First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.

Start Date18 Feb 2020

Sponsor / Collaborator

ENB Therapeutics, Inc.Startup

[+1]

100 Clinical Results associated with Vodudeutentan

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100 Patents (Medical) associated with Vodudeutentan

News (Medical) associated with Vodudeutentan

08 May 2024

·www.globenewswire.com

Coherus Announces Clinical Collaboration with the Cancer Research Institute for a Novel Combination Evaluating LOQTORZI® (toripalimab-tpzi) with ENB Therapeutics' ENB-003 for the Treatment of Ovarian Cancer

REDWOOD CITY, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus; Nasdaq: CHRS) today announced that the Cancer Research Institute (CRI) and its Immunotherapy Platform Study in Platinum-Resistant High-Grade Serous Ovarian Cancer (IPROC) Drug Selection Committee (DSC) have selected LOQTORZI (toripalimab-tpzi), anti-PD-1 antibody, to explore in combination with ENB-003, a first-in-class small molecule inhibitor of endothelin B receptor (ETBR), for the treatment of drug-resistant cancers in the iPROC platform study. Endothelin B receptor is implicated in tumorigenesis and tumor immune suppression for several solid tumors, including melanoma, ovarian, and pancreatic cancers. “The iPROC DSC is pleased to have access to this next-generation PD-1 inhibitor and advance this combination supported by preclinical and clinical data in this study in ovarian cancer,” said John Stagg, Ph.D., Professor, Faculty of Pharmacy at the University of Montreal and Principal Investigator, Centre Hospitalier de l’Université de Montréal (CHUM) and its affiliated Cancer Institute of Montreal. Dr. Stagg continued, “The iPROC study DSC brings together a group of scientific experts within the CRI community to select promising combinations and rapidly advance them to clinical trials. Importantly, the DSC is not confined by a pipeline but looks to work with companies with drugs that have a strong data package. For this multiparty platform study to succeed, it requires science-driven, highly collaborative, and engaged companies. Coherus and ENB Therapeutics are two such partners, and we are excited to advance this clinical study.” “CRI is an established and preeminent organization leading immunotherapy discovery and advancement through its global network of scientific experts, and we are excited that the CRI network has selected LOQTORZI for this study to gain more insight into the potential clinical benefit that LOQTORZI might have when combined with novel mechanisms such as ENB Therapeutics’ ETBR blocker, particularly in this underserved patient population,” said Rosh Dias, M.D., Chief Medical Officer at Coherus. “There is a large body of clinical evidence for LOQTORZI, including positive phase 3 studies published in top-tier scientific journals, showing efficacy and safety in multiple tumor types,” said Jay Campbell, Managing Director, Clinical Accelerator and Venture Fund at CRI. “This level of scientific evidence is what we are looking for when selecting immunotherapies to bring into our network, with the goal of advancing clinically meaningful solutions to patients. We are grateful to have the opportunity to collaborate with Coherus and ENB Therapeutics on this study and excited to be working with them on this novel combination that we hope will lead to improved outcomes in these patient populations.” Dr. Sumayah Jamal, CEO of ENB Therapeutics, added, “We are honored to be collaborating with CRI and Coherus to further accelerate the development of innovative immunotherapy solutions and expand the pool of patients benefitting from this approach to harness the immune system to fight cancer.” Under the terms of a clinical supply agreement with the Cancer Research Institute (CRI), Coherus will supply toripalimab-tpzi for combination treatment with ENB-003 to be investigated in the iPROC platform study. About the IPROC Platform TrialThe IPROC clinical trial uses an adaptive platform study design that utilizes a single master protocol to evaluate multiple immunotherapy combinations. This allows multiple treatments to be evaluated in different groups of patients, or cohorts, from the same patient population. Such a study design offers flexibility in that different treatments can be evaluated in different cohorts, treatment regimens can be modified between cohorts, and treatment selection criteria can be customized for a specific cohort. The trial, titled Immunotherapy Platform Study in Platinum-Resistant High-Grade Serous Ovarian Cancer (IPROC) (NCT04918186), has two ongoing cohorts. About LOQTORZI (toripalimab-tpzi)LOQTORZI is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site with high affinity and activates anti-tumor immunity. LOQTORZI is indicated in the United States in combination with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) and as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy. For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit www.loqtorzi.com. About ENB-003ENB-003, a small-molecule drug candidate targeting the ETBR, is expressed in solid tumors and plays a role in tumorigenesis and immune evasion. ETBR, a G-protein-coupled receptor, is overexpressed in a variety of tumor cell types and plays a key role in tumor cell proliferation, invasion, epithelial-mesenchymal transition (EMT), and angiogenesis. It also plays a role in tumor immunosuppression and blocks T-cell trafficking. As reported in November 2023, preliminary results from the ENBOLDEN-101 demonstrated that ENB-003 in combination with KEYTRUDA® (pembrolizumab) demonstrated encouraging objective responses, disease control, and progression-free survival in patients with metastatic platinum refractory/resistant ovarian cancer (PROC). About the Cancer Research InstituteThe Cancer Research Institute, established in 1953, is the preeminent U.S. nonprofit organization dedicated to saving more lives by fueling the discovery and development of powerful immunotherapies for all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 35 members of the National Academy of Sciences, CRI has invested over $517 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. Learn more at cancerresearch.org. About Coherus BioSciences Coherus is a commercial-stage biopharmaceutical company focused on researching, developing, and commercializing innovative cancer treatments. Coherus is developing an innovative immuno-oncology pipeline that is expected to synergize with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors. CHS-1000, a novel ILT4-targeted antibody, is a preclinical candidate targeting immune-suppressive mechanisms via the pathway ILT4. Coherus markets LOQTORZI® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, and YUSIMRY® (adalimumab-aqvh), a biosimilar of Humira®. About ENB TherapeuticsENB Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, ETBR inhibitors, to overcome resistance to CAR-T in solid tumors and immune-based therapies such as immune checkpoint inhibitors. ETBR causes uncontrolled cancer growth, drives cancers to spread through the body, and prevents the immune system from detecting and killing cancer cells. ENB’s lead product candidate, ENB-003, specifically blocks the ETBR and can potentially drive the efficacy of CAR-T and anti-PD1 therapies in solid tumors. ENB-003 is being investigated in an ongoing Phase 1/2 clinical trial in collaboration with Merck. Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ ability to identify synergies between its I-O pipeline and its commercial capabilities; Coherus’ expected initiating clinical trials for CHS-1000; Coherus’ expectations to be able to advance its candidates through clinical trials; and Coherus’ expectations that its immunotherapy candidates will enhance outcomes for patients with cancer. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance, or achievements to differ significantly from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the preclinical and clinical drug development process; risks related to Coherus’ existing and potential collaboration partners; risks of Coherus’ competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; the risks of competition; the risk that Coherus is unable to complete commercial transactions; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission on March 15, 2024, including the section therein captioned “Risk Factors” and in other documents Coherus files with the Securities and Exchange Commission. UDENYCA®, YUSIMRY®, and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies, or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. Neulasta® is a registered trademark of Amgen, Inc.Humira® is a registered trademark of AbbVie Inc. Coherus Contact Information:For Investors:Jami TaylorHead of Investor RelationsIR@coherus.com For Media:Jodi SieversVP, Corporate Communicationsmedia@coherus.com

ImmunotherapyPhase 2Phase 1Phase 3License out/in

07 Nov 2023

·www.biospace.com

ENB Therapeutics Presents Top-line Results from Phase 1b ENBOLDEN-101 Study in Platinum Refractory/ Resistant Ovarian Cancer at SITC 2023

