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Chipscreen Biosciences’ Brain-Penetrant Aurora B Selective Inhibitor CS231295 Tablet Receives FDA IND Approval, Advancing Global Clinical Development

On July 31, 2025 Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences") reported that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative drug CS231295 tablet for the treatment of advanced solid tumors (Press release, Shenzhen Chipscreen Biosciences, JUL 31, 2025, View Source [SID1234654694]). This significant milestone marks a key step forward in the global development strategy for CS231295.

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Malignant tumors remain one of the leading causes of death worldwide. Despite continuous advancements in clinical treatments and efficacy, most cancers remain incurable. Drug resistance, recurrence, and metastasis pose significant threats to long-term patient survival. In particular, due to the presence of the blood-brain barrier, primary brain tumors and brain metastases not only pose a severe danger to life but also serve as natural barriers to effective drug therapy. Thus, developing novel brain-penetrant anti-cancer drugs has become a pressing challenge and a key research focus.

CS231295 is a next-generation brain-penetrant Aurora B selective inhibitor discovered through years of mechanism-based research by Chipscreen Biosciences. On one hand, it precisely inhibits tumor-specifically overexpressed Aurora B kinase to induce synthetic lethality, directly targeting the genetic vulnerability of hard-to-treat cancers such as those with RB1 deletion. On the other hand, due to its strong blood-brain barrier permeability, it shows significant therapeutic potential for both primary and metastatic brain tumors. Furthermore, this molecule also exhibits broad-spectrum anti-tumor activity, which improves the tumor microenvironment. It is expected to provide a novel solution for tumors with similar genetic defects and the global challenge of brain metastases. Currently, there is no similar compound with this design that has entered clinical trials globally.

With its unique mechanism and chemical structure, CS231295 demonstrates synergistic effects when combined with chemotherapy, targeted therapy, and cancer immunotherapy. In preclinical studies, CS231295 has shown remarkable pharmacodynamic activity, ideal pharmacokinetic properties, and a favorable safety profile.

Notably, CS231295 completed the first patient enrollment in its Phase I first-in-human clinical trial in China in May 2025, providing preliminary evidence to support the scientific rationale and feasibility of global multicenter clinical development. The FDA’s IND approval will further accelerate the initiation and implementation of its clinical research in the United States.

Immunophotonics Completes Treatment of Last Patient in INJECTABL-1 Phase 1b/2a Clinical Trial of IP-001 for Advanced Solid Tumors

On July 31, 2025 Immunophotonics, Inc., a clinical-stage biotech company developing novel immunostimulatory drugs to improve efficacy of routine tumor destruction techniques, reported the completion of treatment of the last patient in its INJECTABL-1 multicenter Phase 1b/2a clinical trial of IP-001 for advanced solid tumors (Press release, Immunophotonics, JUL 31, 2025, View Source [SID1234654693]). The 41-patient trial, which focused on three distinct cancer types — colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma— was conducted in France, Germany, Switzerland, the UK, and the US.

The INJECTABL-1 trial was designed to evaluate the systemic immune-mediated anti-cancer effects of IP-001 following tumor ablation, which aims to destroy all cells in targeted tumor lesions in patients with advanced solid tumors but fails to induce robust anti-tumor immunity. Tumor ablation is an approved and well-established procedure that is readily available at most hospitals and clinics. IP-001 is a novel immunotherapy administered by injection into the ablation zone. It works by retaining tumor debris, including tumor antigens, and by activating the patient’s own immune system to allow systemic tumor surveillance. Such immune surveillance enables the patient’s own defense mechanisms to recognize and destroy tumor cells that had escaped the destroyed metastatic lesion.

Prof. Dr. Markus Jörger, Principal Investigator for the trial at the Cantonal Hospital St. Gallen Clinic for Medical Oncology and Hematology, commented: "We are proud to announce the completion of treatment of the last patient in our INJECTABL-1 Phase 1b/2a clinical trial. This significant milestone brings us closer to potentially providing a new treatment option for patients with advanced solid tumors."

"Immunophotonics is committed to leading the field of Interventional Immuno-Oncology through a therapeutic approach intended to reduce tumor recurrence after standard-of-care local ablation therapy, which remains a significant unmet medical need. With the completion of our INJECTABL-1 trial, we will evaluate data to assess IP-001’s ability to transform ablation into something more powerful as we continue to advance the clinical development of our proprietary novel asset. Early signals are positive, and the company has expanded clinical collaborations to further assess the efficacy of this novel therapy," stated Lu Alleruzzo, Immunophotonics co-founder and CEO.

