Sonnet BioTherapeutics Selected for Poster Presentation at the 2025 AACR IO Conference

On February 18, 2025 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported its abstract has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) IO Conference taking place on February 23-26, 2025 at the JW Marriott in Los Angeles, CA (Press release, Sonnet BioTherapeutics, FEB 18, 2025, View Source [SID1234650346]).

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Details of the poster presentation are as follows:

Session: Poster Session B
Abstract title: Combination immunotherapy with an albumin-binding interleukin-12 fusion protein that extends cytokine half-life, targets the tumor microenvironment, and enhances therapeutic efficacy
Session Date and Time: Tuesday, February 25, 2025 from 1:45-4:45 PM PT

For more information about the conference, please visit the event website.

Anixa Biosciences Announces Approval of Protocol Amendment for Ovarian Cancer CAR-T Clinical Trial

On February 18, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer reported that it, along with its partner Moffitt Cancer Center ("Moffitt"), has received approval for an amendment to the protocol governing its ongoing clinical trial using CAR-T therapy for the treatment of ovarian cancer (NCT05316129) (Press release, Anixa Biosciences, FEB 18, 2025, https://ir.anixa.com/news/detail/1066/anixa-biosciences-announces-approval-of-protocol-amendment-for-ovarian-cancer-car-t-clinical-trial [SID1234650329]).

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The key changes in the protocol allows patients who may benefit from a second dose of the CAR-T therapy to receive it and expands enrollment eligibility to include patients with sex cord-stromal tumors (SCSTs) and Sertoli Leydig cell tumors (SLCTs). Previously, Anixa and Moffitt had secured a single patient IND approval for an additional dose for a patient whose biopsy showed cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy. With this amendment, all eligible patients in the trial can receive a second dose of the CAR-T therapy without the need to submit individual INDs for each case.

Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt and the principal investigator of the trial, stated, "This amendment is a crucial development in our ongoing efforts to advance the treatment of ovarian cancer with CAR-T therapy. The ability to administer a second dose to patients who show potential for additional benefit provides us with more flexibility and an opportunity to further evaluate the effectiveness of this innovative therapy."

"We are excited about the approval of this protocol amendment, as it allows us to potentially enhance the efficacy of our CAR-T therapy by providing a second dose to patients who might benefit from it and to treat additional rare types of ovarian cancer. This is a significant step in optimizing the treatment for ovarian cancer, and we look forward to continuing our work with Moffitt Cancer Center as we strive to improve outcomes for patients facing this difficult disease," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.

Petosemtamab granted Breakthrough Therapy designation by the U.S. FDA for 1L PD-L1 positive head and neck squamous cell carcinoma

On February 18, 2025 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic programmed death-ligand 1 (PD-L1) positive head and neck squamous cell carcinoma (r/m HNSCC) with combined positive score (CPS) ≥ 1 (Press release, Merus, FEB 18, 2025, View Source [SID1234650347]).

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This second BTD designation follows the initial receipt of BTD and Fast Track designation for petosemtamab for the treatment of patients with r/m HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-programmed cell death protein 1 (anti-PD-1) antibody announced in May 2024 and August 2023, respectively.

BTD is supported by updated data from the ongoing phase 1/2 open-label, multicenter trial evaluating petosemtamab in combination with pembrolizumab in 1L HNSCC expressing PD-L1 (CPS≥1) (NCT03526835). Data for this cohort was initially presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024, which demonstrated a 67% response rate among 24 evaluable patients. The oral presentation was detailed in our press release, Merus’ Petosemtamab in Combination with Pembrolizumab Interim Data Demonstrates Robust Response Rate and Favorable Safety Profile in 1L r/m HNSCC (May 28, 2024). In the BTD application, Merus provided updated interim clinical data on efficacy, durability and safety of the cohort of petosemtamab with pembrolizumab in 1L PD-L1+ r/m HNSCC.

"We believe petosemtamab’s second BTD continues to validate its potential to become a new standard of care for patients with r/m HNSCC and underscores our commitment to accelerate development of petosemtamab for these patients," said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. "Importantly, this designation indicates the interim clinical data we shared with the FDA demonstrates petosemtamab’s potential for substantial improvement over available therapies in the 1L PD-L1+ setting."

BTD is intended to expedite the development and review of a medicine to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints over available therapies. BTD allows for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review, and eligibility for rolling review and priority review. With this BTD, Merus plans to engage in these discussions with the FDA in an expedited manner as we move toward our goal of a potential Biologics License Application (BLA) submission.

About LiGeR-HN1
LiGeR-HN1, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab in combination with pembrolizumab, compared to pembrolizumab in 1L PD-L1+ r/m HNSCC patients. The trial is open to adult patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.

About LiGeR-HN2
LiGeR-HN2, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab compared to investigator’s choice of methotrexate, docetaxel, or cetuximab in 2/3L r/m HNSCC patients. The trial is open to adult patients that have progressed on or after anti-PD-1 therapy and platinum-containing therapy. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.

About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) describes a group of cancers that develop in the squamous cells that line the mucosal surfaces of the mouth, throat, and larynx. These cancers begin when healthy cells change and grow in an unchecked manner, ultimately forming tumors. HNSCC is generally associated with tobacco consumption, alcohol use and/or HPV infections, depending on where they develop geographically. HNSCC is the sixth most common cancer worldwide and it is estimated that there were more than 930,000 new cases and over 465,000 deaths from HNSCC globally in 2020.1 The incidence of HNSCC continues to rise and is anticipated to increase by 30% to more than 1 million new cases annually by 2030.2 HNSCC is a serious and life-threatening disease with poor prognosis despite currently available standard of care therapies.

About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

Results of Operations and Financial Condition

On February 18, 2025, Arcus Biosciences, Inc. (the "Company") reported that, as of December 31, 2024, it had approximately $992 million in cash, cash equivalents and marketable securities (Press release, Arcus Biosciences, FEB 18, 2025, View Source [SID1234650330]). This estimate of its cash, cash equivalents and marketable securities balance is preliminary and subject to completion of its financial closing procedures, including the completion of management’s reviews. Accordingly, the unaudited preliminary cash, cash equivalents and marketable securities balance set forth above reflects its preliminary estimate with respect to such information, based on information currently available to management, and may vary from its actual financial position as of December 31, 2024. Further, this preliminary estimate is not a comprehensive statement or estimate of its financial results or financial condition as of December 31, 2024.

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Item 8.01 Other Events.

The contents of Item 2.02 above are also incorporated by reference into this Item 8.01.

Gilead Opt-in Decision

On February 18, 2025, the Company announced that the time-limited exclusive option of Gilead Sciences, Inc. ("Gilead") to the casdatifan program has expired without exercise by Gilead. As a result, Gilead has no future rights to casdatifan; the Company retains full global development and commercial rights, subject to Taiho Pharmaceutical Co., Ltd.’s option right for its territory, which is limited to Japan and certain other Asian countries (excluding China).

ARC-20 Data Release

On February 15, 2025, the Company reported new data from three cohorts of its ARC-20 study for casdatifan in patients with metastatic clear cell renal cell carcinoma, most of whom had progressed on at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor therapy. The new data include median progression-free survival and overall response rate ("ORR") for the cohort evaluating 50mg of casdatifan twice a day ("BID"), and ORR for the cohorts evaluating 50mg of casdatifan once daily ("QD") and 100mg QD. The patient population was heavily pretreated; more than half (52-59%) of subjects received at least three prior lines of therapy and approximately one quarter (24-29%) had received at least four prior lines of therapy. Most patients (70-76%) had an International Metastatic Renal Cell Carcinoma Database Consortium risk factor of intermediate or poor.

With a data cut-off of January 3, 2025 (the "DCO"), most patients (81-87%) experienced disease control with either a partial response or stable disease. The median duration of response had not been reached, with all but two of the 26 responders across all three cohorts still on treatment.

No unexpected safety signals were observed at the time of the DCO, and casdatifan had an acceptable and manageable safety profile across all doses. Across all three cohorts, one patient discontinued treatment as a result of anemia and two due to hypoxia. A summary of the efficacy and safety results is below:

50mg BID
(n=32) 50mg QD
(n=28) 100mg QD Tablet
(Go-forward dose)
(n=27)
Efficacya

Median Follow-up 15 months 12 months 5 monthsb
Median Progression-Free

Survival [95% CI]

9.7 months
(5.5, NE)

NE
(6.8, NE)

NE
Confirmed ORR per

RECIST v1.1 [95% CI]

25% (8)c
[11.5, 43.4]

32% (9)c
[15.9, 52.4]

33% (9)
[16.5, 54.0]

Best Overall Responsed:

Complete Response

Partial Response

Stable Disease

Progressive Disease

31% (10)
0

31% (10)

50% (16)

19% (6)

32% (9)
4% (1)

29% (8)

54% (15)

14% (4)

33% (9)
0

33% (9)

52% (14)

15% (4)e

Median Time to Response 2.8 months 4.1 months 1.6 months
Disease Control Rate

[95% CI]

81%
[63.6, 92.8]

86%
[67.3, 96.0]

85%
[66.3, 95.8]

Safetyf

Any Serious Treatment-Emergent

Adverse Events (TEAEs)

related to casdatifan

3% (1) 10% (3) 7% (2)
Grade ≥3 TEAEs related to

casdatifan

Anemia

Hypoxia

42% (14)
9% (3)

32% (10)
7% (2)

17% (5)
10% (3)

CI=confidence interval, NE=not estimable

a Efficacy-evaluable population for this expansion cohort is defined as all eligible participants who received any study treatment and have at least one post-baseline efficacy assessment, or who discontinue study treatment due to progressive disease or death.

b Majority of patients (n=21) were still on treatment at time of DCO.

c In the 50mg BID cohort, one unconfirmed responder remains on treatment. In the 50mg QD cohort, one unconfirmed responder became a confirmed responder after the DCO, increasing the cORR to 32%.

d Unconfirmed best overall response.

e Includes two patients with radiological progressive disease and two patients who had clinical progression before the first scan.

f The safety-evaluable population included all dose expansion enrolled patients who received any amount of any study treatment.

Plus Therapeutics Secures $5.7 Million Financing to Support Leptomeningeal Metastases Program

On February 18, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company," or "Plus Therapeutics"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that it has closed a private placement with aggregate initial upfront proceeds of approximately $3.7 million and received a $2.0 million advance payment from CPRIT as part of its existing $17.6 million grant award (Press release, Plus Therapeutics, FEB 18, 2025, View Source [SID1234650348]). The funding from the private placement and the CPRIT advance will support the Company’s clinical development of Rhenium (186Re) Obisbemeda for leptomeningeal metastases (LM), as well as further development of the Company’s CNSide LM diagnostic test as a pivotal trial endpoint.

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"We are grateful for the enthusiasm and ongoing support from both existing investors and key funding agencies, including CPRIT, the National Institutes of Health, and the U.S. Department of Defense," said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. "This capital, along with expected grant allocations later in 2025, is expected to fully support the completion of two planned LM trials, strategically positioning the company for a pivotal trial in 2026."

Private Placement Financing

The private placement comprised the issuance and sale of secured convertible promissory notes, or Funding Notes, in the aggregate amount of $3,362,251 and common stock purchase warrants to purchase up to an aggregate of 3,002,009 shares of the Company common stock at an exercise price of $1.12 per share. The notes have a maturity date of one year from the closing of the financing and are convertible in future financings of the Company or into common stock at the election of the investors. The financing includes participation from AIGH Capital Management LLC with additional participation from existing healthcare-focused institutional investors.

The accompanying Warrants will be exercisable until the five-year anniversary of the closing of the financing.

The Notes are convertible, under certain circumstances, to shares of common stock of the Company at an exercise price of $1.12 per share. The Notes are senior, secured obligations of the Company. The Notes bear interest at the rate of ten percent (10%) per annum, payable on the last business day of each quarter, except as provided therein.

The gross proceeds to the Company from the private placement were approximately $3.7 million, before deducting offering expenses payable by the Company. The Company currently intends to use the net proceeds from the private placement for general corporate and working capital purposes.

The securities offered in the private placement and described above were offered in transactions not involving a public offering under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the private placement may not be reoffered or resold in the United States except pursuant to an effective registration statement with the SEC or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

CPRIT Funding Advance

In addition to the $3.7 million private placement financing from existing investors, the Company announced a $2.0 million advance payment from CPRIT as part of its existing $17.6 million grant award. The funding will support and accelerate the Company’s clinical development of Rhenium (186Re) Obisbemeda for the ReSPECT-LM P2a single-dose expansion trial and further develop the Company’s CNSide LM diagnostic test as a key pivotal trial endpoint.

To date, the Company has received multiple disbursements under its CPRIT grant. Following this $2.0 million advance payment, approximately $5.2 million remains from the original $17.6 million grant award.

Exchange and Financing Waiver

On February 13, 2025, the Company also issued secured convertible promissory notes, or Exchange Notes, in the aggregate amount of $3,188,922 in exchange for existing investors agreeing to cancel 3,543,247 Series A common stock purchase warrants issued by the Company in May 2024 and waive certain existing restrictions on the Company’s ability to raise capital. The terms of the Exchange Notes are substantially similar to the terms of the Funding Notes.

Additional information on the terms of the Funding Notes, Warrants, Exchange Notes and related matters can be found in the Company’s Current Report on Form 8-K that is being filed by the Company on February 18, 2025.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (186Re) obisbemeda

Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).