for preclinical, clinical and commercial development of any IL-10 therapeutics.? Sanofi has agreed to give Synthekine a $40m upfront payment, with the potential for additional payments upon reaching preclinical, development, regulatory and commercial milestones, including possible royalties on net sales. In its programme, the biotech aims to remove the immunostimulatory effects of the drug class, hampering the drug’s toxicity while maintaining efficacy. In its pipeline, the biotech currently has two Phase I candidates and seven candidates in preclinical and investigational new drug application (IND)-enabling stages. These therapies include engineered cytokine partial agonists, surrogate cytokine agonists, and orthogonal cytokine and cell therapy combinations. Synthekine’s most advanced therapy, STK-012, is a modified IL-2 cytokine that selectively stimulates?antigen-activated T cells. In September 2023, Synthekine announced the?dosing of the first patient?in its Phase Ib study (NCT05098132). The ongoing trial is investigating the therapy for solid tumour types, including renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). Read more: https://lnkd.in/esxbuU9Y Stay in touch with all the leading stories by subscribing to our LinkedIn Newsletter here: https://bit.ly/3RbdKtc

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