Core Insights - HanchorBio and WuXi Biologics have signed a strategic collaboration agreement to develop and manufacture next-generation bi- and multi-functional fusion programs from HanchorBio's pipeline [1][3][4] Company Overview - HanchorBio is a global clinical-stage biotechnology company focused on advancing immunotherapies for oncology and autoimmune diseases, utilizing its proprietary Fc-Based Designer Biologics (FBDB™) platform [1][8][9] - WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) that provides end-to-end solutions for biologics development and manufacturing [10][11] Collaboration Details - Under the agreement, WuXi Biologics will offer integrated services including cell line development, process and bioassay development, drug product formulation, and GMP manufacturing to support HanchorBio's innovative fusion protein portfolio [3][4] - The partnership aims to enhance clinical translation, improve CMC execution efficiency, and support scalable global development and manufacturing [3][4] Strategic Goals - HanchorBio's strategy focuses on advancing its multi-asset pipelines with speed, robustness, and capital efficiency from early clinical stages to commercialization [4][6] - The collaboration is expected to shorten development timelines and maintain flexibility across multiple clinical programs [4][6] Expertise and Capabilities - WuXi Biologics has extensive experience in complex modalities, supporting 945 projects as of 2025, with approximately 60% involving bi- and multi-specific antibodies, ADCs, and fusion proteins [5][11] - The company utilizes proprietary technology platforms to enhance speed, quality, and scalability in biologics development [5][11] Future Outlook - The partnership represents a significant step for HanchorBio in aligning discovery innovation with industrial-scale execution, advancing its oncology and autoimmune pipelines toward global clinical development [6][7]

Core Viewpoint - PDS Biotechnology Corporation has received a Notice of Allowance for its lead asset PDS0101, enhancing its intellectual property estate and providing significant market protections for over 20 years due to the new patent and anticipated biologics exclusivity [1][3]. Intellectual Property and Patent Details - The new patent (U.S. Application No. 16/210,750) is titled "Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes" and will grant broad composition and method of use claims [2]. - This patent strengthens the company's existing intellectual property portfolio, which includes patents granted in major markets such as the U.S., Europe, Japan, China, Australia, Canada, Israel, Mexico, and Hong Kong [2]. Clinical Development and Market Position - PDS0101 is currently in the Phase 3 VERSATILE-003 clinical trial for HPV16-positive head and neck cancers, with a protocol amendment submitted to the FDA to change the progression-free survival endpoint to a primary endpoint for earlier evaluation [3]. - The company is well-positioned to advance its immunotherapy, with the potential for approximately twenty years of market exclusivity for PDS0101 [3]. Company Overview - PDS Biotechnology is focused on transforming cancer treatment through immunotherapy, specifically targeting HPV16-positive head and neck squamous cell cancers [4]. - The lead investigational product PDS0101 (Versamune HPV) is being developed in combination with standard-of-care immune checkpoint inhibitors and other therapies [4].

Core Viewpoint Greenwich LifeSciences, Inc. has made significant progress in its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with the FDA approving the first commercial lot of GP2 for use in the trial, which is a crucial step towards filing a Biological License Application (BLA) in the US. Group 1: Clinical Trial Updates - The first three commercial lots of GP2 were manufactured in 2023, capable of preparing approximately 200,000 doses [2] - The first commercial lot of GP2 vials has been approved for use in FLAMINGO-01 in the US [2][3] - More than 1,000 patients have been screened in FLAMINGO-01, with a current screening rate of approximately 600 patients per year [5] Group 2: Manufacturing and Regulatory Progress - The company plans to start using the new GP2 vials at all 40 US sites in the coming weeks [3] - The submission of commercial manufacturing data for three lots is critical for the BLA filing in the US and other countries [4] - At least two more lots of finished GP2 product will be manufactured to support clinical and manufacturing data review by the FDA [4] Group 3: Efficacy and Safety Data - Preliminary analysis shows an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) in the non-HLA-A*02 arm of FLAMINGO-01 [6] - The immune response and safety profile of non-HLA-A*02 patients are trending similarly to HLA-A*02 arms and the Phase IIb study [6] - The Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences in HER2/neu 3+ patients treated with GLSI-100 [8] Group 4: Future Plans and Market Potential - The company aims to conduct FLAMINGO-01 at 150 leading clinical sites in the US and Europe, facilitating a smooth transition to product launch if GLSI-100 is approved [5] - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, with an interim analysis planned when at least 14 events have occurred [9] - The company is preparing to submit the same manufacturing data to regulatory agencies in Europe, the UK, and Canada [5]

Core Insights - ImmunityBio's shares increased by 17.4% following a meeting with FDA officials to discuss the regulatory path for Anktiva in treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors [1][6] - The company plans to resubmit its supplemental biologics license application (sBLA) for Anktiva plus Bacillus Calmette-Guérin (BCG) after addressing FDA's requests for additional information [4][10] Company Developments - Anktiva is already approved in the U.S., EU, and UK for treating adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) [2] - The recent FDA meeting allowed ImmunityBio to present over five years of follow-up data supporting the papillary indication, demonstrating a safety profile consistent with the approved CIS indication [3][5] - The company has completed the requested analyses and plans to submit the sBLA package within a month, without the need for a new clinical study [4][6] Clinical Evidence - The proposed sBLA resubmission is supported by long-term data from the phase II/III QUILT-3.032 study, which showed a 12-month disease-free survival rate of 58.2% in patients with high-grade papillary-only disease [7] - Disease-specific survival reached 96% at 36 months, with progression-free survival at 94.9% at 12 months and 83.1% at 36 months, indicating sustained disease control [8] - Anktiva demonstrated a bladder-sparing benefit, with cystectomy-free survival rates of 92.2% at 12 months and 81.8% at 36 months, allowing over 80% of patients to avoid radical surgery [8][10] Market Context - High-grade papillary NMIBC that does not respond to BCG represents a significant unmet medical need, as current standard treatment involves radical cystectomy, which has considerable morbidity [9] - ImmunityBio aims to provide a bladder-sparing alternative, potentially reshaping the treatment landscape for these patients if Anktiva is approved [10][12]

Core Viewpoint - Corvus Pharmaceuticals has initiated an underwritten public offering of $150 million in common stock and pre-funded warrants, with an additional option for underwriters to purchase up to $22.5 million more [1][2]. Group 1: Offering Details - The public offering consists of $150 million in shares of common stock and pre-funded warrants, all offered by Corvus Pharmaceuticals [1]. - The underwriters have a 30-day option to purchase an additional $22.5 million in shares at the public offering price [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or terms [1]. Group 2: Use of Proceeds - The net proceeds from the offering are expected to be used for working capital and general corporate purposes, including capital expenditures and research and development [2]. - Specific clinical trials funded by the proceeds include Phase 3 for T cell lymphoma and Phase 2 for atopic dermatitis, hidradenitis suppurativa, and asthma [2]. Group 3: Underwriters - Jefferies and Goldman Sachs & Co. LLC are the lead book-running managers for the offering, with Mizuho as the bookrunner and Ladenburg Thalmann as a co-manager [3]. Group 4: Regulatory Information - A shelf registration statement on Form S-3 was declared effective by the SEC on August 15, 2024, allowing the sale of these securities [4]. - A preliminary prospectus supplement will be filed with the SEC on January 20, 2026, and will be available on the SEC's website [4].

Core Viewpoint - Tiziana Life Sciences has announced the peer-reviewed publication of its study on intranasal foralumab for treating non-active secondary progressive multiple sclerosis (na-SPMS), marking a significant milestone in validating its therapeutic potential [1][2]. Study Publication - The publication titled "Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis" details positive results from an open-label study, integrating TSPO-PET imaging, proteomics, and clinical assessments [2][4]. Study Highlights - The study represents a major milestone and external validation of intranasal foralumab's potential in treating secondary progressive MS, emphasizing its unique mechanism in addressing progression independent of relapse activity (PIRA) [4]. - Clinical stabilization and microglial PET findings support the biological effects of nasal foralumab in addressing PIRA in na-SPMS [4]. - The innovative intranasal delivery method modulates the immune system to suppress neuroinflammation without broad systemic immunosuppression, distinguishing it from existing MS therapies [4]. Ongoing Trials - Tiziana is advancing intranasal foralumab in a randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS, with top-line data expected in the first half of 2026 [5]. Patient Outcomes - In the open-label study, 14 patients with na-SPMS were dosed, showing stabilization of Expanded Disability Status Scale (EDSS) scores, with three out of four patients treated for 12 months demonstrating improvement [6]. - Fatigue improved in six out of ten patients, and no new T2 lesions appeared on MRI, indicating a favorable safety profile [6]. Unique Positioning - Foralumab is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel approach for treating neuroinflammatory and neurodegenerative diseases [8][9].

Core Insights - Corvus Pharmaceuticals, Inc. will host a conference call and webcast on January 20, 2026, to report results from cohort 4 of a Phase 1 clinical trial evaluating soquelitinib for moderate to severe atopic dermatitis [1] - Soquelitinib is an investigational oral small molecule drug that selectively inhibits ITK and is currently in a registration Phase 3 clinical trial for relapsed/refractory PTCL [3] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition as a novel immunotherapy approach for various immune diseases and cancers [3] - The company is developing multiple clinical-stage candidates targeting a range of cancer indications [3] Conference Call Details - The conference call can be accessed via a toll-free domestic number or an international number, and a live webcast will be available on the investor relations section of the Corvus website [2] - A replay of the webcast will be accessible on the Corvus website for 60 days following the event [2]

Core Viewpoint - Tiziana Life Sciences has successfully closed a registered direct offering of 7,040,000 ordinary shares at $1.25 per share, raising gross proceeds of $8.8 million, which will support its clinical trials for intranasal foralumab, its lead candidate [1][3]. Group 1: Offering Details - The offering was conducted without an underwriter or placement agent and was primarily subscribed by senior management and existing shareholders [1]. - Participants in the offering will receive warrants to purchase additional shares at $1.50, potentially raising an additional $10.56 million [1]. - The offering was led by CEO Ivor Elrifi, who purchased 2,400,000 shares, increasing his total holdings to 2,757,848 shares [2]. Group 2: Clinical Development - Proceeds from the offering will enable Tiziana to complete Phase 2 clinical trials for non-active secondary progressive multiple sclerosis (na-SPMS) and multiple system atrophy (MSA) [3]. - Foralumab, the lead candidate, is a fully human anti-CD3 monoclonal antibody that has shown promise in stimulating T regulatory cells when administered intranasally [6][7]. - The drug is currently being tested in a Phase 2a trial, with positive early results reported in an open-label program involving 14 patients [6]. Group 3: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies [8]. - The company's nasal delivery approach aims to enhance the efficacy, safety, and tolerability of immunotherapy compared to traditional intravenous methods [8]. - Tiziana's technology for alternative routes of immunotherapy is patented, with several applications pending, indicating potential for a broad pipeline of therapies [8].

Core Insights - ImmunityBio, Inc. (NASDAQ: IBRX) shares surged 34% on Friday and have increased 127% this week due to positive developments in clinical trials and potential FDA submissions [1][2][4] Group 1: Clinical Trial Developments - Enrollment for the Anktiva therapy trial for non-muscle-invasive bladder cancer exceeded expectations, allowing the company to potentially submit a biologics licensing agreement to the FDA by year-end [1][4] - A clinical trial for the CAR-NK therapy showed 100% disease control in the first four patients with Non-Hodgkin lymphoma, indicating promising long-term implications for the company [2][4] Group 2: Market Response and Financials - The market reacted positively to ImmunityBio's updates, reflecting optimism about Anktiva's sales growth and expanding indications, despite the company only starting to generate revenue in 2024 [4][6] - ImmunityBio has a market capitalization of $5.3 billion and approximately $800 million in net cash, positioning it as a well-funded immunotherapy growth stock [4][6] Group 3: Recent Business Updates - The stock's significant rise followed multiple positive updates, including a 700% increase in Anktiva sales, approval from the Saudi Food and Drug Authority, and positive data for Anktiva in treating non-small cell lung cancer [5][7]

Core Viewpoint - Tiziana Life Sciences, Ltd. has announced a registered direct offering of 6,400,000 ordinary shares at $1.25 per share, aiming to raise approximately $8.0 million to fund clinical trials for its lead candidate, intranasal foralumab [1][3]. Group 1: Offering Details - The offering is conducted without an underwriter or placement agent and is targeted at senior management and existing shareholders [1]. - Participants in the offering will receive warrants to purchase additional shares at $1.50, potentially raising an additional $9.6 million [1]. - The offering is expected to close on January 16, 2026, pending customary closing conditions [1]. Group 2: Management Participation - CEO Ivor Elrifi purchased 2,400,000 ordinary shares, increasing his total holdings to 2,757,848 shares [2]. - Executive Chairman Gabriele Cerrone acquired 1,600,000 shares through Panetta Partners Ltd, raising his total holdings to 44,974,830 shares [2]. Group 3: Use of Proceeds - Proceeds from the offering will be utilized to complete Phase 2 clinical trials for non-active secondary progressive multiple sclerosis (na-SPMS) and multiple system atrophy (MSA), with top-line data expected from both trials [3]. Group 4: Product Information - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally [7]. - The drug is currently being tested in a Phase 2a trial for na-SPMS, with positive outcomes reported in an open-label program involving 14 patients [7]. - Foralumab represents a novel approach to treating neuroinflammatory and neurodegenerative diseases [8]. Group 5: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies [8]. - The company aims to improve efficacy, safety, and tolerability of treatments compared to traditional intravenous delivery methods [8].