On December 4, 2024 Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") reported that it has successfully completed an underwritten public offering of 18,000,000 shares of its common stock to the public at a price of NT$76 per share (Press release, Foresee Pharmaceuticals, DEC 4, 2024, View Source [SID1234648811]). The aggregate gross proceeds to Foresee from the offering were NT$1,368 million (or US$42.1 million at FX=32.5).

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The proceeds of the public offering will be used for general corporate purposes, including FP-014 (triptorelin), a ready-to-use long-acting injectable, administered either every three months or six months, in two Phase 3 clinical trials for advanced prostate cancer, respectively; FP-020 (linvemastat), an MMP-12 inhibitor, in two Phase 2 studies for both asthma and inflammatory bowel disease (IBD), and FP-045 (mirivadelgat), an ALDH2 activator, in a Phase 2 clinical trial for pulmonary hypertension associated with interstitial lung disease (PH-ILD).

"We are pleased to announce the successful completion of the public offering. I would like to express my gratitude once again for shareholders’ full support and trust in us." said Dr. Ben Chien, Founder and Chairman of Foresee. "This funding will enable us to accelerate our R&D progress and create more value for our shareholders."

On December 4, 2024 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the results from a prospective, open-label, single-arm, multi-center phase Ib/II clinical study (AK104-IIT-018) of cadonilimab (PD-1/CTLA-4 bispecific antibody) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had progressed after prior PD-(L)1 inhibitor treatment, were presented at the 2024 Asian Conference on Lung Cancer (ACLC) (Press release, Akeso Biopharma, DEC 4, 2024, View Source [SID1234648812]).

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Professor Han Baohui from Shanghai Chest Hospital presented the initial positive results of the cadonilimab combination therapy for immune-resistant NSCLC at the conference. The treatment demonstrated a 6-month progression-free survival (PFS) rate of 56.9%, a median PFS of 6.5 months, a disease control rate (DCR) of 94.0%, and a median duration of response (DoR) of 5.0 months. Nearly all patients showed long-lasting tumor control, highlighting cadonilimab as a promising and effective second-line treatment for advanced immune-resistant NSCLC.

The AK104-IIT-018 study is a prospective, open-label, single-arm, multicenter Phase Ib/II clinical trial (NCT05816499) conducted across four centers in China. The study was initated in February 2023, and this report presented the preliminary data analysis. The study enrolled patients with unresectable, incurable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC), who tested negative for driver mutations and had previously received PD-1/L1 inhibitors along with platinum-based doublet chemotherapy (either in combination or sequentially, regardless of sequence), with disease progression. Patients were treated with a combination regimen of cadonilimab (10 mg/kg every 3 weeks), anlotinib, and docetaxel (60 mg/m²). The primary endpoint of the study is the 6-month progression-free survival (PFS) rate.

As of May 31, 2024, 46 patients had been enrolled in the study. Among these, 41.3% had non-squamous NSCLC and 58.7% had squamous NSCLC. Regarding PD-L1 expression, 10.9% of patients had levels <1%, 28.3% between 1-49%, and 15.2% had PD-L1 expression≥50%. Reflective of the real-world NSCLC patient population, 10.9% of patients had brain metastasis, 6.5% of the patients had liver metastasis, and 23.9% of the patients had bone metastasis.

Progression-Free Survival (PFS):

As of May 31, 2024, the maturity of PFS was 30.4%, with a 6-month PFS rate of 56.9% (compared to 30% for docetaxel monotherapy). The median PFS was 6.5 months (versus 4 months for docetaxel monotherapy).

Tumor Response:

Out of 33 patients, 10 achieved partial response (PR), and 21 had stable disease (SD). The overall objective response rate (ORR) was 30.3%, which is significantly higher than the 14% ORR observed in previous studies of docetaxel alone. Among the 10 patients with partial response, the median duration of response (DoR) was 5.0 months.

Disease Control Rate (DCR):

The DCR reached 94.0%, with nearly all patients experiencing effective tumor control.

