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Alkermes to Participate in Upcoming Investor Conferences

On November 25, 2024 Alkermes plc (Nasdaq: ALKS) reported that management will participate in two upcoming investor conferences (Press release, Alkermes, NOV 25, 2024, View Source [SID1234648598]).

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7th Annual Evercore ISI HealthCONx Conference
Date/Time: Tuesday, Dec. 3, 2024 at 10:25 a.m. ET (3:25 p.m. GMT)

Piper Sandler 36th Annual Healthcare Conference
Date/Time: Wednesday, Dec. 4, 2024 at 4:00 p.m. ET (9:00 p.m. GMT)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

Adcendo ApS Completes Oversubscribed $135 Million Series B Financing to Advance First-in-class ADC Pipeline

On November 25, 2024 Adcendo, a biotech company focused on the development of first-in-class ADCs for the treatment of cancers with a high unmet medical need, reported the successful closing of an oversubscribed $135 million Series B financing round (Press release, ADCendo, NOV 25, 2024, View Source [SID1234648597]). Proceeds from the fundraise will be used to advance, broaden, and accelerate the development of the Company’s first-in-class ADC pipeline, including the ADCE-T02 (Tissue Factor ADC), ADCE-D01 (uPARAP ADC), ADCE-B05 and A0401 programs.

The financing round was led by TCGX, with participation from new investors TPG Life Sciences Innovations, Orbimed Advisors, Venrock Healthcare Capital Partners, Surveyor Capital (a Citadel company), and Logos Capital, as well as all existing investors, including RA Capital Management, Novo Holdings, Pontifax Venture Capital, Dawn Biopharma, a platform controlled by KKR, HealthCap, Gilde Healthcare and Ysios Capital.

"We are thrilled with a financing round of this magnitude and the support shown from such a strong group of investors as we continue to advance our pipeline of breakthrough ADCs for the treatment of underserved cancers," said Michael Pehl, Chief Executive Officer of Adcendo. "The excitement in the ADC space paired with our team’s experience and passion for the underlying science motivates us to continue pushing our programs forward into the clinic. We look forward to achieving key milestones across our pipeline with the support of this fundraising."

Cariad Chester, Managing Partner of TCGX, commented: "ADCs have transformed the clinical landscape and standard of care in the treatment of solid tumors. Continued progress for hard-to-treat cancers will require innovative approaches and I’m confident Adcendo will be a leader in the next era of ADC drug development. With this financing, Adcendo can rapidly advance a pipeline of exciting, differentiated ADC candidates. These programs have the potential to significantly change the treatment paradigm in multiple cancers and serve patients in need of better therapies."

As part of the financing, the new Adcendo Board of Directors will consist of John Haurum (Chairman), Cariad Chester (Managing Partner of TCGX), Nandita Shangari (Managing Director at RA Capital), Jeroen Bakker (Partner at Novo Holdings), Carolyn Ng (Business Unit Partner at TPG Life Sciences Innovations), Ohad Hammer (Partner at Pontifax Venture Capital), Iyona Rajkomar (Managing Partner of DawnBio, a platform controlled by KKR) and Michael Pehl (CEO of Adcendo). Roy Amariglio, Principal at Orbimed Advisors, will serve as a board observer.

Hanmi Pharmaceutical and Beijing Hanmi Progress Clinical Trials of Co-developed BH3120 as a Next-Generation Cancer Immunotherapy

On November 25, Hanmi reported that it presented the research and clinical progress of BH3120 in a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference, held in Houston, USA, from November 6 to 10 (Press release, Hanmi, NOV 25, 2024, View Source [SID1234648591]).

BH3120 is a novel anticancer drug based on Hanmi’s proprietary dual antibody platform, "Pentambody." This technology enables a single antibody to simultaneously bind to two distinct targets, allowing for a targeted anticancer action by specifically attacking cancer cells while activating immune cells to enhance immunotherapy effects.

BH3120 is designed to target PD-L1 on cancer cells and 4-1BB on immune cells, thereby acting as a "bridge" that facilitates immune cells’ recognition and killing of tumor cells.

While other 4-1BB-targeting antibody candidates have faced anticancer efficacy or safety challenges, BH3120’s preclinical studies reveal robust anticancer efficacy alongside a unique decoupling of immune activity between the tumor microenvironment (TME) and normal tissues. This distinct mechanism highlights BH3120’s potential as a breakthrough in developing an effective and safer anticancer therapy.

During the SITC (Free SITC Whitepaper) presentation, Hanmi outlined the background, design, and clinical progress of BH3120. Currently, a global Phase 1 clinical trial is underway in South Korea and the United States, assessing the safety and tolerability of BH3120 as a monotherapy in patients with advanced or metastatic solid tumors.

The Phase 1 clinical trial has progressed smoothly through cohort 3 (1 mg/kg) of the dose escalation phase, with no dose-limiting toxicities (DLT) or grade 3 or higher adverse drug reactions observed to date.

Dr. Dong-wan Kim, director of the Seoul National University Hospital Clinical Trials Center (Hemato-Oncology Department) and lead investigator for the phase 1 clinical trial of BH3120 remarked, "The phase 1 clinical trial of BH3120 is a critical step in verifying the potential of this next-generation immunotherapy. We are optimistic about achieving positive outcomes." He added, "We hope further research will establish BH3120 as an effective and safe treatment option for various cancer types, reducing the side effects often associated with current immunotherapies."

