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Interius BioTherapeutics to Present at Upcoming Scientific Meetings

On April 17, 2025 Interius BioTherapeutics, a clinical-stage company engineering targeted, programmable vectors for the precision delivery of genetic medicines, reported that it will present at several upcoming scientific meetings (Press release, Interius BioTherapeutics, APR 17, 2025, View Source [SID1234651973]).

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Cellicon Valley ’25: The Future of Cell and Gene Therapies
Philadelphia, PA
April 30 – May 2, 2025

Plenary Session: Are In Vivo Cell Therapies the Key to the Future of Medicine?
Presentation Title: Cell-specific in vivo gene delivery: A pipeline dream no longer
Presenter: Philip Johnson, M.D., Chief Executive Officer, Interius BioTherapeutics
Presentation Date and Time: Thursday, May 1, at 3:50 pm EDT
International Society for Cell and Gene Therapy (ISCT) 2025 Annual Meeting
New Orleans, LA
May 7 – 10, 2025

Scientific Session: In Vivo Cell Engineering: Breaking Through the Manufacturing Bottleneck
Presentation Title: INVISE: A first-in-human Phase 1 clinical trial evaluating the safety of INT2104 for in vivo generation of CAR T and CAR NK cells in adults with relapsed/refractory B cell malignancies
Presenter: Dr. David Bishop, Haematologist, Westmead Hospital, Sydney, Australia
Presentation Date and Time: Friday, May 9, at 9:15 am CT
American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting
New Orleans, LA
May 13 – 17, 2025

Scientific Symposium: The Coalition of International Gene Therapy Societies Showcases: Moving from ex vivo Cell Therapies to in vivo
Presentation Title: Investigational in vivo CAR-T therapy designed to treat B-cell malignancies
Presenter: Philip Johnson, M.D., Chief Executive Officer, Interius BioTherapeutics
Presentation Date and Time: Thursday, May 15, from 3:45 – 5:30 pm CT
Location: Room 265-268

Blenrep (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma

On April 17, 2025 GSK plc (LSE/NYSE: GSK) reported the authorisation of Blenrep by the Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide (Press release, GlaxoSmithKline, APR 17, 2025, View Source [SID1234651972]). This UK regulatory authorisation marks the first in the world for Blenrep in this treatment setting.

Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHRA authorisation of Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7.2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.2,3

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Today’s approval of Blenrep combinations in the UK is a transformative milestone for patients with multiple myeloma, a cancer marked by remission and relapse. As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse."

Currently, most patients with multiple myeloma experience relapse, and in the UK only 55% remain alive five years after diagnosis.5 Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) in multiple myeloma, providing patients at or after relapse with a differentiated mechanism of action. Blenrep combinations can be administered to a range of patient types in any oncology treatment setting without complex pre-administration regimens or hospitalisation.

Joseph Mikhael, MD, Chief Medical Officer, International Myeloma Foundation and Professor, Translational Genomics Research Institute, City of Hope Cancer Center, said: "As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival. We are pleased to see this advancement in the treatment landscape extended across both academic and community settings where many patients are treated."

Both DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma.2,3 In DREAMM-7, the Blenrep combination nearly tripled median PFS versus the daratumumab-based comparator (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001).2 DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring the Blenrep combination (n=243) versus the daratumumab-based comparator (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023).4 The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm. In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached with the Blenrep combination compared to 12.7 months in the bortezomib combination.3

Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators.2,3

Eye-related side effects, a known side effect of treatment with Blenrep, were generally resolvable, manageable with extended time between infusions and dose reductions while maintaining efficacy, and led to low (≤9%) treatment discontinuations in both trials.2,3 The most commonly reported non-ocular adverse events (>30% of participants) in the Blenrep combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in the Blenrep combination arm of DREAMM-8.

Blenrep combinations are currently under review in 14 countries, including in the US with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025,6 European Union,7 Japan (with priority review),8 China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application),9 Canada, and Switzerland (with priority review for DREAMM-8).

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.10,11 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.12 Multiple myeloma is a significant concern in the UK, which ranks fifth in incidence rate of all European countries. There are approximately more than 6,500 new cases of multiple myeloma diagnosed each year and an expected 5-year prevalence of over 19,400 cases in the UK.13,14 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.1 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.15,16

About Blenrep
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication
In the UK, Blenrep is indicated in adults for the treatment of multiple myeloma:

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
IMPORTANT SAFETY INFORMATION FOR BLENREP
More information can be found in the Blenrep Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes. Results were first presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024 and published in the New England Journal of Medicine.2

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes. Results were first presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.

Evotec SE unveils new strategy and provides 2025 guidance bolstered by strong Q4 2024 results

On April 17, 2025 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported its financial results for FY 2024, provided guidance for FY 2025 and outlook for 2028 reflecting the path to sustainable profitable growth, following the completion of its strategic review process (Press release, Evotec, APR 17, 2025, View Source [SID1234651971]).

Dr Christian Wojczewski, Chief Executive Officer of Evotec, said:

"Evotec’s ambitious new direction paves the way for sustainable profitable long-term growth. We are refocusing Evotec on its core strengths: technology and science leadership, where we deliver maximum impact for customers and patients. By combining cutting-edge technology platforms, disruptive science, and AI-driven innovation, we are accelerating the journey from concept to cure with our partners. We delivered on 2024 financial guidance, and I am excited about the opportunities that lie ahead of us. Together with our talented teams, we are writing the next chapter of Evotec’s success story as a drug discovery pioneer."

Evotec unveils new strategy to refocus on core strengths and define clear roadmap to sustainable profitable growth

· Technology and science leadership – refocusing on our strong, unique heritage

· Two pillars: Drug Discovery & Pre-clinical Development (Shared R&D) and Just – Evotec Biologics

· Drug Discovery & Pre-clinical Development will leverage automation, industrialisation, next generation platforms and AI to accelerate our customers journey and to increase their success rates

· Business model simplified: focus on high-value services and therapeutic areas, asset portfolio streamlined by ~30%, R&D supporting next-generation technology development. Exiting equity participations

· Just – Evotec Biologics growth underpinned by existing partnerships and further strengthened by leveraging its capabilities as a scalable technology and service provider, anticipating pivot to an asset lighter model

· Beating market growth via our scientific and operational expertise, focus, and differentiated technology

· Commitment to operational excellence for a step-change in performance. Driving operational leverage through our backbone with higher focus on automation. Anchored cost-out initiatives via refined footprint, optimised COGS and SG&A delivering > € 50 m gross savings by 2028 on top of Priority Reset (€ 40 m)

2024 revenue and EBITDA within guidance. Priority Reset on track. Q4: Second highest quarterly revenues ever amid challenging market environment

· Group revenues increased by 2% to € 797.0 m (2023: € 781.4 m); Q4 2024 revenues increased by 10% to € 221.2 m from € 201.3 m in Q4 2023

· Evotec’s Just – Evotec Biologics segment saw impressive growth, with revenues rising by 71% year-over-year, contributing € 185.6 m (2023: € 108.4 m) to the overall topline

· Total Shared R&D revenues decreased by 9% to € 611.4 m (2023: € 673.0 m); Demand still affected by temporary Pharma restructuring and selective funding for Biotech

· Adjusted Group EBITDA totalled € 22.6 m (2023: € 66.4 m) driven by a mismatch between revenues and cost base in the Shared R&D segment

· Priority Reset on track to secure an annualised adjusted EBITDA improvement of over € 40 m. One-off costs recognised at € 54.9 m, vs. initial provision of € 68.5 m

· Net debt leverage ratio significantly improved to 1.9x net debt / EBITDA

Strengthened partnerships in 2024 paving the way for 2025 growth in soft market environment

· Group revenue growth expected to accelerate vs. 2024, driven by Just – Evotec Biologics, while Shared R&D revenues expected to remain around 2024 levels

· Tariffs & US government funding development are expected to have a limited impact on Evotec’s business

· Expansion of technology partnership with Sandoz and new customers for long-term development and commercial manufacturing in Biologics

· Progress and extension of multi-year collaboration with Bristol Myers Squibb ("BMS") in neuroscience and targeted protein degradation

· New technology development partnership with Novo Nordisk to support next-generation cell therapies

· New multi-year master research collaboration with Pfizer, initially focusing on early discovery research for metabolic and infectious diseases

Guidance for full-year 2025

· Group revenues expected in the range of € 840 – 880 m (2024: € 797.0 m)

· R&D expenditures are expected in a range of € 40 – 50 m (2024: € 50.8 m)

· Adjusted Group EBITDA is expected to reach € 30 – 50 m (2024: € 22.6 m)

Outlook 2028

· Group revenues CAGR2024-2028 targeted to be in a range of 8 – 12 %

· Adj. EBITDA margin 2028 expected to be above 20%

CAGR: Compound annual growth rate

More detailed information and financial tables are available in the annual report published on the Evotec website under the following link: View Source

Webcast/Conference Call

The Company is going to host a conference call to discuss 2024 results as well as to provide an update on the concluded strategic review process. The conference call will be held in English.

Webcast details

Date: Thursday, 17 April 2025

Time: 2.00 pm CEST (1.00 pm BST, 8.00 am ET)

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand version of the webcast will be available on our website: www.evotec.com.

Conference call detail

To join via phone, please pre-register via this link

You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite’s Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients

On April 17, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that leading Medical Centers in the US are approaching the FDA, asking for compassionate use approval to treat patients with pancreatic carcinoma with the company oncological drug Namodenoson (Press release, Can-Fite BioPharma, APR 17, 2025, View Source [SID1234651970]).

Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.

Simultaneously, Can-Fite is actively enrolling patients in Israel for a Phase IIa study—an open-label trial designed for individuals with advanced pancreatic adenocarcinoma whose disease has progressed despite at least first-line therapy. The trial aims to assess the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this challenging patient population. The study is led by Dr. Salomon Stemmer, a renowned key opinion leader at the Institute of Oncology, Rabin Medical Center, Israel. Notably, Namodenoson has been granted Orphan Drug Designation by the U.S. FDA, further underscoring its potential as a promising therapeutic option.

"We are thrilled that more top-tier U.S. medical centers are recognizing the potential of Namodenoson and are eager to participate in our compassionate use program," said Motti Farbstein, CEO of Can-Fite. "Our goal is to provide this underserved patient population with a novel treatment that may extend survival and improve quality of life."

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

Clarity signs high-volume commercial-scale copper-64 Supply Agreement with Nusano

On April 17, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop and commercialise next-generation products that improve treatment outcomes for people with cancer, reported the signing of a commercial-scale Supply Agreement for copper-64 with Nusano (Press release, Clarity Pharmaceuticals, APR 17, 2025, View Source [SID1234651958]).

Nusano’s 190,000 square foot state-of-the-art facility in West Valley City, Utah is expected to begin production in 2025 with copper-64 isotope supply planned to commence in early 2026. The accelerator-based proprietary technologies employed by Nusano are particularly well suited for cost-effective mass production of copper-64. The Nusano facility is capable of producing more than 1,000 Ci (37,000 GBq) of copper-64 per day at capacity, which translates into more than 18,000 patient doses per day at 200 MBq per dose, with a 48-hour shelf-life, well in excess of commercial-scale demands across multiple large oncology indications in line with Clarity’s commercialisation strategy. Nusano is also developing in-house production of the target material for copper-64 manufacturing, nickel-64 (Ni-64), and plans to commence production of copper-67 (Cu-67 or 67Cu) and actinium-225 (Ac-225 or 225Ac) isotopes in 2025-2026. Both of these isotopes are used in Clarity’s pipeline of theranostic products in development.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The signing of this Supply Agreement with Nusano will complement Clarity’s existing network of US-based copper-64 suppliers, providing capacity to ensure abundant and seamless supply of the isotope. As Clarity is generating exceptional data in a number of late-stage clinical trials, we now also have a cost-effective, large-scale supply strategy locked in for the commercial roll-out of our Targeted Copper Theranostics (TCTs) in the largest healthcare market in the world, the US. This Agreement is an important part of a larger commercial manufacturing strategy, which we will continue implementing as we get closer to the filing of New Drug Applications (NDA) with the US Food and Drug Administration (FDA).

"The ability to make isotopes and products in the US for the treatment of the American people is an important advantage in the current geo-political and economic environment. By building a supply chain that is fully integrated, from high-volume isotope production, to centralised product manufacture, to delivering these ready-to-use diagnostics to imaging sites in every state of the US on time and on demand, we are aiming to build a model that is impervious to economic and political instability.

"In large oncology indications, such as prostate-specific membrane antigen (PSMA) positron emission tomography (PET) diagnostics (which Clarity is addressing with our key product, SAR-bisPSMA), ensuring stable, abundant and seamless supply of isotopes is crucial for a successful commercial launch.

"We have seen first-hand from the current generation of radio-diagnostics that efficient and timely product supply can make or break the adoption of the products and their expansion in the oncology practice. The current market leaders in PSMA PET imaging face several limitations associated with their short half-life (less than 2 hours vs. 12.7 hours for copper-64). These include short shelf-lives, restricted availability throughout the imaging site’s workday, and narrow imaging windows. At Clarity, our strategy is straightforward: we are determined to overcome these limitations and lay a strong foundation for the successful roll-out of TCTs globally.

"Our goal is to take radiopharmaceuticals to the next level by building a reliable and accessible supply that is consistent with the big pharma oncology model and deliver advantages to patients, their treating clinicians and imaging sites. Under this central manufacture model, the imaging sites will receive the copper-64 based diagnostics on demand, at any time and in volumes consistent with the rapidly growing demand of this blockbuster market. The clinicians have the added flexibility to administer the copper-based diagnostics and image patients over a significantly longer timeframe than what the current products allow. This translates into more flexibility for patient imaging and potentially higher lesion detection sensitivity that could lead to better identification of cancer lesions, helping to determine the best course of treatment for oncology patients.

"With our SAR-bisPSMA product generating a lot of exciting data and 3 US FDA Fast Track Designations granted for this product1,2,3 for accelerating its development, locking in commercial-scale supply of copper-64 means we are now closer than ever to changing the paradigm of prostate cancer diagnosis, ensuring no man is left waiting for a PSMA PET scan," said Dr Taylor.

Nusano’s Chief Executive Officer, Chris Lowe, commented, "Nusano is commercialising a breakthrough radioisotope production platform in 2025 capable of producing more than 25 radioisotopes for life science applications, including copper-64, copper-67 and actinium-225. We are excited to enter into a Supply Agreement with Clarity for copper-64 to enable their clinical and commercial efforts with a dependable supply of radioisotopes from our world-class production facility in Utah."

Additional Disclosure
The Supply Agreement is effective as of 16 April 2025 and is for an initial period of 3 years with automatic renewal for successive 2-year periods. Cancellation provisions are aligned with industry standard rates.