On February 18, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that Frank Karbe has been appointed Chief Financial Officer (CFO), effective February 24, 2025 (Press release, Cidara Therapeutics, FEB 18, 2025, View Source [SID1234650332]). Mr. Karbe will succeed Preetam Shah, Ph.D., MBA, who is departing to pursue other professional opportunities. Dr. Shah will serve as a consultant to the Company.

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"We are pleased to welcome Frank to the team as we advance our long-acting influenza antiviral drug CD388 through the end of this flu season in the Phase 2b NAVIGATE study and plan for Phase 3 and beyond." said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "We expect that Frank’s extensive experience as a leader in the biopharma industry and proven track record for transitioning companies to multi-billion-dollar commercial organizations will prove invaluable to the strategic vision of Cidara. On behalf of the entire Cidara team, I thank Preetam for his guidance and dedication which helped position Cidara for success. We wish him luck in his future endeavors."

Mr. Karbe added, "Cidara is at an important stage in the company’s evolution, with its novel DFC candidate, CD388, showing immense potential as a universal influenza preventative. Influenza continues to drive significant morbidity and mortality despite the availability of vaccines and antiviral treatments. I am excited to join the Cidara team and look forward to leveraging my experience to drive the company’s growth and bring CD388 to the tens of millions of patients who can benefit from it."

Mr. Karbe is a widely experienced senior executive with over 25 years of leadership experience in life sciences, healthcare, and technology. Most recently, he served as Chief Executive Officer and President of Better Therapeutics, where he led the company to the first-ever FDA authorization of a digital therapeutic for the treatment of type 2 diabetes. Previously, as President and Chief Financial Officer of Myovant Sciences, Mr. Karbe played a pivotal role in scaling the company from a startup to a publicly listed company with 500+ employees and two FDA approved products in under five years, raising over $2 billion in capital and securing a $4 billion partnership with Pfizer. He also served for over a decade as Executive Vice President and Chief Financial Officer at Exelixis, where he drove the company’s transformation from discovery to commercialization. Earlier in his career, he worked as an investment banker for Goldman Sachs, focusing on corporate finance and mergers & acquisitions in the life sciences industry.

On February 18, 2025 Celyad Oncology (Euronext: CYAD) (the "Company"), reported the publication of the preclinical data of the non-gene edited allogeneic CYAD-211 and clinical data from the Phase I IMMUNICY-1 clinical study which evaluated CYAD-211 in relapsed or refractory (r/r) multiple myeloma (MM) patients (Press release, Celyad, FEB 18, 2025, View Source [SID1234650331]). The findings were published in the International Journal of Molecular Science (IJMS).

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CYAD-211 is the Company’s first allogeneic chimeric antigen receptor (CAR) T-cell candidate, engineered to co-express a B-cell maturation antigen (BCMA)-specific CAR and a microRNA-based single shRNA which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex, evaluated clinically.

The IJMS publication includes preclinical data which showcases the knockdown of CD3ζ efficiently removed the TCR complex from the cell surface, and inhibited TCR mediated activation in vitro and in vivo. The publication also presents clinical data of the dose-escalation segment of the IMMUNICY-1 phase-I clinical trial (NCT04613557) in patients with r/r MM. Importantly, data highlighted an overall good safety profile and some clinical responses, with no signs of graft-versus-host disease (GvHD), demonstrating the effectiveness and safeness of the technology to abrogate the risk of GvHD.

Overall, these data provides the proof-of-concept of the safe administration of CAR T-cells engineered using a miRNA-based shRNA technology. CYAD-211 is the first allogeneic CAR T-cell candidate using a non-gene edited approach to achieve allogenicity. This differentiated strategy provides key advantages by being easily implemented, safe, efficient, tunable, and with the possibility to modulate multiple target genes simultaneously.

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.

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.

On February 18, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported that it will host a virtual Research and Development (R&D) Day webcast on Wednesday, March 5, 2025, at 6:00 a.m. PT/9:00 a.m. ET (Press release, ALX Oncology, FEB 18, 2025, View Source [SID1234650328]). The virtual webcast event will focus on information and updates related to the company’s pipeline, lead investigational CD47-blocker evorpacept, as well as business and financial updates.

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R&D Day Webcast Information
The ALX Oncology virtual R&D Day will be webcast live and a replay will be available after the event by visiting the "Investors" section of ALX Oncology’s website and selecting "Events and Presentations."

Date & Time: Wednesday, March 5, 2025, 6:00 a.m. PT/9:00 a.m. ET
Webcast Access: View Source