On July 2, 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 the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona (abstract #388MO) (Press release, I-Mab Biopharma, JUL 2, 2025, View Source [SID1234654218]). Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. I-Mab plans to host a virtual investor event on Tuesday, July 8th (register here) to review these data.

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The Phase 1b data (NCT04900818) show a confirmed objective response rate (ORR) of 71% across all doses (12/17), and 83% (10/12) at doses selected for the ongoing dose expansion study (8 mg/kg and 12 mg/kg). Responses occurred in tumors with low levels of PD-L1 expression and/or Claudin 18.2 (CLDN18.2) expression, with favorable overall tolerability. There were no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 TRAE for increased liver enzymes. The data are based on the results of the dose escalation part of a Phase 1b study evaluating the givastomig combination as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). The primary endpoint is safety. The study enrolled only patients in the U.S.

"The positive Phase 1b combination data presented at ESMO (Free ESMO Whitepaper) GI bolster our confidence in givastomig’s potential to be a best-in-class Claudin 18.2 directed therapy. Givastomig has been well tolerated when combined with immuno-oncology and chemotherapy, has shown a high objective response rate, with rapid onset and durable responses that have deepened over time, supported by consistent pharmacokinetic data and soluble 4-1BB induction," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "In addition, we are optimistic about the results from the 8 mg/kg and 12 mg/kg doses. These doses showed an ORR of 83%, with consistent responses across PD-L1 and Claudin 18.2 expression levels, and a favorable overall safety profile. These data further our conviction in the ongoing Phase 1b dose expansion study. We believe givastomig has broad potential in a number of gastric cancer settings and look forward to continued advancement of the program."

"I am encouraged by the response rates, as well as the deepening of responses over time, demonstrated by the givastomig combination regimen in the Phase 1b dose escalation study that we presented today at ESMO (Free ESMO Whitepaper) GI. Despite approved therapies, targeted treatment options for gastric cancers continue to be limited. While the data are early, givastomig combination therapy demonstrates a high response rate across Claudin18.2 and PD-L1 expression levels," said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. "In addition, I have been pleased to observe that givastomig has a favorable overall tolerability profile with a low level of gastrointestinal side effects — especially important for patients with gastric cancer. I look forward to participating in the ongoing givastomig clinical development program, and hope we may be able to expand the population of patients who may benefit from Claudin 18.2 directed agents."

Virtual Investor Event:

Register (here) for the Post-ESMO GI 2025 Investor Event to be held on Tuesday, July 8th at 2:00 PM EDT. A replay of the webinar will be accessible on the Events page of the I-Mab website for 90 days.

Fireside Chat Event with Lucid Capital Markets to Recap the Presentation:

Tune in (here) for a fireside chat sponsored by Christopher Liu, PharmD, Managing Director at Lucid Capital Markets that will be accessible today at 2:00pm EDT on the Events page of the I-Mab website. A replay of the fireside chat will be available for 90 days.

ESMO GI Presentation Details:

A full copy of the ESMO (Free ESMO Whitepaper) GI presentation is available on the Publications and Presentations page of the I-Mab website here.

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 May 15, 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+ IHC staining intensity in ≥1% of tumor cells), regardless of PD-L1 expression levels
•
All patients were enrolled at sites within the United States

Efficacy Results:

•
Confirmed 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)
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 pharmacokinetics (PK) were 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)

ORR: % (n)

PD-L1 ≥ 5

PD-L1 < 5

CLDN18.2 ≥ 75

80 (8/10)

0 (0/2)

CLDN18.2 < 75

100 (1/1)

75 (3/4)

Durability:

•
8 of 17 patients remained on study treatment and the longest treatment duration was 13.3 months as of the data cutoff
•
Median follow-up was 9.0 months across all dose levels as of the data cutoff

Safety:

•
Treatment-related adverse events (TRAEs) leading to discontinuation of any treatment were 12% (two patients), five patients had progressive disease, two patients withdrew from the study for social reasons
•
No dose limiting toxicities (DLT) were observed and a maximum tolerated dose (MTD) was not reached
•
Common 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
•
Four cases of Grade 3 and two cases of Grade 4 treatment-related neutropenia were observed driven by an early restriction on prophylaxis use of G-CSF, which has been subsequently lifted. The neutropenia cases were primarily attributed to mFOLFOX6 in the 8 mg/kg cohorts
•
No Grade 5 TRAEs were reported

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.

On July 2, 2025 Curis, Inc. ("Curis") (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported that it has entered into a definitive agreement with a combination of existing and new investors for the purchase of 1,538,460 shares ("Shares") of its common stock in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Curis also agreed to issue to the investors in the registered direct offering unregistered pre-funded warrants to purchase up to an aggregate of 1,538,461 shares of Common Stock ("Pre-Funded Warrants") at an exercise price of $0.01 per share and unregistered warrants to purchase up to an aggregate of 3,076,921 shares of Common Stock ("Common Warrants" and together with the Pre-Funded Warrants, the "Unregistered Warrants") at an exercise price of $2.15 per share (Press release, Curis, JUL 2, 2025, View Source [SID1234654214]). The Pre-Funded Warrants will be exercisable immediately and will be exercisable until exercised in full. The Common Warrants will be exercisable immediately and will be exercisable for five years following the date of issuance. The combined purchase price for one Share and the associated Common Warrant is $2.275. The combined purchase price for one Pre-Funded Warrant and the associated Common Warrant is $2.265.

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Gross proceeds to Curis from the offering are expected to be approximately $7.0 million, before deducting the placement agents’ fees and other offering expenses payable by Curis. Curis intends to use the net proceeds from the offering on research, development, working capital, and other general corporate purposes.

The registered direct offering and concurrent private placement are each expected to close on or about July 3, 2025, subject to the satisfaction of customary closing conditions.

Laidlaw & Company (U.K.) Ltd. and Jones are acting as placement agents for the registered direct offering and the concurrent private placement.

The Shares of common stock offered in the registered direct offering (but excluding the Unregistered Warrants to be issued in the concurrent private placement and shares of common stock underlying the Unregistered Warrants) are being offered by Curis pursuant to a shelf registration statement on Form S-3 (File No. 333-276950) that was filed with the U.S. Securities and Exchange Commission ("SEC") on February 8, 2024 and declared effective by the SEC on April 12, 2024. A prospectus supplement relating to and describing the terms of the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. The registered direct offering is being made only by means of a prospectus and related prospectus supplement. When available, electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained from Laidlaw & Company (U.K.) Ltd., 521 Fifth Avenue, 12th Floor, New York, NY 10175, Attention: Syndicate Dept., e-mail: [email protected]; or JonesTrading Institutional Services LLC, Attention: Equity Capital Markets, 325 Hudson Street, 6th Floor New York, New York 10013; email: [email protected].

The Unregistered Warrants are being offered in the concurrent private placement pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), provided in Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such Unregistered Warrants, have not been registered under the Securities Act or applicable state securities laws. Curis has agreed to file a resale registration statement with the SEC covering the resale of the shares of common stock underlying the Unregistered Warrants.

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 state or other jurisdiction.

On July 2, 2025 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "Company"), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the closing of its previously announced underwritten public offering for gross proceeds of approximately $6.9 million prior to deducting underwriting commissions and offering expenses (Press release, Cellectar Biosciences, JUL 2, 2025, View Source [SID1234654213]). The offering includes participation from healthcare dedicated funds and executive management.

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The offering is composed of (i) 1,045,000 Class A Units (which includes 180,000 Class A Units issued pursuant to the Underwriter’s exercise of the over-allotment option in full) with each Class A Unit consisting of (a) one share of common stock and (b) one common warrant to purchase one share of common stock (the "Common Warrants"), and (ii) 335,000 Class B Units with each Class B Unit consisting of (a) one pre-funded common stock purchase warrant to purchase one share of common stock ("Pre-funded Warrants") and (b) one Common Warrant. The price per Class A Unit is $5.00 and the price per Class B Unit is $4.99999 (collectively, the "Offering"). The Common Warrants have an exercise price of $5.25 per share, are exercisable upon issuance, and have a term expiring five years from issuance.

Ladenburg Thalmann & Co. Inc. acted as sole bookrunning manager in connection with this Offering.

The gross proceeds from the Offering to the Company, before deducting underwriting discounts and commissions and other Offering expenses and excluding any proceeds that may be received upon the exercise of the Common Warrants were approximately $6.9 million. The Company currently intends to use the net proceeds of the Offering for general corporate purposes, including working capital and operating expenses, and to initiate a Phase 1b clinical study of our compound CLR 121125 (CLR 125) in triple-negative breast cancer.

The securities described above were sold pursuant to a registration statement on Form S-1 (File No. 333-288333), which was declared effective by the United States Securities and Exchange Commission ("SEC") on July 1, 2025. A prospectus relating to the securities was filed with the SEC on July 1, 2025 and is available on the SEC’s website at View Source Electronic copies of the final prospectus, may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

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

On July 2, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported a presentation and discussion on immunotherapies involving AIM’s drug Ampligen at the recent U.S.-Poland Science and Technology Symposium 2025, held June 17-20, 2025, across Silicon Valley, San Francisco and Stanford University (Press release, AIM ImmunoTech, JUL 2, 2025, View Source [SID1234654212]). Pawel Kalinski, MD, PhD, a world-renowned research oncologist, presented on the drug and participated in a discussion session titled Revolution in Healthcare.

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Dr. Kalinski has been a senior investigator for multiple oncology clinical studies involving Ampligen, which has been studied for conditions such as solid tumors, viral diseases and disorders of the immune system. In his presentation and panel discussion, Dr. Kalinski presented his work with Ampligen as evidence of the potential successes that private-public partnerships can produce if companies, institutions and governmental agencies work together via joint clinical trials in the development of new treatments and therapies. Specifically, Dr. Kalinski believes that there is great potential to expand within the United States as well as Poland and other Central and Eastern European Countries, through such initiatives as the Translational Research Cancer Centers Consortium, or Marie Sklodowska-Curie Symposia on Cancer Research and Care (5th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care).

This year’s conference theme was "Opportunities in Singularity." The conference was organized by the US-Poland Science and Technology Symposium in partnership with Taube philanthropies, the Consulate General of the Republic of Poland in Los Angeles, leading Polish universities, the Council of Polish Engineers in North America and Top 500 Innovators alumni.

AIM CEO Thomas K. Equels stated: "We can advance cancer research rapidly if we work together. This combined determination can pair innovative therapies with the critical funding needed to turn promising ideas into successful actions. In fact, putting this concept into practice will be one of my main goals at the upcoming Marie Sklodowska-Curie Symposia on Cancer Research & Care in Warsaw, Poland in September, where I will be working to establish government- and industry-funded clinical partnerships and potential licensing agreements in Europe, with an emphasis on Poland."

On July 1, 2025 Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, reported that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme (TEM-GBM) study, with 25 patients receiving Temferon (Press release, Genenta Science, JUL 1, 2025, View Source [SID1234654216]). Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years from the time of 1st surgery. One of these long-term survivors has not experienced disease progression following Temferon administration and has not required any second-line therapies. The other showed initial signs of disease progression that subsequently stabilized without additional therapeutic intervention. Both these cases suggest possible Temferon-mediated control of disease progression, which warrants further investigation in larger studies.

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As of the April data cutoff, the survival rate at two years in the GBM trial for unmethylated MGMT (uMGMT) patients remained consistent at 29% with median overall survival holding steady at 17 months. In historical cohorts, uMGMT patients receiving standard of care have shown a two-year survival rate of approximately 14% and a median overall survival of 13 to 15 months.

In parallel, the TEM-GU Phase 1 study—designed to enroll 12 patients with genitourinary tumors—has begun recruitment. In this trial, Temferon is administered at a fixed dose of 4 million genetically modified cells per kilogram of body weight—a level previously shown to be safe and well tolerated in the TEM-GBM dose-ranging study. Genenta aims to demonstrate the safety and tolerability of Temferon in patients with Metastatic Renal Cell Carcinoma by year-end. The study is designed to evaluate Temferon in combination with immune checkpoint inhibitors or tyrosine kinase inhibitors to assess the potential for immunologic synergy in this patient population. Further clinical updates will be shared once sufficient patient experience has been gained to support meaningful interpretation.

Temferon’s mechanism of action is based on the reprogramming of the tumor microenvironment, which promotes the activation and durability of adaptive immune responses. A scientific manuscript demonstrating Temferon’s potential to enhance and prolong the durability of CAR-T activity in preclinical murine models of solid tumors has been accepted for publication in Science Translational Medicine.

"For the first time, we show that hematopoietic stem cells can be engineered to durably give rise to myeloid cells that localize to the tumor and reprogram its immune environment. In glioblastoma, this strategy induced a pro-inflammatory shift in macrophages and the emergence of tumor-reactive T cells, offering a promising new avenue for immune engagement against one of the most resistant cancers," said prof. Luigi Naldini, co-founder of Genenta Science.
"We are encouraged by the consistent clinical signals emerging from our glioblastoma trial," said Pierluigi Paracchi, CEO of Genenta Science. "These findings reinforce our confidence in Temferon’s differentiated mechanism and support our commitment to advancing the platform."