In parallel, Hanmi is also conducting a Phase 1 trial to assess the safety and efficacy of BH3120 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced or metastatic solid tumors.

In September, Hanmi obtained approval from both the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) to modify the Phase 1 trial plan to evaluate BH3120 in combination with KEYTRUDA. Full-scale clinical development is expected to commence early next year. Hanmi will serve as the lead sponsor and conduct the clinical trial, while MSD will supply KEYTRUDA for the trial.

Young Su Noh, Director of Hanmi’s ONCO Clinical Team, emphasized, "The BH3120 trial represents a milestone as Hanmi’s first global clinical research project utilizing our proprietary Pentambody dual antibody platform in immuno-oncology, a field at the forefront of cancer treatment innovation." He continued, "We are committed to advancing a next-generation immunotherapy that overcomes the limitations of existing treatments and enhances therapeutic efficacy."

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

Alpheus Medical Announces Positive Phase 1/2 Trial Results for the Treatment of Recurrent High-Grade Gliomas

On November 24, 2024 Alpheus Medical, Inc., a private, clinical-stage oncology company pioneering sonodynamic therapy (SDT) for the treatment of solid body cancers, reported positive results from their Phase 1/2 clinical trial in patients with recurrent or refractory high-grade gliomas (Press release, Alpheus Medical, NOV 24, 2024, View Source [SID1234648593]). The company’s proprietary therapy demonstrated a strong safety profile and extended median overall survival (OS) and progression-free survival (PFS) compared to historical data. The data were presented by Michael Schulder, MD, at the 2024 Society of Neuro-Oncology (SNO) Annual Meeting.

"Glioblastomas are the most common and aggressive primary brain cancer, presenting a devasting diagnosis for patients and their familes," said David Reardon, MD, Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, and member of the Alpheus Medical Scientific Advisory Board. "Current treatment options are limited and often ineffective due to the diffuse spread of the disease across the blood-brain barrier and often across the entire hemisphere, making it universally fatal with a rapid timeline. The early clinical results of Alpheus’s therapy are promising, offering hope for this new approach. I look forward to further exploring the potential benefits of their SDT therapy for this patient population who is in critical need of an effective solution."

Alpheus Medical’s non-invasive SDT treatment, which can be delivered in an outpatient setting, combines low-intensity diffuse ultrasound (LIDU) with oral 5-aminolevulinic acid (5-ALA) to target and kill cancer cells across the entire hemisphere without the need for imaging or sedation. Key findings from the study include:

Median overall survival (OS): 15.7 months vs. historical ~6-8 months
Median progression-free survival (PFS): 5.5 months vs. historical 1.8 month
Safety: No treatment-related deaths, serious adverse events (SAEs), or duration-limited toxicities (DuLTs) reported
"In addition to the strong safety data and early indications of efficacy, Alpheus’ non-invasive SDT therapy stands out for its ease of use – a significant improvement over the uncomfortable and often toxic treatments currently available for this rapidly fatal condition," stated Dr. Schulder, Director of the Brain Tumor Center at Northwell Health, and one of the trial’s primary investigators. "We look forward to expanding the ability for patients to receive this promising therapy."

The Phase 1/2 trial (NCT05362409) is an open-label, multicenter, duration-escalation study evaluating the safety, optimal dose, and efficacy of Alpheus Medical’s proprietary SDT platform. Twelve patients were enrolled across three cohorts, with treatment durations escalating to 60, 90, and 120 minutes per monthly session.

The company plans to initiate a randomized, controlled trial at multiple centers across the U.S. in 2025.

Innovent to Present Clinical Data of Multiple Novel Molecules at ESMO Asia 2024

On November 24, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that nearly 10 accepted clinical data of its novel oncology molecules, including an oral presentation of updated Phase 1 result of its novel TOPO1i CLDN18.2 ADC (IBI343) in previously-treated pancreatic cancer, will be released at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia (ESMO Asia) Congress 2024 from Dec 06-08, 2024, in Singapore (Press release, Innovent Biologics, NOV 24, 2024, View Source [SID1234648592]).

Details on the abstracts are listed below:

Mini Oral

Abstract Title: Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients with advanced pancreatic ductal adenocarcinoma (PDAC): updated results from a Phase 1 study

Abstract No: 132MO

Session Type and Title: Mini Oral session: Gastrointestinal tumors

Presentation Time: 2024-12-07, 09:50-09:55

Presenter: Jian Zhang, Fudan University Shanghai Cancer Center, CN

Abstract Title: mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody in Locally Advanced MSS CRC (BASKETⅡ): A Prospective, Single-Arm, Open-Label, Phase 2 Study

Abstract No: 74MO

Session Type and Title: Mini Oral session: Gastrointestinal tumors

Presentation Time: 2024-12-07, 10:20-10:25

Presenter: Jun Huang, The Sixth Affiliated Hospital, Sun Yat-sen University, CN

Posters

Abstract Title: Anlotinib plus Sintilimab as First-line Treatment for Patients with Advanced Colorectal Cancer (APICAL-CRC): an Open-Label, Single-arm, Phase 2 study

Abstract No: 75P