On November 11, 2022 AimedBio reported that its candidate of ‘P018’ has been selected as a "novel therapeutics-based expansion research" project by the Korean Drug Development Project (KDDF) and will receive research funds to derive its lead over the next two years.

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P018 is an antibody targeting the tumor microenvironment (TME) which activates immune cells such as T cells and NK cells by removing tumor-associated macrophages (TAM).

AimedBio expects to solve unmet medical needs in solid cancers such as brain tumors and lung cancer through combination of P018 and immuno-oncology drugs.

(Press release, AimedBio, NOV 11, 2022, View Source;s_keyword=&s_where=&start=0 [SID1234656922])

On November 11, 2022 Oncopeptides, a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, reported that Pepaxti[] (melphalan flufenamide, also called melflufen) has been granted marketing authorization in combination with dexamethasone, by the Medicines & Healthcare products Regulatory Agency, MHRA, in UK (Press release, Oncopeptides, NOV 11, 2022, View Source [SID1234646787]).

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"The approval of Pepaxti in UK is one additional important milestone for Oncopeptides that further validates our science and data," says Jakob Lindberg, CEO Oncopeptides AB. "Pepaxti provides clinical benefit to patients with triple class refractory disease. This is very good news for patients with multiple myeloma, whose treatment options ultimately become exhausted."

The marketing authorization in the UK is based on data from the phase 2 HORIZON study and is supported by data from the randomized controlled phase 3 OCEAN study as a confirmatory study.

The clinical benefit of melflufen in multiple myeloma patients with a treatment history with no stem-cell transplant or a successful prior stem-cell transplant has recently gained additional support with data from the phase 3 LIGHTHOUSE study.

Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

On August 18, Pepaxti was granted marketing authorization by the European Commission in EU and in the EEA-countries Iceland, Lichtenstein, and Norway.

Multiple myeloma is an incurable disease that mainly affects people over 65 years of age. Data from Cancer Research UK (Cancer Research UK, 2010) and the Global Cancer Observatory (Globocan, 2020) states that the estimated prevalence of multiple myeloma is around 17.600 patients. There are around 6.000 new cases diagnosed every year.

Oncopeptides is currently assessing the market access opportunities for Pepaxti in the UK.

On November 11, 2022 BioInvent International AB (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immuno-modulatory antibodies for cancer immunotherapy and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that a paper co-authored by researchers from BioInvent and Transgene is the recipient of this year’s Journal for ImmunoTherapy of Cancer (JITC) Best Oncolytic and Local Immunotherapy Paper Award (Press release, BioInvent, NOV 11, 2022, https://www.bioinvent.com/en/press/bioinvent-and-transgene-joint-paper-bt-001-wins-jitc-best-oncolytic-and-local-immunotherapy [SID1234624033]). The paper was highlighted at the annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference being held November 8-12, 2022, in Boston, MA, US.

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The annual award, judged by a prestigious review committee of SITC (Free SITC Whitepaper) leadership and the JITC Editorial Board, recognizes one paper in the Oncolytic and Local Immunotherapy category for presenting outstanding research on the role of therapeutic agents designed to target tumor cells or the tumor microenvironment.

The winning paper, Vectorized Treg-depleting αCTLA-4 elicits antigen cross-presentation and CD8+ T cell immunity to reject ‘cold’ tumors, demonstrates in vivo proof of concept for Treg depleting immune checkpoint blocking vectorized αCTLA-4 as a highly effective and safe strategy to target CTLA-4.

Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO platform that is armed with an anti-CTLA-4 antibody to illicit a strong and effective anti-tumor response. The drug is currently being evaluated in a Phase 1/2a clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab) against solid tumors. Positive Phase 1 data announced in June 2022 confirmed the mechanism of action of BT-001 as a single agent and demonstrated first signs of anti-tumor activity.

The papers’ two co-first authors, Dr Monika Semmrich, Principal Scientist at BioInvent, and Dr Jean-Baptiste Marchand, Head of the Protein Science Lab at Transgene, will each receive a monetary prize. The award will be presented at the SITC (Free SITC Whitepaper) Meeting Awards Ceremony, taking place Friday, November 11 from 8:00 – 8:20 a.m. EST.

The full paper can be accessed here.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On November 11, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that enrollment is complete in a Phase 2a trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) with standard of care (SOC) therapy in patients with nonoperable lung cancer (Press release, NanOlogy, NOV 11, 2022, View Source;utm_medium=rss&utm_campaign=nanology-completes-enrollment-in-phase2a-trial [SID1234624007]).

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The single arm trial (NCT04314895) enrolled 18 subjects at four clinical sites with primary or recurrent nonoperable locally advanced stages II and III with nodal disease or stage IV advanced disease. Up to three monthly doses of IT LSAM-PTX were administered and subjects enrolled into the trial had prior or concurrent chemotherapy, radiotherapy, and/or immune checkpoint inhibitor (ICI) therapy as part of SOC.

