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."

On July 1, 2025 Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for GLIX1 for the treatment of malignant glioma, a category of devastating brain cancers that includes glioblastoma (Press release, Hemispherian, JUL 1, 2025, View Source [SID1234654200]).

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Significant clinical benefit beyond current therapies.

The designation marks a major regulatory milestone for Hemispherian, recognizing both the urgent unmet medical need in glioma and the potential of GLIX1 to offer significant clinical benefit beyond current therapies.

"This designation from the FDA further validates our scientific approach and mission to address high unmet needs in oncology," said Zeno Albisser, CEO of Hemispherian. "GLIX1 is a first-in-class small molecule with a unique mechanism of action, and we are encouraged by the recognition from both U.S. and EU regulators of its potential to offer meaningful benefit to patients with malignant glioma."

About the Designation

The FDA’s Office of Orphan Products Development granted ODD under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb). The designation is based on GLIX1’s potential to treat a rare and life-threatening disease affecting fewer than 200,000 people in the United States. GLIX1 demonstrated substantial preclinical efficacy, including tumor regression and survival benefit in validated models of glioma.

Benefits of Orphan Drug Designation

The Orphan Drug Designation from the FDA provides several benefits intended to support and accelerate the development of promising therapies for rare diseases, including:

7 years of market exclusivity in the U.S. upon FDA approval
Tax credits for qualified clinical trial expenses
Exemption from FDA application fees
Eligibility for accelerated regulatory pathways

On July 1, 2025 HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, reported the signing of a major out-licensing agreement with Shanghai Henlius Biotech, Inc. (hereafter "Henlius") (Press release, Hanchor Bio, JUL 1, 2025, View Source [SID1234654201]). The deal grants Henlius exclusive development and commercialization rights to HCB101 across Greater China (including Mainland China, Hong Kong, and Macau), key Southeast Asian countries, as well as all countries in the Middle East and North Africa (MENA).

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Under the terms of the agreement, HanchorBio will receive an upfront payment of USD 10 million, with additional payments tied to development and regulatory milestones of up to USD 192 million. Henlius will also pay tiered royalties and assume full responsibility for development, manufacturing, and commercialization in the licensed territories. HanchorBio retains all rights outside the licensed regions.

HCB101 is a novel engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary Fc-Based Designer Biologics (FBDB) platform. It is designed to selectively block the CD47 "don’t eat me" signal and activate macrophage-mediated anti-tumor immunity. Compared to earlier CD47-targeted agents, HCB101 reduces hematologic toxicity while maintaining strong efficacy, as demonstrated in over 80 CDX and PDX tumor models, and exhibits durable pharmacokinetics. Its binding affinity to CD47 is 100-fold higher than that of wild-type SIRPα-Fc fusions, and its signal-blocking potency exceeds 1,000-fold that of earlier versions.

In a global Phase 1 dose-escalation study (NCT05892718), HCB101 monotherapy demonstrated a favorable safety profile, high CD47 receptor occupancy (saturating RO levels across multiple doses), and early signs of anti-tumor activity. Two patients achieved confirmed partial responses (PRs): one with head and neck squamous cell carcinoma and another with marginal zone lymphoma confirmed by both PET imaging and CT, as reported at ASCO (Free ASCO Whitepaper) 2025. Both tumors continued to shrink with ongoing weekly dosing. Additionally, six patients achieved stable disease at low to mid dose levels, including one ovarian cancer patient who maintained disease control for over 40 weeks.

Following regulatory clearance from the U.S. FDA, Mainland China’s NMPA, and Taiwan’s TFDA, HCB101 has advanced into multi-regional Phase 2 trials in patients with solid tumors and hematologic malignancies, including head and neck, gastric, colorectal, and breast cancers.

"This agreement positions HCB101 as a key asset in Greater China and reinforces HanchorBio’s scientific strength and global partnering strategy," said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. "It also marks a critical milestone for HanchorBio’s biopharmaceutical innovation as we pursue our mission to deliver globally accessible, next-generation cancer immunotherapies, and as Taiwan continues to gain global recognition."

On July 1, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported new data that will be presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI) in Barcelona, Spain (Press release, Natera, JUL 1, 2025, View Source [SID1234654202]). These presentations reinforce the strong clinical and economic utility of Signatera monitoring across colon and rectal cancers (CRC), as well as new clinical validation data on its tissue-free MRD assay.

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Signatera in CRC surveillance

Data on >3,000 CRC patients will be shared in an oral presentation, concluding that adding Signatera ctDNA* monitoring to the current standard of care in surveillance can better identify patients who are candidates for metastasis-directed therapy (MDT). Results indicated that Signatera-positive patients were up to 20x more likely to receive curative-intent MDT than Signatera-negative patients. By comparison, CEA positivity led to only a 2x increase, with no added value in stage IV.