Safety:

The combination of cadonilimab, anlotinib, and docetaxel for treating advanced, driver gene-negative, immune-resistant NSCLC was well-tolerated. The adverse events were manageable and controllable, and the safety profile was favorable.

For patients with advanced, driver gene-negative NSCLC who progress after first-line immunotherapy combined with chemotherapy, treatment options are limited. The standard treatment recommended by the NCCN guidelines is single-agent chemotherapy, but its efficacy is limited, with an objective response rate (ORR) of 14%–17%, a 6-month progression-free survival (PFS) rate of approximately 30%, PFS of 4.0–5.4 months, and overall survival (OS) of 10.5–12 months. The cadonilimab regimen holds potential as a new treatment option for immune-resistant NSCLC. Cadonilimab is a bispecific antibody that targets both PD-1 and CTLA-4, and is independently developed by Akeso. It is a humanized immunoglobulin G1 (IgG1) bispecific antibody (BsAb). Cadonilimab promotes "immune normalization" in the tumor microenvironment through multiple mechanisms. Its unique tetravalent symmetric structure design and Fc modifications enable enhanced accumulation in tumor tissues. As a result of this study, cadonilimab demonstrated the potential to improve the efficacy of tumor immunotherapy while reducing adverse reactions.

Akeso has conducted several clinical trials to evaluate cadonilimab in the treatment of immune-resistant or poorly responsive tumors. These include the registrational phase III trial (AK109-301) of cadonilimab combined with its VEGFR-2 monoclonal antibody for advanced gastric cancer progressing after PD-1/L1 inhibitors plus chemotherapy, and the phase III trial (AK104-307) comparing cadonilimab plus chemotherapy to tislelizumab plus chemotherapy as first-line treatment for PD-L1-negative NSCLC.

On December 04, 2024 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported plans to implement cost-controls and explore strategic alternatives to support advancing the Phase 1 study of VIP943, the Company’s novel CD123-targeted antibody-drug conjugate (ADC) developed with the Company’s next-generation VersAptx platform (Press release, Vincerx Pharma, DEC 4, 2024, https://investors.vincerx.com/news-releases/news-release-details/vincerx-pharma-implement-cost-controls-support-advancing-phase-1 [SID1234648796]).

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"We believe VIP943 is a highly differentiated and valuable asset, and we remain fully committed to advancing this program," said Ahmed Hamdy, M.D., Chief Executive Officer. "As we shared in October, the Phase 1 dose-escalation study of VIP943 has demonstrated encouraging safety, efficacy, and tolerability. Of nine evaluable patients, one patient whose acute myeloid leukemia (AML) relapsed post-transplant achieved a CRi and one patient with higher-risk myelodysplastic syndrome (HR-MDS) achieved a CRL. Notably, since October, the patient with CRi has continued to improve, with their most recent bone marrow results showing only 1% cancer cells. This patient has now been on the study for seven months and counting. Monotherapy responses in post-transplant patients are rare, so we believe this type of response highlights the potential of VIP943 in this challenging population and supports the next-generation technology of our VersAptx platform."

Dr. Hamdy continued, "Our immediate focus is to give the program time to generate more data, with results from additional cohorts expected by early Q1 2025. To support this, we are implementing significant cost-cutting measures to focus resources on VIP943’s advancement. Additionally, we will begin exploring strategic alternatives to complement our ongoing fundraising efforts, with the goal of maximizing the value of the VIP943 program and our VersAptx platform."

As part of its review of potential strategic alternatives, Vincerx will consider options such as out-licensing, merger and acquisition opportunities, including reverse mergers, sales of assets and technologies, and other transactions. To streamline operations and focus resources, Vincerx will implement a significant reduction in force of approximately 55%. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. The Company is in the process of engaging a financial advisor to assist in the strategic review process.

Vincerx has not set a timetable for completion of the evaluation process and does not intend to disclose further developments or guidance on the status of its exploration of strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary.

As of October 31, 2024, the Company had approximately $8.4 million in cash, cash equivalents, and marketable securities.

About VIP943
VIP943, the first ADC from the VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with Vincerx’s CellTrapper technology. Vincerx’s proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities. VIP943 is being evaluated in a Phase 1 dose-escalation trial in patients with relapsed/refractory AML, HR-MDS, and B-ALL who have exhausted standard therapeutic options (NCT06034275).

About VersAptx Platform
VersAptx is a versatile and adaptable next-generation bioconjugation platform. The modular nature of this innovative platform allows the combination of different targeting, linker, and payload technologies to develop bespoke bioconjugates that address different cancer biologies. With this platform, (i) antibodies and small molecules can be used to target different tumor antigens, (ii) linkers can be designed to reduce non-specific release of the payload, cleave intracellularly or extracellularly, and conjugate to single or multiple payloads, and (iii) payloads can be designed with reduced permeability using our CellTrapper technology to ensure accumulation in cancer cells or to be permeable for release in the tumor microenvironment. The VersAptx platform allows the development of bioconjugates designed to address the safety and efficacy challenges of historical ADCs.

On December 6, 2024 Treovir, Inc. reported the opening of a Phase 2 trial testing G207, an oncolytic HSV immunotherapy, in pediatric brain tumor patients (Press release, Treovir, DEC 4, 2024, View Source [SID1234648855]).

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G207 is being evaluated for efficacy in a single-arm Phase 2 study of 30 pediatric patients with high grade gliomas at first recurrence, a uniformly fatal form of pediatric brain tumors with no currently approved therapies. The Phase 2 trial will evaluate efficacy (overall survival) and confirm safety of G207, an oncolytic HSV virus. The trial is being conducted in collaboration with the Pediatric Brain Tumor Consortium, a National Cancer Institute (NCI)-supported consortium comprising 15 pediatric cancer centers, and is currently enrolling patients at Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center. NCI is part of the National Institutes of Health. Treovir anticipates that additional US and Canadian sites will open for enrollment in late 2024 and 2025. ClinicalTrials.gov ID NCT04482933; PBTC 061 www.pbtc.org

"With the opening of the Phase 2 study Treovir expects to expand on the positive data obtained from the Phase 1 study in pediatric patients completed in 2021" stated Michael Christini, CEO of Treovir. "There are no approved therapies for pediatric glioma and we anticipate that Phase 2 data will ultimately be used in support of a BLA filing for market approval of G207 offering a treatment option for patients in this critically underserved therapeutic area."

On December 4, 2024 Delta-Fly Pharma reported that as a result of consultation with the PMDA on December 3rd, 2024, the Phase II/III clinical trial of DFP-17729 in combination with TS-1 versus TS-1 alone in patients with pancreatic cancer after third-line treatment was approved (Press release, Delta-Fly Pharma, DEC 4, 2024, View Source [SID1234648815]).

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In a Phase I/II study of DFP-17729 in combination with TS-1 in patients with end-stage pancreatic cancer, no significant difference was observed against the control treatment (TS-1 or gemcitabine), but stratified analysis showed that when patients in the third-line or later treatment were treated for more than 6 weeks, DFP-17729 in combination with TS-1 showed a predominant median overall survival (mOS) prolongation (9.0 months vs. 6.1 months) and a significant correlation was also observed between urinary alkalinization and mOS in pancreatic cancer patients treated with DFP-17729, as key proof of concept. We had presented these results at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2024 and the 55 Annual Meeting of the Japan Pancreas Society, where much attention was paid to the presentation.

DFP-17729 is a novel approach to neutralize the acidic cancer microenvironment, and several patents on related inventions have been granted in major countries around the world, and its potential of efficacy has been published in peer-reviewed journals.

We will first identify DFP-17729 as a treatment for refractory pancreatic cancer, for which effective treatment is not yet available, and then seek to expand the indication to other types of cancer through partnership with major global pharmaceutical companies.