On October 22, 2025 Electra Therapeutics, a clinical stage biotechnology company pioneering therapies against novel targets for diseases in immunology and cancer, reported an oversubscribed $183 million Series C financing. The round was co-led by Nextech and EQT Life Sciences, with participation from new investors Sanofi, HBM Healthcare Investments, and Mubadala Capital, as well as existing investors OrbiMed, Redmile Group, New Leaf Venture Partners, Westlake BioPartners, Cormorant Asset Management, Blue Owl Capital, and RA Capital Management.

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Proceeds from the financing will fund a global pivotal Phase 2/3 study of ELA026 in secondary hemophagocytic lymphohistiocytosis (sHLH), a hyperinflammatory disease with high mortality and a lack of treatment options. The pivotal study is enrolling patients at research sites across the U.S. and Europe and has initiated dosing. Beyond sHLH, Electra is also evaluating ELA026 in hematologic cancers, where initial clinical data have shown potential for promising therapeutic benefit. The financing will further support advancement of ELA822, Electra’s second SIRP-targeted program that selectively depletes activated T lymphocytes, into the clinic and through initial data readouts.

"We are pleased to have the support of a distinguished group of investors who share our vision to deliver life-changing treatments for patients with underserved diseases," said Kathy Dong, PharmD, MBA, President and CEO of Electra Therapeutics. "Our team has a proven record of translating novel biology into first-in-class breakthrough therapies, as exemplified by ELA026. With strong momentum, we are driving the pivotal study of ELA026 in sHLH forward and accelerating our second SIRP-targeted program into the clinic."

Electra has pioneered the development of novel therapies targeting SIRP, a family of cell surface receptors, to selectively deplete pathological immune cells. This approach was clinically validated in the Phase 1b study of ELA026 in sHLH, where frontline treatment with ELA026 in malignancy-associated HLH patients achieved 100% overall survival at 8 weeks, compared with approximately 50% reported for available therapies in historical benchmarks. These results provide a foundation to expand development of ELA026 into additional indications and to advance ELA822 for broad application across immunology and inflammation (I&I).

In conjunction with this financing, Thomas Geninatti, PhD from Nextech will join Electra’s board of directors and Christoph Broja from EQT Life Sciences will join as board observer.

"We are very impressed by the compelling clinical data the Electra team has generated for ELA026 in sHLH, a life-threatening disease with a growing patient population. These encouraging results provide validation for targeting SIRP as a novel mechanism and position Electra to expand its application across immunology and oncology," said Thomas Geninatti, PhD. "We look forward to partnering with Electra to advance the company’s pipeline and help bring new therapeutic breakthroughs to patients."

About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening hyperinflammatory disease with a lack of treatment options. It can be triggered by cancer, infection, autoimmune disease, or immunotherapy. sHLH is associated with a severe inflammatory response that requires immediate intervention. Without effective treatment, patients may experience multiorgan failure and death. sHLH is associated with high mortality early in the disease course, with malignancy-associated HLH (mHLH) patients having a mortality rate of approximately 50% at two months with available therapies.

(Press release, Electra Therapeutics, OCT 22, 2025, View Source [SID1234656896])

On October 22, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that the Company has accepted offers from multiple leading biotech institutional and individual investors to purchase an aggregate of approximately 26.68 million shares of the Company’s common stock at $18.74 per share, the closing price on Tuesday, October 21, 2025, for aggregate gross and net proceeds to the Company of approximately $500 million.

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Robert W. Duggan, the Company’s Co-Chief Executive Officer, Executive Chairman of the Board of Directors (the "Board") and majority stockholder, Dr. Mahkam Zanganeh, Co-Chief Executive Officer, President and member of the Board, Manmeet Soni, Chief Operating Officer, Chief Financial Officer and member of the Board, Bhaskar Anand, Chief Accounting Officer and certain non-executive employees each participated as Investors in the Private Placement, investing an aggregate of $272 million. Additionally, Akeso, Inc. ("Akeso"), participated as an Investor in the Private Placement, investing $10 million. Dr. Yu (Michelle) Xia, a member of the Board, is the Chief Executive Officer and Chairwoman of Akeso.

Summit’s insiders including Akeso invested a total of $282 million. The remaining funds of $218 million were raised with multiple leading biopharma institutional investors and other individual investors.

Summit intends to use the net proceeds to advance, in part, the clinical development of ivonescimab, in addition to working capital needs and general corporate purposes.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Summit has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock following the closing of the securities purchase agreement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these 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 the registration or qualification under the securities laws of any such jurisdiction.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, SITC (Free SITC Whitepaper), 2023) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 3,000 patients have been treated with ivonescimab in clinical studies globally, and over 40,000 patients when considering those treated in a commercial setting in China as noted by Akeso.

Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In early 2025, the Company began enrolling patients in the United States for HARMONi-7. Summit intends to open clinical trial sites in the United States for the Phase III study in CRC by the end of 2025.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second half of 2024, and top-line results were announced in May of 2025, with detailed results provided in September 2025.

HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a planned Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary tract cancer, colorectal cancer, breast cancer, pancreatic cancer, small cell lung cancer, and head and neck cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

(Press release, Summit Therapeutics, OCT 22, 2025, View Source [SID1234656912])

On October 22, 2025 Onco3R Therapeutics, a clinical-stage immunology and oncology biotech company dedicated to transforming patients’ lives with best-in-class medicines, reported that it will present preclinical data from its FGFR3, SMARCA2 and P53 Y220C small molecules programs in 3 posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place October 22-26, 2025, in Boston (Press release, Onco3R Therapeutics, OCT 22, 2025, View Source [SID1234656928]).

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"First generation precision medicines are often suboptimal in the clinic due to low target coverage, off-target toxicity and emergence of resistance. At Onco3R, our vision is to design best-in-class medicines to address the unmet needs left by first generation drugs and unlock the full potential of therapeutic targets" said François Gonzalvez, PhD, CSO and co-Founder of Onco3R Therapeutics.

"We are thrilled to present the first preclinical data from our lead oncology programs FGFR3, SMARCA2 and P53 Y220C. Each program has identified best-in-class molecules which offer the potential to deliver transformational efficacy and improved tolerability for patients. Our FGFR3 and SMARCA2 candidates, G-012 and G-141 respectively, have reached the optimum potency and selectivity profile to mitigate dose-limiting toxicities while maintaining maximum target coverage. This has translated into robust anti-tumor activity in vivo. The poster presentations will highlight data supporting the advancement of these two candidates towards the clinic, as well as the discovery of unique small molecule P53 reactivators."

"These compelling preclinical results further validate our patient-centric drug discovery approach, which integrates deep translational science with rational, structure-based and AI-augmented drug design", Pierre Raboisson, PhD, CEO and co-Founder of Onco3R Therapeutics said. "We look forward to advancing these two candidates and remain on track to initiate IND-enabling studies in mid-2026. The identification of these candidates, alongside the continued clinical progress of our SIK3 inhibitor O3R-5671 in autoimmune indications, reinforces Onco3R’s strong strategic position. With a robust pipeline and clear execution momentum, we are confidently advancing toward our next value-driving milestones."

Presentation details
Title: Discovery of Best-in-Class FGFR3 small molecule inhibitors with high isoform selectivity and activity against gatekeeper mutations

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: Sandrine Vendeville, PhD

Key findings from preclinical studies include:

G-012 demonstrated best-in-class potency and selectivity with favorable drug-like properties.

Based on translational modelling, the compound reached the optimal selectivity against other FGFR isoforms to mitigate off-target toxicity and maintain maximal target coverage.

G-012 showed robust anti-proliferative activity in FGFR3-driven cancer cells and induced significant tumor regression in vivo.

G-012 is currently advancing in 14 days toxicology studies.

IND-enabling studies are anticipated in mid-2026.

Title: Discovery of novel SMARCA2 small molecule inhibitors with best-in-class potency and selectivity for the treatment of SMARCA4-mutant cancers

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: Lijs Beke, PhD

Key findings from preclinical studies include:

G-141 combined best-in-class cellular potency and selectivity to allow optimal target coverage and unlock the full therapeutic potential of SMARCA2 inhibition.

The compound showed synthetic lethality in SMARCA4-deficient cells and induced robust anti-tumor activity in vivo without signs of SMARCA4-related toxicity.

G-141 showed favorable drug-like properties and is currently advancing in 14 days toxicology studies.

IND-enabling studies are anticipated in mid-2026.

Title: Discovery of a Best-in-Class small molecule p53 Y220C reactivator: Breaking through the potency ceiling

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: François Gonzalvez, PhD

Key findings from preclinical studies include:

Onco3R patient-centric drug discovery approach identified unique small molecule P53 reactivators with best-in-class cellular potency.

Onco3R leads exhibit the optimal potency and residence time to induce deep and sustain target engagement and fully unlock the tumor suppressive function of P53 in cells.

This translated into robust anti-proliferative activity in P53 Y220C mutant cancer cell lines (single digit nanomolar IC50s) and tumor regression in a Y220C P53 mutant xenograft model.

Further characterization of the lead candidates is ongoing.

On October 22, 2025 Charles River Laboratories International, Inc. (NYSE: CRL) and The Francis Crick Institute (Crick) reported a new collaboration around Antibody-Drug Conjugate (ADC) drug discovery and development, leveraging combined strengths to accelerate the development and delivery of next-generation targeted therapies.

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This agreement leverages an integrated approach to streamline discovery and characterization—bringing promising ADC candidates to the clinic faster and more efficiently. This end-to-end approach—spanning antibody discovery, conjugation, in vitro profiling, and preclinical studies—will be fully integrated and managed jointly by Charles River and the Crick to minimize timelines and maximize efficiency.

"This integrated ADC development agreement represents a powerful synergy between cutting-edge antibody discovery and rigorous safety profiling," said Justin Bryans, PhD, Chief Scientific Officer, Charles River. "Together, we’re enabling the development of smarter, safer therapeutics that are more likely to succeed in the clinic—ultimately supporting the mission of delivering life-changing therapies to patients."

This collaboration will feature antibody generation leveraging phage display libraries, ensuring high-affinity, target-specific antibodies as the foundation for ADC development. It will also utilize Charles River’s advanced Retrogenix platform, an in vitro profiling technology designed to evaluate off-target interactions and enhance safety and therapeutic index early in the development process.

David Allen, Director of Translation at the Crick, added, "This collaboration marks a powerful convergence of innovation and execution. Working together will allow us to translate our research discoveries into new treatments at a scale and speed that simply wouldn’t be possible alone."

(Press release, Charles River Laboratories, OCT 22, 2025, View Source [SID1234656913])

On October 22, 2025 I-Mab (NASDAQ: IMAB) (I-Mab or the Company), is a global biotechnology platform company committed to accelerating access to innovative medicines for patients worldwide, reported that updated data from the Phase 1 study (NCT04900818) of givastomig as a monotherapy in heavily pre-treated patients (n=45) with gastroesophageal carcinoma (GEC) will be presented as a "short-talk" at the Triple Meeting on October 23, 2025 in Boston, Massachusetts (Presentation #B016). Givastomig is a bispecific antibody targeting CLDN18.2 (Claudin 18.2) and 4-1BB.

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"The Phase 1 givastomig monotherapy data that will be shared at the Triple Meeting continue to demonstrate impressive safety and efficacy, with an 18% ORR in heavily pre-treated gastric cancer patients, with favorable overall safety. These data, showing responses over a dose range from 5 mg/kg Q2W to 18 mg/kg Q3W, further enrich givastomig’s emerging product profile and bolster our confidence that givastomig has the potential to be a best-in-class Claudin18.2-directed therapy across a broad range of CLDN18.2 expression. In Q1 2026, we expect to report topline results from the fully-enrolled Phase 1b dose expansion immune-chemotherapy combination study and initiate a global, randomized Phase 2 combination study. We believe the data from these studies will clearly demonstrate givastomig’s potential to significantly improve the standard of care in the treatment of first line GEC patients with a broad range of Claudin 18.2 expression levels," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab.

"In our experience, givastomig integrates well into the workflow at our center. Based on the monotherapy efficacy across a range of doses and Claudin 18.2 expression levels, and excellent overall safety, givastomig has the potential to be the best-in-class Claudin-directed therapy and combination partner for the treatment of frontline gastric cancer. These follow-up data, plus encouraging initial results from the Phase 1b immune-chemotherapy frontline combination studies, presented earlier this year, give us hope that givastomig treatment can lead to improved treatment outcomes for patients with gastric cancers. We are eager to move forward with the planned Phase 2 study and continue to advance this program," said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital.

AACR-NCI-EORTC "the Triple Meeting" Conference Information:

Title: Updated Safety, Efficacy and Biomarker Analysis from the Phase I Study of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Claudin 18.2 Positive Advanced Gastroesophageal Carcinoma (GEC)

Session: Concurrent Session 2: Bispecifics/T-cell Engagers

Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital

Presentation Number: B016

Date and Time: Thursday, October 23, 2025, 6:20 – 6:35 PM ET

Location: Hynes Convention Center

A copy of the Triple Meeting presentation and poster will be available on the Publications and Presentations page of the I-Mab website on October 23, 2025.

Givastomig Phase 1 Monotherapy Updated data Summary GEC (per June 10, 2025 data cut-off):

▪
Givastomig was well tolerated up to 15 mg/kg Q2W and 18 mg/kg Q3W and continues to show monotherapy activity in heavily pre-treated GEC patients with a wide range of CLDN18.2 expression
▪
Givastomig may have the ability to target patients with lower CLDN18.2 expression compared with other CLDN18.2 agents
Patients Characteristics:

•
45 GEC patients were dosed with givastomig every two weeks (Q2W) across dose levels of: 5mg/kg (n=7), 8 mg/kg (n=5), 12 mg/kg (n=21), 15 mg/kg (n=6) and 18 mg/kg Q3W (n=6) as of the June 10, 2025 data cutoff
•
Patients had received a median of 3 prior therapies including 74% with a prior PD-L1 inhibitor
Efficacy Results:

•
Confirmed Objective Response Rate (ORR):
o
18% of patients (8/45) achieved a partial response (PR)
▪
5 mg/kg (1/7)
▪
8 mg/kg (1/5)
▪
12 mg/kg (4/21)
▪
15 mg (0/6)
▪
18 mg/kg Q3W (2/6)
o
Claudin 18.2 expression in responders ranged from 11% (1+, 10%; 2+, 1%) to 100% (2+, 10%; 3+, 90%)
•
The Disease Control Rate (DCR) was 49%, including stable disease (SD) in 14 patients
Follow-up and Biomarker Data:

•
2 patients are ongoing (4%), with 1 PR (8 mg/kg) at 33 months (mo), and 1 PR (18 mg/kg Q3W) at 10 mo
•
The median progression free survival (mPFS) and median overall survival (mOS) are 2.96 mo (95% CI 1.71-3.91) and 7.49 mo (95% CI 4.96-12.5), respectively

No statistical difference in ORR, DCR, PFS or OS, between CLDN18.2-high (n=21) and CLDN18.2-low patients (n=24): ORR 19% v. 17% (p=1.00), DCR 57% v. 42% (p=0.46), mPFS 3.68 mo v. 1.84 mo, PFS hazard ratio (HR) 0.87 (p=0.67), and mOS 7.49 mo v. 7.49 mo, OS HR 0.88 (p=0.74), respectively
Safety:

•
There were no new safety signals identified with longer follow-up
•
No dose limiting toxicities were observed
•
Common TREAEs (≥15%, any grade/grade 3) included anemia (27%/9%), white blood cell count decrease (22%/7%), nausea (20%/2%), ALT increase (16%/2%) and AST increase (16%/4%)
About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

(Press release, I-Mab Biopharma, OCT 22, 2025, View Source [SID1234656898])