On June 26, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported it will announce major advancements to its industry-leading oncology pipeline during today’s investor R&D Day (Press release, BeOne Medicines, JUN 26, 2025, View Source [SID1234654142]). The event comes at a pivotal moment for the Company, which has more than 40 clinical and commercial stage assets in development, a signal of both scale and ambition.

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"At BeOne, our mission is simple yet bold: to create the world’s first next-generation oncology company," said John V. Oyler, Co-Founder, Chairman, and CEO. "What we will unveil demonstrates our progress towards this goal today, and the promise for tomorrow. From our innovative discovery engine to one of the broadest pipelines in oncology, we are well-positioned to bring transformative medicines to patients worldwide—and to do so with speed, quality, and purpose."

BeOne’s integrated, end-to-end R&D model is engineered for efficiency without compromise. The Company’s differentiated approach—combining in-house discovery targeting unmet patient needs, parallel early-stage exploration at low incremental cost, and rapid proof-of-concept generation—enables swift progression from bench to clinic. Our in-house manufacturing around the world, including our flagship facility in Hopewell, NJ, means we have a sustainable business model, purpose built with competitive advantages. This rigorous model has fueled a pipeline of more than 40 clinical and commercial-stage assets, making it one of the most productive in the industry. To complement this research engine, BeOne has built a robust global clinical development platform, with more than 170 trials conducted across 40 countries and more than 25,000 patients enrolled to date.

In hematologic cancers, the Company’s program is driven by its wholly-owned assets including BRUKINSA (zanubrutinib), a second-generation covalent BTK inhibitor and the backbone of the hematology franchise, sonrotoclax, a potential best-in-class next-generation BCL2 inhibitor, and BGB-16673, a BTK CDAC. New clinical data from CaDAnCe-101 highlight the promise of BGB-16673, a potential first-in-class BTK degrader, for patients with relapsed or refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL). Meanwhile, early data show the combination of sonrotoclax and BRUKINSA has demonstrated compelling efficacy and the potential to offer a best-in-class fixed-duration treatment in CLL, setting the stage for a possible new standard of care.

In solid tumors, the Company is advancing multiple targeted modalities beyond its foundational PD-1 inhibitor TEVIMBRA (tislelizumab-jsgr), including CDK4 inhibitor BGB-43395, which has shown clear pharmacodynamic activity and is expected to enter registration-enabling studies for the treatment of breast cancer within the next six to 12 months.

Promising new data for the B7-H4 ADC (BG-C9074) point to a potential first-in-class therapeutic option for patients with B7-H4 expressing tumors, including those without selection criteria. Additionally, early data from the novel PRMT5 inhibitor suggest a favorable safety profile and promising efficacy, supporting its potential for differentiation in the competitive lung cancer field.

"Our R&D team is running at full speed," said Lai Wang, Ph.D., Global Head of R&D. "With more than 1,200 scientists and more than 3,700 clinical development and medical affairs colleagues dedicated to pushing the boundaries of oncology, we have built the infrastructure, mindset, and capabilities to deliver sustained innovation. The volume of clinical milestones we anticipate over the next few years is extraordinary, and our agility in moving from idea to execution sets us apart."

Speakers at today’s event include BeOne’s executive leadership team, senior R&D leaders, and distinguished key opinion leaders, offering a multi-faceted view of the Company’s scientific strategy and execution momentum. The live webcast begins at 8:30 a.m. U.S. Eastern Time and is available on the investor relations section of BeOne’s website, where an archived version will also be accessible.

On June 26, 2025 Cidara Therapeutics, Inc. ("Cidara") (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported the closing of its underwritten public offering of 9,147,727 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,193,181 shares, at a price to the public of $44.00 per share (Press release, Cidara Therapeutics, JUN 26, 2025, View Source [SID1234654141]). The gross proceeds to Cidara from the offering, before deducting underwriting discounts and commissions and offering expenses, were $402.5 million. All of the shares in the offering were sold by Cidara.

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J.P. Morgan, Morgan Stanley, Guggenheim Securities and Cantor acted as joint book-running managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 8, 2025, and declared effective by the SEC on May 15, 2025. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co. by mail at Attention: Capital Markets, 110 East 59th Street, New York 10022 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 26, 2025 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer (Press release, Phio Pharmaceuticals, JUN 26, 2025, View Source [SID1234654138]). Phio reported that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of intratumoral (IT) PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma.

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Five patients were enrolled in the fourth cohort of the Phase 1b clinical trial (NCT 06014086). Four of the enrolled patients were diagnosed with cSCC and one patient with Merkel cell carcinoma. As with the previous three cohorts, injections were well-tolerated and there were no dose-limiting toxicities, serious adverse events, or clinically relevant treatment-emergent adverse reactions reported.

Pathology results related to the efficacy of PH-762 in the fourth cohort will be forthcoming.

"We are encouraged by the continuing safety profile of PH-762 having now progressed through four escalating dose concentrations, and we anticipate that IT administration of the highest dose concentration of PH-762 in cohort 5 will result in a similar safety profile," said Mary Spellman, MD, Phio’s acting Chief Medical Officer.

To date, a total of 15 patients with cutaneous carcinomas have been treated with PH-762 in Cohorts 1 through 4. These cohorts included 13 patients with cSCC, one patient with metastatic melanoma, and one patient with Merkel cell carcinoma.

Pathological response at Day 36 (planned tumor excision) in the previous three cohorts demonstrated complete response (100% tumor clearance) in 4 of 9 patients with cSCC. One cSCC patient had a near complete response (>90% clearance) and one cSCC patient had a partial response (>50% clearance). The other three patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients exhibited clinical progression of disease. Patients with a pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection.

Phio expects to complete enrollment in the expected final cohort in this trial in the third quarter of 2025.

"The continuing favorable safety profile of PH-762 through the fourth cohort provides promise of a well-tolerated treatment for skin cancer," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

On June 26, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, and Nusano, a physics company transforming the production of radioisotopes, reported the signing of a multi-year supply agreement in which Nusano will provide Cellectar with iodine-125 (I-125) and actinium-225 (Ac-225) for its clinical studies and future commercial needs (Press release, Nusano, JUN 26, 2025, View Source [SID1234654137]).

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"Securing a reliable supply of both iodine-125 and actinium-225 is a critical milestone in advancing our targeted radiotherapy programs," said James Caruso, chief executive officer of Cellectar. "This agreement ensures uninterrupted access to these essential isotopes, providing the necessary clinical development supply for our innovative clinical stage programs, including CLR 125 for triple negative breast cancer and CLR 225 for pancreatic cancer. We look forward to partnering with Nusano to support our mutual vision to deliver new radiotherapeutics to patients in critical need of novel treatment options. I-125 and Ac-225 will be produced at Nusano’s next-generation radioisotope production facility in Utah. This production platform enables the creation of rare and hard-to-produce medical radioisotopes in quantities needed for commercial-stage therapeutics and diagnostics."

"The power and flexibility of the Nusano production platform is designed to solve the critical supply chain challenges and enable innovation across multiple industries," said Chris Lowe, chief executive officer of Nusano. "We’re proud to support Cellectar with critical isotope supplies so they can advance their product pipeline and create new, personalized cancer treatments."

On June 26, 2025 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported publication of ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) abstract #388MO related to positive data from a Phase 1b study evaluating givastomig in combination with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers. An objective response rate (ORR) of 71% (12/17) was observed across all dose levels with an ORR of 83% (10/12) observed at dose levels selected for the ongoing dose expansion study (8 and 12 mg/kg) (Press release, I-Mab Biopharma, JUN 26, 2025, View Source [SID1234654136]). Responses were rapid and deepened over time, and were observed in tumors with low levels of PD-L1 expression and/or low levels of Claudin 18.2 (CLDN18.2) expression. There was a favorable safety profile, with low incidence of GI and liver toxicities. I-Mab intends to host a virtual investor event on Tuesday, July 8th (register here) to recap the data being presented at ESMO (Free ESMO Whitepaper) GI.

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The abstract is based on the results of the dose escalation part of a Phase 1b study (NCT04900818) evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig used in combination with nivolumab and mFOLFOX6 as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ intensity in ≥1% of cells). The primary endpoint is safety. The study only enrolled patients in the U.S.

"We are excited to share positive initial data from the Phase 1b dose escalation study of givastomig in gastric cancers at ESMO (Free ESMO Whitepaper) GI 2025. Givastomig shows promising activity in the first line setting, with responses that are both rapid onset and durable, deepening over time. This is the first study to evaluate givastomig in combination with immunochemotherapy and we are very pleased by the overall tolerability, consistent pharmacokinetic data and soluble 4-1BB induction. We look forward to sharing the data with the oncology and investment communities at ESMO (Free ESMO Whitepaper) GI 2025 on July 2nd," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab.

"Givastomig’s strong response data and favorable safety profile are encouraging. I look forward to presenting the data for this novel Claudin 18.2 targeted therapy next week at ESMO (Free ESMO Whitepaper) GI and discussing with colleagues," said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. "Gastroesophageal cancers continue to be a significant unmet medical need, and novel combination approaches are critical. On behalf of the study team, I am enthusiastic to continue to support the givastomig clinical program."

ESMO GI Presentation Details:

Title: Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC)

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

Presentation Number: 388MO

Date and Time: Wednesday, July 2nd at 16:50 CEST (10:50am EST)

Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers

•
17 advanced metastatic gastric cancer patients were treated with givastomig across the 5 mg/kg (n=5), 8 mg/kg (n=6), and 12 mg/kg (n=6) dose levels as of the February 28, 2025, data cutoff. All patients were efficacy evaluable

Patient Characteristics:

•
The 17 patients enrolled in the study were treatment naïve metastatic gastric, esophageal or gastroesophageal adenocarcinomas
•
Patients were HER2-negative, Claudin 18.2-positive (defined as >1+ intensity in >1% of tumor cells) regardless of PD-L1 expression levels
•
All patients were enrolled at sites within the United States

Efficacy Results:

•
Objective Response Rates (ORRs):
o
71% of patients (12/17) achieved a partial response (PR) per RECIST v1.1
▪
5 mg/kg (2/5)
▪
8 mg/kg (5/6)
▪
12 mg/kg (5/6), with one unconfirmed response as of the data cutoff
o
At the doses selected for dose expansion (8 and 12 mg/kg), 83% (10/12) of patients achieved PRs
o
80% of patients (4/5) with CLDN18.2 expression below 75% (CLDN-Low) achieved a PR. The CLDN-Low response rate increased to 100% of patients (3/3) in the doses selected for expansion (8 and 12 mg/kg)
•
The disease control rate (DCR) was 100% across the three dose levels
•
Dose-dependent PK was observed, similar to monotherapy PK.
•
Patients also experienced a dose dependent induction of soluble 4-1BB, a positive indicator of T cell activation and engagement

ORR: % (n)

All

(n=17)

Cohorts Chosen for expansion

(8 and 12 mg/kg)

(n=12)

PD-L1

Any

71 (12/17)

83 (10/12)

≥5

82 (9/11)

89 (8/9)

<5

50 (3/6)

67 (2/3)

≥1

73 (11/15)

82 (9/11)

<1

50 (1/2)

100 (1/1)

CLDN18.2

≥75

67 (8/12)

78 (7/9)

<75

80 (4/5)

100 (3/3)

Durability:

•
8 of 17 patients remained on study treatment and the longest treatment duration was 11.3 months as of the data cutoff

Safety:

•
No dose limiting toxicities (DLT) were observed and a maximum tolerated dose (MTD) was not reached
•
Common treatment related adverse events (TRAEs, ≥10% of patients) were generally Grade 1 or Grade 2 including nausea, vomiting, infusion related reaction, fatigue, decreased appetite, diarrhea, abdominal pain, chills, dyspepsia and gastritis
•
Grade 3 TRAEs attributed to givastomig were rare, with single cases of abdominal pain, ALT/AST increases, gastritis, and infusion related reaction
•
No Grade 4 or Grade 5 TRAEs were reported

Virtual Investor Event:

Register for the Post-ESMO GI 2025 Investor Event here. A replay of the webinar will be accessible on the News & Events page of the I-Mab website for 90 days.

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 first line (1L) metastatic gastric cancers, with further potential in other solid tumors. 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.

An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data.

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.