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Year: 2023

Agillic joins partner Immeo in supporting the ‘Knæk Cancer’ (fight cancer) fundraising campaign

Cancer affects one out of every three people in Denmark before the age of 75, making cancer something that touches most, if not every Dane. Whether as a patient, next of kin, friend, or colleague, we all know someone. Every year, Kræften Bekæmpelse (The Danish Cancer Society) partners with TV2 for a national ‘Knæk Cancer’ fundraising campaign. For the past several years, Agillic partner Immeo has been supporting the campaign by organising a one-day tennis tournament as a fundraiser, bringing clients, partners, and friends together to contribute. Ivan Beltoft, Partner at Immeo, explains:“We have chosen to combine fun with sport and fundraising. We are very happy with the great support from our colleagues and clients who showed up with families and participated in our tennis tournament. We are very proud of this year’s collection and that...

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TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared with Chemotherapy in Global Phase 3 innovaTV 301 Trial

Media ReleaseTIVDAK demonstrated statistically significant overall survival, progression-free survival and objective response rate compared to chemotherapy in late-breaking results presented at ESMO 2023 congress Results from innovaTV 301 intended to serve as pivotal confirmatory trial for U.S. accelerated approval and to support global regulatory applicationsCOPENHAGEN, Denmark, and BOTHELL, Wash.; October 22, 2023 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) announced additional results today from the Phase 3 innovaTV 301 randomized global trial, which showed treatment with TIVDAK demonstrated a statistically significant and clinically meaningful 30 percent reduction in the risk of death in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, compared with chemotherapy...

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Potential of Arvinas’ PROTAC® AR Degraders Reinforced by 11.1 months rPFS with Bavdegalutamide and Updated Positive Interim Data from Second Generation ARV-766 in mCRPC

– Data presented at the European Society for Medical Oncology from the Phase 1/2 trial with bavdegalutamide showed 11.1 months radiographic progression free survival in mCRPC patients with tumors harboring AR 878/875 mutations – – Interim data from the Phase 1/2 trial of Arvinas’ second PROTAC AR degrader, ARV-766, showed robust efficacy in a broader mCRPC patient population with a tolerability profile well-suited to both early- and late-line settings – – Company to prioritize the initiation of a Phase 3 trial with ARV-766 in mCRPC – – Arvinas will host conference call to discuss results on Sunday, October 22 at 3:00 p.m. CEST / 9:00 a.m. ET – NEW HAVEN, Conn., Oct. 22, 2023 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation,...

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HOOKIPA Pharma Presents Additional Preliminary Phase 2 Data on HB-200 in Combination with Pembrolizumab as First-Line Treatment in Patients with HPV16+ Head and Neck Cancers at European Society for Medical Oncology Congress 2023

42 percent objective response rate (ORR) was observed among 19 evaluable patients with recurrent/metastatic head and neck cancer in the first-line setting—doubling historical ORR reported with pembrolizumab alone1Strong immunogenicity and activation of antigen-specific CD8+ T cells observedData reinforce HOOKIPA’s commitment to start a randomized trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ head and neck cancer in 2024Data presented at the European Society for Medical Oncology Congress 2023NEW YORK and VIENNA, Austria, Oct. 22, 2023 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today presented updated data from its ongoing Phase 2 trial of...

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Sutro Biopharma Announces Presentation of Data for Luveltamab Tazevibulin (luvelta) from the Phase 1 Dose-Expansion Study in Endometrial Cancers at ESMO 2023

– Luvelta demonstrated encouraging preliminary anti-tumor activity (29% response rate) in late-stage patients with recurrent/relapsed endometrial cancer with tumor proportion score (TPS) >25% FolRα expression – – Safety profile was consistent with prior data in patients with platinum-resistant ovarian cancer – SOUTH SAN FRANCISCO, Calif., Oct. 22, 2023 (GLOBE NEWSWIRE) — Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced initial results from a Phase 1 dose-expansion study of luveltamab tazevibulin (luvelta), a novel Folate receptor alpha (FolRα)-targeting ADC, in patients with endometrial cancer, in a mini oral presentation at the 2023 European Society For Medical Oncology (ESMO)...

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Revolution Medicines Presents Promising Clinical Activity and Safety Data from Phase 1/1b Trial of RMC-6236

Investor Webcast to be held Sunday, October 22 at 12:30 p.m. Eastern Time REDWOOD CITY, Calif., Oct. 22, 2023 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced promising anti-tumor and safety data for RMC-6236, its RASMULTI(ON) Inhibitor, in patients with previously treated non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) across several dose levels and KRASG12X genotypes, including common KRAS-mutant genotypes G12D and G12V. These initial results were presented during a Proffered Paper session at the European Society for Medical Oncology (ESMO) Congress in Madrid, October 20-24, 2023. “Today’s presentation marks an important milestone in the clinical development of RMC-6236, an unprecedented,...

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Olema Oncology Announces Positive Phase 2 Monotherapy Clinical Study Results for Palazestrant

Across all 86 heavily pretreated patients, the median PFS was 4.6 months with a CBR of 40%; in patients with ESR1 mutations at baseline, the median PFS was 5.6 months with a CBR of 52% In an analysis of 49 second- and third-line patients, the median PFS was 7.2 months with a CBR of 48%; the median PFS was 7.3 months with a CBR of 59% in patients with ESR1 mutations Results support continued development of palazestrant in the OPERA-01 monotherapy Phase 3 pivotal trial Olema will host an investor conference call at 8:00 a.m. ET on Monday, October 23, 2023SAN FRANCISCO, Oct. 22, 2023 (GLOBE NEWSWIRE) — Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”, or the “Company”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers,...

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Notice for a bondholder meeting

MILA 300929 – Bondholders meeting 20 October 2023 In accordance with the provisions of the bond MILA 300929 (the “Bond”), Sunstone IV hf. (the “Issuer”) now calls for a Bondholders Meeting, to be held at the Issuer’s office at Stórhöfði 22-30, 110 Reykjavík, Iceland at 13:00 on 6 November 2023. The Bondholders Meeting’s agenda:Proposal to change the Article of the Bond relating to payments of principal and interest, for the purpose of correcting a drafting error in the Bond.Attached to this meeting notification are the Issuer’s proposals. In accordance with the provisions of the Bond, the Bond can be amended by a Bondholders Meeting, which shall be called with no less than two-week notice. Bondholders Meetings can conclude all matters within the agenda if the meeting is called in accordance with the provisions of the Bond. The voting...

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Harpoon Therapeutics Announces Updated Interim Tolerability and Response Data from Phase 1/2 Clinical Trial of T Cell Engager HPN328 at ESMO Congress 2023

Confirmed response rate 35% (11/31), across all tumor types and patient cohorts treated with 1 mg priming dose, including three confirmed, complete responses32% (6/19) confirmed response rate in patients with small cell lung cancer (SCLC), including one confirmed complete response 42% (5/12) confirmed response rate in other neuroendocrine tumor types, including two confirmed complete responsesGenerally well tolerated; cytokine release syndrome (CRS) most common, predominantly low-grade, with no Gr3 CRS in 1 mg priming dose cohorts Enrollment in monotherapy dose cohorts nearing completion, on track to select Phase 2 dose(s) by end of 2023 Results will be presented in a poster session at ESMO Congress 2023 on Monday, October 23, 2023 and management will hold a webcast at 8:00 a.m. ET / 2:00 p.m. CEST to review the data, following...

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Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC)

89% estimated event-free survival at one year among patients with stage II to IV resectable CSCC who received Libtayo prior to surgery in a Phase 2 trial No disease recurrence among the 51% of patients who experienced a pathologic complete response in the primary analysis TARRYTOWN, N.Y., Oct. 21, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The results from an international Phase 2 trial were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology. “Advanced, resectable cutaneous...

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