On April 10, 2025 Alterome Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering the development of next-generation, small molecule targeted therapies for the treatment of cancer, reported the appointment of Jung Choi as Chief Executive Officer (CEO) and Richard Heyman, Ph.D., as Chair of the Board of Directors (Press release, Alterome Therapeutics, APR 10, 2025, View Source [SID1234651880]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ms. Choi brings significant experience in growing companies from privately held, preclinical to publicly traded, commercial-stage organizations. Dr. Heyman is a scientist and entrepreneur with more than 25 years of experience in co-founding and building biotech and life science companies.

"Jung’s deep experience in building innovative portfolios and effectively scaling organizations will be invaluable to Alterome as we advance our two clinical-stage precision oncology programs from early clinical development towards commercialization. We are thrilled to welcome Jung to lead our next phase of growth and Rich to an expanded role as Chair. He has been instrumental in advising the company from our discovery phase to clinical development, and we look forward to his continued guidance," said Melissa McCracken, Partner at Nextech Ventures and member of the Board of Directors at Alterome Therapeutics. "The company thanks co-founder and former CEO Eric Murphy for his contributions to Alterome, and we are grateful for his service and leadership."

"I am honored to join the Alterome team at this important phase, as we work to advance two potential best-in-class and first-in-class treatment options for cancer patients and maximize the impact of our entire portfolio," said Ms. Choi. "My career has been driven by a passion to make transformative changes in people’s lives by delivering the best medicines science can create, and I see a great opportunity to bring this passion to life with the team at Alterome."

Ms. Choi is an expert in strategic deal making, having led or managed more than 50 transactions exceeding $17 billion in value. Her leadership experience includes serving most recently as Entrepreneur-in-Residence at Third Rock Ventures. Previously, she was Chief Business & Strategy Officer at Global Blood Therapeutics, where she was instrumental in building the company from preclinical stage to commercialization, establishing a portfolio of therapeutic hematology candidates, and leading the company’s $5.4 billion acquisition by Pfizer. She previously served as head of corporate development at InterMune (acquired by Roche), Chimerix, and Gilead Sciences, and began her career at Bay City Capital and McKinsey. She currently serves on the Boards of Annexon Biosciences and New York Blood Center.

Dr. Heyman takes the role of Chair of the Board of Directors after serving as a senior advisor to the company since 2022 and has more than 25 years of experience building oncology companies. Most recently, he served as Chair of Vividion Therapeutics, Rayze Bio and Amunix Pharma. Previously, Heyman was the Co-Founder and CEO of Aragon and Seragon Pharmaceuticals. Johnson & Johnson purchased Aragon in 2013, and Genentech purchased Seragon one year later. Dr. Heyman is the Co-Founder and Chair of ORIC Pharmaceuticals, a Venture Partner for Arch Ventures, and a Science Partner at Nextech Invest. He is also Chair of PMV Pharma and Enliven Therapeutics.

"I have had the privilege of experiencing up close Alterome’s progress since the inception of the company, as the team advanced from concept to discovery to clinical development in record time," said Dr. Heyman. "The collective experience and unwavering focus at Alterome, along with the strong support of investors, has enabled the development of two extremely promising clinical candidates with the potential to make a significant impact on the oncology therapeutic landscape."

On April 10, 2025 Arima Genomics, Inc. (Arima), a company leveraging 3D genomics to reveal actionable insights that will empower researchers and clinicians to improve human health, reported the publication of a study in The Journal of Molecular Diagnostics showing its proprietary technology detected clinical structural variants missed by conventional clinical tests (Press release, Arima Genomics, APR 10, 2025, View Source [SID1234651881]). Conducted in collaboration with researchers from NYU Langone Health, Weill Cornell School of Medicine, Scripps Cancer Center, Moores Cancer Center at the University of California, San Diego, and the University of Colorado School of Medicine, the retrospective study found that Arima’s technology identified gene fusions or rearrangements in 71% of cases where standard molecular techniques failed. Importantly, in 14% of these cases where no driver had been found by other techniques, a clinically actionable variant was identified.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Structural variants like gene fusions are central to cancer diagnostics, but current clinical tests miss many events that are crucial to diagnostic and therapeutic decision-making," said Matija Snuderl, MD, Professor of Pathology and Director of Molecular Pathology and Diagnostics at NYU Langone Health and corresponding author of the study. "Arima’s technology allowed us to detect hidden variants — many of them clinically actionable — in cases where standard tests came up empty. This provided important information to our understanding of the cancers and directly impacted patient care in some cases, confirming diagnoses and improving treatment options."

In the current study, researchers analyzed 71 formalin-fixed, paraffin-embedded (FFPE) specimens across ten solid tumor types, comparing results using Arima’s technology to results from prior clinical testing via fluorescence in situ hybridization (FISH), RNA sequencing, and DNA sequencing. Arima’s technology demonstrated 98% concordance with positive cases detected by conventional methods. Among the 14 samples negative by standard techniques, structural variants in 71% (10/14) were uncovered. Among these:

14% (2/14) harbored gene fusions or rearrangements listed in current clinical guidelines, directly impacting patient care.
14% (2/14) involved rearrangements affecting therapeutically targetable genes, potentially expanding treatment options even though they are not currently classified as actionable in guidelines.
Several cases described in the paper highlight the utility of Arima’s technology in achieving proper diagnosis and enabling appropriate therapeutic intervention.

For example, one young patient experiencing seizures was initially believed to have a non-tumorous brain abnormality called focal cortical dysplasia. DNA methylation results hinted at a possible low-grade glioma but remained inconclusive following two commercial RNA sequencing panels, which did not identify a diagnostic fusion for low-grade glioma. Only when the patient’s sample was analyzed with Arima’s technology did doctors detect a MYBL1::MAML2 fusion, confirming a low-grade glioma diagnosis and allowing the patient to receive the proper treatment.

In another case involving a pediatric glioblastoma patient, Arima’s technology detected a complex rearrangement involving PD-L1 that standard RNA and DNA tests missed. Later confirmatory testing using immunohistochemistry showed that PD-L1 was overexpressed on the tumor cells and provided an opportunity for immunotherapy treatment based on PD-L1 expression—an option that would have been overlooked without the enhanced sensitivity of Arima’s technology.

Arima’s technology uses high-throughput chromosome conformation capture (Hi-C) sequencing to map the spatial architecture of the genome within FFPE tumor samples. By revealing how DNA is organized in 3D space, it detects gene fusions, rearrangements, and translocations with 100-1000 times higher signal compared to standard methods like RNA or DNA sequencing or FISH, resulting in superior sensitivity.

Beyond actionable findings, the study also described how Arima’s technology offers deep insights into tumor biology by detecting complex genomic rearrangements such chromothripsis and extrachromosomal DNA (ecDNA). Recent literature has suggested ecDNA may be involved in treatment resistance, but may also be targetable with on-market therapies.

"Our technology provides a unique method to amplify the signal of rearrangements," said Anthony Schmitt, PhD, Senior Vice President of Science at Arima Genomics. "This allows us to capture structural rearrangements with far greater sensitivity and detail in FFPE samples—bringing both immediate clinical benefit and new avenues for research."

This new publication adds to a growing body of clinical evidence supporting Arima’s technology, building on recent studies conducted in collaboration with institutions such as Yale School of Medicine, Harvard Medical School, and Seattle Children’s Hospital.

On April 10, 2025 3B Pharmaceuticals GmbH (3BP), a leader in the development of targeted radiopharmaceuticals, and TetraKit Technologies (TT), developing cuttingedge click chemistry radiolabeling technologies, reported a strategic collaboration in the targeted radiotherapy field (Press release, 3B Pharmaceuticals, APR 10, 2025, View Source [SID1234651866]). This partnership will leverage the unique strengths of both companies towards development of a drug candidate, which can be labeled with astatine-211, a highly promising alpha particle-emitting radionuclide to treat cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This collaboration has the potential to advance an emerging class of peptide radiopharmaceuticals labeled with astatine-211. "We are very excited to work with 3BP," said Andreas Jensen, CEO of TetraKit Technologies. "By combining our radiolabeling platform with the impressive drug discovery know-how and expertise of a highly reputable and established company such as 3BP, we are confident that we can advance the development of a ground-breaking novel drug that harnesses the promising properties of astatine-211 and sets the stage for further advances in the field."

On April 10, 2025 CureVac N.V. (Nasdaq: CVAC) ("CureVac"), a global biotech company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported financial results for the fourth quarter and full-year 2024 and provided a business update (Press release, CureVac, APR 10, 2025, View Source [SID1234651867]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Commenting on the quarter Dr. Alexander Zehnder, Chief Executive Officer of CureVac said:

"The fourth quarter of 2024 marked a strong finish to a year of significant transformation for CureVac. We strategically repositioned the company around impactful R&D and technology innovation, which enabled us to advance several novel development programs, leveraging our unique mRNA platform. The successful restructuring and improved financial discipline position the company for stronger performance, supported by recent validation of our intellectual property in Europe."

Selected Business Updates

Protection of Intellectual Property Rights

Litigation in Europe was successfully advanced with a positive ruling by the Opposition Division of the European Patent Office (EPO), announced on March 27, 2025, confirming the validity of CureVac’s European patent EP 3 708 668 B1, subject to amendments to specify the scope of protection. The decision is appealable. The patent describes a foundational invention of CureVac, called split poly-A tail technology, which aims to enhance medical efficacy by improving expression of the protein encoded on an mRNA construct.

In its decision, the Opposition Division largely dismissed the opposition originally filed by BioNTech SE in April 2023 challenging the patent’s validity and maintained the patent in amended form. The ruling represents a major milestone in the ongoing patent dispute between CureVac and BioNTech in Germany, which involves a total of six intellectual property rights. CureVac believes that this patent is infringed in its amended form. An infringement hearing is scheduled for July 1, 2025, before the Regional Court Düsseldorf. A positive infringement decision would trigger proceedings to assess damages in the same court.

"The positive litigation development in Europe sends a strong message that reinforces the strength and impact of our patent portfolio, which is one of the broadest and most diverse portfolios in the entire mRNA space," said Dr. Zehnder. "Our breakthrough and pioneering inventions have contributed significantly to innovation in mRNA medicine and most assuredly deserve formal recognition where due."

The next milestone in the European litigation will be a hearing to rule on the validity of European patent EP 4 023 755 B1 scheduled for May 13-15, 2025, before the same EPO board.

Oncology

CureVac aims to create breakthrough treatment options for earlier settings of multiple solid tumor types and is strengthening its clinical development pipeline with two complementary approaches: off-the-shelf precision immunotherapies targeting tumor antigens shared across different patient populations and/or tumor types and fully personalized precision immunotherapies based on a patient’s individual tumor genomic profile.

New off-the-shelf program in squamous non-small cell lung cancer

CureVac’s new program for a shared-antigen precision immunotherapy targeting squamous non-small cell lung cancer (sqNSCLC) is on track with recent Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions to regulatory authorities in the U.S. and Europe, respectively. With the FDA clearance received, as reported on April 7, 2025, to proceed with the Phase 1 study of CureVac’s investigational precision immunotherapy, CVHNLC, in patients with sqNSCLC, dosing of the first patient is expected in the second half of 2025.

CVHNLC is a multiepitope mRNA-based precision immunotherapy consisting of two different mRNA constructs encoding a total of eight tumor-associated antigens with prevalence across sqNSCLC patients. Four of the encoded antigens represent established antigens, while the other four are novel antigens lying outside of the exome space identified under the CureVac myNEO Therapeutics collaboration, applying myNEO Therapeutic’s advanced AI-powered technology platform. These novel antigens have not been previously tested in cancer immunotherapy trials. CVHNLC will be tested in combination with the check point inhibitor pembrolizumab.The Phase 1, dose-finding, open-label study will assess the safety and tolerability of CVHNLC as a first line treatment for metastatic disease. In Part A, patients with metastatic Stage IV sqNSCLC, who have received at least three cycles of pembrolizumab, either as monotherapy or in combination with chemotherapy, will be enrolled. CVHNLC doses between 100 µg and 400 µg will be administered in escalating fashion in combination with pembrolizumab maintenance therapy for up to 12 months or until disease progression or undue toxicity occurs.

"Our approach to precision immunotherapy aims to induce a potent immune response that translates into clinical benefit for patients by applying the ability of mRNA to precisely and safely guide the immune system to one or more tumor antigens," said Dr. Myriam Mendila, Chief Scientific Officer at CureVac. "With this approach, we aim to target earlier stages of cancer in patients, who have not previously undergone multiple lines of treatment, where there is a higher chance to increase cure rates."

Further discovery work in CureVac’s oncology therapeutic area aims to deliver additional off-the-shelf precision immunotherapies, with the selection of a second clinical candidate anticipated in 2026.

In parallel, the program for fully personalized precision immunotherapies is on track with the Phase 1 study expected to begin in the second half of 2026.

Clinical off-the-shelf program in glioblastoma

Part B of CureVac’s Phase 1 study with shared antigen precision immunotherapy candidate CVGBM is ongoing in patients with resected glioblastoma. Part B successfully completed patient enrollment, adding 20 patients to be treated with CVGBM monotherapy at the recommended dose of 100 µg. Data from Part B and a decision on advancing the program to Phase 2 are expected in the second half of 2025.

CureVac presented preliminary clinical data from Part A of the CVGBM Phase 1 study in September 2024 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and in November at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the Society for Neuro-Oncology (SNO) congresses. Preliminary immunogenicity results demonstrated cancer antigen-specific T-cell responses in 77 % of 13 evaluable patients; 84 % of immune responses were being generated de novo. At the 100 µg dose, the majority of responses were sustainable over a 99-day monitoring period. Induction of cellular responses was accompanied by systemic cytokine and chemokine activation, indicating innate immune response activation. The treatment was generally well tolerated, with no dose-limiting toxicities. 91 % of treatment-related adverse events (TRAEs) were mild to moderate systemic reactions, resolving within 1-2 days post-injection. Seven patients reported nine severe TRAEs, including four serious adverse events.

More information can be found at clinicaltrials.gov (NCT05938387).

Prophylactic Vaccines

Urinary Tract Infections Program

In November 2024, CureVac announced the initiation of a new program to address urinary tract infections (UTIs), supported by promising preclinical data. UTIs are among the most frequent bacterial infections, most commonly caused by uropathogenic Escherichia coli (UPEC) bacteria. UPEC can enter the urinary tract, invade and colonize bladder and kidney tissues. These infections can lead to complications such as kidney damage and urosepsis. UTIs lead to approximately 8-10 million doctor office visits and 1-3 million emergency department visits per year in the U.S. alone.

The program is progressing, and it is expected to file an IND submission in the second half of 2025 for a Phase 1 study to commence in the first half of 2026.

Seasonal Influenza/COVID-19 Combination Vaccine – Program Licensed to GSK

In November 2024, GSK initiated the Phase 1 of a combined Phase 1/2 study to assess reactogenicity, safety and immune responses of a multivalent seasonal influenza/COVID-19 combination vaccine candidate. The start of the Phase 1 was accompanied by a €10 million milestone payment to CureVac, which was invoiced in the fourth quarter of 2024.

More information can be found at clinicaltrials.gov (NCT06680375 ).

As previously announced in July 2024, CureVac and GSK restructured their collaboration into a new licensing agreement. Under the new agreement, GSK has assumed full control of the development, manufacturing and global commercialization of mRNA vaccine candidates against influenza and COVID-19, including combinations. All vaccine candidates currently in clinical development are based on CureVac’s proprietary second-generation mRNA backbone.

Financial Update for the Fourth Quarter and Full-Year 2024

Commenting on the financial results, Axel Sven Malkomes, CureVac’s Chief Financial Officer, said:

"Our decisive actions in 2024 to enhance fiscal discipline have significantly strengthened our financial foundation, securing a robust cash position that supports our runway into 2028. This financial strength provides CureVac with the flexibility and resources needed to accelerate innovation in our mRNA pipeline."

Cash Position

Cash and cash equivalents amounted to €481.7 million at the end of December 2024, increasing from €402.5 million at the end of 2023. The company received the €400 million upfront payment from the new GSK licensing agreement in August 2024. In 2024, cash used in operations was mainly allocated to extraordinary payments amounting to a total of €137 million, related to the termination of raw material commitments for the first-generation COVID-19 vaccine, CVnCoV, the payment of contract manufacturing organization (CMO)-related arbitration awards, payments related to the restructuring of the organization and related to the litigation to enforce intellectual property rights. All CMO-related arbitrations are closed, with the last payment made in the third quarter of 2024. Looking forward, there will be no further payments related to CVnCoV.The remaining cash spend was mainly related to ongoing R&D activities. The company reaffirms its expected cash runway into 2028.

Revenues

Revenues amounted to €14.5 million and €535.2 million for the three and twelve months ended December 31, 2024, respectively, representing a decrease of €8.1 million and an increase of €481.4 million from €22.6 million and €53.8 million for the same periods in 2023.

The increase year-on-year was primarily driven by the new license agreement with GSK, which closed in July 2024. CureVac received a non-refundable upfront payment of €400 million. Under the new license agreement, CureVac has no obligation to perform R&D work in connection with the newly granted licenses, and GSK is provided with the exclusive right to use CureVac’s intellectual property relating to licensed vaccine programs. As such, the upfront payment was fully recognized in the third quarter of 2024 as revenue.

CureVac and GSK agreed in the new license agreement that all unfulfilled performance obligations from prior collaborations relating to R&D services had expired. As a result, the remaining €80.4 million of contract liabilities for prior collaborations were recognized as non-cash revenue in the third quarter of 2024.

€480.4 million of the revenue recognized in 2024 must therefore be seen as a positive one-time event that will not be repeated in the future.

Additionally, in 2024, Curevac reached development milestones of €15.0 million under the previous GSK collaboration for the Phase 1 and Phase 2 transition of the pre-pandemic avian influenza (H5N1) program, and a development milestone of €10.0 million under the new license agreement for the initiation of Phase 1 of the combined Phase 1/2 study of a seasonal influenza/COVID-19 combination vaccine. These milestones were recognized as revenue in 2024.

The remaining revenues mainly relate to the CRISPR collaboration.

Operating Result

Operating loss amounted to €43.8 million for the three months ended December 31, 2024, and operating profit amounted to €177.7 million for the twelve months ended December 31, 2024, respectively, representing a decrease of €44.2 million and €451.9 million from an operating loss of €88.0 million and €274.2 million for the same periods in 2023.

The operating result was affected by several key drivers partially related to the new strategy and the closing of the first-generation vaccine effort in COVID-19:

· Cost of sales decreased year-on-year mainly due to the change in strategy associated with the new license agreement with GSK, resulting in adapted R&D activities. As CureVac’s manufacturing organization is no longer supporting revenue generating activities, such costs are subsequent to the change no longer classified as cost of sales. In addition, higher material costs appeared in the prior year, which were driven by write-offs of raw materials originally purchased for the stock piling of the terminated Pandemic Preparedness Agreement.

· Research and development expenses increased primarily due to the costs of CureVac’s manufacturing organization classified as R&D expenses rather than cost of sales following the change in strategy, and due to increased activity in oncology R&D projects. Additionally, 2024 was impacted by extraordinary expenses related to the litigation to enforce intellectual property rights, and by higher personnel expenses related to the restructuring of the organization.

· General and administrative expenses decreased compared to the prior year period, mainly driven by lower personnel expenses.

· Other operating expenses increased year-on-year due to a partial impairment of CureVac’s production facility.

While the production facility was initially planned and set up for commercial (large scale) production, CureVac no longer has large scale production obligations in addition to the strategic re-focus on technology innovation, research and development. Most parts of the production process can be scaled down to provide products for clinical production. One production line, which cannot be scaled down, will not be developed further and was impaired with an amount of €32.1 million.

Financial Result (Finance Income and Expenses)

Net financial result for the three and twelve months ended December 31, 2024, amounted to €5.2 million and €13.2 million, or an increase of €3.7 million and a decrease of €1.0 million, from €1.5 million and €14.2 million, respectively, for the same periods in 2023. This decrease was mainly driven by lower interest income on cash investments.

Pre-Tax Results

Pre-tax loss was €38.6 million for the three months ended December 31, 2024, and pre-tax profit was €190.9 million for the twelve months ended December 31, 2024, compared to a pre-tax loss of €86.5 million and €260.0 million in the same periods of 2023.Conference call and webcast details

CureVac will host a conference call and webcast today at 3 p.m. CET / 9 a.m. EST.
Dial-in numbers to participate in the conference call:

U.S. Toll-Free: +1-877-407-0989

International: +1-201-389-0921

Germany: 0800-182-0040 (landline access) / 0800-184-4713 (cell phone access)

The live webcast link can be accessed via the newsroom section of the CureVac website at View Source

Corresponding presentation slides will be posted shortly before the start of the webcast.A replay will be made available at this website after the event.

On April 10, 2025 Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK), reported that its independently developed antibody-drug conjugate (ADC), SIM0686, which targets FGFR2b (Fibroblast Growth Factor Receptor 2b), has received clinical trial approval from the China National Medical Products Administration (Press release, Jiangsu Simcere Pharmaceutical Company, APR 10, 2025, View Source [SID1234654314]). This achievement permits the company to initiate clinical trials involving Chinese patients with FGFR2b-positive, locally advanced, or metastatic solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FGFR2b is a transmembrane tyrosine kinase receptor expressed in epithelial tissues. Its overexpression or gene fusion has been associated with various solid tumors. SIM0686 is a clinical-stage ADC developed using Simcere Zaiming’s proprietary technology platform. The molecule combines the tumor-specific targeting capabilities of antibodies with the anti-cancer properties of topoisomerase inhibitors. Preclinical studies indicate that it demonstrates significant anti-tumor activity, not only in FGFR2b-positive tumor cells but also in FGFR2b-negative tumor cells via a bystander effect. The preclinical findings will be presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), Abstract No. 2964.