On December 12, 2023 Plexium, Inc. (Plexium), a leading next-generation targeted protein degradation company, reported that the first subjects have been dosed in a Phase 1 clinical study of orally administered PLX-4545, a potent and selective molecular glue degrader of IKZF2, a classically undruggable transcription factor also known as Helios (Press release, Plexium, DEC 12, 2023, View Source [SID1234638499]).

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"We are very pleased to have dosed the first subjects in the Phase 1 study with PLX-4545, advancing Plexium into a clinical stage company," said Mike Grey, Executive Chairman of Plexium. "Initiation of this study represents an important milestone for Plexium, as PLX-4545 is our first small molecule degrader program stemming from our proprietary drug discovery platform to enter human studies. In addition, we continue to discover potent and selective protein degraders of important cancer targets, such as SMARCA2, CDK2 and CRaf, and we look forward to progressing one or more of these programs into development in 2024."

The randomized, double-blind, placebo-controlled, single- and multiple-ascending dose Phase 1 clinical study is designed to primarily assess the safety and tolerability profile of orally administered PLX-4545, as well as measure pharmacokinetics and pharmacodynamics to identify a pharmacologically effective dose.

"While checkpoint inhibitors have demonstrated broad clinical activity in several tumor types, many cancer patients are unresponsive to therapy, often due to immune suppression within the tumor stroma," said Simon Bailey, Ph.D., Executive Vice President, Drug Discovery at Plexium. "The immune transcription factor IKZF2 is a marker of highly suppressive regulatory T cells, and we have shown that potent and selective degradation of IKZF2 results in the conversion of Tregs into effector-like T cells. We have also shown that oral administration of PLX-4545 in preclinical in vivo cancer models has demonstrated promising efficacy, an effect that is even more pronounced when PLX-4545 is co-administered with a checkpoint inhibitor."

"Data from this initial study will provide a strong foundation for subsequent clinical studies to evaluate PLX-4545 in cancer patients with tumors that are refractory to checkpoint inhibitors, both as a single agent and in combination with a checkpoint inhibitor, an area of high unmet need," continued Dr. Bailey.
Plexium expects to announce results from the PLX-4545 Phase 1 study in the second half of 2024.

About PLX-4545

PLX-4545 is a potent, selective and orally bioavailable molecular glue degrader of IKZF2, designed to destabilize highly suppressive regulatory T cells (Tregs). PLX-4545 delivers rapid, deep and selective degradation of IKZF2 resulting in destabilization of Tregs in vitro and in vivo. In preclinical studies, PLX-4545 has demonstrated single agent anti-tumor activity in vivo comparable to pembrolizumab and increased efficacy in combination.
To learn more about the PLX-4545 clinical trial, visit View Source (Trial registration #ACTRN12623001265662).

On December 12, 2023 PharmaMar (MSE:PHM) reported that its licensing partner, Luye Pharma Group Ltd, has received marketing approval for Zepzelca (lurbinectedin) by the Pharmacy and Poisons Board of the Hong Kong Special Administrative Region (SAR), for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy (Press release, PharmaMar, DEC 12, 2023, View Source [SID1234638498]).

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The approval of lurbinectedin in Hong Kong is based on the data of the open-label, multi-center, single-arm monotherapy clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), which is the same that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin.

Lung cancer is the most common of all cancers in Hong Kong, in terms of incidence and mortality. In 2020, 5,422 new cases were diagnosed[1], of which SCLC accounts for 13-17%[2], and a total of 3,910 people died from this pathology in that region, representing 26.4% of all cancer deaths1.

Currently, lurbinectedin is under review for its New Drug Application (NDA) in mainland China and other countries around the world. Lurbinectedin is now approved in 16 territories: 9 in Asia (United Arab Emirates, Singapore, South Korea, Qatar, Israel, Oman, Taiwan, Macau and Hong Kong); 5 in the Americas (U.S.A, Canada, Ecuador, Mexico and Peru); 1 in Oceania (Australia) and 1 in Europe (Switzerland). Patients in the other European Countries currently can only benefit from lurbinectedin through compassionate use or in a clinical trial. In order to submit in Europe the dossier for approval, the LAGOON Phase III trial is being conducted.

On December 12, 2023 Nusano, Inc., a company reshaping the production of cancer-fighting radioisotopes, reported that it will host a virtual KOL event on December 19, 2023 at 11:00 AM ET, led by Suji Jeong PhD (Founding Partner, The SJR Group), featuring Phil Nicklin (Senior Analyst, LifeSci Consulting) and Dr. Ashley Mishoe, PharmD (Vice President of Regulatory Affairs and Quality Assurance, PharmaLogic) (Press release, Nusano, DEC 12, 2023, View Source [SID1234638497]). They will discuss emerging trends in the radiotherapeutics landscape, a market that is projected to have a $30 billion potential in the next five years, a prospect that is capturing the attention of investors and companies alike. To register, click here.

