CEBIOTEX receives approval to initiate a paediatric phase II clinical trial for locally resectable abdominal tumours

On June 18, 2025 Cebiotex reported that the clinical trial to evaluate the safety, pharmacokinetics and efficacy of CEB-01 in locally resectable abdominal tumours of children has been green lighted by the regulatory authorities (Press release, Cebiotex, JUN 18, 2025, View Source [SID1234653973]). This is a basket trial designed for pediatric patients under 18 years of age diagnosed with de novo or recurrent soft tissue sarcoma, neuroblastoma, or other rare tumors such as Wilms’ tumor or germ cell tumors.

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Why it matters
It marks the first time that the potent active substance SN-38 is being evaluated in these patients as a local chemotherapy, with the goal of controlling tumor recurrence and addressing an unmet medical need. This step brings us closer to delivering new therapeutic options to children with rare cancers.

Thank You
This milestone reflects the commitment to developing innovative surgical treatments for children of our team and collaborators in Hospital Sant Joan de Déu Barcelona, i4KIDS I i4KIDS-EUROPE and Ship2B Ventures.

Simcere Zaiming Announces First Patient Dosed in the US in a Phase 1 Trial of Trispecific Antibody SIM0500 in Patients with Relapsed/Refractory Multiple Myeloma

On June 18, 2025 Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK) reported the first US patient has started treatment in the ongoing Phase 1 trial (SIM0500-101, NCT06375044) at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of SIM0500 in patients with relapsed/refractory multiple myeloma (RRMM) (Press release, Jiangsu Simcere Pharmaceutical Company, JUN 18, 2025, View Source [SID1234653985]).

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SIM0500 (formerly SCR-8572) is a humanized trispecific antibody targeting GPRC5D, BCMA and CD3, developed using Simcere Zaiming’s proprietary T-cell engager polyspecific antibody platform. [1] "In the last few years, BCMA and GPRC5D-targeted therapies have demonstrated significant promise in treating RRMM and have been anticipated as the cornerstones of the next chapter in the pursuit of curing myeloma. SIM0500 is the natural evolution of combining these targets with the aim to optimize outcomes in the RRMM," said Dr. Joshua Richter, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Director of Multiple Myeloma at the Blavatnik Family Chelsea Medical Center at Mount Sinai, and Principal Investigator.

"SIM0500 is designed to bind to two tumor antigens, GPRC5D and BCMA. It has shown strong T-cell cytotoxicity against multiple myeloma cells in preclinical studies," said Prof. Shaji Kumar, M.D. "I look forward to participating in the Phase 1 study of SIM0500 to evaluate the safety and efficacy of this potentially transformative therapy in patients with RRMM."

"We are quite pleased with the safety and encouraging efficacy results generated to-date in the ongoing dose escalation and look forward to the extension of the SIM0500 Phase 1 trial to the US. This marks an important step forward in Simcere Zaiming’s continued commitment to advance new oncology treatments and elevate the standard of care for patients with RRMM," said Yongyu Wang, M.D., Chief Medical Officer, Simcere Zaiming.

SIM0500 is being developed in partnership with AbbVie.

About SIM0500

SIM0500 stands as a potentially best-in-class candidate, poised to offer novel therapeutic options for solving drug resistance encountered in existing multiple myeloma treatments. In April 2024, the FDA awarded SIM0500 a Fast Track designation. In January 2025, Simcere Zaiming entered into an agreement with AbbVie granting AbbVie an option to license SIM0500.

SIM0500 is an investigational agent that has not been approved by the FDA or any other regulatory authority.

About SIM0500-101 Phase 1 study

SIM0500 is currently being investigated in a phase 1 clinical trial both in US and in China. Preliminary data suggested a good safety profile, desired pharmacokinetic profile of SIM0500 with encouraging efficacy.

Aptevo Therapeutics Announces $8 Million Offering Priced At-the-Market Under Nasdaq Rules

On June 18, 2025 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that it has entered into securities purchase agreements with certain healthcare-focused and institutional investors to purchase (i) 2,465,000 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to purchase up to an aggregate of 12,325,000 shares of its common stock (the "Common Warrants") at a purchase price of $3.25 per share and associated Common Warrants in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aptevo Therapeutics, JUN 18, 2025, View Source [SID1234653984]). Each share of common stock is being offered together with five Common Warrants, each to purchase one share of common stock. The Common Warrants will have an exercise price of $3.25 per share, are exercisable upon stockholder approval, and will expire five years following the date of stockholder approval.

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The offering is expected to close on or about June 20, 2025, subject to customary closing conditions. Roth Capital Partners is acting as placement agent for the offering. Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $8 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-288061), that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on June 18, 2025. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected]. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

Transgene CompletesInitial Patient Screening in Phase II Part of TG4050 Trial
in Operable Head and Neck Cancer

On June 18, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the completion of initial patient screening in the randomized multicenter Phase II part of its Phase I/II clinical trial with TG4050, an individualized neoantigen therapeutic vaccine, as a single agent in the adjuvant treatment of HPV-negative squamous head and neck cancers (NCT04183166) (Press release, Transgene, JUN 18, 2025, View Source [SID1234653982]). TG4050, Transgene’s lead asset, is based on its proprietary myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection for individual patients.

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All patients treated with TG4050 in the Phase I part of the trial remained disease-free after a minimum of two years of follow-up, confirming clinical proof of principle. Translational data showed sustained T cell responses at 24 months in these patients. The results, which met all trial endpoints including safety, feasibility, immune activation and disease-free survival (DFS, defined as survival without recurrence or death for any cause), were presented in an oral presentation at the recent American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2025) annual meeting.

Transgene expects to complete randomization of all patients in the Phase II part by the end of 2025, following a second screening of patients conducted after surgery and adjuvant (chemo)radiotherapy. These screenings represent key steps during which patients are evaluated to determine whether they meet the eligibility criteria to participate in the clinical trial. In total, approximately 80 patients with a complete response to adjuvant therapy are anticipated to be enrolled and subsequently randomized in the Phase I/II trial. First immunogenicity data from the Phase II part of the trial are expected to be available in H2 2026, and preliminary efficacy data are expected in H2 2027.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene added: "Timely completion of first patient screening of the Phase II part of our Phase I/II trial is an important milestone for Transgene and brings us one step closer to providing a new treatment option for patients living with operable squamous head and neck cancer. With meaningful data readouts expected over the next two years, we are preparing to deliver important data for TG4050 and at the same time explore its wider potential. We are grateful to the patients, their families, investigators, and clinical staff whose commitment made this achievement possible."

Dr. Alessandro Riva, CEO of Transgene commented: "The positive results from the Phase I part of our TG4050 trial support the strong potential of our myvac platform. The successful completion of the first screening of the randomized Phase II part in less than a year and ahead of schedule underscores the investigators’ commitment to rapidly advance the development of TG4050. In the ongoing Phase II part of the trial, we have been able to scale efficiently, strengthen our manufacturing capabilities and operate with the agility needed to lead in a highly competitive and fast-moving environment.

The myvac individualized cancer vaccine platform can be applied across a range of solid tumors where in many cases a significant unmet medical need remains. Consequently, Transgene is starting initial preparations for a new Phase I trial in a second, undisclosed indication in an early treatment setting, with the aim to initiate the trial in Q4 2025."

Quince Therapeutics Announces Closing of Up to $22 Million Private Placement of Securities

On June 18, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX) ("Quince" or the "Company"), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported the closing of its previously announced sale and issuance to certain institutional and accredited investors, of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants ("Warrants") that resulted in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying Warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses (Press release, Quince Therapeutics, JUN 18, 2025, View Source [SID1234653981]).

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The private placement priced at a premium and was led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince’s senior management.

Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "We are pleased to secure additional financing that allows us to complete enrollment of our pivotal Phase 3 NEAT clinical trial and extend our cash runway beyond topline results. This transaction reflects a significant commitment from high caliber healthcare investors who believe in our technology platform and Phase 3 asset, eDSP. Success in our lead indication of Ataxia-Telangiectasia (A-T) would demonstrate our ability to deliver corticosteroid efficacy without toxicity and would expand opportunities for pursuing additional indications for both rare and non-rare diseases."

Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in A-T, research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince’s current cash, cash equivalents, and short-term investments of $31.6 million as of March 31, 2025, are expected to fund the Company’s operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash. In addition, the Company expects to use proceeds to continue to expand and accelerate its development pipeline by funding new program expansion into Duchenne muscular dystrophy and other high priority rare disease indications for its lead asset eDSP.

The Company continues to make meaningful progress in enrolling participants in its pivotal Phase 3 NEAT clinical trial. Key highlights to date include:

A total of 95 participants have been enrolled, including 77 participants in the six to nine year-old primary analysis population and 18 participants aged 10 years or older.
All 39 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study.
Quince expects to report topline results from the Phase 3 NEAT clinical trial in the first quarter of 2026. Assuming positive study results, the Company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2026.
Quince was granted FDA Fast Track designation for the Company’s eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need.
NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T.
Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo.
About the Private Placement

At the closing, the Company issued to the investors an aggregate of 6,671,928 shares of common stock, 2,000,000 pre-funded warrants and accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company’s common stock on June 11, 2025). The accompanying Warrants have an exercise price of $1.20 per share and are exercisable immediately. The Warrants will expire five years from the date of issuance.

Citizens Capital Markets acted as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agents for the private placement.

The securities issued in connection with the private placement described above were offered in a private placement and were not registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdictions’ securities laws, and were not offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

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