Numab Therapeutics AG

NM32 is a first-in-class half-life-enhanced T-cell engager targeting ROR1, a tumor associated antigen with broad expression in solid tumors and hematological malignancies Low molecular weight of NM32 allows to efficiently achieve higher tumor concentrations than larger immunoglobulin G molecules, the current standard format for CD3 engagers HORGEN, Switzerland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Numab Therapeutics AG (“Numab”) announced today the start of a Phase 1 clinical trial evaluating NM32, a next generation tri-specific immuno-oncology therapeutic targeting the receptor tyrosine kinase-like orphan receptor 1 (ROR1) and the T-cell receptor associated antigen CD3. The third binding moiety of NM32 targets serum albumin to provide half-life extension allowing for convenient bi-weekly dosing and to keep the lower molecular weight than immunoglobulin enabling efficient tumor penetration. “Generated from our proprietary Lambda-capTM and MATCHTM technology platform, NM32 represents a T-cell engager designed to help the patient’s immune system recognize and attack tumor cells. ROR1 is overexpressed on a wide spectrum of highly prevalent solid tumor indications but has very limited expression on normal tissue, making it an optimal antigen for a CD3 engager,” said David Urech, Ph.D., Founder and Chief Executive Officer of Numab Therapeutics. “We are pleased to start NM32’s clinical development path enabling us to potentially bring this novel therapy to patients with advanced solid tumors who are in need of treatment options that provide durable anti-tumor activity with a tolerable safety profile. Enrollment is progressing nicely, with patients completing the first treatment cycle of the initial dose level”, commented Martin Stern, Senior Vice President Clinical Science at Numab Therapeutics. “Despite the introduction of checkpoint inhibitors and several commercially available CD3 engagers for the treatment of hematological malignancies, there has been limited success in solid tumors mainly due to the lack of highly tumor-specific antigens allowing selective T-cell activation against tumor cells.” This multi-center Phase 1 study of NM32 is a dose-escalation trial to characterize the pharmacokinetic properties, pharmacodynamic effects and safety profile of NM32 and to select an optimal dosing regimen for further clinical development. It is planned to enroll up to 60 patients with solid tumors overexpressing ROR1 from major clinical sites across the United States. Generated preclinical data in non-human primates indicate a high potency and an excellent safety profile. About NM32 (NM32-2668)NM32 is a next generation tri-specific immuno-oncology drug targeting the receptor tyrosine kinase-like orphan receptor 1 (ROR1) and the T-cell receptor associated antigen CD3. The third domain targets serum albumin to provide half-life extension to allow convenient bi-weekly dosing. T-cell redirection using CD3 engagers is an established treatment modality showing high response rates and durable activity in hematological malignancies and has more recently also shown promising results for selected targets overexpressed in solid tumors. ROR1 is a clinically validated tumor associated antigen with overexpression in several indications with high unmet need including lung, breast, ovarian, endometrial, renal and gastric cancer and limited expression on healthy tissue. About Numab Therapeutics AGNumab Therapeutics AG is developing multi-specific antibody-based immunotherapies for inflammation and cancer. Reproducible plug-and-play therapeutic design process using proprietary platforms λ-CapTM and MATCHTM puts Numab in a unique position to overcome historical drug discovery barriers and build a pipeline of new and important medicines aimed to maximize patient benefits. Numab’s diverse research pipeline spans multiple therapeutic areas and creates the opportunity for the next generation of first-in-class and best-in-class medicines. Our lead candidate NM26, a unique multi-specific targeting IL-4/13 and IL-31 for best-in-class efficacy, is developed with a vision of delivering a lifelong cure to patients suffering from atopic dermatitis and other potential indications. Multiple partnerships with leading pharma companies validate the platform and development capabilities. For further information, visit https://www.numab.com. For further details, please contact: Numab TherapeuticsDavid UrechChief Executive Officerd.urech@numab.com Investor Contact: Patrick Till Meru Advisorsptill@meruadvisors.com

Phanes’ PT217 is a delta-like ligand 3 (DLL3) and a cluster of differentiation 47 (CD47- targeting bispecific antibody. Image Credit: Huen Structure Bio / Shutterstock. The US Food and Drug Administration (FDA) has granted an orphan drug designation to Phanes Therapeutics’ PT217 in neuroendocrine carcinoma (NEC) indication. This is the second orphan drug designation the therapy has received from the FDA. In 2022, PT217 received the designation for the treatment of small cell lung cancer (SCLC). The orphan drug status gives sponsors tax credits from clinical trials, exemption from user fees, and a potential seven years of market exclusivity for the therapy after approval, compared to the usual five years. PT217 is a delta-like ligand 3 (DLL3) and a cluster of differentiation 47 (CD47)-targeting bispecific antibody. Phanes is investigating the therapy in patients with advanced or refractory cancers expressing DLL3, including SCLC, extrapulmonary NECs, and large cell neuroendocrine carcinoma of the lung (LCNEC). The Phase I SKYBRIDGE trial (NCT05652686) is evaluating the safety, tolerability and pharmacokinetics of PT217 in combination with Roche’s PD-L1 therapy Tecentriq (atezolizumab). Multiple pharmaceutical companies have invested in the development of bispecific antibody therapies . Earlier this month, Merck & Co (MSD) unveiled plans to acquire a CD3 and CD19-targeting T cell engager bispecific antibody, CN201, from Curon Biopharmaceutical. The deal is worth approximately $1.3bn in upfront and milestone-based payments. It is expected to close in Q3 this year. In May, Johnson & Johnson (J&J) paid $1.25bn to acquire global rights for Numab Therapeutics’ IL-4R and IL-31-targeting bispecific antibody. The therapy is being evaluated as a treatment for atopic dermatitis in a Phase I trial (NCT05859724). See Also: AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting Hoth and Aronnax partner for HT-KIT cancer therapy development Other therapies in Phanes’s pipeline are a CD73-targeting monoclonal antibody PT199, a Claudin 18.2 (CLDN18.2), and the CD47-targeting bispecific antibody PT886. The company is evaluating PT199 as a combination treatment with BeiGene’s Tivimbra (tislelizumab) for solid tumours in a Phase I MORNINGSTAR trial (NCT05431270). The bispecific antibody PT886 is being trailed in combination with MSD’s Keytruda (pembrolizumab) in a Phase I/II TWINPEAK study (NCT05482893). The trial is expected to enrol approximately 114 participants with either unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC).

NM26 is a Phase 2-ready, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD) The Company is leveraging a multi-pathway approach to transform treatment in atopic dermatitis and other immune-mediated diseases NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson1 (NYSE: JNJ) announced today that it has successfully completed the acquisition of Yellow Jersey, a demerged subsidiary of Numab Therapeutics to secure the global rights to NM26, a novel, investigational first-in-class bispecific antibody, in an all-cash transaction of approximately $1.25 billion, as announced on May 28, 2024. NM26, which is ready to enter Phase 2 studies in atopic dermatitis (AD), targets two clinically proven pathways, IL-4R alpha subunit (IL-4Rα) and IL-31, which trigger Th2-mediated skin inflammation and skin itch, respectively. “NM26 is designed to help different subpopulations of patients by targeting two disease-driving pathways, which is key when treating a heterogeneous disease like AD,” said David Lee, Global Immunology Therapeutic Area Head, Johnson & Johnson Innovative Medicine. “We are excited about the potential this represents to transform the standard of care for AD, as well as other inflammatory skin diseases involving Th2 inflammation and itch.” AD is the most common inflammatory skin disease2. It causes itching and inflammation which are made worse by scratching. It can lead to increased risk of skin infections, skin pain, difficulty sleeping, anxiety, stress, depression and even an increased risk of suicide. “Nearly three-quarters of people with AD are not achieving remission with currently available treatments3. The unmet need is high, and we must do better for patients,” said Candice Long, Worldwide Vice President, Immunology, Johnson & Johnson. “Our investment in NM26, and other bispecific antibodies, is another important step towards our mission of durable, symptom-free remission for all patients living with immune-mediated diseases.” 1 Legal entity, Cilag Holding AG 2 3 About Atopic Dermatitis Atopic dermatitis (AD), also referred to as eczema, is a chronic inflammatory skin disorder affecting more than 9.6 million children and 16.5 million adults in the United States. AD is characterized by an overactive immune system that causes damage to the skin barrier, leaving it dry, itchy, and prone to rashes. AD may come and go throughout life and patients can experience severe flares of their disease. The condition can cause poor quality of life by causing social stigma impacting the ability to interact with family and friends, interrupting sleep due to intense itching and/or painful skin, and leading to anxiety, stress and depression with an increased risk of suicide. About the agreement Under the terms of the transaction Johnson & Johnson (the Company) has acquired Yellow Jersey Therapeutics which includes the NM26 program, and which was formed through a demerger with Numab. J&J entered a separate agreement with Kaken Pharmaceutical to secure rights in the Asia Pacific Region. In accordance with US GAAP, the transaction is being accounted for as an asset acquisition, resulting in an in-process research and development charge of approximately $1.25B in the third quarter of 2024 and full year Adjusted EPS dilution of $0.56 in 2024 and approximately $0.10 in 2025. The 2024 impact will be reflected in updated guidance at the second quarter earnings call on July 17, 2024. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Cautions concerning Forward-Looking Statements This press release contains “forward-looking statements” regarding the acquisition of NM26 from Numab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Cilag Holding AG, Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the acquisition may not be realized or may take longer to realize than expected; challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; economic conditions, including currency exchange and interest rate fluctuations; the risks associated with global operations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; change in behavior and pending patterns or financial distress of purchasers of health care services and products; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties, and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q, and other filings by Johnson & Johnson with the SEC. Copies of these filings are available online at , at or on request from Johnson & Johnson. None of Cilag Holding AG, Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments, except as required by law. Non-GAAP Financial Measures This press release includes Adjusted EPS, which represents a non-GAAP financial measure. The Company believes that providing this non-GAAP financial measure enhances the Company’s and investors’ understanding of our financial performance. Non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures determined or calculated in accordance with GAAP. The Company’s definitions of its non-GAAP financial measures may not be comparable to similarly titled measures reported by other companies. The most directly comparable GAAP measure to Adjusted EPS is earnings per share, or EPS. The Company is not providing a reconciliation of Adjusted EPS to EPS, however, because Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis as the Company is unable to predict with reasonable certainty the ultimate outcome of adjusted items, such as legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. View source version on businesswire.com: Contacts Media contact: Michelle Romano Mobile: +1 215 385 0372 mromano3@its.jnj.com Investor contact: Raychel Kruper investor-relations@its.jnj.com Source: Johnson & Johnson View this news release online at: