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.

On September 6, 2022 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that the Company will present at the H.C. Wainwright 24th Annual Global Investment Conference, a hybrid conference (Press release, Protalix, SEP 6, 2022, https://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-present-at-the-hc-wainwright-24th-annual-global-investment-conference-301618133.html [SID1234619110]). The conference is being held on September 12-14, 2022 at the Lotte New York Palace Hotel in New York City. Virtual participation will also be available.

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Dror Bashan, the Company’s President and Chief Executive Officer, will provide a corporate overview at the conference. A webcast of the presentation will be available commencing on Monday, September 12, 2022 at 7:00 AM, Eastern time, and will be archived.

Webcast Details:

The conference will be webcast live from the Company’s website and will be available via the following links:

The Company’s management will participate in one-on-one meetings with investors who are registered to attend the conference. If you are an institutional investor and would like to attend the Company’s presentation, registration for the conference is available at View Source Once your registration is confirmed, you will be prompted to log onto the conference website to request a one-on-one meeting with the Company.

On September 6, 2022 Milestone Pharmaceuticals Inc. ( Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported that Joseph Oliveto, President and Chief Executive Officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12, 2022 at 12:00 p.m. ET in New York, NY (Press release, Milestone Pharmaceuticals, SEP 6, 2022, https://www.prnewswire.com/news-releases/milestone-pharmaceuticals-to-present-at-the-hc-wainwright-24th-annual-global-investment-conference-301617233.html [SID1234619109]).

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A live webcast of the presentation can be accessed in the News & Events section of Milestone’s website at www.milestonepharma.com. An archived replay of the presentation will be available on the same website for approximately 90 days following the presentation.