On March 17, 2025 Partex NV and Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company, reported a strategic collaboration aimed at identifying and evaluating biopharmaceutical compounds using artificial intelligence (AI) for potential acquisition or licensing by Fortress (Press release, Fortress Biotech, MAR 17, 2025, View Source [SID1234651198]).

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Partex will deploy its proprietary AI-based drug discovery and development technology platform, which delivers diverse recommendations on alternative targets or indications and helps search and evaluate compounds across therapeutic areas.

"This strategic collaboration leverages the synergistic strengths of both organizations," said Dr. Frank Grams, Chief Commercial Officer, Partex. "Fortress’ expertise in identifying promising biopharmaceutical assets and advancing them through clinical development to their full potential, coupled with Partex’s advanced AI-driven platform, will enable a highly efficient and data-rich approach to identifying, evaluating, and potentially repositioning promising bio-pharmaceutical assets."

Partex’s platform will provide comprehensive analyses, including target identification, indication expansion, and molecular profiling, ultimately accelerating the process of bringing innovative therapeutics faster to market.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, also added, "In addition to the advancement of our robust late-stage pipeline of compelling product candidates at Fortress along with our partner companies and subsidiaries, plus the launch of two recently approved medicines and a third with a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of this year, we are also focused on business development opportunities and expanding our portfolio. This collaboration with Partex will allow us to expeditiously identify and evaluate assets using their AI platform in conjunction with our already-established large network of Key Opinion Leaders in various therapeutic areas. The Fortress business model is focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. We believe utilizing AI technology will allow us to scale more efficiently and cost effectively going forward."

The collaboration is expected to expedite and support the process of search and evaluation to in-license differentiated assets, with both companies committed to utilize AI to its fullest potential.

On March 17, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the fourth quarter and full year 2024 and provided an update on the company’s recent developments (Press release, FibroGen, MAR 17, 2025, View Source [SID1234651180]).

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"We entered 2025 optimistic about our future, highlighted by the planned initiation of the Phase 2 monotherapy trial of FG-3246, our first-in-class ADC targeting CD46 for the treatment of mCRPC, by mid-2025," said Thane Wettig, Chief Executive Officer. "Through the successful implementation of our cost reduction plan, and upon the closing of our recently announced sale of FibroGen China, we will be a leaner and more focused organization, with a stronger financial position and a cash runway that takes us into 2027, with multiple potential value-creating milestones in sight."

Recent Developments and Key Highlights of 2024:

•
Announced the sale of FibroGen China to AstraZeneca for a total consideration of approximately $160 million, representing an enterprise value of $85 million plus estimated net cash held in China at closing of approximately $75 million. The transaction is expected to close by mid-2025.
o
Upon closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure.
o
FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas.
•
Appointed David DeLucia, CFA, as Senior Vice President and Chief Financial Officer.
•
Completed previously announced cost reduction program.

Upcoming Milestones:

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

•
Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC by mid-2025.
o
Phase 2 trial will include a sub-study of FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246.
•
Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 2H 2025.
o
Phase 2 portion of the study will include data on FG-3180.
Roxadustat

•
Plan to meet with FDA in 2Q 2025 to determine the potential next steps for the development of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS), an indication with significant unmet medical need, in the U.S.Financial:

•
Total revenue from continuing operations for the fourth quarter of 2024 was $3.1 million, as compared to $3.6 million for the fourth quarter of 2023.
•
Total revenue from continuing operations for the full year 2024 was $29.6 million, as compared to $46.8 million for the full year 2023.
•
Net loss from continuing operations for the fourth quarter of 2024 was $8.7 million, or $0.08 net loss per basic and diluted share, compared to a net loss of $62.5 million, or $0.63 net loss per basic and diluted share, one year ago.
•
Net loss from continuing operations for the full year 2024 was $153.1 million, or $1.53 net loss per basic and diluted share, compared to a net loss of $323.0 million, or $3.32 net loss per basic and diluted share, for the full year 2023.
•
At December 31, 2024, FibroGen reported $51.0 million in cash, cash equivalents and accounts receivable in the U.S. and $121.1 million in total consolidated cash, cash equivalents and accounts receivable.
•
Upon closing of the announced sale of FibroGen China, the Company expects its cash, cash equivalents and accounts receivable to be sufficient to fund operations into 2027.