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The event will highlight the isotopes that are the next frontier in radiotherapeutics development, exploring alternatives to industry staples like Lutetium-177 and Actinium-225. Additionally, the discussions will delve into supply chain complexities, the role of CDMOs in bringing radiotherapeutics to patients, and the optimal timing for commercial-scale product development.

Nusano’s production platform enables the creation of rare and hard-to-produce medical radioisotopes in quantities needed for commercial-stage diagnostics and therapeutics. A reliable supply of radioisotopes is an important requirement for drugmakers developing and manufacturing next-generation pharmaceuticals needed to advance the fight against cancer.

A live question and answer session will follow the moderated panel discussion.

Emerging Trends in Radiotherapeutics: Beyond Lu-177 and Ac-225
Format: Panel Discussion
Date: Tuesday, December 19, 2023
Time: 11:00 AM ET
Location: Virtual Event

On December 12, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta, will present live at the Life Science Investor Forum, hosted by VirtualInvestorConferences.com, on December 14th, 2023 (Press release, Kineta, DEC 12, 2023, View Source;utm_medium=rss&utm_campaign=kineta-to-present-at-the-life-sciences-investor-forum-december-14th [SID1234638496]). Dr. Iadonato will engage in a "CEO Chat" session with John Vandermosten, Senior Biotechnology Analyst with Zacks Small-Cap Research.

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DATE: December 14th , 2023
TIME: 11:30 A.M. Eastern
LINK: https://bit.ly/3FgGsBt
Available for 1×1 meetings: December 14th, 15th, 18th and 19th

This will be a live, interactive online event with Dr. Iadonato and John and investors will be given the opportunity to ask Dr. Iadonato and John questions at the end of the session. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.

It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates.

Learn more about the event at www.virtualinvestorconferences.com.

On December 12, 2023 ISA reported positive anti-tumor response data with ISA101b, an HPV16 directed therapeutic cancer vaccine given in combination with Libtayo, an anti-PD1 checkpoint inhibitor (CPI) (Press release, ISA Pharmaceuticals, DEC 12, 2023, View Source [SID1234638495]). The data were generated in the OpcemISA trial, a large scale randomized double blind study that is ongoing in patients with advanced oropharyngeal cancer (OPC), a type of head and neck cancer. It is the first time that the combination of a tumor-specific therapeutic vaccine and a CPI has generated such high response rates, albeit in a predefined subpopulation of metastatic cancer patients.

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ISA101b is a therapeutic cancer vaccine targeting cancers caused by the human papillomavirus type 16 (HPV16). More than 60 percent of head-and-neck cancers are HPV16-related, and incidence rates are going up. ISA101b elicits a powerful and targeted T-cell immune response to the HPV16 virus.

OPC is a solid cancer with a high unmet medical need that does not always respond to immunotherapy. Best responses in the OpcemISA trial are found in a subcategory of patients with characteristics suitable for immunostimulatory treatments.

Study design & results

A total of 199 first- and second-line patients with recurrent/metastatic HPV16+ OPC were enrolled in the OpcemISA trial. Patients were randomized to receive either ISA101b plus CPI, or placebo plus CPI. The primary endpoint was the objective response rate (ORR) at 6 months, confirmed by independent central review. The secondary endpoints included drug safety, progression free survival (PFS) and overall survival (OS). Further details can be found at clinicaltrials.gov (NCT03669718).

Whereas the addition of ISA101b to the CPI led to a doubling of the ORR (from 26.7% to 51.9%) in a large subgroup of patients, the study as a whole did not meet this primary endpoint. Patients in the aforementioned subgroup, predefined based on a validated biomarker, also showed a clear overall survival benefit compared to the placebo arm. ISA101b was well tolerated.

Gerben Moolhuizen, Chief Executive Officer of ISA, said, "Recurrent and/or metastatic head and neck cancer is notoriously difficult to treat. Patients suffering from this terrible disease need new treatment options. In our OpcemISA study, ISA101b shows compelling results in a large, predefined subset of patients. This provides us with a clear development path to make ISA101b a treatment option for these patients."

Phase 3 and beyond

ISA is preparing for a confirmatory Phase 3 trial in this subpopulation of patients. This subgroup represents an important proportion of head and neck cancer patients, and an attractive commercial opportunity. The OpcemISA trial was part of a clinical collaboration between ISA and Regeneron. Regeneron has elected not to exercise its option on the ISA101b asset. ISA is currently in discussions with potential partners with interest in ISA101b and ISA’s technology platform in general.