SciRhom GmbH

Transition into clinical-stage development marks a significant corporate and R&D milestone . MUNICH, Germany I October 17, 2024 I SciRhom GmbH, a biopharmaceutical company pioneering the development of first-in-class therapeutic iRhom2 antibodies, today announced that the dosing of participants has commenced in the first clinical study evaluating the company’s most advanced development program SR-878. The first-in-human, double-blind, placebo-controlled, single ascending dose study will assess the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of SR-878 in up to 48 healthy volunteers. SciRhom is conducting the study in collaboration with the Department of Clinical Pharmacology at the Medical University of Vienna, Austria. The study is expected to read out in H2 2025. “ Initiating the first clinical study with our iRhom2-targeting approach represents a transformational milestone and value inflection point for the company. Our goal is to underpin the favorable safety profile of SR-878 observed in preclinical studies, and progress swiftly toward demonstrating the clinical benefits of our novel approach in patients in the subsequent Phase 2 trials, ” commented Dr. Jürgen Reess, CMO of SciRhom. Dr. Jan Poth, Managing Director & CEO of SciRhom added: “ Today’s exciting event brings us closer than ever before to demonstrating the breakthrough potential of targeting iRhom2 and thereby modulating the disease-relevant pathways controlled by TACE/ADAM17. We are very happy that we could engage the Department of Clinical Pharmacology at the Medical University of Vienna for this first study in humans, whose expertise will be very valuable in establishing a solid foundation for potentially multiple subsequent studies. ” With its SR-878 program, SciRhom aims to provide a new treatment paradigm for autoimmunediseases and potentially other indications by simultaneously blocking several pro-inflammatoryand disease-driving pathways. The highly selective engagement of iRhom2 is expectedto lead to superior efficacy compared to currently available treatments while preservingother vital functions of iRhom2’s interaction partner TACE/ADAM17, which should contributeto a favorable safety profile. About iRhom2 TACE (TNF-alpha converting enzyme, also known as ADAM17) controls several major signaling pathways, including TNF-alpha, IL-6R, and EGFR signaling. TACE is therefore widely accepted as a potential target to block pro-inflammatory pathways, but direct inhibition of TACE causes severe side effects. The more recent discovery that iRhom2 (inactive Rhomboid 2, RHBDF2) simultaneously and very specifically regulates the TACE-dependent release of TNF-alpha and other pro-inflammatory molecules from immune cells provides the exciting opportunity to target the disease-driving activities of TACE while preserving its other vital functions. Given the pivotal role of iRhom2, numerous new research studies have recently highlighted the therapeutic potential of targeting iRhom2 to treat immunological and inflammatory diseases and beyond, including oncological, infectious, and metabolic diseases. About SciRhom GmbH At SciRhom, we are translating world-leading expertise in the TACE/ADAM17 pathway and its central role in autoimmunity and other indications into breakthrough biopharmaceuticals. We are developing proprietary and first-in-class iRhom2-targeting therapies and are accelerating our lead antibody program SR-878 into and through clinical development. With strong support from international lead investors Andera Partners, Kurma Partners, Hadean Ventures, MIG Capital, Wellington Partners, as well as Bayern Kapital and current shareholders, SciRhom aims to push the boundaries in autoimmune medicine. For further information, please visit www.SciRhom.com SOURCE: SciRhom

Flush with €63 million ($68 million) from an upsized series A funding, SciRhom is looking to challenge conventional wisdom in autoimmune disease treatment. The investment will support clinical development of the company's lead antibody candidate SR-878, which is directed against a protein many experts initially dismissed as an improbable therapeutic target.The oversubscribed round was co-led by Andera Partners, Kurma Partners, Hadean Ventures, MIG Capital, and Wellington Partners, with participation from new investor Bayern Kapital and existing backers including High-Tech Gründerfonds and PhiFund Ventures.Selective antibody approachSciRhom's approach focuses on iRhom2, a key regulator of TACE (also known as ADAM17), which plays a central role mediating major inflammatory signaling pathways like TNF-alpha, IL-6 and EGFR. For a long time, iRhom2 was thought to function exclusively inside cells and was therefore considered unsuitable for therapeutic antibodies. However, SciRhom co-founder Carl Blobel's work indicated it might actually be accessible on the cell surface, making it a potential antibody target after all.There have also been numerous attempts in the past to block TACE directly with small-molecule inhibitors – Pfizer/Wyeth's apratastat, Bristol Myers Squibb's DPC 333 and Incyte's INCB7839 were among the most studied, although all three ultimately failed. These drugs, chief operating officer Jens Ruhe told FirstWord, not only targeted TACE, but also interfered with closely related proteins."This sort of unspecificity was associated with additional side effects such as liver toxicity in one case or thrombosis…. One molecule was not effective at all," Ruhe said. "So this is being overcome with the fact that we have highly selective antibodies, which we tested in multiple preclinical screens, really only to interfere with iRhom2 itself and nothing else."The idea is to block only those aspects of TACE biology that are tied to disease-driving pathways, while at the same time preserving other vital functions that rely on TACE signaling.Dosing start in a few weeksSR-878 is poised to enter clinical testing in the coming weeks. "We actually have all the necessary regulatory approvals," said CEO Jan Poth. "It will be basically a standard single ascending dose trial in healthy volunteers. As usual, you want to see what the pharmacokinetics are of your drug in humans… and you certainly also want to get a first indication of the safety."If all goes well, the company is looking to move into Phase II "in the later second half of next year," he said.While the initial focus will be on rheumatoid arthritis and inflammatory bowel disease, based on positive preclinical data, the company sees room for eventual expansion. According to Poth, iRhom2 "is such a central mechanism in quite a number of autoimmune diseases that this is basically a pipeline in a molecule," along the lines of other immunological drugs like TNF inhibitors and AbbVie's anti-IL-23 antibody Skyrizi (risankizumab).SciRhom's early insight has also allowed the company, which was founded in 2016, to build up a solid patent portfolio around iRhom2-targeting therapies. Poth noted that with no existing patents on iRhom2, SciRhom had a "green field" to strategically secure patents, resulting in "a very strong patent portfolio covering that space."Looking ahead, the CEO acknowledged the significant funding required to fully develop SR-878 across multiple indications. "We can easily go up into the hundreds of millions, which you will need in order to bring it fully fledged to the market in all the possible indications. That is something which will definitely need more money than we have. So there will be different ways of how that can be approached by partnerships, by licensing, by an IPO. Nothing is fully decided yet,” he added.

The upsized and oversubscribed Series A financing round will be used to drive the lead development program toward clinical proof-of-concept and to broaden the therapeutic value of the proprietary iRhom2 strategy. Munich, Germany, July 9, 2024 – SciRhom GmbH, a biopharmaceutical company pioneering the development of first-in-class therapeutic iRhom2 antibodies, announced today the closing of a EUR 63 million (USD 70 million) Series A financing round. The round was co-led by Andera Partners, Kurma Partners, Hadean Ventures, MIG Capital, and Wellington Partners, with participation from new investor Bayern Kapital and existing investors including High-Tech Gründerfonds (HTGF) and PhiFund Ventures from New York, USA. The new funds will be used to accelerate and broaden the impact of the company’s innovative therapeutic strategy in autoimmune disorders. The first clinical study evaluating SR-878, a highly specific monoclonal antibody for iRhom2, is expected to start dosing in the second half of 2024. SciRhom was founded with the mission to provide a new treatment paradigm for autoimmune diseases and potentially other indications by selectively addressing TACE/ADAM17, a master switch for various autoimmune disease-relevant signaling pathways, via iRhom2. The SciRhom team collaborated closely with co-founders Prof. Carl Blobel and Hospital for Special Surgery (HSS), the world’s leading academic medical center specialized in Rheumatology and musculoskeletal health, where Prof. Blobel serves as Director of the Arthritis and Tissue Degeneration Program. He has made seminal contributions to the understanding of how iRhom2 controls the activity of TACE/ADAM17 in inflammation and autoimmune diseases. SciRhom designed its most advanced development candidate SR-878 to simultaneously block several pro-inflammatory and disease-driving pathways, including TNF-alpha, IL-6R, and EGFR signaling, while preserving other vital functions dependent on TACE/ADAM17. This unique ability to attack multiple cytokines and to potentially promote immune tolerance through restoring beneficial TNFR2 signaling, and regulatory T-cell expansion promises to have a transformative effect in patients across a wide range of autoimmune diseases. Moreover, the selective targeting of iRhom2 is expected to have a favorable safety profile. “Since its foundation, SciRhom has applied rigorous science to establish a leading position in iRhom2-targeting biopharmaceuticals including a comprehensive IND/CTA-enabling data and CMC package and strong patent protection. Now is the time to shift gears and accelerate our novel and potentially groundbreaking therapeutic strategy toward clinical proof-of-concept and beyond to reach patients in need of better autoimmune treatments,” commented co-founder Dr. Jens Ruhe, Managing Director & COO of SciRhom. Based on positive preclinical data sets generated in vitro and in established animal models of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), SciRhom has advanced its first program to a Phase 1-ready stage. As announced on June 12th, 2024, the first CTA approval was achieved paving the way for initiating a first clinical study in Austria in the second half of 2024. The study aims to evaluate safety in healthy volunteers and provide initial evidence of clinical activity in the second part of the study. Dr. Jan Poth, Managing Director & CEO of SciRhom added: “We are excited to have attracted such a high-caliber international consortium of investors and appreciate our existing shareholders backing SciRhom in this crucial period of its development. We look forward to collaborating with our new as well as existing partners and board members to bring a differentiated therapeutic option to patients and address the unmet medical need for much more effective and safe treatments for autoimmune disorders.” “We are delighted to have supported SciRhom from its inception all the way to CTA approval and are now looking forward to working with the new investors to take SciRhom's lead antibody into the clinic,” commented Hans-Ulrich Rabe, current Chairman of the Advisory Board and one of the four founding investors who jointly invest in biotech start-ups via their investment platform Ventura Ace. In conjunction with this investment, Dr. Olivier Litzka from Andera Partners, Dr. Peter Neubeck from Kurma Partners, Dr. Georgina Askeland from Hadean Ventures, Dr. Fei Tian from MIG Capital and Dr. Varun Gupta from Wellington Partners will join SciRhom’s Board of Directors. They together stated “iRhom2 is a key driver of inflammation and SR-878 offers a first-in-class opportunity for multi-pathway inhibition as well as promoting immune and tissue homeostasis. This approach has a transformative potential for patients with autoimmune diseases that are currently difficult to treat with existing drugs. SciRhom is led by a highly experienced and dedicated team of people who we strongly believe will be able to drive SR-878 to clinical validation.” The team of SNP Schlawien Partnerschaft led by Dr. Thomas Schmid acted as legal advisor to SciRhom in the transaction. About iRhom2 TACE (TNF-alpha converting enzyme, also known as ADAM17) controls several major signaling pathways, including TNF-alpha, IL-6R, and EGFR signaling. TACE is therefore widely accepted as a potential target to block pro-inflammatory pathways, but direct inhibition of TACE causes severe side effects. The more recent discovery that iRhom2 (inactive Rhomboid 2, RHBDF2) simultaneously and very specifically regulates the TACE-dependent release of TNF-alpha and other pro-inflammatory molecules from immune cells provides the exciting opportunity to target the disease-driving activities of TACE while preserving its other vital functions. Given the pivotal role of iRhom2, numerous new research studies have recently highlighted the therapeutic potential of targeting iRhom2 to treat immunological and inflammatory diseases and beyond, including oncological, infectious, and metabolic diseases. About SciRhom At SciRhom, we are translating world-leading expertise in the TACE/ADAM17 pathway and its central role in autoimmunity and other indications into breakthrough biopharmaceuticals. We are developing proprietary and first-in-class iRhom2-targeting therapies and are accelerating our lead antibody program SR-878 into and through clinical development. With strong support from international lead investors Andera Partners, Kurma Partners, Hadean Ventures, MIG Capital, Wellington Partners, as well as Bayern Kapital and current shareholders, SciRhom aims to push the boundaries in autoimmune medicine. For further information, please visit Contact SciRhom GmbH Dr. Jan Poth (Managing Director & CEO) Email: info@SciRhom.com Valency Communications Mario Brkulj Email: mbrkulj@valencycomms.eu Attachments SciRhom Leadership Team (2024) 240709_SciRhom_Series_A_Financing_FINAL SciRhom Leadership Team (2024) From left to right: Dr. Jens Ruhe, Managing Director and Chief Operating Officer - Dr. Jan Poth, Managing Director and Chief Executive Officer - Dr. Matthias Schneider, Chief Scientific Officer (© SciRhom, taken by Paul Paulsen · Photodesign, Munich)