Signatera Genome in rectal cancer

An analysis will be presented from the MD Anderson INTERCEPT study (n=31) that used serial Signatera Genome testing in patients with locally advanced rectal cancer after neoadjuvant therapy. Results demonstrated 100% specificity/PPV, with surveillance sensitivity of 100% in the surgical cohort and 88% (7/8) overall.

Economic utility of Signatera-guided therapy in adjuvant CRC

A budget impact model from BUPA, a multinational health insurance provider with over 60 million customers, will outline a 43% expected reduction in healthcare costs using Signatera-guided adjuvant treatment versus standard of care in stage II-III CRC.

"We’re excited to present these new findings that continue to support the utility of Natera’s products across GI cancers," said Adham Jurdi, M.D., senior medical director of oncology at Natera. "These data highlight our commitment to improving outcomes and driving innovation in MRD detection."

Full list of data featuring Natera’s technology at ESMO (Free ESMO Whitepaper) GI:

July 4, 16:40-16:50 CET | FPN: 20 | Signatera (Oral Presentation)
Presenter: Arvind Dasari, M.D., MS
Clinical utility of including circulating tumor DNA (ctDNA) monitoring in standard of care (SoC) colorectal cancer (CRC) surveillance

July 4, 16:50-17:00 CET | FPN: 30 | Signatera (Oral Presentation)
Presenter: Hideaki Bando, M.D.
Association of ctDNA Clearance with Disease-Free Survival and Safety and Quality of Life from ctDNA-Directed Therapy: Findings from the ALTAIR Study

July 4, 15:30-16:30 CET | FPN: 102P | Signatera (Poster Presentation)
Presenter: Christos Mikropoulos, MBBS, MSc, M.D. (Res), MRCP, FRCR
Direct cost of healthcare analysis of Signatera ctDNA testing in the adjuvant setting for a hypothetical cohort of stage II and stage III colorectal cancer (CRC) patients: a UK private payer perspective

July 4, 15:30-16:30 CET | FPN: 243P | Signatera Genome (Poster Presentation)
Presenter: Arvind Dasari, M.D., MS
Clinical performance of Signatera Genome assay in a sub-cohort of locally advanced rectal cancer (LARC) patients (pts) in the MD Anderson INTERCEPT program

July 4, 15:30-16:30 CET | FPN: 93P | Tissue-free MRD (Poster Presentation)
Presenter: Yoshiaki Nakamura, M.D., Ph.D.
Clinical validation of a methylation-based, tissue-free colorectal cancer test for the detection of molecular residual disease by circulating tumor DNA

July 4, 15:30-16:30 CET | FPN: 89P | Early Cancer Detection (Poster Presentation)
Presenter: John P.Y. Shen, M.D.
Development of methylation-based biomarkers to predict metastases, treatment effect, and microsatellite status in colorectal cancer

On July 1, 2025 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the "Company"), a clinical stage pharmaceutical company, reported that, on June 30, 2025 intraday, it entered into a definitive agreement with accredited investors on the purchase and sale of approximately $5.0 million of shares of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock and Common Warrants (Press release, Lixte Biotechnology, JUL 1, 2025, View Source [SID1234654236]). The offering was priced at the market under Nasdaq rules.

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The offering consists of the sale of an aggregate of 2,382,084 shares of Common Stock (or Pre-funded Warrants in lieu thereof), 3,573,130 shares of Series B Convertible Preferred Stock and 6,355,214 Common Warrants. The Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.00001 and may be exercised at any time until exercised in full. The initial exercise price of each Common Warrant is $1.00 per share of Common Stock. The Common Warrants are exercisable immediately and expire 60 months after the resale registration statement registering the underlying shares is declared effective.

Aggregate gross proceeds to the Company are expected to be approximately $5.0 million, $4.0 million of which will be paid at closing and $1.0 million of which will be paid when the resale registration statement registering Common Stock and the underlying shares is declared effective. The transaction is expected to close on or about July 2, 2025, subject to the satisfaction of customary closing conditions. The Company expects to use the net proceeds from the offering, together with its existing cash, for general corporate purposes and working capital.

Spartan Capital Securities, LLC is acting as exclusive placement agent for the private placement. TroyGould PC is acting as counsel to the Company. Kaufman & Canoles, P.C. is acting as counsel to Spartan Capital Securities, LLC.

The securities described above are being sold in a private placement transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the Common Stock and the Shares issuable upon exercise of the pre-funded warrants and warrants.

This press release shall not constitute an offer to sell or the 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.