ENB-003 in combination with KEYTRUDA® (pembrolizumab) demonstrated encouraging objective responses, disease control and progression-free survival in patients with metastatic platinum refractory/resistant ovarian cancer (PROC) Encouraging results support further development Expansion cohort in primary PROC and other refractory advanced cancers (ENB-003 + KEYTRUDA) to commence in 2024 NEW YORK--(BUSINESS WIRE)-- ENB Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology and immunology, today announced top-line results from the dual combination arm of the Phase 1b ENBOLDEN-101 study, evaluating ENB-003 in combination with Merck & Co.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced refractory cancers. The results show encouraging objective responses, disease control and extended progression-free survival in patients with platinum resistant/ refractory ovarian cancer (PROC). The poster, entitled, "ENB-003, an ETBR antagonist, in combination with pembrolizumab, shows promise in microsatellite stable platinum refractory/resistant ovarian cancer: Data from the ENBOLDEN-101 Phase 1B study" was presented on November 3, 2023 at a poster session at the SITC 2023 meeting, was held November 1-5, in San Diego, California, USA. The data included 5 patients with metastatic microsatellite stable (MSS) PROC who had disease progression after one or more previous lines of treatment. Study treatment consisted of an initial 7-day run-in period of ENB-003 monotherapy, followed by repeated 3-week cycles of ENB-003 in combination with KEYTRUDA. The data demonstrated that the treatment regimen was safe and well tolerated. The objective response rate (ORR) and disease control rate (DCR- patients exhibiting a response or stable disease) in MSS PROC was 40% and 80% respectively (N=5), including 2 patients with partial responses showing a 95% and 33% reduction in tumor burden respectively, as well as 4 patients with stable disease; 80% of PROC patients demonstrated shrinkage of target lesions overall. The 8-month progression-free survival rate was 60%. This compares favorably with a historical ~20% progression-free survival data at 6 months for single agent anti-PD1 and an ~8% ORR and an ~22% DCR. "These data, demonstrate that ENB-003 in combination with KEYTRUDA is safe, with encouraging signs of clinical activity and support the combination’s potential to become an effective immunotherapy regimen for MSS primary PROC – a disease that has responded very poorly to available treatments,” stated Sumayah Jamal, MD-Ph.D., President, Chief Scientific Officer, and Co-Founder of ENB Therapeutics. "We are extremely pleased with the top-line results from this ongoing study. We look forward to continuing our collaboration with Merck and anticipate initiating Part 2 of the study next year.” For more information on this Phase 1/2a study, see NCT04205227. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About ENB-003 ENB-003 is a selective endothelin B receptor (ETBR) inhibitor that, in preclinical studies, enhances efficacy of CAR-T and anti-PD-1 in solid tumors across multiple cancer types in preclinical studies. In an ongoing multi-center Phase 1/2 clinical trial, early efficacy signals suggest that ENB-003 overcomes resistance to pembrolizumab in heavily pre-treated drug resistant cancer patients. The Phase 2 portion of the ENB-003 + pembrolizumab combination study is expected to start in the first half of 2024. The trial will enroll MSS primary PROC, as well as MSS pancreatic cancer patients and patients with other advanced solid tumors that have failed standard of care. About ENB Therapeutics, Inc. ENB Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, endothelin B receptor (ETBR) inhibitors, to overcome resistance to CAR-T in solid tumors and immune-based therapies such as the immune checkpoint inhibitors. ETBR causes uncontrolled cancer growth, drives cancers to spread through the body and prevents the immune system from detecting and killing cancer cells. ENB’s lead product candidate, ENB-003 specifically blocks the ETBR and has the potential to drive the efficacy of CAR-T and anti-PD1 therapies in solid tumors. ENB-003 is currently being investigated in an ongoing Phase 1/2 clinical trial in collaboration with Merck. Learn more by visiting the ENB Therapeutics website. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the clinical development of ENB-003 or any of ENB’s other product candidates or programs; the design of ENB’s clinical trials; the safety, durability, or efficacy of ENB-003; and the potential benefits of ENB-003 or any of ENB’s other product candidates. ENB may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of ENB’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; expectations for regulatory approvals to conduct trials or to market product; risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as to ENB’s abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and ENB expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Clinical ResultImmunotherapyPhase 1ASCO

18 Jul 2023

·pipelinereview.com

ENB Therapeutics Presents Top-line Results from Phase 1b ENBOLDEN-101 Study in Solid Tumors Refractory to Standard of Care at the Immuno-oncology Summit 2023

ENB is developing first in class small molecule ENB-003 to selectively targeting the ETB receptor - a novel immune checkpoint NEW YORK, NY, USA I July 18, 2023 I ENB Therapeutics, Inc., a biotechnology company pioneering a new and differentiated class of therapeutics targeting the endothelin B receptor (ETBR) inhibitor, today announced that the company has completed enrollment of its international Phase 1 ENBOLDEN-101 trial investigating the safety and efficacy of lead product ENB-003 in combination with KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy. The Phase ½a study is a multicenter, open-label study conducted in the US and Australia and is comprised of two parts. Part 1 recruited 46 patients and was a dose-escalation study to determine the recommended dose for the Part 2 expansion phase of the study. The results of this study will be presented by ENB Therapeutics in a poster titled, “ENB-003, an ETBR antagonist, in combination with pembrolizumab for refractory advanced solid tumors: Topline data from the ENBolden-101 Phase 1B study” at the Immuno-oncology Summit which is being held August 7-9, 2023 in Boston, Massachusetts. ENB-003 in combination with pembrolizumab was well tolerated in the dose escalation study and demonstrated no DLTs across the 6 dosing cohorts. The most common treatment emergent adverse events irrespective of grade or causality included fatigue (28.2%), constipation (26.1%), abdominal pain (26.1%), nausea (23.9%), anemia 17.4%, diarrhea (17.4%). Serious adverse events, grade 3 and above considered possibly related to study treatment included fatigue (n=4), diarrhea (n=3), dyspnea (n=3) constipation (n=2), rash (n=2). 15 patients with evaluable disease were enrolled in cohorts 1-5 (ENB-003 dose range 150ug-1000ug) and 15 patients with evaluable disease were enrolled in the 6 th cohort (ENB-003 dose 2000ug). The dosing frequency for cohort 6 was doubled to 6 doses every 3 weeks from 6 doses every 6 weeks in cohort 1-5. The DCR across all cohorts irrespective of ETBR status was 33% (1 PR, 9 SD, 20 PD). The DCR in ETBR-Hi patients was 33% in cohorts 1-5 (4 SD, 1 PR, 10 PD) and 83% in cohort 6 (5 SD, 1 PD). The DCR for ETBR-Lo patients in cohort 6 was 0% (9 PD). ETBR-Lo patients were not enrolled in cohorts 1-5. For microsatellite stable (MSS) platinum refractory/ resistant ovarian cancer there was an 80% DCR across all cohorts (1 PR, 3 SD, 1 PD) with a trend for durable responses at higher doses of ENB-003. A platinum refractory MSS ovarian cancer patient experienced a 95% PR of 12-month duration. The sample size was not powered for statistical significance. “The completion of enrollment of the Phase 1 ENBOLDEN-101 first-in-man study is a significant milestone for our Company. We are extremely encouraged by the results in heavily treated cancer patients refractory to standard of care treatment,” stated Sumayah Jamal, MD-PhD, President, Chief Scientific Officer and Co-Founder of ENB Therapeutics. “Our data suggest potential efficacy in patients that do not historically respond to immunotherapy and support further clinical development. We are grateful to our patients and their families for their participation in our study. “ Part 2 is a dose expansion study at the recommended dose designed to evaluate the safety, tolerability and efficacy of ENB-003 in combination with pembrolizumab in cancers refractory to standard of care including MSS R/R ovarian cancer, MSS pancreatic cancer, anti-PD1 refractory HNSCC, anti-PD1 refractory melanoma and anti-PD1 refractory TNBC. For more information on this Phase 1/2a study, see NCT04205227 . KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About ENB-003 ENB-003 is a selective endothelin B receptor (ETBR) inhibitor that, in preclinical studies, enhances efficacy of CAR-T and anti-PD-1 in solid tumors across multiple cancer types in preclinical studies. In an ongoing multi-center Phase 1/2 clinical trial, early efficacy signals suggest that ENB-003 overcomes resistance to the anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) in heavily pre-treated drug resistant cancer patients. The Phase 2 portion of the ENB-003 + pembrolizumab combination study is expected to start in the first half of 2024. The trial will enroll microsatellite stable platinum refractory and primary platinum resistant ovarian cancer patients, as well as microsatellite stable pancreatic cancer patients that have failed standard of care. About ENB Therapeutics, Inc. ENB Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, endothelin B receptor (ETBR) inhibitors , to overcome resistance to CAR-T in solid tumors and immune-based therapies such as the immune checkpoint inhibitors. ETBR causes uncontrolled cancer growth, drives cancers to spread through the body and prevents the immune system from detecting and killing cancer cells. ENB’s lead product candidate, ENB-003 specifically blocks the ETBR and has the potential to drive the efficacy of CAR-T and anti-PD1 therapies in solid tumors. ENB-003 is currently being investigated in an ongoing Phase 1/2 clinical trial in collaboration with Merck. Learn more by visiting the ENB Therapeutics website . SOURCE: ENB Therapeutics

Phase 1ImmunotherapyClinical ResultPhase 2ASCO

100 Deals associated with Vodudeutentan

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	US	ENB Therapeutics, Inc.Startup	18 Feb 2020
Advanced Malignant Solid Neoplasm	Phase 2	AU	ENB Therapeutics, Inc.Startup	18 Feb 2020
Melanoma	Preclinical	AU	ENB Therapeutics, Inc.Startup	18 Feb 2020
Central Nervous System Neoplasms	Discovery	US	ENB Therapeutics, Inc.Startup	14 Dec 2020
Melanoma	Discovery	US	ENB Therapeutics, Inc.Startup	18 Feb 2020
Ovarian Cancer	Discovery	US	ENB Therapeutics, Inc.Startup	18 Feb 2020
Ovarian Cancer	Discovery	AU	ENB Therapeutics, Inc.Startup	18 Feb 2020
Pancreatic Cancer	Discovery	US	ENB Therapeutics, Inc.Startup	18 Feb 2020
Pancreatic Cancer	Discovery	AU	ENB Therapeutics, Inc.Startup	18 Feb 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04205227 (ENBOLDEN-101 \| MK-3475-951, SITC2023) Manual	Phase 1	Ovarian Cancer	46	ENB-003+pembrolizumab	(zyvvxzxwuw) = yfurlmoqzn ioznpcewox (vezyjngxvm ) View more	Positive	31 Oct 2023
				ENB-003+pembrolizumab (microsatellite stable (MSS) platinum refractory/resistant ovarian cancer)	(hegwpzlnxh) = dwvzktobsl tfarofqzzg (vtkionqrii ) View more
NCT04205227 (ENBOLDEN-101, Biospace) Manual	Phase 1/2	Ovarian Cancer \| Solid tumor Microsatellite Stable	46	ENB-003+Pembrolizumab	(sfyaubeqbe) = uzylpqkbzy gpgjkoqqau (knwjxsmvis ) View more	Positive	18 Jul 2023
				ENB-003+Pembrolizumab (Platinum refractory/ resistant microsatellite stable ovarian cancer)	(sfyaubeqbe) = elvmrxatda gpgjkoqqau (knwjxsmvis )
NCT04205227 (ENBolden, AACR2023) Manual	Phase 1	Advanced Malignant Solid Neoplasm Microsatellite Stable (MSS)	21	ENB-003+pembrolizumab	(hxxqiwxwhs) = hgetbehvgi etiwamkvev (ueznifxnvj ) View more	Positive	14 Apr 2023

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