Visceral Pain

Early interim safety data from Phase 2 TAMARACK study, including comparison to retrospective analysis from Phase 1 study,as submitted in ASCO abstract Company plans to provide updated interim data, including safety and preliminary efficacy, by May 31 Company plans to provide additional clinical data – including rPFS – in the Fall of 2024 ROCKVILLE, MD, April 03, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc., (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on the Phase 2 TAMARACK study of vobramitamab duocarmazine (vobra duo, previously known as MGC018) in patients with metastatic castration-resistant prostate cancer (mCRPC). As previously disclosed, safety data from the Company’s ongoing TAMARACK Phase 2 study was submitted in early February to the American Society of Clinical Oncology (ASCO) for presentation at the upcoming Annual Meeting that begins May 31. The abstract containing this early interim data, based on a January 4, 2024 data cut-off, was not accepted. The submitted abstract is provided below. “While the TAMARACK data will not be presented at the ASCO Annual Meeting, we intend to maintain our previously disclosed plan to share further TAMARACK interim data, including updated safety and preliminary efficacy, by the end of May,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer. “This updated information will be based upon a future data cut-off. In addition, we still anticipate presenting updated clinical data – including radiographic progression-free survival, or rPFS, the study’s primary endpoint – in the Fall of 2024.” Abstract as submitted on February 6, 2024: “Title Vobramitamab duocarmazine (vobra duo), a B7-H3 directed antibody drug conjugate (ADC) in metastatic castration resistant prostate cancer (mCRPC): Early data from the Phase 2 TAMARACK study. Background Vobra duo (MGC018) is an ADC with a duocarmycin-based DNA-alkylating payload. Vobra duo targets B7-H3, which is highly expressed in multiple tumor types including prostate cancer and has limited expression in normal tissue. Phase 1 testing (NCT03729596) of vobra duo at 3.0 mg/kg Q3W demonstrated anti-tumor activity in mCRPC, although adverse events resulted in high rates of dose modifications and early treatment discontinuation. Lowering the starting dose may improve tolerability, extend treatment duration, and enhance effectiveness. Methods TAMARACK is an ongoing randomized, open-label, Phase 2 dose selection study assessing the efficacy, safety, and tolerability of two dose levels of vobra duo (2.0 mg/kg and 2.7 mg/kg IV Q4W). The study enrolled patients (pts) with mCRPC previously treated with abiraterone, enzalutamide, or apalutamide; prior docetaxel was allowed. The primary endpoint is investigator-assessed PFS at 6 months. Results At data cutoff (Jan 4, 2024), 182 pts with mCRPC enrolled on TAMARACK, of which 177 received vobra duo. Enrolled pts were 46 to 89 years of age (median 70.5) with ECOG performance status ≤ 2. Thirty (16.5%) had visceral disease at baseline, 109 (59.9%) had RECIST-evaluable disease, and 98 (53.8%) received prior docetaxel. At this early data cut, pts have received a median of 3 (range 1 to 7) cycles of vobra duo; treatment is ongoing in 156 (85.7%). A summary of treatment-emergent adverse events (TEAEs) is presented below. Vobra duo 2.0 mg/kg (n=91) Vobra duo 2.7 mg/kg (n=86) Any TEAE 85 (93.4%) 82 (95.3%) TEAE Grade ≥ 3 23 (25.3%) 27 (31.4%) Serious AE 11 (12.1%) 17 (19.8%) Drug Interruption due to AE 10 (11.0%) 16 (18.6%) Drug Discontinuation due to AE 4 (4.4%) 2 (2.3%) Fatal AE 0 0 The most common (≥10%) TEAEs regardless of dose were asthenia (40.7%), nausea (27.7%), fatigue (20.3%), decreased appetite (19.2%), anemia (17.5%), constipation (16.4%), diarrhea (14.7%), headache (13.0%), neutropenia (12.4%), and peripheral edema (10.7%). In the subset (n = 95) of TAMARACK pts on treatment for ≥ 12 weeks or who discontinued study treatment within 12 weeks, TEAEs led to drug interruption in 12 (12.6%) and discontinuation in 5 (5.3%) pts. This compares favorably to the rate of drug interruption (58.5%) and discontinuation (14.6%) observed at 12 weeks in pts with mCRPC who received vobra duo at 3.0 mg/kg Q3W on the Phase 1 study. Following the pre-specified interim analysis for futility on both arms, the IDMC recommended continuing the study as planned without modification. Conclusions Preliminary safety data from TAMARACK suggest that reducing the dose and frequency of vobra duo improves its safety and tolerability in men with mCRPC. The authors anticipate sharing preliminary efficacy data and updated safety data at the conference. Clinical trial information: NCT05551117.” MacroGenics would like to thank the abstract authors, including: Johann S. De Bono, Carole Helissey, Karim Fizazi, Eric Voog, Pablo Maroto-Rey, Guilhem Roubaud, Emmanuel S. Antonarakis, Shahneen Sandhu, Neal D. Shore, Raffaele Ratta, Begoña Pérez Valderrama, Christof Vulsteke, Galina Marr, Ashley Ward, Enxu Zhao, Josep M. Piulats, on behalf of the TAMARACK Investigators. About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at . MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, including initiation and enrollment in clinical trials, expected timing of results from clinical trials, discussions with regulatory agencies, commercial prospects of or product revenues from MARGENZA and the Company’s product candidates, if approved, manufacturing services revenue, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company, as well as future global net sales of TZIELD and the Company’s ability to achieve the milestone payments set forth under the terms of the agreement with DRI (or its successors or assigns with respect to such agreement), and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises such as the novel coronavirus (referred to as COVID-19 pandemic); and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. CONTACTS: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 info@macrogenics.com

GPR35 is a novel target with an established genetic association to IBDUK regulatory approval received to commence first-in-human studiesReturn of rights follows change in immunology research strategy by GSK Tokyo, Japan and Cambridge, UK, 21 March 2024 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) announces it has regained full ownership from GSK of HTL0027477 (formerly GSK4381406), a clinic-ready, highly selective, first-in-class, oral GPR35 agonist in development as a potential new treatment for Inflammatory Bowel Diseases (IBD). GPR35 is an important orphan G protein-coupled receptor (“GPCR”) with an established genetic association to IBD, for which there remains significant unmet need for millions of sufferers worldwide. HTL0027477 was designed by Sosei Heptares using its proprietary structure-based drug design (SBDD) platform and licensed to GSK in 2020. Since then, HTL0027477 has been advanced through a joint development program, generating promising mechanistic, preclinical efficacy and safety data suggesting that it may have the potential to improve intestinal barrier function and reduce visceral pain in gastrointestinal indications such as ulcerative colitis and irritable bowel syndrome. The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) gave approval in mid-2023 for HTL0027477 to be investigated in first-in-human studies. The process to regain rights to the program was initiated in late 2023 following a decision by GSK to deprioritize and discontinue its development following changes to both its immunology research strategy and immunology research leadership. The decision was not based on any scientific, preclinical or safety data related to the candidate. Sosei Heptares regained full ownership of the HTL0027477 program including associated intellectual property licensed by Sosei Heptares to GSK, and preclinical data generated under the partnership for no upfront payment. Sosei Heptares expects to determine the optimal strategy for further clinical development of the program, which could include in-house development and re-partnering. Matt Barnes, President of Heptares Therapeutics and Head of UK R&D, commented: “The return of the GPR35 agonist program, with its first-in-class mechanism of action and potential to address major unmet needs in IBD worldwide, is a strong addition to our growing clinical pipeline. This exciting program has already delivered highly promising preclinical data that support its potential as a new therapy for IBD and is poised to enter a Phase 1 clinical trial. This presents a clear opportunity for Sosei Heptares to further advance this program while determining the optimal path forward for further development and commercialization.” -ENDS- About Sosei Heptares Sosei Heptares is a fully integrated biopharmaceutical company focused on bringing life-changing medicines based on world-class science to patients globally. Our vision is to become one of Japan’s global biopharmaceutical champions. Our global business combines our world-leading GPCR-targeted StaR® technology, structure-based drug design and early development capabilities in the UK with a highly experienced clinical development capability and a commercial operation in Japan. We are leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We intend to develop these opportunities for patients in Japan and globally both internally and through our partnerships with global biopharmaceutical companies and emerging technology companies. Sosei Heptares operates from key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea). “Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies. For more information, please visit https://soseiheptares.com/LinkedIn: @soseiheptaresco | X: @soseiheptaresco | YouTube: @soseiheptaresco Enquiries: Sosei Heptares – Media and Investor RelationsKentaro Tahara, VP Investor Relations and Corporate Strategy Shinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@SoseiHeptares.com MEDiSTRAVA Consulting (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | SoseiHeptares@medistrava.com Forward-Looking StatementsThis press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Sosei Group Corporation’s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

KELOWNA, BC / ACCESSWIRE / March 12, 2024 / Tryp Therapeutics, Inc. ("Tryp" or the "Company") (CSE:TRYP)(OTCQB:TRYPF) is pleased to announce that the Company's securityholders overwhelmingly approved the previously announced arrangement (the "Arrangement") involving the Company and Exopharm Limited CAN 163 765 991 at the Company's annual general and special meeting of securityholders (the "Meeting") held on March 8, 2024. The Company is also pleased to announce that the Supreme Court of British Columbia issued its Final Order approving the Arrangement on March 11, 2024. The special resolution approving the Arrangement (the "Arrangement Resolution") was required to be approved by at least two-thirds (66 2/3%) of the votes cast by: (i) the Company's shareholders and (ii) the Company's shareholders, option holders and the holders of certain warrants, voting as a class. A total of 37,738,906 common shares of Tryp were voted at the Meeting, representing approximately 39.14% of the Common Shares entitled to be voted at the Meeting. Approximately 99.92% of the votes cast by Tryp shareholders were in favor of the Arrangement Resolution. All other matters to be determined at the Meeting also passed by similar overwhelming majorities of votes cast. Closing of the Arrangement remains subject to satisfaction of certain closing conditions, including receipt of final court, stock exchange and regulatory approvals and the satisfaction of certain conditions set forth in the arrangement agreement. Subject to the satisfaction of these closing conditions, the parties currently expect to complete the Arrangement in late March 2024. Further details regarding the Arrangement, including the principal closing conditions and the anticipated benefits for shareholders, can be found in the Company's management information circular dated January 26, 2024 in respect of the Meeting (the "Circular"), which can be found under the Company's SEDAR+ pro . About Tryp Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp's lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has completed a Phase 2a clinical trial for the treatment of binge eating disorder at the University of Florida, which demonstrated an average reduction in binge eating episodes of greater than 80%. The Company also recently announced commencement of patient dosing in a Phase 2a clinical trial for the treatment of fibromyalgia in collaboration with the University of Michigan and is preparing to initiate a Phase 2a clinical trial in collaboration with Massachusetts General Hospital for the treatment of abdominal pain and visceral tenderness in patients suffering from irritable bowel syndrome. Each of the studies is utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate clinical benefit in these indications. Where a positive clinical response is demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin), which has the potential to further improve efficacy, safety, and patient experience. For more information, please visit Investor & Media Contact Peter Molloy Chief Business Officer Tryp Therapeutics Inc. pmolloy@tryptherapeutics.com Forward-Looking Information This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities legislation (collectively referred to herein as "forward-looking statements"). The forward-looking statements herein are made as of the date of this press release only, and the Company does not assume any obligation to update or revise them to reflect new information, estimates or opinions, future events or results or otherwise, except as required by applicable law. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budgets", "scheduled", "estimates", "forecasts", "predicts", "projects", "intends", "targets", "aims", "anticipates" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements in this press release include: stock exchange and other regulatory approvals and the satisfaction of conditions to closing the Arrangement; and anticipated timing of the closing of the Arrangement. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of Tryp to control or predict, that may cause Tryp's actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein, including, but not limited to, the Company not obtaining stock exchange approvals; all conditions to completion of the Arrangement not being satisfied or waived and the Arrangement not being completed as anticipated; and the risk factors set out in the Circular dated and other filings available for review on the Company's pro . Such forward-looking statements represent management's best judgment based on information currently available. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information. NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. SOURCE: Tryp Therapeutics View the original press release on accesswire.com