About IP-001
IP-001 is a proprietary glycan polymer that generates tumor antigen depots and acts as a potent, multimodal immune stimulant intended to induce immunological responses to eradicate cancer. IP-001 is designed to (1) prolong the availability of the targeted tumor antigens, (2) facilitate the recruitment and activation of innate immune cells such as antigen-presenting cells (APCs), (3) increase the uptake of the tumor antigens into the APCs, and (4) lead to a downstream adaptive immune response against the tumor cells. Activation of a systemic, adaptive immune response allows immune effector cells to seek out and eliminate tumor cells throughout the body.

Actinium Presents Data Supporting Paradigm Changing Potential of ATNM-400 in Prostate Cancer Demonstrating Its Superior Efficacy and Improved Survival in Treatment Resistant Tumor Models versus Pluvicto and ARPI Therapy, and Also Enhanced Efficacy in Combination with ARPI Therapy at the 4th Annual Targeted Radiopharmaceuticals Summit

On July 31, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported additional preclinical data supporting its ATNM-400 radiotherapy prostate cancer candidate at the 4th Annual Targeted Radiopharmaceuticals Summit (TRP) being held July 29 – 31, 2025 in San Diego, CA (Press release, Actinium Pharmaceuticals, JUL 31, 2025, View Source [SID1234654691]). ATNM-400 is a novel, first-in-class targeted radiotherapy designed to deliver potent Actinium-225 (Ac-225), an alpha-emitter radioisotope, to prostate cancer cells by targeting a non-Prostate Specific Membrane Antigen (PSMA), disease-driving protein overexpressed in advanced and treatment-resistant disease. Unlike PSMA-targeted agents that primarily serve as imaging and targeting tools, the ATNM-400 target is directly implicated in tumor progression, survival signaling, and resistance to androgen receptor (AR) pathway inhibitor (ARPI) therapy. The presentation titled, "Building a Transformative Ac-225 Portfolio for Next-Generation Precision Oncology" on Wednesday, July 30, 2025, highlighted new PET imaging data showing tumor-specific uptake of ATNM-400, robust tumor control and improved survival outcomes in preclinical studies.

ATNM-400 Demonstrated Sustained Tumor-Specific Uptake

PET imaging confirmed tumor-specific uptake of the ATNM-400 antibody

The ATNM-400 antibody showed sustained tumor uptake up to 216 hours with rapid clearance from normal tissues
ATNM-400 Produced Robust Tumor Control, Improved Survival and Superior Efficacy After Pluvicto Resistance

ATNM-400 is more efficacious than Pluvicto (Lu-177-PSMA-617) with potent tumor control

ATNM-400 significantly improved survival compared to Pluvicto with continued follow-up ongoing

ATNM-400 is highly effective in prostate cancer tumors with acquired Pluvicto resistance, halting tumor growth and producing potent tumor cell killing after Pluvicto stops working, highlighting its potential in advanced disease settings that are resistant to standard treatments
Enhanced Efficacy of ATNM-400 with Enzalutamide Supports Potential for Novel Combinations

ATNM-400 demonstrated significant in vitro tumor cell killing when used in combination with AR-targeting agents, such as enzalutamide (Xtandi)

The ATNM-400 enzalutamide combination produced superior anti-tumor efficacy and durable tumor control compared to enzalutamide alone with 40% of prostate cancer tumor-bearing animals having complete cures

Actinium previously highlighted that ATNM-400 inhibited tumor growth of enzalutamide resistant tumors whereas re-treatment with Pluvicto or additional enzalutamide did not

Actinium highlighted that follow-up continues to further evaluate the durability of ATNM-400’s anti-tumor efficacy in prostate cancer with additional data expected in the second half of 2025. Actinium’s TRP presentation can be accessed via the Investor Relations page of Actinium’s website HERE.

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are highly encouraged by the growing body of data supporting the therapeutic potential of ATNM-400 and the significance of its target being directly implicated in tumor progression, survival signaling, and resistance to ARPI therapy. The new data presented at TRP highlight the utility of the differentiated mechanism of action of ATNM-400 via the Ac-225 alpha-emitter payload evidenced by durable tumor control, improved survival rates compared to Pluvicto, and efficacy in enzalutamide and Pluvicto resistant models. We believe ATNM-400 has the potential to redefine the treatment paradigm in the high-value, advanced disease, and metastatic castrate-resistant prostate cancer settings, which impact tens of thousands of patients annually. We look forward to presenting additional data in the second half of this year and further highlighting ATNM-400’s differentiated potential in treatment settings with high unmet needs."

