On December 4, 2025 Formycon AG (FSE: FYB, Prime Standard) and MS Pharma reported that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206, Formycon’s biosimilar candidate to the blockbuster drug Keytruda[1] (pembrolizumab), in the Middle East and North Africa ("MENA region"). The agreement includes an option for future technology transfer.

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"This licensing deal for the MENA region represents the start of the commercial partnering activities for our Keytruda biosimilar candidate. Further agreements for additional regions and countries shall follow in due time. With MS Pharma, we are leveraging the well-established excellent collaboration that has already been successfully implemented for our biosimilars FYB201, FYB202, and FYB203. MS Pharma is a strong player that can sustainably improve access to this important cancer drug across the MENA region. FYB206 is currently approaching the end of its clinical development phase, and we expect results for the primary endpoint in the first quarter of 2026," said Nicola Mikulcik, CBO of Formycon AG.

"Extending our partnership with Formycon for FYB206 (pembrolizumab), is a strategically important milestone for MS Pharma. This collaboration not only strengthens our position as a leader in biosimilars across the MENA region but also demonstrates our commitment to expanding access to innovative cancer therapies. Leveraging Formycon’s scientific expertise with our established local capabilities and our advanced manufacturing facility in Saudi Arabia, we are well-positioned to deliver high-quality biosimilars that meet the needs of patients and healthcare systems in the MENA region," commented Kalle Känd, CEO of MS Pharma.

Upon signature of the agreement, Formycon will receive an upfront remuneration and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones, Formycon will further receive a significant share of the gross profits generated in the region.

MS Pharma will continue to contribute to greater treatment availability while supporting national strategies focused on localization, resilience, and sustainable access to oncology care. This collaboration reinforces MS Pharma’s role as a long-term partner to governments and healthcare institutions across the region, helping maintain continuity and quality of care for patients.

Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 2024[2], Keytruda is currently one of the world’s best-selling drugs. In the MENA region, estimated sales reached approximately US$ 240 million[3], positioning it as the highest-selling biologic in the region and underscoring the substantial oncology demand and market potential across MENA.

(Press release, Formycon, DEC 4, 2025, View Source [SID1234661141])

On December 4, 2025 iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, reported it has dosed the first patient in its Phase I/II clinical trial evaluating roginolisib in patients with MF who are no longer responding to JAK inhibition. Further details of the trial will be presented in a poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida on Sunday, December 7 at 6pm EST.

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This milestone marks an important step toward addressing the significant unmet medical needs of MF patients who face diminishing therapeutic options, as their disease progresses or becomes resistant to standard-of-care JAK inhibitor treatment.

The Phase I/II trial is part of a comprehensive development program evaluating next-generation PI3Kδ inhibitor roginolisib’s tolerability and anti-tumor response across a number of solid and hematologic malignancies.

"Based on non-clinical data being presented at ASH (Free ASH Whitepaper), we anticipate that targeting both the PI3Kδ and JAK pathways could have a synergistic effect in MF — an approach that has previously eluded older generation PI3Kδ inhibitors because of their unfavorable tolerability profiles." said Dr Michael Lahn, Chief Medical Officer of iOnctura.

Overactivation of the PI3K-Akt signaling pathway contributes to the occurrence and progression of cancer[1]. In MF, pathway activation is a well described mechanism of resistance in response to JAK inhibition[2]. Inhibition of this pathway using roginolisib may overcome the lack of response and lead to a beneficial therapeutic effect. Non-clinical evidence in support of this mechanism is being presented at ASH (Free ASH Whitepaper) on Monday, December 8, 2025 at 6pm EST.

These data demonstrate monotherapy activity of roginolisib against MF cell lines and in vitro models of primary MF cells. Further, roginolisib and JAK inhibition (ruxolitinib or momelotinib) exerts a synergistic anti-cancer effect. These data support the rationale behind the ongoing HEMA-MED clinical trial.

Professor Alessandro Vannucchi, Professor of Hematology and Department Head of the Center for Research and Innovation in Myeloproliferative Neoplasms (CRIMM) at the University of Florence, Florence, Italy and Principal Investigator of the HEMA-MED study said: "Myelofibrosis patients often have suboptimal responses to ruxolitinib and/or acquire resistance over time. Roginolisib’s intriguing mechanism of action and favorable toxicity profile position it as a compelling partner for ruxolitinib. By combining these agents, we could unlock more durable responses and redefine therapeutic expectations for this challenging rare disease."

In addition to the two posters related to MF, trials in progress posters for the ongoing investigations of roginolisib in peripheral T-cell lymphoma and chronic lymphocytic leukemia (CLL) will also be presented at ASH (Free ASH Whitepaper).

iOnctura poster presentations at the 67th ASH (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, USA:

1. A Vannucchi et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-4153: A study of roginolisib in combination with ruxolitinib in patients with myelofibrosis who are unresponsive to JAK inhibitors (HEMA-MED)

2. M Balliu et al.: Monday, December 8, 06:00 PM – 08:00 PM EST

Abstract 25-7102: The selective PI3Kd inhibitor roginolisib synergizes with ruxolitinib against progenitor cells from naïve and JAK-inhibitor-refractory/resistant patients with myelofibrosis

3. D Sibon et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-11050: PlatΤform: A multicenter, multi-arm, academic platform trial evaluating novel agents and combinations in relapsed or refractory peripheral T-cell lymphomas

4. J Brown et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-7765: Roginolisib (IOA-244), an orally bioavailable, selective PI3Kδ inhibitor, in combination with venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL)

About myelofibrosis (MF)

MF is a rare myeloproliferative neoplasm marked by activation and growth of mutated cells in the bone marrow, with approximately 0.5 cases per 100,000 individuals diagnosed globally a year[3].

JAK inhibitors are a key treatment option for MF patients and improve symptoms and quality of life, but approximately half of patients discontinue therapy within three years[4]. Reasons for discontinuation include disease progression, tolerability and adverse events and death resulting from resistance to the JAK therapy[5],[6].

About the HEMA-MED clinical trial

The HEMA-MED trial (NCT06887803) is a prospective, multi-center, open-label Phase I/II single arm trial consisting of two parts. Part 1 (Phase 1) will enroll 13 patients to assess the safety of the combination of the PI3Kδ inhibitor roginolisib in combination with the JAK inhibitor ruxolitinib, and Part 2 (Phase 2) will expand to enroll 13 additional patients to further allow the assessment of benefit/risk for all 26 patients. In addition to safety, the secondary endpoints of the HEMA-MED trial include blood biomarker and spleen reduction responses, and improvements of MF related symptoms. Exploratory measures will assess endpoints associated with the mechanism of action (MOA) of roginolisib.

(Press release, iOnctura, DEC 4, 2025, View Source [SID1234661140])

On December 4, 2025 iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, reported it has dosed the first patient in its Phase I/II clinical trial evaluating roginolisib in patients with MF who are no longer responding to JAK inhibition. Further details of the trial will be presented in a poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida on Sunday, December 7 at 6pm EST.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This milestone marks an important step toward addressing the significant unmet medical needs of MF patients who face diminishing therapeutic options, as their disease progresses or becomes resistant to standard-of-care JAK inhibitor treatment.

The Phase I/II trial is part of a comprehensive development program evaluating next-generation PI3Kδ inhibitor roginolisib’s tolerability and anti-tumor response across a number of solid and hematologic malignancies.

"Based on non-clinical data being presented at ASH (Free ASH Whitepaper), we anticipate that targeting both the PI3Kδ and JAK pathways could have a synergistic effect in MF — an approach that has previously eluded older generation PI3Kδ inhibitors because of their unfavorable tolerability profiles." said Dr Michael Lahn, Chief Medical Officer of iOnctura.

Overactivation of the PI3K-Akt signaling pathway contributes to the occurrence and progression of cancer[1]. In MF, pathway activation is a well described mechanism of resistance in response to JAK inhibition[2]. Inhibition of this pathway using roginolisib may overcome the lack of response and lead to a beneficial therapeutic effect. Non-clinical evidence in support of this mechanism is being presented at ASH (Free ASH Whitepaper) on Monday, December 8, 2025 at 6pm EST.

These data demonstrate monotherapy activity of roginolisib against MF cell lines and in vitro models of primary MF cells. Further, roginolisib and JAK inhibition (ruxolitinib or momelotinib) exerts a synergistic anti-cancer effect. These data support the rationale behind the ongoing HEMA-MED clinical trial.

Professor Alessandro Vannucchi, Professor of Hematology and Department Head of the Center for Research and Innovation in Myeloproliferative Neoplasms (CRIMM) at the University of Florence, Florence, Italy and Principal Investigator of the HEMA-MED study said: "Myelofibrosis patients often have suboptimal responses to ruxolitinib and/or acquire resistance over time. Roginolisib’s intriguing mechanism of action and favorable toxicity profile position it as a compelling partner for ruxolitinib. By combining these agents, we could unlock more durable responses and redefine therapeutic expectations for this challenging rare disease."

In addition to the two posters related to MF, trials in progress posters for the ongoing investigations of roginolisib in peripheral T-cell lymphoma and chronic lymphocytic leukemia (CLL) will also be presented at ASH (Free ASH Whitepaper).

iOnctura poster presentations at the 67th ASH (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, USA:

1. A Vannucchi et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-4153: A study of roginolisib in combination with ruxolitinib in patients with myelofibrosis who are unresponsive to JAK inhibitors (HEMA-MED)

2. M Balliu et al.: Monday, December 8, 06:00 PM – 08:00 PM EST

Abstract 25-7102: The selective PI3Kd inhibitor roginolisib synergizes with ruxolitinib against progenitor cells from naïve and JAK-inhibitor-refractory/resistant patients with myelofibrosis

3. D Sibon et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-11050: PlatΤform: A multicenter, multi-arm, academic platform trial evaluating novel agents and combinations in relapsed or refractory peripheral T-cell lymphomas

4. J Brown et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-7765: Roginolisib (IOA-244), an orally bioavailable, selective PI3Kδ inhibitor, in combination with venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL)

About myelofibrosis (MF)

MF is a rare myeloproliferative neoplasm marked by activation and growth of mutated cells in the bone marrow, with approximately 0.5 cases per 100,000 individuals diagnosed globally a year[3].

JAK inhibitors are a key treatment option for MF patients and improve symptoms and quality of life, but approximately half of patients discontinue therapy within three years[4]. Reasons for discontinuation include disease progression, tolerability and adverse events and death resulting from resistance to the JAK therapy[5],[6].

About the HEMA-MED clinical trial

The HEMA-MED trial (NCT06887803) is a prospective, multi-center, open-label Phase I/II single arm trial consisting of two parts. Part 1 (Phase 1) will enroll 13 patients to assess the safety of the combination of the PI3Kδ inhibitor roginolisib in combination with the JAK inhibitor ruxolitinib, and Part 2 (Phase 2) will expand to enroll 13 additional patients to further allow the assessment of benefit/risk for all 26 patients. In addition to safety, the secondary endpoints of the HEMA-MED trial include blood biomarker and spleen reduction responses, and improvements of MF related symptoms. Exploratory measures will assess endpoints associated with the mechanism of action (MOA) of roginolisib.

(Press release, iOnctura, DEC 4, 2025, View Source [SID1234661140])

On December 4, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, reported the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November 17, 2025, to review regulatory strategy for advancing (Z)-endoxifen. During the meeting, the FDA provided the Company feedback on potential expedited regulatory pathways and development options across metastatic disease, neoadjuvant treatment, and breast cancer risk-reduction settings.

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The meeting focused on clinical development design, endpoint strategy, and pathways that could support a streamlined registrational approach. Atossa believes the FDA interaction meaningfully clarified potential routes to accelerate clinical development and regulatory review for (Z)-endoxifen, helping to position the Company to pursue a faster and more focused development strategy across multiple breast cancer indications.

"This meeting was a meaningful development milestone for our programs," said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. "We used this discussion to incorporate FDA feedback into our development planning that could meaningfully shorten our regulatory timeline. We continue to aggressively execute the advancement of (Z)-endoxifen across the breast cancer continuum and toward potential registration pathways."

This includes multiple high-value clinical settings, including:

Metastatic breast cancer (mBC): A dose-ranging study is in preparation as part of the Company’s strategy to support registrational development.
Neoadjuvant ER+/HER2- breast cancer: Enrollment and data generation continue in the Phase 2 EVANGELINE trial.
Breast cancer risk-reduction: Development includes a low-dose strategy targeting mammographic breast density and overall breast cancer risk.
In support of its metastatic breast cancer program, Atossa recently submitted an Investigational New Drug application ("IND") to the FDA and is awaiting feedback. The Company also anticipates additional IND submissions in 2026 to advance combination strategies and explore opportunities beyond monotherapy and breast cancer.

"Our clinical program is now structured around decisive value-creating milestones," said Janet Rea, MSPH, Senior Vice President of Research and Development. "We have completed multiple clinical trials involving nearly 800 participants, and are optimistic that this foundation, combined with anticipated upcoming data, and FDA input supports an active push towards multiple regulatory endpoints."

About (Z)-Endoxifen

(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated ability to inhibit and potentially degrade estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets the oncogenic signaling pathway, protein kinase C beta 1 (PKCβ1), at clinically achievable blood and tumor levels. (Z)-endoxifen also seems to deliver comparable or superior bone-protective effects relative to tamoxifen.

Atossa is developing a proprietary enteric oral formulation of (Z)-endoxifen that bypasses stomach acid, which would otherwise partially convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In nearly 800 adults (healthy volunteers and breast cancer patients) receiving doses up to 360 mg/day, no maximum tolerated dose (MTD) has been identified, supporting continued dose-range exploration.

Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including four recently issued U.S. patents and numerous pending applications worldwide.

(Press release, Atossa Therapeutics, DEC 4, 2025, View Source [SID1234661139])

On December 4, 2025 Alpha-9 Oncology, a clinical-stage radiotherapeutic company developing targeted cancer therapies, reported the initiation of dosing in a Phase 1 study evaluating A9-3408, a novel Actinium-225-based radiotherapeutic targeting melanocortin 1 receptor (MC1R) for the treatment of patients with melanoma. The Phase 1 study is a multi-center, open-label trial designed to evaluate the safety, dosimetry, and dose escalation of A9-3408 in patients with MC1R-positive melanoma, who have progressed on standard-of-care therapies.

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This milestone advances Alpha-9’s melanoma program, which first entered the clinic last year with A9-3202, a Gallium-68-based imaging agent used to assess MC1R expression and identify patients for the A9-3408 therapeutic study.

"Dosing the first patient with our MC1R radiotherapeutic marks an important milestone for the company and validates our internal R&D platform," said Paul Blanchfield, Chief Executive Officer, Alpha-9 Oncology. "We are excited to have initiated trials for our first therapeutic program and look forward to advancing additional best-in-class assets into the clinic as we aim to bring novel, life-improving treatments to people living with cancer."

"MC1R is an ideal target due to its high expression in melanoma and limited presence in healthy tissue," said Robert Meehan, M.D., Chief Medical Officer at Alpha-9. "Despite advances in immunotherapy, significant unmet needs remain for patients who progress on current standard of care. In our A9-3202 imaging study, 92% of patients had strong MC1R expression after progression on immunotherapy, demonstrating the potential for this program to provide a new modality for patients."

Dr. Meehan recently joined Alpha-9 as Chief Medical Officer, bringing progressive leadership experience in biopharma and biotechnology, specializing in the creation of complex, novel development programs. Dr. Meehan is a board-certified physician trained in hematology and oncology, with expertise in all phases of drug development across multiple modalities. Prior to Alpha-9, Dr. Meehan was the Senior Vice President, Clinical Development at Dragonfly Therapeutics, held multiple senior clinical leadership roles at Moderna, and was a staff clinician in the Developmental Therapeutics Clinic at the National Cancer Institute.

Alpha-9’s platform is built on a systematic approach to molecule design, optimizing binders, linkers, and chelators to create radiotherapeutics with superior uptake and retention in tumors while minimizing off-target effects. The advancement of the MC1R program highlights the company’s capability to develop best-in-class molecules and deliver on the promise of precision oncology.

(Press release, Alpha9 Oncology, DEC 4, 2025, View Source [SID1234661138])