Pierre Fabre Laboratories SA has extended its global partnership with Atara Biotherapeutics, licencing tabelecleucel commercialisation rights for Northern America and beyond. Paris-based Pierre Fabre Laboratories SA already held a licence for the EU-approved tabelecleucel, an allogeneic T cell based second-line treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a rare, acute, and potentially deadly hematologicmalignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. The orphan diesease has a median survival of 0.7 months and 4.1 momths. Under an extented licence agreement for the US and Canada, where the BLA for tabelecleucel is expected in Q2/2024, Atara will receive up to US$640m and significant double-digit tiered royalties on net sales from Pierre Fabre Laboratories. In addition, Pierre Fabre Laboratories has agreed to reimburse Atara for expected global development costs through transfer of the BLA (Biologics License Application) approval by the FDA in the US and purchase current and future tabelecleucel inventory through the BLA transfer date. Near-term payments to Atara include approximately US$30m in cash upfront and initial inventory purchase at closing as well as US$100m in potential regulatory milestones through BLA approval The geographical expansion of the licensing rights encompasses the USA, Canada and all remaining territories. Pierre Fabre Laboratories already acquired the rights for Europe in October 2021.
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💡 Innovation in action: #OrpheliaPharma secures a US patent for the ready-to-use drinkable formulation of temozolomide, an oral chemotherapy drug used in the treatment of certain types of cancer, typically developed for children. Specifically crafted for children with high-risk neuroblastoma, KIZFIZO offers precise dosing in a small volume. This US patent, along with the European patent from 2021, ensures double exclusivity protection in the US and Europe until 2038. Chief Development Officer Jeremy Bastid emphasizes the formulation's innovation, addressing critical hospital needs. Developed in collaboration with Gustave Roussy, KIZFIZO marks a significant step in advancing pediatric oncology. 👉 For further insights, follow this link: https://lnkd.in/d2__skn4 #OrpheliaPharma #KIZFIZOInnovation #USPatentSuccess #intellectualproperty #patent #pharma #pharmaceuticalindustry
Orphelia Pharma Secures US Patent
pharmaceuticalmanufacturer.media
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Breaking news! - First immunocytokine product in Regulatory Review! Philogen S.p.A. and Sun Pharmaceutical Industries Limited (SUN PHARMA) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy™, an investigational treatment for neoadjuvant (i.e., prior to surgery) locally advanced fully resectable melanoma. Nidlegy™ is a mixture of two immunocytokines, L19IL2 and L19TNF, manufactured independently and mixed prior to intralesional administration. L19IL2 (bifikafusp alpha) and L19TNF (onfekafusp alfa) are composed by the L19 scFv targeting fibronectin extra-domain B fused with the pro-inflammatory cytokine IL-2 and TNF, respectively. If approved, Nidlegy™ would become the first immunocytokine product to gain marketing authorization. https://lnkd.in/ep6BdR3n
240531_Press_release_Nidlegy_MAA_submission_to_EMA_FINAL.pdf
philogen.com
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Myelofibrosis Landscape to Change with Ojjaara Approval & Jakafi Patent Cliff The myelofibrosis treatment landscape is dominated by Janus kinase (JAK) inhibitors. In September 2023, the FDA approved GSK's (NYSE, LSE: GSK) JAK inhibitor, Ojjaara (momelotinib), for treating intermediate or high-risk myelofibrosis in adults with anemia. Ojjara's competitors in the market include the following JAK inhibitors: Incyte's (NASDAQ: INCY) Jakafi, Bristol-Myers Squibb's (NYSE: BMY) Inrebic, and Swedish Orphan Biovitrum's (STO: SOBI) Vonjo. The future competitive landscape of JAK inhibitors for myelofibrosis is gearing for change as Jakafi approaches patent expiry in 2028. Ojjaara and potential Jakafi generics could change the market dynamics. According to Visible Alpha consensus, Ojjaara is expected to generate revenues of $184 million in 2024, its first full year on the market, with peak sales of $1.03 billion anticipated in 2031. In comparison, Incyte’s Jakafi is estimated to generate $1.28 billion in 2024, reaching peak sales of $1.38 billion by 2027. Jakafi projections are expected to decline post-2027 as its patent expires in 2028. Inrebic, approved in August 2019, has modest revenue projections, markedly lower than Jakafi and Ojjaara. This is primarily attributed to the black box warning label for serious and fatal encephalopathy associated with Inrebic, a condition causing brain