About ATNM-400

ATNM-400 is a highly innovative, first-in-class, non-PSMA targeting Actinium-225 (Ac-225) radiotherapy candidate for prostate cancer. In comparison to Pluvicto (Lu-177-PSMA-617) and the majority of radiotherapies in development for prostate cancer, which target prostate specific membrane antigen (PSMA) and are either non-differentiated or barely differentiated, ATNM-400 targets a distinct non-PSMA disease-driving protein overexpressed in advanced and treatment-resistant disease. The receptor specifically targeted by ATNM-400 is highly expressed in metastatic castration-resistant prostate cancer (mCRPC), contributes directly to disease progression, poorer survival outcomes, and continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) and Pluvicto treatment. ATNM-400 leverages the alpha-particle emitter Ac-225, which can cause lethal irreversible double-stranded DNA breaks and is more potent compared to the beta-particle emitter Lutetium-177 (Lu-177) used by Pluvicto, as well as a shorter path length that could result in fewer off-target effects.

Prostate cancer is the most commonly diagnosed cancer in men, with ~1.5 million new cases globally and over 313,000 expected in the U.S. in 2025. While early-stage disease is typically managed with surgery, radiation, and ARPI therapy, up to 20% of cases progress to mCRPC – a lethal stage with limited treatment options. Targeted radiotherapy is a growing field in prostate cancer, dominated by PSMA-targeting agents like Pluvicto, which had sales of over $1.3 billion in 2024, yet many patients either lack PSMA expression or develop resistance to Pluvicto. In the U.S., 40,000–60,000 mCRPC patients annually progress after ARPIs such as Xtandi, which had sales of over $5.9 billion in 2024, highlighting a significant unmet need.

BeOne Medicines Receives PRIME Designation from the European Medicines Agency for BGB-16673 in Waldenstrom’s Macroglobulinemia

On July 31, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to the Company’s investigational Bruton’s tyrosine kinase (BTK) degrader, BGB-16673, for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor (Press release, BeOne Medicines, JUL 31, 2025, View Source [SID1234654690]).

"This is the Company’s first PRIME designation, marking a milestone for BeOne and providing early and enhanced interaction with the EMA as we advance BGB-16673," said Julie Lepin, Senior Vice President, Chief Regulatory Affairs Officer at BeOne. "PRIME allows us to align early with the EMA on key evidence requirements and potentially accelerate our path to marketing authorization of BGB-16673 for patients with relapsed or refractory Waldenstrom’s macroglobulinemia."

In addition to the PRIME designation, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the EU Orphan Drug Designation (ODD) application for BGB-16673 in WM. A final decision is anticipated in the coming weeks. The U.S. Food and Drug Administration (FDA) also granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL).

The EMA’s CHMP granted PRIME designation to BGB-16673 based on data demonstrating its novel mechanism and anti-tumor activity in B-cell malignancies. The CHMP recognized the limited treatment options available for WM patients post-BTK inhibitor therapy and acknowledged the strong biological rationale and promising clinical data for BGB-16673 in this setting, thereby demonstrating the potential to address the unmet medical need.

The PRIME initiative, launched by the EMA in 2016, provides early, proactive, and enhanced regulatory support to developers of promising medicines. It is designed to optimize development plans and accelerate evaluation, helping innovative therapies reach patients with unmet medical needs faster.

About BGB-16673

BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting protein degrader from BeOne’s chimeric degradation activation compound (CDAC) platform. BGB-16673 is designed to promote the degradation, or breakdown, of both wild-type and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease. BGB-16673 is the most advanced BTK protein degrader in the clinic, with an extensive global clinical development program.

Supernus Pharmaceuticals Completes Acquisition of Sage Therapeutics

On July 31, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) ("Supernus") reported that it has successfully completed its previously announced acquisition of Sage Therapeutics, Inc. (Nasdaq: SAGE) ("Sage") (Press release, Supernus, JUL 31, 2025, View Source [SID1234654689]).

"Sage is an ideal fit in our corporate development strategy, adding a significant fourth growth product to our portfolio and further diversifying our sources of future revenue," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "With our proven track record of strong commercial execution along with the expected cost synergies, the acquisition is expected to be accretive in 2026."

Compelling Strategic Rationale

Strengthens psychiatry portfolio with ZURZUVAE (zuranolone) capsules CIV, the first and only FDA-approved oral medicine indicated for the treatment of postpartum depression in adults.
Diversifies and increases revenue base and cash flow:
Addition of collaboration revenue from net sales of ZURZUVAE (50% of total net revenue Biogen, Inc. records for ZURZUVAE in the U.S. pursuant to a collaboration agreement), and
Combined with its three other growth products (Qelbree, ONAPGO, and GOCOVRI), Supernus believes it is poised for significant future growth.
Augments Supernus central nervous system discovery platforms and expertise.
Strong fit with existing Supernus infrastructure is expected to result in cost synergies of up to $200 million on an annual basis.
The acquisition is expected to be accretive in 2026.
The Offer and the Merger

The Offer and withdrawal rights for all outstanding shares of common stock, par value $0.0001 per share (the "Shares"), of Sage in exchange for (i) $8.50 per Share, net to the seller in cash, subject to any withholding of taxes and without interest (the "Closing Amount"), plus (ii) one non-transferable and non-tradable contingent value right per Share (a "CVR"), which represents the right to receive up to $3.50 per Share upon the satisfaction of specified milestones (as described further in the Offer to Purchase), net to the seller in cash, without interest and subject to any withholding of taxes, pursuant to the CVR Agreement (the Closing Amount plus one CVR collectively, the "Offer Price"), expired as scheduled at one minute following 11:59 p.m., New York time, on July 30, 2025 (the "Expiration Time").

Each CVR paid to Sage stockholders represents a non-transferable and non-tradable contractual contingent right to receive a cash payment of up to $3.50, net to the seller in cash, subject to any withholding of taxes and without interest, upon the achievement of certain milestones in accordance with the terms of the Contingent Value Rights Agreement entered into between Supernus and Equiniti Trust Company, LLC as rights agent, (the "CVR Agreement").

One milestone payment of $0.50 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) upon the first commercial sale after Regulatory Approval (as defined in the CVR Agreement) in Japan to a third-party customer of the pharmaceutical product that is marketed in the United States under the name ZURZUVAE and is the subject of the current regulatory filing (including any amended filings based thereon) by Shionogi & Co., Ltd., inclusive of its affiliates, in Japan for Major Depressive Disorder by June 30, 2026.

A second milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $250 million in the United States during a calendar year on or prior to December 31, 2027.

A third milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $300 million in the U.S. during a calendar year on or prior to December 31, 2028.

A fourth milestone payment of $1.00 per CVR, net to the seller in cash, subject to any withholding of taxes and without interest, is payable (subject to certain terms and conditions) if Net Sales (as defined in the CVR Agreement) of ZURZUVAE are equal to or exceed $375 million in the U.S. during a calendar year on or prior to December 31, 2030.

Each milestone may only be achieved once. The maximum amount payable with respect to the CVR issued in respect to each Share is $3.50 in the aggregate. There can be no assurance any payments will be made with respect to any CVR. It is possible that no milestone is achieved and no payment is made with respect to the CVRs.

Equiniti Trust Company, LLC, the depositary for the Offer, has advised Supernus that a total of 36,313,509 Shares were validly tendered and not validly withdrawn in the Offer, representing approximately 58 percent of the Shares outstanding.

All of the conditions of the Offer have been satisfied, and effective as of the Expiration Time, Supernus and its wholly owned subsidiary, Saphire, Inc. ("Purchaser"), accepted for payment all Shares that were validly tendered and not validly withdrawn in the Offer, and will as promptly as practicable thereafter pay for all such validly tendered Shares. Following the completion of the Offer, Supernus completed the acquisition of Sage through the merger of Purchaser with and into Sage, without a vote of Sage stockholders in accordance with Section 251(h) of the General Corporation Law of the State of Delaware ("DGCL"), with Sage surviving the merger as a wholly owned subsidiary of Supernus. In connection with the merger, each Share not previously purchased in the Offer (other than (i) Shares held by Sage (or held in Sage’s treasury) immediately prior to the effective time of the merger, (ii) any Shares held by Supernus or Purchaser or any direct or indirect wholly owned subsidiary of Supernus or Purchaser immediately prior to the effective time of the merger, or (iii) Shares held by any stockholder who was entitled to appraisal rights under Section 262 of the DGCL and properly exercised and perfected their respective demands for appraisal of such Shares pursuant to Section 262 of the DGCL and, as of the effective time of the merger, has neither effectively withdrawn nor lost their rights to such appraisal and payment under the DGCL with respect to such Shares) was converted into the right to receive the Offer Price, less any applicable withholding taxes and without interest. The Shares will be delisted from the Nasdaq Global Market.

Advisors

Moelis & Company LLC acted as the exclusive financial advisor to Supernus. Goldman Sachs & Co. LLC acted as the exclusive financial advisor to Sage. Saul Ewing LLP served as legal counsel to Supernus. Kirkland & Ellis LLP served as legal counsel to Sage.