On July 27, 2025 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported a positive profit alert for the six months ended June 30, 2025 (the "Reporting Period") (Press release, Harbour BioMed, JUL 27, 2025, View Source [SID1234654556]).

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Based on a preliminary review of the Company’s unaudited management accounts for the Reporting Period, total profit is expected to range between US$68 million (equivalent to approximately HK$532 million) and US$74 million (equivalent to approximately HK$579 million).

The anticipated increase in profit is primarily attributable to:

Continuing strategic partnerships with leading global pharmaceutical companies, including the global strategic collaboration with AstraZeneca.
– The Company has received gross proceeds totaling approximately US$175 million from the allotment and issuance of the subscription shares, as well as partial upfront, milestone, and option exercise fees.
Newly secured out-licensing and collaboration agreements for innovative products, which contributed significantly to revenue during the Reporting Period and are evolving into a normalized revenue stream of the Company.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented: "This anticipated improvement in profitability underscores the meaningful progress we’ve made in executing our strategic priorities. The performance reflects the strength of our diversified business model and our ability to translate scientific innovation into tangible value. We will continue to build on this momentum through innovation and high-impact collaborations to deliver sustainable growth."

On July 27, 2025 Elpis Biopharmaceuticals, a clinical-stage cell therapy company developing bispecific armored CAR-T therapies for solid tumors, reported the signing of a Memorandum of Understanding (MOU) with the National Cancer Centre Singapore (NCCS) (Press release, Elpis Biopharmaceuticals, JUL 27, 2025, View Source [SID1234654557]). The partnership aims to support collaborative cell therapy research and clinical trials for the treatment of a variety of cancers, including colorectal, pancreatic and ovarian cancers. CAR-T cell therapy is a form of immunotherapy that is currently only approved for use to treat blood cancers, such as certain types of lymphomas and multiple myeloma.

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As part of the agreement, Elpis will contribute clinically validated technologies for cancer treatment, including multi-mechanism armor, bispecific targeting antibodies, cytokine cocktails, and a rapid mRNA display discovery engine, to drive the development of next-generation cell therapies. These technologies are already being investigated in Elpis’ global clinical trials of EPC-002 and EPC-003, with the goal of expanding their translational relevance across multiple tumor types. Plans are also underway for Elpis to establish a laboratory space at NCCS and co-share its equipment to enable more integrated and efficient collaboration.

"This partnership reflects our commitment to rapidly advancing innovative immunotherapies from discovery to clinical development through to regulatory review and, hopefully saving patients’ lives," said Yan Chen, MD, PhD, Founder and CEO of Elpis Biopharmaceuticals. "By combining Elpis’s proprietary technology with NCCS’s clinical expertise, we look forward to accelerating the delivery of these potential groundbreaking new cancer therapies to patients in Singapore and beyond."

NCCS will contribute its expertise in clinical research and access to clinical trial infrastructure to support the evaluation of novel cell therapy candidates.

"The potential of using cell therapies for solid tumors is still being explored, and this collaboration will enable us to evaluate promising new technologies in a clinical context to address current unmet needs and improve patient outcomes," said Professor Lim Soon Thye, CEO of NCCS.

"This is a key collaboration with NCCS’ precision immunotherapy program. With our respective strengths and the shared goal of transforming clinical care through translational science, we look forward to offering clinical trials and developing novel cell therapies to better meet the needs of patients in Singapore and the region," added Professor Daniel Tan, Head, Division of Clinical Trials and Epidemiological Sciences and Senior Consultant, NCCS.

The collaboration will support the development of bispecific armored CAR-T cell therapies for solid tumors, while Elpis’s global leading mRNA display technology will support NCCS in the rapid discovery of human antibodies to novel targets and enable novel modalities to cell therapy and beyond.

"The MOU represents an expansion of Elpis’s living drug strategy and a key step toward enabling broader clinical translation of our cutting-edge cell therapy technologies," said Chee-Yong Lim, Co-Founder, Co-CEO & Chief Strategy Officer, Elpis Biopharmaceuticals. "Together, we are working to make living drugs a reality for patients with cancers that currently lack effective treatment options."

On July 25, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will be presenting two-year clinical efficacy data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025 (Press release, Evaxion Biotech, JUL 25, 2025, View Source [SID1234654522]).

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Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The trial has yielded numerous convincing data already, including interim one-year data presented at the ESMO (Free ESMO Whitepaper) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013).

"We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025. As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners," says Birgitte Rønø, CSO and interim CEO of Evaxion.

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Presentation details

Abstract Title: EVX-01, a personalized cancer vaccine, induces potent T-cell responses and durable disease control in advanced melanoma: 2-year follow-up
Abstract#: #6308
Presentation#: 1516MO
Track: Mini oral session: Investigational immunotherapy
Location: Nuremberg Auditorium – Hall 5.2
Date/Time: October 17 at 14:10 – 14:15 CEST
Presenter: Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia
About EVX-01

EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is a personalized therapy designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology predictions was observed, underlining the predictive power of the platform.

On July 25, 2025 Inmagene Biopharmaceuticals ("Inmagene"), a clinical stage biotechnology company dedicated to developing disease-modifying treatments for immunological/autoimmune and inflammatory ("I&I") diseases, reported the completion of its previously announced merger with Ikena Oncology, Inc. (Nasdaq: IKNA) ("Ikena") (Press release, Ikena Oncology, JUL 25, 2025, View Source [SID1234654523]). The combined company will operate under the name ImageneBio, Inc. ("ImageneBio") and will trade on The Nasdaq Capital Market ("Nasdaq") under the ticker symbol "IMA" beginning at market open on July 28, 2025.

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Concurrent with the closing of the merger, Inmagene and Ikena completed a $75.0 million private placement with a syndicate of existing and new investors including Deep Track Capital, Foresite Capital, RTW Investments, and existing Ikena investors such as BVF Partners L.P., Blue Owl Healthcare Opportunities, Omega Funds, and OrbiMed. The combined company will be led by Kristin Yarema, Ph.D. as its Chief Executive Officer, as announced earlier this week.

"We are pleased with the outcome of this transaction and are well-positioned to advance IMG-007 into late-stage development. OX40 inhibition is a promising approach that may have the potential to treat a broad range of immunological and inflammatory diseases where patients continue to wait for more and novel treatment options. We are excited about the emerging profile of IMG-007, which we believe will prove to be differentiated, and we look forward to executing our development plan in atopic dermatitis and potentially initiating studies in additional indications," commented Dr. Kristin Yarema.

Additionally, in connection with the completion of the transaction and as recently approved by Ikena’s shareholders, Ikena implemented a reverse split of its common stock at a ratio of 1-for-12 shares. Following the reverse stock split and based on the final exchange ratio of approximately 0.003051 shares of Ikena common stock for each Inmagene share, immediately following the closing of the merger, the legacy equity holders of Inmagene owned approximately 55.0% of the combined company’s outstanding common stock and the legacy equity holders of Ikena owned approximately 45.0% of the combined company’s outstanding common stock, in each case, on a fully diluted basis. Following the consummation of the concurrent private placement, the legacy equity holders of Inmagene owned approximately 43.1% of the combined company’s outstanding common stock, the legacy equity holders of Ikena owned approximately 35.3% of the combined company’s outstanding common stock, and the investors in the concurrent financing owned approximately 21.6% of the combined company’s outstanding common stock, in each case, on a fully diluted basis. Following the reverse stock split, the closing of both the merger and concurrent financing, ImageneBio will have approximately 11.6 million shares of common stock outstanding. ImageneBio’s shares are expected to begin trading on Nasdaq at market open on July 28, 2025 under the ticker symbol "IMA" and new CUSIP number, 45175G 207.

Advisors

Goodwin Procter LLP served as legal counsel to Ikena, and Cooley LLP served as legal counsel to Inmagene. Leerink Partners LLC served as exclusive financial advisor to Ikena. Evercore served as exclusive financial advisor to Inmagene.

On July 25, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported preliminary financial results for the fiscal quarter ended June 30, 2025, and clinical progress across its pipeline (Press release, ImmunityBio, JUL 25, 2025, View Source [SID1234654524]).

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Key Highlights

Q2 2025 Revenue Growth with Continued Strong Sales Momentum: $26.4 million, up 60% from Q1 2025, with year-to-date sales of ~$43 million.
ANKTIVA Unit Growth Since J-Code: 246% unit sales volume growth in 1H 2025 compared to 2H 2024.
Cash Position: $153.7 million in cash, cash equivalents and marketable securities as of June 30, 2025.
NSCLC: Initiated randomized clinical trial (RCT) ResQ201A with N-803 + tislelizumab in 2nd line lung cancer; US sites initiated, submitted clinical trial applications in EU, UK; Canada and Asia filings planned.
Lymphopenia: FDA supportive of new data; reaffirmed RMAT/EAP; collaborative discussion outlining regulatory endpoints, trial design and registrational pathways to full approval for the treatment of lymphopenia with randomized trial design in progress.
Full Enrollment Reached in the Randomized NCI Cancer Prevention Clinical Trial Using ANKTIVA + Adenovirus Vaccine in 186 Patients with Lynch Syndrome.
United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorization application of ANKTIVA approved.
Papillary NMIBC: Discussion with FDA regarding filing status of supplemental BLA. ImmunityBio performing ongoing evaluation of next steps to address the Refuse to File decision by the FDA, following June Type A meeting with the Agency. New updated data on Papillary disease provided to the FDA and discussions with Agency to continue. Separately, ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease.
Financial Overview

In the second quarter of 2025, ImmunityBio reported $26.4 million in revenue, representing a 60% increase from $16.5 million in the first quarter of 2025. This growth reflects continued commercial traction of ANKTIVA + BCG in BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without Papillary tumors. The 1H 2025 sales of $42.9 million represents a 246% increase in unit volume during the first two quarters of 2025 since the J-code approval versus the last two quarters of 2024. The Company ended the quarter with $153.7 million in cash, cash equivalents and marketable securities as of June 30, 2025.

Non-Muscle Invasive Bladder Cancer (Papillary NMIBC)

ImmunityBio conducted a Type A meeting with the FDA in June to discuss its program targeting papillary-only NMIBC and the Agency’s response to the supplemental BLA filing. Contrary to the advice the FDA gave the Company in January 2025 to submit the supplemental BLA, the FDA responded with a Refuse-to-File (RTF) notice in May on the basis of requiring a randomized controlled trial (RCT) against chemotherapy. At the June meeting, ImmunityBio provided new data regarding the updated results since the initial BLA filing of papillary only data as well as real-world data of chemotherapy just published in this indication. In the papillary only NMIBC new data based on 26 of the 100 subjects in Cohort A and 80 subjects in Cohort B (Papillary Alone) of our QUILT-3.032 trial, demonstrated long-term (36-month) progression free survival and bladder sparing with ANKTIVA + BCG. ImmunityBio presented the newly published real-world data which demonstrates that compared to chemotherapy, ANKTIVA + BCG led to improved outcomes of progression free survival and cystectomy avoidance at 36-months. To our knowledge, the results to date of ANKTIVA + BCG represent the longest duration of follow-up with the longest duration of bladder sparing in these subjects. The Company indicated at the meeting that it would seek a new meeting request with this new data and withdraw the prior supplemental BLA filing; however, the Company is re-evaluating this approach in consultation with its regulatory counsel and may seek to amend the initial filing with the new data rather than withdrawing it, with a commitment to initiate a randomized controlled trial of chemotherapy free ANKTIVA + BCG versus chemotherapy in the papillary alone indication.

Separately, ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease, in addition to the currently recognized CIS with or without papillary disease. The NCCN is expected to review the submission at its August 2025 meeting.

Non-Small Cell Lung Cancer (NSCLC)

ImmunityBio has launched ResQ201A, a randomized controlled trial, in the United States, evaluating its IL-15 superagonist N-803 in combination with tislelizumab, a PD-1 checkpoint inhibitor from BeOne Medicines in patients with 2nd line lung cancer who were progressing on checkpoint inhibitors. The Company has also submitted clinical trial applications for ResQ201A in the European Union and the United Kingdom, with Canada expected to be submitted in early Q3 2025, and with plans underway to submit in Asia.

Lymphopenia

The Company also met with the Division of Non-Malignant Hematology at the FDA in June to present updated data from its lymphopenia program. The Division was supportive of the findings including the underlying science of stimulating lymphocytes with ANKTIVA and expressed a desire to support an efficient path to approval, noting that additional time will be required to finalize the appropriate development plan. Expanded Access Program (EAP) authorization has been activated for the indication for all solid tumors in patients who have failed first-line treatment on chemotherapy, radiotherapy or immunotherapy and exhibit low Absolute Lymphocyte Counts (ALC < 1,000/μL).

Disclaimer Regarding Financial Overview

The information and amounts presented above, including under the caption "Financial Overview," reflects the Company’s preliminary estimates based solely upon information available to it as of the date of this press release, and the amounts reported are not a comprehensive statement of its financial results or position as of June 30, 2025. Any actual amount that the Company reports in its Quarterly Report on Form 10-Q for the period ended June 30, 2025 will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its financial results for the period ended June 30, 2025 are finalized. As a result, these preliminary estimates may differ materially from the actual results that will be reflected in the Company’s condensed consolidated financial statements for the quarter when they are completed and publicly disclosed.

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 and by UK MHRA in 2025 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.