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Arvinas Announces Upcoming Vepdegestrant Poster Presentations at the 2024 San Antonio Breast Cancer Symposium

On November 25, 2024 Arvinas, Inc. (Nasdaq: ARVN) reported that three posters for vepdegestrant, including clinical data, will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), being held December 10-13, 2024, in San Antonio, Texas (Press release, Arvinas, NOV 25, 2024, View Source [SID1234648600]). Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic estrogen receptor positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

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Poster session details are as follows:

Poster Title: Evaluation of the Combination of Vepdegestrant, a PROTAC Estrogen Receptor (ER) Degrader, Plus Palbociclib in CDK4/6 Inhibitor-Resistant WT ER and ER Y537S Mutant Patient Derived Xenograft (PDX) Models
Poster Session 3 (ID: P3-01-16)
Date: Thursday, December 12
Time: 12:30 p.m. – 2:00 p.m. CT

Poster Title: Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) Estrogen Receptor (ER) Degrader, Plus Abemaciclib in ER-Pos/Human Epidermal Growth Factor Receptor 2 (HER2) Negative Advanced or Metastatic Breast Cancer: TACTIVE-U Prelim Phase 1b Results
Poster Session 4 (ID: P4-12-03)
Date: Thursday, December 12
Time: 5:30 p.m. – 7:00 p.m. CT

Poster Title: Evaluating CYP3A4-Mediated Drug Interaction Risks for Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) Estrogen Receptor (ER) Degrader, in Combination with Cyclin Dependent Kinase (CDK)4/6 Inhibitors and Everolimus
Poster Session 4 (ID: P4-08-13)
Date: Thursday, December 12
Time: 5:30 p.m. – 7:00 p.m. CT

For copies of the abstracts, please visit the official SABCS website here.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.

The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.

Aptose Biosciences Inc. Announces Closing of $8 Million Public Offering

On November 25, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported the closing of its previously announced "reasonable best efforts" public offering with participation from the CEO and existing and new healthcare focused investors for the purchase and sale of 40,000,000 common shares at a price of $0.20 per share and warrants to purchase up to 20,000,000 common shares (the "Offering") (Press release, Aptose Biosciences, NOV 25, 2024, View Source [SID1234648599]). The warrants have an exercise price of $0.25 per share, are exercisable immediately and will expire five years from the issuance date. The Company received aggregate gross proceeds of $8 million, before deducting placement agent fees and other offering expenses, and intends to use the net proceeds from this Offering for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent for the Offering.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-281201) previously filed with the Securities and Exchange Commission ("SEC") on August 2, 2024, as amended, which was declared effective on November 21, 2024. This Offering was made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the Offering has been filed with the SEC. An electronic copy of the final prospectus relating to the Offering may be obtained on the SEC’s website located at View Source and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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]).

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.