Conference Call and Webcast Presentation

The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.

About FG-3246

FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.

FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The initiation of the Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer is anticipated by mid-2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

On March 17, 2025 Tract Bio, a biotechnology company discovering and developing novel therapies for cancer and inflammatory disease, reported the publication of preclinical research in Gastroenterology (Press release, Tract Bio, MAR 17, 2025, View Source [SID1234651199]). The article, "Evolution of Esophageal Adenocarcinoma from Precursor Lesion Stem Cells" describes results from a preclinical study applying the Company’s proprietary stemECHO epithelial stem cell cloning technology, where regenerative stem cells were cloned from epithelial tissues to analyze the evolution of esophageal adenocarcinoma (EAC) and identify potential therapeutic targets and drug combinations.

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In the study, each of the precursor lesions in the evolution of EAC, including Barrett’s esophagus (BE), low-grade dysplasia (LGD), and high-grade dysplasia (HGD), were shown to possess discrete populations of clonogenic cells that are potential therapeutic targets. DNA sequencing of these clones revealed intralesional heterogeneity and clonal resolution of the mutation progression in patients with BE, LGD, HGD, and EAC. High-throughput chemical screens against BE stem cells reveal drug combinations that are similarly effective against stem cells of LDG, HGD, and EAC. Synthetic lethal combinations were then developed that appear effective against BE, LGD, HGD, and EAC, both in vitro and in vivo, while simultaneously promoting normal esophageal stem cells.

"EAC, as with all metastatic cancers, is the result of an evolutionary process which is dominated by a succession of precursor lesions," said Frank McKeon, Ph.D., Interim Chief Scientific Officer of Tract Bio. "In this study, our unique and proprietary epithelial stem cell cloning platform, stemECHO, allowed us to clone epithelial stem cells while preserving their genetic integrity, enabling the discovery of the underlying mechanism. By maintaining the genetic consistency of the cloned cells, we are able to study disease mechanisms with unprecedented precision, opening the door to new diagnostic tools and therapies. We look forward to continuing this important work."

"The clonogenic cells in each of the regenerative lesions described in this paper, BE, LGD, HGD and EAC, each display functional properties of stem cells. Given the role of stem cells of normal epithelia in the regenerative growth of these tissues, the lesional stem cells could represent important therapeutic targets within tumors," said Richard Russell, Chief Executive Officer of Tract Bio. "Toward this end, our synthetic lethal strategies identified highly effective drug combinations against BE stem cells that showed similar efficacy against stem cells from each lesion in the progression to EAC and EAC itself. Based on these findings, we expect that the continued development of these drug combinations may lead to clinically effective treatments to prevent or treat EAC and perhaps other epithelial cancers by targeting the root causes of these conditions."

On March 17, 2025 Genmab A/S (Nasdaq: GMAB) reported updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRα)-targeted, TOPO1 antibody-drug conjugate (ADC) that showed Rina-S 120 mg/m2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels (Press release, Genmab, MAR 17, 2025, View Source [SID1234651181]). With a median on-study follow-up of 48 weeks, 1 out of 10 patients experienced disease progression and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). The data are from the dose expansion cohort of the multi-part study evaluating the safety and efficacy of Rina-S as a single agent in solid tumors that are known to express FRα and were presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) in Seattle, Washington.

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"The antitumor activity observed in the dose expansion cohort continues to demonstrate the potential for a much-needed treatment option for patients with PROC, who have historically had poor prognosis. I am hopeful that further exploration of Rina-S will lead to advancements in the treatment landscape." said Elizabeth Lee, M.D., a medical oncologist in the gynecologic oncology program at Dana-Farber.

The B1 cohort is a dose expansion study in patients with histologically or cytologically confirmed advanced OC (epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer). Rina-S 120 mg/m2 Q3W at a median on-study follow-up of 48 weeks showed encouraging antitumor activity; the confirmed ORR was 55.6% (95% CI: 30.8-78.5), the disease control rate (DCR) was 88.9% (95% CI: 65.3-98.6), and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). In the 18 patients evaluable for response treated with 120 mg/m2 Q3W, complete responses were observed in 4 patients (2 confirmed; 2 unconfirmed) and 8 patients experienced confirmed partial responses (44.4%). Most responses with Rina-S 120 mg/m2 were observed early (at week 6). Only one patient in the 120 mg/m2 treatment arm was not evaluable. In the Rina-S 100 mg/m2 Q3W treatment arm (N=22), at a median on study follow-up of 46 weeks, the confirmed ORR was 22.7% (95% CI: 7.8-45.4), the DCR was 86.4% (95% CI: 65.1-97.1), and the mDOR was not reached (95% CI, 16.3-NR). Partial responses were observed in 4 patients (18.2%) and 1 patient (4.5%) experienced a complete response. Rina-S 120 mg/m2 has been selected for further evaluation in the RAINFOL-01 and Phase 3 RAINFOL-02 trials for patients with platinum resistant ovarian cancer (PROC).

In this Phase 1/2 study, common treatment-emergent adverse events (TEAEs) included anemia, nausea, neutropenia, leukopenia, fatigue, thrombocytopenia, vomiting, diarrhea, alopecia, and hypokalemia. Dose reductions and treatment discontinuations were infrequent and no new safety signals were observed.

"The updated results reinforce the potential of Rina-S and further validate our development approach in advanced ovarian cancer," said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer of Genmab. "We are excited to keep moving forward with the ongoing Phase 3 trial, to evaluate the potential of Rina-S as a treatment option for patients facing this challenging disease."

The safety and efficacy of rinatabart sesutecan has not been established for these investigational uses.

About the RAINFOLTM -01 Trial
RAINFOL-01 (NCT05579366) is an open-label, multicenter Phase 1/2 study, designed to evaluate the safety and efficacy of rinatabart sesutecan (Rina-S) as a single agent Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part A dose-escalation cohorts; Part B tumor-specific monotherapy dose-expansion cohorts; Part C platinum-resistant ovarian cancer (PROC) cohort; and Part D combination therapy cohorts.

Part B of the trial includes the B1 cohort, a dose expansion study in patients with histologically or cytologically confirmed advanced OC (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Patients were randomized 1:1 to 100 mg/m2 and 120 mg/m2 dose cohorts. Median age was 62.5 and 64.5 years in the 100 mg/m2 and 120 mg/m2 cohorts, respectively. Study participants were previously treated with a median of 3 prior lines of therapy (range 1-4). Patients received prior treatment with bevacizumab (90.9% in the 100 mg/m2 group and 90.0% in the 120 mg/m2 group respectively), PARP inhibitors (68.2%; 65%), and mirvetuximab soravtansin (18.2%; 19%). Initial results from Part B of this trial were presented during a mini-oral session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 (ESMO) (Free ESMO Whitepaper).

About Ovarian Cancer
Ovarian cancer is a major global health issue, with over 320,000 new cases diagnosed annually worldwide.i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.ii The disease is often diagnosed at an advanced stage due to its subtle and non-specific symptoms, such as abdominal bloating, pelvic pain and difficulty eating.iii Standard of care for platinum resistant ovarian cancer typically involves single agent chemotherapy (pegylated liposomal doxorubicin (PLD), topotecan, gemcitabine or paclitaxel).iv Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment.v Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.vi,vii

About Rinatabart Sesutecan (Rina-S; GEN1184)
Rinatabart sesutecan (Rina-S; GEN1184) is a FRα-targeted, TOPO1 ADC, currently being evaluated for the potential treatment of ovarian cancer and other FRα-expressing cancers. A Phase 3 trial (RAINFOL-02, NCT06619236) evaluating Rina-S in patients with platinum resistant ovarian cancer compared to treatment of investigator’s choice is ongoing. In January 2024, the U.S. Food and Drug Administration granted Fast Track designation to Rina-S for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

Please visit www.clinicaltrials.gov for more information.

On March 17, 2025 Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) reported that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘ANVISA’) has approved Illuccix (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company’s lead prostate cancer imaging agent (Press release, Telix Pharmaceuticals, MAR 17, 2025, View Source [SID1234651200]). Illuccix is the first and only PSMA-PET[1] prostate cancer imaging agent to receive full regulatory approval in Brazil.

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Illuccix, after radiolabeling with 68Ga, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

With suspected metastasis who are candidates for definitive initial therapy treatment, and
With suspected recurrence based on an elevated specific antigen (PSA) level in the serum.
The marketing authorization is granted to Telix’s partner R2PHARMA, Brazil’s leading cold kit manufacturer, nuclear pharmacy and cyclotron network, and a subsidiary of GSH Corp Participações S.A. (Grupo GSH). Telix has provided Grupo GSH with an exclusive license to manufacture, distribute and market Illuccix in Brazil[2].

PSMA-PET is a diagnostic technology demonstrated to detect advanced prostate cancer. ANVISA becomes the latest regulatory body worldwide to approve Illuccix[3], which is already commercially available in Australia, Canada, New Zealand and the United States, and has recently been approved in the United Kingdom and in multiple countries within the European Economic Area (EEA).

Dr. Sérgio Altino de Almeida, nuclear medicine specialist, at Rede D’Or, the largest integrated healthcare network in Brazil said, "The ANVISA approval of Illuccix provides access to advanced prostate cancer imaging for men across Brazil, a large and rapidly growing market for gallium-68 based radiopharmaceuticals. The ‘cold kit’ format with generator-produced gallium will facilitate broad equity of access for men living with prostate cancer, regardless of whether they are based in regional, rural or metropolitan areas."

JV to manufacture and distribute radiopharmaceuticals for clinical and commercial use in Brazil

Telix also announces a joint venture (JV) with R2PHARMA to commercialize and distribute Telix’s therapeutic and diagnostic radiopharmaceutical products in Brazil, building on the existing partnership established in 2019. The JV further strengthens this relationship with a commitment to jointly bring to market innovative and first-in-class therapeutic radiopharmaceuticals and imaging agents in Brazil.

The market for radiopharmaceuticals in Brazil is experiencing significant growth driven by the increasing prevalence of chronic diseases such as cancer, advancements in imaging technologies, and a growing senior population. Over the next decade, the Brazilian radiopharmaceuticals market is projected to reach US$330 million[4], with this growth supported by rising investments in the healthcare industry, public health awareness, and the introduction of new and advanced radiopharmaceuticals.

Under the agreement, Telix and R2PHARMA will establish a JV company in Brazil (Telix Innovations Brazil, Ltda.). Telix Innovations Brazil will hold the exclusive licence to commercialize and distribute Illuccix as well as future product candidates from Telix’s industry-leading theranostic pipeline. Telix Innovations Brazil will leverage the local knowledge and expertise of R2PHARMA to obtain the necessary licenses and governmental authorizations in Brazil[5].

Raphaël Ortiz, CEO Telix International, added, "Telix is pleased to bring Illuccix to Brazil and Latin America, with this new imaging modality now recognized in leading clinical practice guidelines and already being adopted in other parts of the world. We would like to acknowledge our partner R2PHARMA for their commitment to gallium-based PSMA-PET and the hope this brings for men living with prostate cancer in Brazil. The JV takes our collaboration to the next stage with the aim to address unmet need for therapeutic and diagnostic radiopharmaceuticals across a range of disease areas."

R2PHARMA Nuclear Medicine & Innovation Vice-President, Rafael Madke, continued, "We are delighted to have been granted this marketing authorization for Illuccix in Brazil. The combination of Telix’s innovative theranostic pipeline and R2PHARMA’s manufacturing and distribution capabilities will support widespread access for patients and physicians to Illuccix and future additional products that until now have not been available in Latin America."

About Prostate Cancer in Brazil

Prostate cancer is the most commonly diagnosed male cancer in Brazil with an estimated 71,730 new cases in 2023[6]. Prostate cancer was also the second most common cause of cancer death in men (after lung cancer), with approximately 20,000 men dying from their disease in 2022. More than 250,000 men in Brazil were estimated to be living with prostate cancer in 2022[7].

About Illuccix

Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for PET imaging combined with computerized tomography (CT) scan in case of suspicion of prostate cancer relapse in adult males to detect and localize recurrent cancerous lesions. 68Ga gozetotide injection targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix enables gozetotide (PSMA-11) to be labelled with the radionuclide 68Ga directly before injection by medical professionals.

Illuccix has been approved by the U.S. Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[11], by the Brazilian Health Regulatory Agency (ANVISA)[12] and in multiple countries within the EEA[13] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM.