On March 3, 2025 Silexion reported the completion of its initial study evaluating SIL-204 in orthotopic pancreatic cancer models, a critical milestone that could continue to position its next-generation RNAi therapy at the forefront of KRAS-driven cancer treatment (Press release, Silexion Therapeutics, MAR 3, 2025, View Source [SID1234650859]). With data analysis now underway and initial results expected in the coming weeks, according to the company’s latest announcement, anticipation seems high for what could be a pivotal breakthrough, if indeed the data is positive.

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A Potential Step Toward Transforming Pancreatic Cancer Treatment

Silexion’s latest study could mark an important advancement in validating systemic administration of SIL-204. The study specifically assessed the therapy’s ability to reduce primary tumor growth and inhibit metastatic spread in clinically relevant orthotopic pancreatic cancer models—providing a more accurate representation of human disease progression than traditional subcutaneous xenograft models.

Silexion’s work with SIL-204 has already demonstrated compelling preclinical efficacy, including a 50% reduction in tumor growth and complete necrosis in half of treated tumors in previous systemic administration studies. Moreover, SIL-204 has shown sustained therapeutic levels for over 56 days from a single dose—an unprecedented achievement in RNAi-based therapies for KRAS-driven cancers.

Why This Matters: A Potential First for Metastatic Pancreatic Cancer

KRAS-driven cancers remain among the most aggressive and difficult-to-treat malignancies, particularly in pancreatic cancer, where over 90% of tumors harbor KRAS mutations. While other companies have attempted to target KRAS with small molecule inhibitors, Silexion’s RNAi-based approach aims to silence multiple key KRAS mutations, including G12D, G12V, G12R, Q61H, and G13D—offering a broader and potentially more effective therapeutic strategy.

The ability to target both primary and metastatic pancreatic cancer via systemic administration would represent a major breakthrough, as Silexion has not previously demonstrated this effect in metastatic models. If the orthotopic model results show significant impact on metastases, this could mark a critical validation step, potentially differentiating SIL-204 from existing KRAS-targeting approaches and opening the door to expanded clinical applications.

The industry seems to be closely watching Silexion’s progress in light of the recent wave of multi-billion-dollar acquisitions in precision oncology. With major players like Pfizer acquiring Seagen for $43 billion and AbbVie purchasing Immunogen for $10.1 billion, the demand for novel cancer therapies seems to have increased in recent years. According to news reports, Maxim Group recently reaffirmed its strong buy rating on SLXN with a $9 price target, citing the company’s strong clinical trajectory and the ongoing validation of its RNAi platform.

Upcoming Data Readout: A Potential Critical Catalyst

Silexion’s announcement that initial results from the orthotopic model study will be released in March 2025 has sparked significant interest. If the data is positive, it could provide further confirmation of SIL-204’s ability to target both primary and metastatic pancreatic cancer, marking the first time the company demonstrates systemic efficacy against metastatic disease.

If the upcoming results align with previous systemic administration findings and show significant impact on metastases, SIL-204 could emerge as a leading next-generation RNAi therapy for KRAS-driven cancers—potentially, in the future, reshaping the treatment paradigm for one of the deadliest malignancies.

Silexion Therapeutics has continued to execute on its strategy, pushing the boundaries of RNAi therapeutics for one of the most aggressive cancers. With data from the orthotopic pancreatic cancer study expected in March, many will likely be watching closely. If the upcoming results are positive and demonstrate impact on metastases, they could serve as a major catalyst for the company, potentially redefining its role in the precision oncology landscape.

Given the strong track record of preclinical success, increasing interest, and a competitive landscape ripe for M&A activity, Silexion Therapeutics is undoubtedly a company to watch in 2025.

On March 3, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the year ended December 31, 2024, and highlighted recent Company progress (Press release, ArriVent Biopharma, MAR 3, 2025, View Source [SID1234650824]).

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"This has been a productive year for ArriVent that included strong achievement across our firmonertinib clinical programs and significant execution of our company strategy through the expansion of our ADC portfolio. The differentiated potential of firmonertinib to address classical and uncommon EGFR mutations was reinforced by the robust anti-tumor activity in NSCLC patients with EGFR PACC mutations reported at the World Conference on Lung Cancer, and the preclinical data presented at AACR (Free AACR Whitepaper)" said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "We also bolstered our ADC portfolio with the recent in-licensing of ARR-217 (MRG007) and research collaboration with Alphamab, underscoring our commitment to further expand our pipeline and develop new innovative therapies to potentially treat cancer patients with unmet medical need."

Dr. Yao continued, "We have achieved our target enrollment of 375 patients in our global, pivotal Phase 3 monotherapy study of firmonertinib in first-line NSCLC patients with EGFR exon 20 insertion mutations. In addition, we plan to provide an update on our plans to investigate firmonertinib as monotherapy in first line NSCLC patients with EGFR PACC mutations in the first half of 2025. For our ADC portfolio, we selected our next-generation ADC candidate, ARR-002, for IND-enabling activities. Our focus continues to be on executing across our near-term catalysts and we are poised for an impactful year ahead."

Recent and Full Year 2024 Highlights

Firmonertinib

● Achieved target enrollment for the global pivotal Phase 3 monotherapy study of firmonertinib in first-line NSCLC EGFR exon20 insertion mutations (FURVENT; NCT05607550). Earlier this year, ArriVent reached its target enrollment in the FURVENT study. Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, received FDA Breakthrough Therapy Designation in this patient population.
● Positive proof-of-concept data in EGFR PACC mutant NSCLC. In September 2024, ArriVent presented interim Phase 1b clinical data for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations (FURTHER; NCT05364043) during the Presidential Symposium at the

2024 World Conference on Lung Cancer and hosted a virtual webinar. Firmonertinib demonstrated robust systemic and CNS anti-tumor activity with a manageable safety profile consistent with previous trials in what we believe to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC.
● Presentation of preclinical data for firmonertinib at the 2024 AACR (Free AACR Whitepaper) Annual Meeting. In April 2024, ArriVent presented data evaluating firmonertinib in preclinical models with EGFR exon 20 insertion mutations and with P-loop and alpha-c helix compressing (PACC) mutations at the AACR (Free AACR Whitepaper) Annual Meeting. In the preclinical study, firmonertinib was observed to be broadly active across a wide range of uncommon mutations including PACC and exon 20 insertion mutations.
● Initiated Phase 1b combination study with firmonertinib and SHP2 allosteric inhibitor ICP-189. In March 2024, ArriVent’s clinical collaboration partner Beijing InnoCare Pharma Tech Co., Ltd., dosed the first patient in the Phase 1b combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations.
Pipeline

● Added ARR-217 (MRG007) to our pipeline from Lepu Biopharma. In January 2025, ArriVent entered into a collaboration with Lepu Biopharma Co., Ltd. for ARR-217, an ADC with the potential to target several GI cancers. Under the agreement, ArriVent obtained the exclusive rights to develop and commercialize ARR-217 worldwide outside of greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
● Selected a next-generation antibody drug conjugate (ADC) candidate. In late 2024, ArriVent and its partner, Aarvik Therapeutics, Inc., selected a multi-target multivalent ADC candidate, ARR-002, for the treatment of solid tumors. ArriVent has initiated IND-enabling studies for ARR-002.
● Entered into an ADC collaboration agreement with Alphamab. In June 2024, ArriVent entered into a collaboration agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (Alphamab), a wholly owned subsidiary of Alphamab Oncology, to discover, develop and commercialize novel ADCs for the treatment of cancers. Under the agreement, both companies leverage Alphamab’s proprietary linker-payload platform and glycan-conjugation technology to identify novel ADCs for oncology indications. The collaboration agreement grants ArriVent exclusive rights to develop and commercialize ADCs globally, except greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
Upcoming Milestones

● EGFR PACC plans. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations. ArriVent expects to provide an update on our plans to develop firmonertinib in EGFR PACC mutant NSCLC in the first half of 2025.

● First IND Filing for ADC Program. ArriVent and its partner, Lepu BioPharma, plan to file the first IND for ARR-217 in the first half of 2025.

● Top-line pivotal Phase 3 data. Firmonertinib has reached its target enrollment in the FURVENT study. ArriVent anticipates having top-line data in 2025 and expects to provide an update on timing of the top-line Phase 3 data release in Q2 2025.
2024 Financial Results

● As of December 31, 2024, the Company had cash, cash equivalents, and short and long-term investments of $266.5 million, which is expected to fund operations into 2026. Net cash used in operations was $70.2 million and $55.8 million for the years ended December 31, 2024 and 2023, respectively. During 2024, ArriVent completed an IPO raising net proceeds of $183.2 million, after deducting underwriting discounts, commissions, and other offering expenses.

● Research and development expenses were $79.0 million and $64.9 million for the years ended December 31, 2024 and 2023, respectively. The increase in expense was primarily due to increased headcount and clinical expense related to firmonertinib.

● General and administrative expenses were $15.3 million and $9.7 million for the years ended December 31, 2024 and 2023, respectively. The increase in expense was primarily due to expenses related to expanding the infrastructure necessary for operating as a public company.

● Net loss was $80.5 million and $69.3 million for the years ended December 31, 2024 and 2023, respectively.

On March 3, 2025 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, reported that its senior management will participate at upcoming investor conferences in the United States and Europe (Press release, Valneva, MAR 3, 2025, View Source;25.htm [SID1234650842]). CEO Thomas Lingelbach and CFO Peter Bühler will present at the TD Cowen 45th Annual Health Care Conference, taking place March 3 – 5, 2025, in Boston, MA. Mr. Lingelbach and Mr. Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen Life Sciences Conference, held April 2 – 3, 2025, in Amsterdam, The Netherlands.

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Management will discuss Valneva’s pipeline of potential first-in-class vaccine candidates, including its lead Lyme disease vaccine, VLA15, and its Shigella and Zika programs alongside the Company’s portfolio of marketed vaccines, which are expected to generate €170-180 million in revenue in 2025.

The TD Cowen presentation will be webcast live and available as a replay in the "investor" section of the Valneva website at www.valneva.com.

TD Cowen 45th Annual Health Care Conference
Date/Time: March 4, 1:10pm ET
Format: Presentation and investor meetings
Location: Boston, Massachusetts
Webcast Link: https://wsw.com/webcast/cowen177/vla/1855281

Van Lanschot Kempen Life Sciences Conference
Date/Time: April 3
Format: Investor meetings
Location: Amsterdam, The Netherlands

Attending institutional investors who would like to meet with Valneva management are asked to submit a request to their representative at the respective bank.

On March 3, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported non-dilutive financings of up to $250 million with Sagard Healthcare Partners (Sagard) (Press release, Nuvation Bio, MAR 3, 2025, View Source [SID1234650860]). The transaction comprises a royalty interest financing of $150 million and a senior term loan of up to $100 million. These financings strengthen Nuvation Bio’s balance sheet to fully fund commercialization of taletrectinib in the U.S., if approved, and development of the Company’s current clinical-stage pipeline. The transaction also provides Nuvation Bio with a path to potential profitability without the need to raise additional capital.

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"This transaction is a significant milestone for Nuvation Bio as we prepare to bring taletrectinib to the U.S. market, subject to FDA approval, in mid-2025," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "With these financings, we are well positioned to launch taletrectinib and drive continued development of our clinical-stage pipeline—all without the need for additional fundraising. This also improves our flexibility to pursue strategic opportunities to deploy our capital. We are thrilled to have support from Sagard and appreciate their shared confidence in taletrectinib and Nuvation Bio as we continue toward our goal of improving outcomes for patients with cancer."

Subject to the approval of taletrectinib by the U.S. Food and Drug Administration (FDA) on or prior to September 30, 2025, Sagard will provide Nuvation Bio with an upfront cash payment of $150 million. In return, Sagard will receive tiered royalties on U.S. net sales of taletrectinib, including 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. Nuvation Bio will retain all annual U.S. net sales above $1 billion. Payments to Sagard will cease upon the earliest occurrence of total royalties reaching 1.6 times its investment by June 30, 2031, 1.75 times its investment by June 30, 2034, or 2.0 times its investment thereafter.

"We are excited to partner with Nuvation Bio, an organization with deep oncology expertise and a commitment to delivering transformative therapies," said Raja Manchanda, Partner at Sagard Healthcare Partners. "We believe taletrectinib has the potential to redefine the treatment landscape for patients with ROS1-positive non-small cell lung cancer, and we are pleased to provide a structured financing that supports both potential near-term commercialization and long-term growth."

In addition to the royalty financing, Sagard has committed to a 5-year, senior secured term loan of up to $100 million, with $50 million to be funded upon U.S. FDA approval of taletrectinib on or prior to September 30, 2025. The second tranche of $50 million is available at Nuvation Bio’s option until June 30, 2026, as long as Nuvation Bio has achieved first U.S. commercial sale of taletrectinib. The term loan will bear interest at SOFR + 6.00%, subject to a 4.00% SOFR floor. There are no scheduled amortization payments associated with the term loan, with all outstanding principal due at maturity.

TD Cowen served as financial advisor and Cooley LLP served as legal advisor to Nuvation Bio. Sidley Austin LLP served as legal advisors to Sagard.

On March 3, 2025 Be Biopharma, Inc. ("Be Bio"), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), reported the appointment of Susan Abu-Absi, Ph.D., as Chief Operating Officer (Press release, Be Biopharma, MAR 3, 2025, View Source [SID1234650825]). With over 20 years of experience in strategic operations, product development and manufacturing in the biotechnology industry, Dr. Abu-Absi brings a wealth of knowledge and expertise to the role, positioning Be Bio for continued growth and operational excellence.

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Dr. Abu-Absi’s career has been marked by her leadership in the development and manufacturing of biologics and cell and gene therapies, contributing to the approval of several key products, including Abecma, Zynteglo, Skysona, Yervoy and Opdivo. Dr. Abu-Absi most recently served as Chief Technology Officer at 2seventy bio, where she built the global manufacturing and supply infrastructure and managed strategic partnerships with academics, partner innovator companies and suppliers to enable the translation of four novel cell therapies into the clinic. Prior to that, she held leadership roles in technical and product development at bluebird bio, Bristol Myers Squibb and Bayer Healthcare. Dr. Abu-Absi holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering from the University of Toledo.

"Susan is an outstanding leader and accomplished executive whose experience will further strengthen our leadership team as we solidify our position as a multi-program, clinical-stage company," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer. "She joins Be Bio at an ideal time, with enrollment now underway in the BeCoMe-9 trial for BE-101 in Hemophilia B, and with our development candidate, BE-102, progressing toward IND as a potential breakthrough for patients with Hypophosphatasia. We look forward to leveraging Susan’s expertise as we pioneer our B Cell Medicines to potentially transform the treatment landscape for a wide range of diseases."

In conjunction with the appointment of Dr. Abu-Absi, Be Bio announced the departure of President & Chief Operating Officer Krishnan Viswanadhan, Pharm.D., who is leaving Be Bio to pursue another leadership position in the biotechnology industry.

"I would like to thank Krishnan for his invaluable contributions to Be Bio, especially his leadership in advancing our lead program, BE-101, to the clinic as a potentially game-changing therapy for people with Hemophilia B," continued Dr. Smith-Farrell. "His dedication and impact have helped shape who we are today, and we are deeply grateful for his time with us. We wish him all the best in his next chapter."

About Engineered B Cell Medicines – A New Class of Cellular Medicines
The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, and over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.