- First clinical data for NVG-111, a novel ROR1xCD3 bispecific antibody in patients with relapsed / refractory CLL and MCL

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NovalGen announces compelling data from the Phase 1/2 Study of NVG-111 at the ASCO Annual Meeting

REDWOOD CITY, Calif., May 26, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced it will present new data at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating BMF-219’s activity in ex vivo preclinical models of CLL. In addition, the company will present a Trial In Progress (TIP) poster presentation detailing the design of COVALENT-101. Once released at the ASCO Annual Meeting, the preclinical and TIP presentations can be viewed on Biomea’s website at https://biomeafusion.com/publications.

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Biomea Fusion to Present New Preclinical Data Showing BMF-219’s Strong Activity in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Tumor...

Basel, 27 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June. Data from the phase II NP30179 expansion study demonstrated that, after a median follow-up of more than 12 months, fixed-duration glofitamab (given for a fixed amount of time, and not taken until disease progression) induces durable complete responses (CRs) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had received a median of three prior therapies.1“These data bring us one step closer towards our goal of finding solutions for people with heavily pre-treated diffuse large B-cell lymphoma, which often relapses and becomes more aggressive each time it returns,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “The potential of glofitamab as a new fixed-duration, readily available treatment could be instrumental to improving outcomes for people with this difficult-to-treat cancer who otherwise have limited options.”The pivotal phase II NP30179 expansion study included patients with heavily pre-treated and highly refractory DLBCL, with 58.3% of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy.1 After a median follow-up of 12.6 months, 39.4% of patients (n=61/155) achieved a CR (primary efficacy endpoint) and half of them (51.6%; n=80/155) achieved an overall response (the percentage of patients with a partial or complete response; secondary efficacy endpoint), as assessed by an independent review committee. The majority (77.6%) of complete responses were durable and ongoing at 12 months and the median duration of complete response had not yet been reached (not evaluable [16.8 months, not evaluable]). Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0% of patients. CRS events were predictable, generally low grade (mainly Grade 1 [47.4%] or 2 [11.7%]), occurred at initial doses, and only one patient discontinued glofitamab due to CRS. Incidence of Grade 3+ CRS was low (3.9%), with no Grade 5 events.1“I’m encouraged by these data as they signify new hope for these patients who otherwise have limited effective treatment options and have faced disappointment from not responding to multiple rounds of treatments,” said Associate Professor Michael Dickinson, Haematologist and Lead of the Aggressive Lymphoma Disease Group within Clinical Haematology at Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Australia. “These glofitamab data suggest that patients may be able to achieve durable responses with a set course of treatment that they don’t have to take continuously until disease progression.”Data from the NP30179 study have been submitted for approval to the European Medicines Agency (EMA), and submissions to additional health authorities worldwide, including to the U.S. Food and Drug Administration (FDA), are planned this year. Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment.Roche is committed to improving standards of care to enhance the treatment experience and outcomes for people with blood cancers and the scientific data we are sharing at ASCO and EHA from our portfolio propels us further towards this goal. Roche is investigating its CD20xCD3 T-cell engaging bispecific antibodies glofitamab and mosunetuzumab further as subcutaneous formulations and in additional phase III studies that will expand the understanding of their impact in earlier lines of treatment, with the aim of providing people with different types of lymphomas with robust and durable treatment outcomes. Additionally, the European Commission (EC) recently granted approval of Polivy® (polatuzumab vedotin) in combination with MabThera® (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), and the EMA’s Committee for Medicinal Products for Human Use recommended mosunetuzumab for approval for patients with R/R follicular lymphoma, who have received at least two prior systemic therapies.Follow Roche on Twitter via @Roche and keep up to date with ASCO 2022 news and updates by using the hashtag #ASCO22. For exclusive materials sharing insights into Roche’s vision and strategy, and providing context behind the data being presented, visit Roche’s Oncology Newsroom here.About glofitamabGlofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. Glofitamab is based on a novel structural format called ‘2:1’. It is engineered to have two ‘Fab’ regions which bind to CD20, and one ‘Fab’ region which binds to CD3. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for glofitamab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and mantle cell lymphoma, and other blood cancers. About the NP30179 studyThe NP30179 study [NCT03075696] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of glofitamab in people with relapsed or refractory diffuse large B-cell lymphoma. Outcome measures include complete response rate by independent review committee (primary endpoint), overall response rate, duration of response, progression-free survival, safety and tolerability (secondary endpoints).About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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New pivotal data demonstrate clinical benefit of Roche’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive...

SALT LAKE CITY, May 26, 2022 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, will present multiple studies at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the value of genetic insights to guide and clarify cancer treatment and risk assessment.

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Myriad Genetics Showcases Advancements in Precision Medicine with Recent Oncology Portfolio Expansion and New Data Presentations at ASCO 2022

Basel, May 27, 2020 — Sandoz is pleased to announce the appointment of Dr. Boumediene Soufi, global head of the Sandoz Antimicrobial Resistance (AMR) program, as its new representative to the Board of the AMR Industry Alliance (AMRIA).

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Sandoz appoints new Board representative to global AMR Industry Alliance

NEW YORK, May 27, 2022 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have a high unmet medical need, today announced three poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3-7, 2022, in Chicago, Illinois.

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BeyondSpring Presents New Clinical Data in the Chemotherapy-Induced Neutropenia and NSCLC Programs at the 2022 ASCO Annual Meeting

Ad Hoc Announcement Pursuant to Art. 53 LR

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Addex Provides Update on Dipraglurant Blepharospasm Phase 2 Feasibility Clinical Study

DALLAS, May 27, 2022 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced IND clearance by the U.S. Food and Drug Administration (“FDA”) of ITIL-306, Instil’s first genetically-engineered Costimulatory Antigen Receptor TIL (CoStAR-TIL) therapy, as well as the presentation of supporting in vivo CoStAR data at the 2022 ASCO Annual Meeting.

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Instil Bio Announces IND Clearance of First CoStAR-TIL program, ITIL-306, Designed to Enhance Activity in the Tumor Microenvironment

BOSTON, May 27, 2022 (GLOBE NEWSWIRE) -- Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, today announced it is presenting a poster on the AMPLIFY-201 study design at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, being held in-person from June 3-7, 2022, in Chicago. AMPLIFY-201 is a Phase 1 study evaluating the safety and efficacy of ELI-002, a lymph node-targeted therapeutic cancer vaccine, as a treatment for patients with mKRAS-driven tumors who have minimal residual tumor cells following surgery to remove the tumor.

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Elicio Therapeutics Presents Design of Ongoing AMPLIFY-201 Study in Mutant KRAS-Driven Cancers at ASCO Annual Meeting 2022

SYDNEY, AUSTRALIA, May 27, 2022 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, is pleased to announce new interim data from Part A of the Phase II TACTI-002 trial in 1st line NSCLC has been published today in an abstract at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting.

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Immutep Announces Publication of TACTI-002 and TACTI-003 Abstracts at ASCO 2022

- Ex vivo data support the high frequency of myeloid cells in tumors, even when T cells are not present -

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Bolt Biotherapeutics to Present Ex Vivo Data Characterizing the Myeloid Cell Landscape in Solid Tumors at ASCO 2022

EDISON, N.J., May 27, 2022 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma (“HCC”), announces that its Chief Medical Officer, Todd Hobbs, MD, gave a clinical presentation entitled “Recofilstat (CRV431): A liver-targeting drug candidate for NASH and HCC” today at the 5th Global NASH Congress.

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Hepion Pharmaceuticals Highlights Upcoming Phase 2 Clinical Trials of Recofilstat at 5th Global NASH Congress

New York, NY, and Tel Aviv, ISRAEL, May 27, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that majority-owned subsidiary 3CL Pharma will present final data from the phase 2 clinical trial of Tollovir™ in the treatment of hospitalized (severe and critical) COVID-19 patients at the Personalized Medicine World Conference (PMWC) on June 30th, 2022 at 1:30pm Pacific Time.

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Todos Medical to Present Final Data from the Tollovir Phase 2 Clinical Trial in Hospitalized COVID-19 Patients at the Personalized Medicine World...

HALIFAX, Nova Scotia, May 27, 2022 (GLOBE NEWSWIRE) -- Today, MedMira Inc. (MedMira) (TSXV: MIR) provides an update on its regulatory progress in Europe and any market accepting the CE mark. MedMira has received the CE mark for three products in 2022 and has four additional applications currently pending with the regulatory body. As of today, the Company has been informed that all applications have been accepted and will be forwarded to the Competent Authority for final CE marking. The Company anticipates the respective decisions and CE marks within the coming weeks.

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MedMira provides an update on the new In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Market

EDISON, N.J., May 27, 2022 (GLOBE NEWSWIRE) -- In the press release issued earlier today by Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), we've been informed by the company that in both the headline and first paragraph the name 'Recofilstat' should be 'Rencofilstat'. Completed corrected text follows.

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CORRECTING and REPLACING - Hepion Pharmaceuticals, Inc.

IRVINE, Calif., May 27, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus, will present a corporate update at the Jefferies 2022 Healthcare Conference on Wednesday, June 8, 2022 at 8:30am PT / 11:30am ET.

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Tarsus to Present at the Jefferies 2022 Healthcare Conference

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

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ObsEva Announces Corporate Updates

New York, NY, and Tel Aviv, ISRAEL, May 27, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today released a corporate update from CEO Gerald Commissiong on the Company’s CLIA/CAP-certified lab Provista Diagnostics, an update on the Company’s 3CL Pharma majority-owned subsidiary progress and plans to take the Company onto a national stock exchange.

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Todos Medical Releases Corporate Update

BUFFALO, N.Y., May 27, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company dedicated to improving human health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technology, today announced that James A. Mish, Chief Executive Officer, and Richard Fitzgerald, Chief Financial Officer, will host meetings with investors at two upcoming investor conference events in June 2022.

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22nd Century Group (Nasdaq: XXII) to Participate in LD Micro, Roth Capital Investor Meetings

Basel, May 28, 2022 — Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. In accordance with the Accelerated Approval Program, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings1. "We are proud of today's FDA approval of a third indication for Kymriah. We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” said Victor Bulto, President, Novartis Innovative Medicines US. “We are on a mission to build on our pioneering work in cell therapy and continue to innovate for patient impact.”

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FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma