On June 10, 2025 Nantes-based biotech XENOTHERA reported the value of its LIS22 antibody in the treatment of peripheral T-cell lymphomas (PTCL). The PALT1 clinical trial (NCT06495723) has just passed a new milestone at the trial’s scientific committee meeting, confirming continued recruitment (Press release, Xenothera, JUN 10, 2025, View Source [SID1234654024]). Clinical and biological safety, as well as injection tolerance, are encouraging. Preliminary efficacy data, yet to be confirmed, are very encouraging.

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To date, 9 patients are participating in the trial. No DLT has been observed, so enrolment at the 6 mg/kg dose is continuing. PALT1 is a Phase I/II trial testing the safety and efficacy of LIS22 in patients with refractory relapsed PTCL. The trial is taking place in France and Italy, with Professor Gandhi Damaj at Caen University Hospital as principal investigator.

The results will be presented orally on Tuesday June 18 at 5:50 p.m. by Firas Bassissi, the biotech’s Scientific Director, at the World Congress on Lymphoma (18th International Conference on Malignant Lymphoma, Lugano, Switzerland, View Source), during the "Experimental Medicines" session under the title "LIS22: An Effective Multimodal Polyclonal Antibody targeting T-Cell Malignancies".

In addition, the PALT1 clinical trial is the subject of an abstract to be published in the proceedings of the same congress (abstract 847: "PALT trial: First in class glyco humanized polyclonal antibody directed against tumoral T cells, in patients with relapsed/refractory peripheral T cells lymphoma (PTCL)").

"To be able to present LIS22 orally and to benefit from an abstract published in the proceedings of the Lugano World Congress is an immense source of pride, and confirms the interest of our treatment, as well as the recognition by the medical and scientific community of the quality and potential of our therapeutic antibody. I am of course delighted to be able to continue this trial, thanks to these results, which are both a validation of our approach and, above all, a source of hope for PTCL patients who have reached a therapeutic impasse. I would like to congratulate the XENOTHERA teams, and above all to thank the patients and medical teams who are working alongside us to analyze the therapeutic potential of LIS22," says Odile Duvaux, President of the biotech company.

On June 10, 2025, Salarius Pharmaceuticals reported to have entered into a Second Amendment to the Merger Agreement ("Amendment No. 2") with Decoy Therapeutics to address significant changes in market conditions and secure necessary consents from Decoy noteholders for the completion of the transaction (Filing, Salarius Pharmaceuticals, JUN 10, 2025, View Source [SID1234653816]).

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Since the execution of the original Merger Agreement in January 2025 and following the execution of Amendment No. 1, the Company’s Common Stock price has experienced substantial deterioration, materially affecting the relative valuations underlying the exchange ratio. As a result, the parties have agreed to reduce the Company’s relative valuation from $4.6 million at the time of the original Merger Agreement to $2.31 million. This reduction results in a change in the exchange ratio such that the number of shares of Common Stock underlying the Company’s Series A Preferred Stock to be issued to Decoy stockholders at Closing will be increased by approximately 17 million shares. Accordingly, under Amendment No. 2, the relative ownership percentages of the combined company will result in Company legacy stockholders retaining 7.6% and Decoy’s legacy stockholders retaining 92.4% of the combined company following the completion of the Merger, in each case calculated on a fully-diluted basis, and before taking into account the dilutive effects of the Qualified Financing and any issuance of shares pursuant to such Qualified Financing after June 10, 2025, the date of Amendment No. 2.

In addition, Amendment No. 2 revises the form of Certificate of Designation (the "Certificate of Designation") for Series A Non-Voting Convertible Preferred Stock (the "Series A Preferred Stock") that will be filed upon Closing to include post-closing anti-dilution price protection for holders of Series A Preferred Stock whereby if, following completion of the Qualified Financing and the Merger, the Company conducts any subsequent dilutive financing of at least $2 million at a weighted average effective price per share below the offering price offered to the public in the Qualified Financing, the conversion ratio will be reset to provide additional shares to preferred stockholders in an amount proportional to the dilution caused by such offering, with such protection applying for one year from issuance. The revised Certificate of Designation also provides that the Series A Preferred Stock will not be convertible until the combined company meets the relevant initial listing standards of Nasdaq and contains a provision designed to prevent holders of Series A Preferred Stock from engaging in short sales of the Company’s common stock. As provided in the original Certificate of Designation, the Series A Preferred Stock will also not convert until the Company obtains stockholder approval pursuant to Nasdaq listing rule 5635.

Except as modified by Amendment No. 2, the terms of the Merger Agreement and Amendment No. 1 remain in full force and effect.

The foregoing descriptions of Amendment No. 2 and the Certificate of Designation are not complete and are qualified in their entirety by reference to the full text of Amendment No. 2 and the Certificate of Designation, copies of which are filed as Exhibit 2.1 and Exhibit 2.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.

On June 10, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that senior leadership plans to present at the following conference (Press release, Iovance Biotherapeutics, JUN 10, 2025, View Source [SID1234653814]):

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Goldman Sachs Global Healthcare Conference
Fireside Chat: June 11, 2025 at 1:20 p.m. ET
Miami, FL
The live and archived webcasts will be available at View Source

On June 10, 2025 Antares Therapeutics, Inc. ("Antares"), a biotechnology company developing first-in-class precision medicines for cancer and other serious diseases, reported to have launched with $177 million in Series A financing (Press release, Antares Therapeutics, JUN 10, 2025, View Source [SID1234653811]). The financing was co-led by Omega Funds, Atlas Venture, Lightspeed Venture Partners, BVF Partners, and Cormorant Asset Management, with participation from Vinyanshu Ventures, Abingworth, Invus, Tenmile, Vida Ventures, and Willett Advisors.

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Antares is a spin-out of Scorpion Therapeutics, Inc. ("Scorpion"), which sold its mutant-selective PI3Kα inhibitor program, STX-478, to Eli Lilly and Company ("Lilly") in March 2025 for up to $2.5 billion in total consideration. Scorpion was founded in 2020 and, in the subsequent five years, raised a total of $420 million in financing, executed partnerships with multiple pharmaceutical companies, and generated six development candidates, three of which are in clinical testing. Antares is led by Scorpion’s former executive leadership team and is advancing a pipeline of small molecule assets developed at Scorpion, including programs in precision oncology and other therapeutic areas, as well as programs initiated through Scorpion’s 2022 transcription factor collaboration with AstraZeneca.

"We took our name from Antares, the brightest star in the Scorpius constellation, and known as ‘the heart of the Scorpion.’ We are building from a strong foundation with a team of experts who are experienced in making new medicines, as well as proprietary drug discovery capabilities and a robust preclinical pipeline fueled by discoveries in drugging previously inaccessible targets," said Adam Friedman, M.D., Ph.D., Chief Executive Officer of Antares and former Chief Executive Officer of Scorpion. "We are committed to leveraging our expertise to address well-validated, first-in-class targets across oncology and other serious diseases, and to continuing to execute a fast-to-clinic strategy to bring medicines to patients in need."

"At Omega, we focus on identifying approaches and working with exceptional teams to deliver impactful products to patients," said Otello Stampacchia, Ph.D., Founder and Managing Director at Omega Funds. "Antares meets each of these criteria. As one of the founding investors in Scorpion, we have had the opportunity to follow the company’s evolution very closely and have been consistently impressed by the breadth of the team’s capabilities, as well as their scientific rigor and rapid execution. I look forward to seeing the company’s vision advance by delivering differentiated, first-in-class products to treat some of the most important unmet medical needs."

Additionally, Antares announced that Pierre Fabre Laboratories, with whom Scorpion previously partnered to advance two clinical-stage, highly selective next-generation mutant EGFR inhibitors for the treatment of non-small cell lung cancer, has acquired global rights to both programs. Under the terms of the agreement, Pierre Fabre Laboratories will lead the continued clinical development and global commercialization of both programs, and Antares will be eligible to receive regulatory and commercial milestones and tiered royalties.

On June 10, 2025 Merck, a leading science and technology company, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment (Press release, Merck & Co, JUN 10, 2025, View Source [SID1234653810]). The submission follows the granting of Priority Review to pimicotinib by the CDE in May for the treatment of patients with TGCT who require systemic therapy, which is expected to expedite the review process. Pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., also has been granted breakthrough therapy designation (BTD) by the NMPA.

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"With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country," said Hong Chow, Head of China and International, Healthcare business of Merck. "Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to the US Food and Drug Administration, with additional filings planned in other markets."

TGCT is a locally aggressive and often recurring tumor of the joints that can cause high morbidity associated with swelling, pain, stiffness, and limited mobility of the affected joints, significantly impacting daily activities and quality of life in the primarily working-age population that it affects. If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. This highlights the need for well-tolerated and effective systemic treatments that can impact tumor growth while relieving the symptoms of the disease.

The application is based on results from Part 1 of the global Phase 3 MANEUVER study, in which once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain. The data were presented earlier this month at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.

About MANEUVER

The pivotal Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21).

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population. Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS).

After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About Pimicotinib (ABSK021)

Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib was recently granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with tenosynovial giant cell tumor (TGCT) who require systemic therapy. Pimicotinib has been granted breakthrough therapy designation (BTD) by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib.