On September 6, 2022 Dong-A ST Co., Ltd. (170900: Korea SE), a Korean pharmaceutical company, and Beactica Therapeutics AB, a Swedish precision oncology company, reported that they have mutually agreed to terminate their collaboration and licensing agreement (Press release, Dong-A ST, SEP 6, 2022, View Source [SID1234619115]). The collaboration focused on developing novel candidate compounds against multiple cancer targets of mutual interest. The partnership has been productive, and multiple compound classes are now in various stages of lead generation and optimization.

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As part of the termination, both Dong-A ST and Beactica Therapeutics will gain exclusive global rights for further development and commercialization for different compounds series developed during the collaboration. No obligations to pay milestone payments or royalties will remain for the assets divided between Dong-A and Beactica. For a limited time, each company is entitled to a revenue share from any related future outlicensing activities by the other party. Full financial details remain undisclosed.

"We appreciate the opportunity we have had to collaborate with Beactica Therapeutics over the past five years. Our combined efforts have led to important breakthroughs," said Dr Jae-Hong Park, President and CSO of Dong-A ST. "We will continue to share with Beactica the ambition to make a clinical impact where it is urgently needed."

"We have valued the partnership with Dong-A and are pleased by what we have achieved together. Gaining exclusive global rights to certain compounds is perfectly aligned with Beactica’s ambition to itself become a clinical-stage precision oncology company," said Dr Per Källblad, CEO of Beactica Therapeutics. "We are excited to now add these assets to our pipeline as wholly-owned programmes."

The collaboration between Dong-A ST and Beactica Therapeutics was initiated in October 2016 and expanded in December 2018. In December 2019, a key milestone was achieved.

On September 6, 2022 Pleco Therapeutics BV, a specialty biopharmaceutical company developing novel treatments designed to detoxify the cancer micro-environment reported the final close of its Series A financing, with total funds raised of €17.3 million (Press release, Pleco Therapeutics, SEP 6, 2022, View Source [SID1234619114]). The funds will be used to complete development and commercialise the Company’s novel lead Plecoid Product, PTX-061, to improve the effectiveness of chemotherapy in patients with Acute Myeloid Leukaemia (AML).

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The investments include €3.6 million in new equity committed by Oost NL and a select number of private investors, €5m in government funding from the Netherlands Enterprise Agency (Rijksdienst voor Ondernemend Nederland, RVO), and €8.7 million in equity and R&D project financing from Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) previously announced in late 2021.

In total, at final close, the round exceeds the Company’s goal of €15 million. It provides sufficient funds to complete the development of PTX-061’s regulatory dossier in AML and to be ready for submission to the FDA and EMA as early as 2024, and to accelerate preclinical work in other indications such as Small-Cell Lung Cancer (SCLC).

Pleco’s novel Plecoid therapies are patented, innovative treatments that include chelating agents with different characteristics, that have the potential to positively change the balance of protein expression within the cancer microenvironment, removing the burden of toxic metals within the cell, thereby improving the effectiveness of existing chemotherapy.

Whilst AML is a relatively rare disease, the effectiveness of current chemotherapy may be limited because the leukaemia cells can become resistant to it over time. The majority of patients will relapse, even after an initial successful treatment. Relapses carry a poor prognosis; most patients no longer respond to treatment and die from anaemia, infection, or multiorgan failure. Worldwide the incidence of AML is estimated to be 350,000 cases per year (4.7 cases per 100,000 population)1. In the US, there was an estimated 20,050 new cases of AML in 2022 and 11,540 deaths2.

Pleco’s technology provides a platform for the development of a pipeline of therapies. In addition to PTX-061 for AML, the current pipeline includes additional candidates in preclinical testing for the treatment of other rare diseases such as SCLC.

Ivo Timmermans, Chief Executive Officer of Pleco Therapeutics, commented: "We are delighted to have secured the funds needed to progress our lead drug candidate through development, for the treatment of AML, a blood cancer that carries a very poor prognosis. We welcome our new shareholders and are grateful for the support from Oost NL and RVO."

Pleco’s funding from the RVO is the maximum granted under its Innovation Credit scheme that helps entrepreneurs with promising and challenging innovations with excellent market perspective. It provides special funding, a national and international network, and personal advice for innovative start-ups.

Pleco recently announced its expansion, with the incorporation of its subsidiary, Pleco Therapeutics USA, Inc., and the appointment of Michael Stalhamer as its President and first US-based employee. Mr Stalhamer also serves on the global leadership team as Vice President (VP) Product Development and Regulatory Affairs.

About Acute Myeloid Leukaemia (AML)

AML is a type of heterogenous haematological malignancy that originates from immature white blood cells (blasts) in the bone marrow, which may be derived from either a hematopoietic stem cell or a lineage-specific progenitor cell. AML generally spreads quickly to the bloodstream and can then spread to other parts of the body including lymph nodes, spleen, central nervous system, and testicles. AML is an orphan disease and is the most common type of acute leukaemia in adults and is primarily a disease of the adulthood; the median age of newly diagnosed AML patients is around 67 years. Worldwide the incidence of AML is estimated to be 350,000 cases per year (4.7 cases per 100,000 population, Globocan). In the US, there was an estimated 20,050 new cases of AML in 2022 and 11,540 deaths. Additionally, AML is more common in males. AML can arise de novo or secondarily either due to the progression of other diseases or due to treatment with cytotoxic agents.

On September 6, 2022 Jacobio Pharma (1167.HK) reported that it has received Phase II pivotal study approval of KRAS G12C inhibitor JAB-21822 from the Center for Drug Evaluation (CDE) of China in September 5, 2022 (Press release, Jacobio Pharmaceuticals, SEP 6, 2022, View Source [SID1234619113]). This study aims to treat advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation as a second line or beyond therapy. Jacobio aims to apply for the new drug marketing application (NDA) for JAB-21822 after the successful completion of this pivotal study.

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"JAB-21822 is the first product entered into pivotal stage since 2015, the year of Jacobio founded, it’s a milestone for the company. We hope to work with clinical study investigators to jointly advance the clinical trials and strive to bring more treatment options to patients with KRAS G12C-mutated non-small cell lung cancer as soon as possible," said Dr. WANG Yinxiang, Chairman and CEO of Jacobio.

The Phase II pivotal clinical trial approved in China will evaluate the efficacy and safety of JAB-21822 as a single agent for the treatment of NSCLC patients with a KRAS G12C mutation. This is a multi-center, single-arm, open-label study.

JAB-21822 is the best-in-class potential project for KRAS G12C inhibitors. The preliminary clinical date of the Phase I study of JAB-21822 published at the 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) shows that as of April 1, 2022, a total of 72 patients with advanced solid tumors were enrolled, and efficacy was assessed for 32 NSCLC patients with KRAS G12C mutation. The overall response rate (ORR) was 56.3% (18/32) and the disease control rate (DCR) was 90.6% (29/32).

Currently, JAB-21822 is simultaneously undergoing clinical trials for monotherapy and combination therapy in China, the United States and Europe, including the monotherapy for NSCLC with KRAS G12C mutation, pancreatic ductal carcinoma and colorectal cancer; the combination therapy with EGFR monoclonal antibody; and the combination therapy with JAB-3312, a self-developed SHP2 inhibitor of the Company.

About JAB-21822

JAB-21822 is a KRAS G12C inhibitor independently developed by the Company. The Company has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer in the front-line setting; combination therapy with SHP2 inhibitor, anti-PD-1 monoclonal antibody and Cetuximab.

On September 6, 2022 Laekna, a clinical-stage biotechnology company dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide, reported that the first patient recently received a dose in the LAE201INT2101 phase I/II study at Seoul National University Hospital (Press release, Laekna Therapeutics, SEP 6, 2022, View Source [SID1234619112]). The company’s multi-regional clinical trials (MRCTs) now cover China, the United States and South Korea.

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LAE201INT2101 is a multi-center, open-label, phase I/II dose-escalation and efficacy study of the LAE001 and LAE002 (afuresertib) combination in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression or intolerability following standard of care (SOC) treatment. Laekna has finished the phase I dose-escalation stage and is starting the phase II stage of the Proof-of-Concept study now.

Metastatic castration-resistant prostate cancer is one of the most intractable cancers. The combination therapy of LAE001 and LAE002 (afuresertib) is expected to provide treatment benefits for patients who progressed after treatments of the new-generation A/AR drugs including abiraterone and enzalutamide. LAE001 inhibits both CYP17A1 and CYP11B2 (aldosterone synthase) as a next-generation anti-androgen inhibitor. LAE002 (afuresertib) is a highly selective AKT kinase inhibitor. Both are the company’s potential core products.

In addition to Seoul National University Hospital, Laekna has already initiated trials in four other clinical sites in South Korea. The study is also ongoing in more than 10 sites across the United States.

"We have been committed to ‘global development and marketing’ since the inception of the company. Based on our clinical team’s strategy and execution capabilities, our trials are now ongoing in more than 90 clinical sites in China, the United States and South Korea," said Dr. Yong Yue, Chief Medical Officer of Laekna. "We are rapidly advancing a number of multi-regional clinical trials to better evaluate the value of our drugs in the treatment of various cancers, and we hope to enable our innovative therapies to benefit more patients worldwide as soon as possible."

On September 6, 2022 IDEAYA Biosciences, Inc. ( Nasdaq: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has initiated an Investigator Sponsored Trial, or IST, in coordination with St. Vincent’s Hospital, Sydney, to evaluate darovasertib as monotherapy in neo-adjuvant and adjuvant settings in primary, non-metastatic uveal melanoma (UM) patients (Press release, Ideaya Biosciences, SEP 6, 2022, View Source [SID1234619111]).

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The study, captioned as "Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM), is being led by principal investigator Professor Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent’s Hospital in Sydney with participating sites of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne. Pursuant to the protocol, the NADOM study will evaluate darovasertib as monotherapy in eligible adult patients having ocular melanoma to determine the feasibility and tolerability of (neo)adjuvant treatment.

"We are excited to be leading this ground-breaking clinical study treating patients with darovasertib in the neo-adjuvant and adjuvant settings. The concept for this study originated from anecdotal observations in a MUM patient treated with darovasertib who also had an intact primary lesion in the eye, where a reduction in the eye lesion was observed at an initial scan with improvement in visual symptoms," said Professor Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent’s Hospital Sydney.

"We are observing an early signal of clinical activity in the first patient enrolled in the NADOM study," said Professor Mark Shackleton MBBS, PhD, FRACP, Director of Oncology at Alfred Health and Professor of Oncology, Monash University. "Our coordinated patient care with eye specialists at the Royal Victorian Eye and Ear Hospital on this trial has enabled a potential paradigm-shifting approach to reduce the size of ocular tumors prior to primary treatment, which we hope will lead to better outcomes for patients," continued Professor Shackleton.

"There are currently limited treatment options for patients with uveal melanoma in the pre-metastatic setting. We are pleased to be collaborating with St. Vincent’s Hospital in Sydney and with Alfred Health and Royal Victorian Eye and Ear Hospital in Melbourne to explore the potential for darovasertib monotherapy to be impactful for patients with primary uveal melanoma," said Dr. Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs, IDEAYA Biosciences.

Uveal melanoma is a rare, lethal form of melanoma that arises from melanocytes of the iris, the ciliary body, or most commonly the choroid, with an annual potential incidence of approximately 8,700 patients aggregate in US and Europe. Current approaches for treatment of primary UM includes radiotherapy (plaque brachytherapy or stereotactic radiosurgery) and, for larger tumors, enucleation of the eye, with consequential patient impact including reduced vision, decreased depth perception, diminished social functioning and unsatisfactory cosmesis.

Darovasertib (IDE196) is a potent, selective small molecule inhibitor of protein kinase C (PKC). Mutations in GNAQ or GNA11 (GNAQ/11) have been identified in approximately 90% of patients with metastatic UM. These mutations are associated with activation of signaling pathways, including oncogenic RAS/RAF/MEK/ERK via Protein Kinase C (PKC) activation, driving tumor progression. In April 2022, the FDA designated darovasertib as an Orphan Drug in Uveal Melanoma.

In addition to supporting the NADOM study with St. Vincent’s Hospital Sydney, IDEAYA is also evaluating the synthetic lethal combination of darovasertib and crizotinib, a small molecule cMET inhibitor, in metastatic uveal melanoma (MUM) in an ongoing Phase 2 clinical trial pursuant to a clinical trial collaboration and drug supply agreement with Pfizer.

IDEAYA is targeting interim Phase 2 clinical results for darovasertib and crizotinib synthetic lethal combination in first-line and any-line MUM patients in September 2022, including clinical efficacy in MUM (e.g., confirmed overall response rate by RECIST, median progression-free survival, median duration of response) and an adverse event summary. The company will also present data supporting clinical proof of concept for potential use of darovasertib in primary (neo)adjuvant UM.