The primary outcome measure for the trial is safety, as determined by treatment emergent adverse events. Secondary measures include plasma paclitaxel concentration, tumor response, survival, and immune response by flow cytometry analysis. A safety assessment was completed for each of the initial three subjects prior to open enrollment.

Preliminary data to date indicate IT LSAM-PTX is well tolerated with encouraging signs of tumor and immune response. Final data and clinical study report are expected by 3Q2023.

Lung cancer has the highest mortality of any cancer with 2.2 million new cases and 1.8 million deaths estimated globally in 2020 by GLOBOCAN. ICIs are rapidly becoming a SOC for the treatment of lung cancer often combined with other agents to increase response.

NanOlogy is in the planning stages of further clinical research in lung cancer to evaluate its LSAM investigational drugs combined with ICIs bolstered by a recently allowed US patent that covers use of locally delivered LSAM taxanes with systemic ICIs.

In all, NanOlogy clinical programs have advanced tumor directed LSAM investigational drugs in multiple solid tumors including pancreas, lung, bladder, peritoneal, ovarian, prostate, and dermal cancers. More than 170 patients have been treated to date across its clinical trials with signals of tumor and immune response and no confirmed drug-related serious adverse events.

On November 11, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported data from the Phase 1 expansion study of CV8102, the company’s non-coding RNA candidate in oncology (Press release, CureVac, NOV 11, 2022, View Source [SID1234623978]). Preliminary results from the completed Phase 1 expansion study in patients with PD-1 refractory melanoma confirm a robust safety profile of CV8102 as a single agent and in combination with anti-PD-1 antibodies. Preliminary efficacy was observed in a cohort of 30 patients treated in combination with anti-PD-1 antibodies, 40% of whom were pretreated with anti-CTLA-4 antibodies. As of June 15, 2022, in the anti-PD-1 combination cohort, five out of 30 patients (17%) experienced a partial response according to RECIST 1.1. Responses appeared durable for up to one year from the start of treatment. No objective responses were observed in the 10 patients of the single-agent cohort, 50% of whom were pretreated with anti-CTLA-4 antibodies. The data will be presented today at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held in Boston, Massachusetts.

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Extensive analysis of immune cell activation was performed to better understand CV8102’s mobilization of the immune system against injected tumors as well as non-injected tumors. The data confirm that single agent or combination treatment, after the first dose, activated systemic pathways of immune response. Preliminary analysis of the tumor microenvironment in a subgroup of patients showed the positive outcome of increased infiltration of T cells, following intra-tumoral injection in 4 out of 8 (single agent cohort) and 10 out of 18 (anti- PD1 combination cohort) analyzed paired biopsy samples.

"The data we collected in the heavily pretreated patients of our Phase 1 expansion study further confirm the safety and immuno-modulatory activity of CV8102" said Ulrike Gnad-Vogt, interim Chief Development Officer at CureVac. "As a non-coding RNA, CV8102 is designed to mimic a viral infection of the tumor and to induce an adaptive immune response against a broad panel of tumor antigens. The preliminary efficacy we see in the small group of pretreated patients further validates this technology. Given our strategic focus on developing a meaningful portfolio of mRNA-based therapeutic cancer vaccines, we will seek to assess CV8102’s potential as a complementary technology."

Final results are expected in H1 2023 and will be submitted for publication in a peer reviewed journal.

CV8102 is being tested in a fully recruited dose-escalation and expansion Phase 1 study to confirm its safety, tolerability and efficacy as a single agent and in combination with licensed anti-PD-1 antibodies. Preliminary results from the completed dose-escalation part of the study in a range of solid tumors, were previously reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in September 2021.

About CV8102

CV8102 is a single-stranded non-coding RNA optimized to maximize activation of cellular receptors that normally detect viral pathogens entering the cells, such as toll-like receptors 7 and 8 (TLR7/8), and retinoic acid inducible gene I (RIG-I), mimicking a viral infection of the tumor. CV8102 is designed to recruit and activate antigen-presenting cells at the site of injection to present tumor antigens released from tumor cells to T cells in the draining lymph node. This potentially leads to activation of tumor-specific T cells, which can kill tumor cells at the injected site, but also at distant non-injected tumor lesions or metastases. The Phase 1, open-label, dose escalation and expansion study of CV8102 aims to assess safety, tolerability and efficacy of CV8102 as a single agent and in combination with licensed PD1-antibodies. Preliminary results from the completed dose-escalation part in patients with advanced melanoma, cutaneous squamous cell carcinoma, squamous cell carcinoma of head and neck or adenoid cystic carcinoma were reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in September 2021. The expansion part of the study focuses on patients with PD-1 refractory melanoma treated with a recommended dose of 600µg.