dysfunction. Clinicians typically use Inrebic as a 2nd line treatment for patients that do not respond to Jakafi. Revenues for Inrebic are projected to be $131 million in 2024, with peak sales anticipated to reach $163 million by 2029. Vonjo revenues are reported as combined with other indications, so we do not make a comparison here. Myelofibrosis is a type of blood cancer affecting around 25,000 patients in the U.S. Nearly all myelofibrosis patients are expected to develop anemia over the course of the disease and JAK inhibitors like Ojjaara address key manifestations of myelofibrosis, namely anemia, constitutional symptoms, and splenomegaly. Ojjaara is an oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. The ability to inhibit ACVR1 in addition to JAK1/JAK2 distinguishes Ojjaara from the others. Currently, Ojjaara is the only approved medication for newly diagnosed and previously treated myelofibrosis patients with anemia. #VisibleAlphaInsights
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Pfizer, through its Wyeth unit, is entitled to receive $107.5 million in damages from AstraZeneca after a Delaware federal jury found that the British-Swedish pharma’s cancer drug Tagrisso violated patent protections. Wyeth, which Pfizer acquired in 2009, sued AstraZeneca in 2021 claiming that Tagrisso infringes on two key patents. The first, dubbed the ‘314 patent, covers methods for treating NSCLC patients resistant to gefitinib and/or erlotinib with an EGFR blocker that covalently binds to the protein’s cysteine 773 residue. AstraZeneca also was found to have violated Wyeth’s ‘162 patent, which protects using these irreversible inhibitors to treat gefitinib- or erlotinib-resistant NSCLC patients with the specific T790M mutation on the EGFR protein. The two technologies are used by Wyeth and Puma Biotechnology’s Nerlynx, a kinase inhibitor that—like Tagrisso—irreversibly binds to EGFR. Nerlynx is indicated for HER2-positive breast cancer. #biotech #biopharma #patents #Tagrisso #Nerlynx #NSCLC
AstraZeneca to Pay Pfizer $107.5M in Damages in Tagrisso Patent Tussle | BioSpace
biospace.com
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🔬 Merck Healthcare's Strategic Licensing Agreement with Inspirna, Inc. Advances Novel CRC Therapy: Ompenaclid Merck Healthcare has entered a significant licensing agreement with Inspirna, Inc., marking a pivotal step in advancing a groundbreaking therapy for #colorectalcancer (CRC). The focus of this collaboration is on #ompenaclid, a first-in-class oral inhibitor targeting the creatine transport channel SLC6A8, and Inspirna's SLC6A8-targeting follow-on compounds. #Ompenaclid is currently undergoing Phase II evaluation for the second-line treatment of RAS-mutated (RASmut) advanced or metastatic CRC. ⭐ Key Highlights: 1. Addressing Unmet Needs in RAS-mutated CRC: Approximately 45% of the second-line population with RAS-mutated CRC lacks major treatment innovations over the past decade. Merck's licensing agreement with Inspirna aims to bring a potential first-in-class therapy, #ompenaclid, to improve outcomes for this patient population. 2. Encouraging Efficacy Data: #Ompenaclid demonstrated promising efficacy and safety in a Phase Ib/II study when combined with #FOLFIRI and #bevacizumab for second-line RASmut mCRC treatment. Key results presented at the 2023 ESMO - European Society for Medical Oncology Congress highlighted a median progression-free survival of 10.2 months and a median overall survival of 19.1 months across all 41 patients. 3. Ongoing Phase II Trial: Inspirna has initiated a Phase II double-blind randomized controlled trial, comparing #ompenaclid versus placebo in combination with #FOLFIRI and bevacizumab for second-line RAS-mutant advanced or metastatic CRC. This trial is a crucial step in further evaluating ompenaclid's potential. Merck Healthcare's collaboration with Inspirna, Inc. aligns with its dedication to advancing therapies for colorectal cancer. Usman "Oz" Azam, #CEO of Inspirna, Inc., expressed excitement about partnering with Merck and the potential of ompenaclid as a first-in-class therapy. 💼 Merck gains an exclusive license to #ompenaclid outside the U.S., with an option to co-develop and co-promote in the U.S. Inspirna, Inc. retains U.S. co-development and co-commercialization rights for follow-on compounds targeting SLC6A8. Inspirna, Inc. receives an upfront payment of $45 million, along with eligibility for milestone payments and tiered royalties based on net sales. This strategic collaboration underscores Merck Healthcare's commitment to advancing innovative therapies in colorectal cancer, addressing a critical gap in second-line treatment for RAS-mutated CRC. The ongoing Phase II trial and the licensing agreement with Inspirna, Inc. position #ompenaclid as a potential game-changer in improving patient outcomes. #Merck #ColorectalCancer #Ompenaclid #Inspirna #CancerTherapy #ClinicalResearch
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Optimizing phase 1 study designs in Oncology is crucial for efficient and effective clinical development, advancing new treatments while minimizing the time, resources, and sample size required for completion. Expedite dose selection and improve patient safety is key. Moving away from the classical 3+3 design to more adaptive and innovative designs can indeed offer several advantages, such as a faster process and better dose escalation strategies. This is especially helpful in scenarios where more precise dose escalation is needed or with investigational medicinal products (IMPs) that have complex PKs or challenging safety profiles. To address these challenges, there are several alternative Phase 1 trial designs that could be suitable for your next trial: -Accelerated Titration Designs, with faster dose escalation by enrolling fewer patients at each dose level initially and then escalating more rapidly based on observed toxicity. -Continuous Reassessment Method (CRM), which continuously updates the estimate of dose-toxicity relationship based on accumulating data. -Bayesian Adaptive Designs, that adaptively allocate patients to different dose levels based on accumulating data, allowing for efficient exploration of the dose-toxicity relationship. -Model-Based Designs, using mathematical models to predict dose-toxicity relationship and guide dose escalation, potentially allowing for faster identification of the maximum tolerated dose (MTD). Choosing the most appropriate design depends on factors such as the specific characteristics of the investigational agent, the anticipated safety profile, and the overall goals of the trial. Additionally, factors such as regulatory requirements and logistical considerations should be taken into account. Our team specializes in designing customized Phase 1 clinical trials in oncology and would be happy to support you to develop the most accurate and efficient design for your next trial. We're excited to collaborate with you to optimize your clinical development plan and expedite the advancement of your investigational therapy.
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There has been some interesting news from the clinic over the past week across biotech and medical devices. Here are some highlights that I found. 📢 Under new leadership, BioMarin axes 4 candidates and centers on 3 assets. After BioMarin’s new leadership conducted a “strategic R&D asset review,” three of its “most productive” assets are being prioritized, leaving four candidates on the wayside. 📢 Roche's pipeline rethink hits 20% of new molecules as cancer candidates join discard pile. The spring cancer clearout affected belvarafenib and RG6286. Belvarafenib, also known as RG6185 and HM95573, is an oral RAF kinase inhibitor that Roche’s Genentech licensed from Hanmi Pharmaceutical for $80 million upfront in 2016 📢 Sanofi pulls off phase 3 LUNA landing, sparking race to regulators for BTK inhibitor. Sanofi’s $3.7 billion Principia Biopharma buyout has delivered a phase 3 victory. The BTK inhibitor moved the needle in a clotting disorder, clearing Sanofi to file for approval of a “multi-indication blockbuster” that it predicts (PDF) could contribute to more than 10 billion euros ($11 billion) of drug launch sales. 📢 The hand-held ultrasound developer Exo has launched two new FDA-cleared artificial intelligence applications tied to its pocket-sized Iris probe, which made its own debut last fall. 📢 FDA approves Lumicell’s fluorescent system for highlighting residual breast cancer tissue. 📢 The U.S. health regulator has sent a warning letter to Cardinal Health after an inspection of its facility in Illinois found the company was marketing and distributing unapproved devices made by a Chinese manufacturer. 📢 GlaxoSmithKline sued Pfizer and BioNTech in Delaware federal court on Thursday, accusing them of infringing GSK patents related to messenger RNA (mRNA) technology in the companies' blockbuster COVID-19 vaccines. 📢 Abbott wins FDA approval for Esprit resorbable scaffold, an angioplasty device. While RBC analysts wrote there’s “strong appetite” for the system, BTIG said the need to train centers could result in a gradual launch. 📢 Despite trial miss, NRx pushes antidepressant forward with blockbuster hopes in bipolar depression. NRx’s investigational antidepressant has failed to reach statistical significance in reducing depression severity in a phase 2/3 trial, though the biotech is pressing forward to a registrational study with the belief that the candidate could eventually become a “paradigm-changing blockbuster drug.”
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t’s not often I get to report on a really meaningful industry-first! EXO Biologics is announcing the start of the first-ever EMA approved #clinicaltrial using #MSC-based #exosomes. The first cohort has just been #dosed in a #PhaseI/II trial evaluating its lead exosome #therapeutic candidate to prevent the #orphan indication BPD, the most common cause of death in pre-term babies. Exosomes have been highlighted as a hot topic across the industry for a number of years now, based on their therapeutic potential, so EXO Biologics being the first to bring MSC-based exosomes to the EMA-approved clinical stage is a major milestone for the company and the sector, as it will pave the way for other therapeutic exosomes to follow suit. https://lnkd.in/eTpXdFyB
EXO Biologics completes dosing of first cohort in first EMA-approved MSC-based exosome clinical trial
exobio.be
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Following three fatalities the FDA has halted a clinical trial involving BioNTech and MediLink ADC due to a significant risk of illness. Here are the key points: Trial Halt: - The FDA has put a temporary hold on a phase 1 clinical trial. - The trial was evaluating an antibody-drug conjugate (ADC) developed by BioNTech and MediLink. - The decision was made due to a serious adverse event observed in a participant. Risk Assessment: - The specific nature of the illness or adverse event has not been disclosed. - However, it was deemed significant enough to warrant an immediate halt to the trial. - The companies are likely working closely with the FDA to assess the situation. Implications: - The halt may impact the development timeline for the ADC. - Safety concerns are a critical factor in drug development, and any potential risks must be thoroughly investigated.
FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'
fiercebiotech.com
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Founder Director, DoseQuantics Consulting. Consultant in Pharmacokinetics, Pharmacodynamics, Quantitative Pharmacology, Drug Discovery & Development
Is the New Oncology Drug Providing True Clinical Benefit? I have indicated in earlier posts that, under the Chemotherapy Pillar of cancer, the true clinical benefit of an anti-cancer drug is seen its ability to provide an significant increase in Overall Survival (OS) and increase in Quality of Life (QOL) for patients. This brings into focus the process of Accelerated Approval of anti-cancer drugs by the FDA based on surrogate responses -molecular responses, tumor regression, PFS. Such drugs are required to be evaluated in confirmatory trials for OS and QOL. The authors of this paper [ https://lnkd.in/g8JEr8aC ] have analysed the relationship between Accelerated approval and Clinical benefit (measured in terms of conversion to regular approval) of anti- cancer drugs between 2013 and 2023. The results are very instructive and evokes some thinking. A total of 129 cancer drug–indication pairs were granted accelerated approval from 2013 to 2023. Among 46 indications with > 5 years of follow-up (approved 2013-2017), ~ two-thirds (29, 63%) were converted to regular approval, 10 (22%) were withdrawn, and 7 (15%) remained ongoing after a median of 6.3 years. Fewer than half (20/46, 43%) demonstrated a clinical benefit in confirmatory trials. Among drugs converted to regular approval, only two-thirds showed improvements in overall survival or quality of life, while one-third failed to show significant improvement in these outcomes. In the expanded cohort of conversion decisions from the past 10 years, the FDA has increasingly used surrogate measures such as response rate to support conversion from accelerated to regular approval. Their conclusions: Most cancer drugs granted accelerated approval did not demonstrate benefit in overall survival or quality of life within 5 years of accelerated approval. Patients should be clearly informed about the cancer drugs that use the accelerated approval pathway and do not end up showing benefits in patient-centered clinical outcomes. It would be useful to see the properties of the drugs which went on to receive full approval (based on OS and QOL ) for the same indication. This will be useful for discovery programs to identify candidates that will have the potential to convert to full approval.
Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval
jamanetwork.com
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