On February 2, 2026 Onchilles Pharma, a private biotech company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, reported the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for N17350 to initiate first-in-human clinical studies in patients with advanced solid tumors. N17350, the company’s first-in-class tumor-directed therapeutic candidate, leverages the ELANE pathway, an innate immune mechanism that selectively kills a wide range of cancer cells while preserving and activating the immune system.

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"IND clearance for N17350 marks an important milestone for Onchilles and reflects years of rigorous work establishing the ELANE pathway as a clinically actionable mechanism to improve the treatment of cancer," said Lev Becker, Ph.D., Co-Founder and Chief Scientific Officer of Onchilles Pharma. "From the beginning, this work was driven by fundamental observations in patients. What emerged was a mechanism that broadly kills cancer cells while preserving and activating immune cells, thereby transforming cancer cell death into long-lasting anti-tumor immunity. We now have the opportunity to evaluate in the clinic a differentiated, cancer-selective mechanism that overcomes limitations of current treatment paradigms."

N17350 demonstrated consistent efficacy in preclinical models spanning dozens of cancer cell lines, patient-derived samples, and multiple in vivo models, including chemotherapy-resistant and immunologically "cold" tumors, where it induced immunogenic cancer cell death and drove CD8+ T cell–mediated immune activation. These findings support its evaluation in a broad first-in-human clinical study.

"The preclinical data supporting N17350 suggest a mechanism that kills tumors and simultaneously primes the immune system," said Alain P. Algazi, M.D., Onchilles N17350 Clinical Advisory Board Chair and Director, Program Leader, UCSF Head and Neck Medical Oncology. "If this dual activity translates clinically, it could represent a meaningful advance for patients with tumors that are difficult to treat with existing cytotoxic or immunotherapy approaches."

The first-in-human study will evaluate the safety, tolerability, and preliminary clinical activity of N17350 as a monotherapy in patients with advanced solid tumors, including melanoma, head and neck neoplasms, squamous cell carcinoma of skin, non-small-cell lung carcinoma, triple-negative breast neoplasms (ClinicalTrials.gov Identifier: NCT07339176). The trial is also designed to assess pharmacodynamic biomarkers associated with ELANE pathway engagement and immune activation, providing early clinical insight into the mechanism. Onchilles plans to initiate first-in-human dosing at multiple sites in the U.S. and Australia.

"N17350 is fundamentally different from traditional cytotoxic chemotherapies or immunotherapies," said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles Pharma. "By leveraging the ELANE pathway, we are advancing a cancer-selective therapeutic approach designed to eliminate tumors as well as preserve and train the immune system to respond at the same time. As we move into clinical testing, we believe this approach has the potential to address unmet needs across many different tumor types."

About Onchilles Therapeutic Programs Targeting the ELANE Pathway

At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages a vulnerability shared by many cancer cell types: elevated histone H1 levels. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential game-changers in cancer therapy.

(Press release, Onchilles Pharma, FEB 2, 2026, View Source [SID1234662410])

On February 2, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted an aggregate of 1,799 restricted stock units (RSUs) to four newly-hired employees. These RSU awards were granted as of January 31, 2026 (the "Grant Date") pursuant to the Company’s 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each RSU award will vest over three years, with 33 1/3% of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the Grant Date. The vesting of each RSU award is subject to the employee’s continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates.

(Press release, Karyopharm, FEB 2, 2026, View Source [SID1234662395])

On February 2, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company and research collaborators at Mayo Clinic and the Alliance for Clinical Trials in Oncology reported publication of the largest study to date evaluating circulating tumor DNA (ctDNA) for MRD detection in patients with resected stage III colon cancer after surgery and before adjuvant chemotherapy. Results of the study, published in the Journal of Clinical Oncology, show that detecting ctDNA with the Guardant Reveal blood test better predicts recurrence and overall survival than standard staging.

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Researchers found that about 20 percent of patients in the phase III trial, which was presented at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, involving more than 2,000 patients still had detectable ctDNA in their blood after surgery. Guardant Reveal identified patients at a four-to-six-fold higher rate of disease recurrence or reduced survival. Even patients with smaller tumors or fewer affected lymph nodes found as part of traditional staging had an over 6-fold higher rate of events if ctDNA was detected. The findings support the integration of tissue-free ctDNA testing into routine postoperative management to better identify patients at high risk of recurrence who may benefit from intensified surveillance or alternative adjuvant strategies.

Measuring the amount of cancer DNA in the blood, a marker known as tumor fraction, further distinguished those at the highest risk of early recurrence and worse survival. This additional layer of information may help clinicians prioritize patients who need the most intensive surveillance or consideration of alternative therapies.

"The data suggest that not only the presence of ctDNA, but the amount of ctDNA, as identified by Guardant Reveal may help refine risk beyond standard TNM staging, and could be used to guide adjuvant treatment and surveillance decisions," said Frank Sinicrope, MD, professor of oncology and medicine at Mayo Clinic and principal investigator for the study. "ctDNA testing after surgery improves the accuracy of estimating a patient’s risk of cancer recurrence, enabling more tailored recommendations for adjuvant chemotherapy and follow-up monitoring. It also identifies high risk patients who are likely to recur despite standard treatment, and who may benefit from alternative therapeutic approaches."

"This large study adds to growing evidence that ctDNA testing with Guardant Reveal after surgery helps answer the question patients care about most: Am I really cancer-free?" said Dr. Craig Eagle, Guardant Health Chief Medical Officer. "Personalizing care after surgery is essential as clinicians and patients decide what comes next. Guardant Reveal fits easily into routine practice and provides timely, actionable insight—helping identify patients at high risk while sparing others unnecessary treatment and anxiety."

Today’s announcement is the latest data reinforcing the clinical utility of Guardant Reveal in molecular residual disease and beyond. Guardant recently expanded Reveal to support late-stage therapy response monitoring, enabling ctDNA-based assessment of treatment effectiveness across solid tumors. This adds to evidence from early-stage breast cancer publications that Reveal’s tissue-free approach can identify patients at elevated risk of recurrence and support more personalized care.

(Press release, Guardant Health, FEB 2, 2026, View Source [SID1234662411])

On January 30, 2026 ALX Oncology Holdings Inc. ("ALX Oncology," Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported new data from a Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii) in heavily pretreated patients with metastatic breast cancer (mBC). The topline findings, from an exploratory analysis in this trial, indicate that among patients with confirmed HER2-positive mBC, CD47 expression is predictive of evorpacept activity.

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"These new findings support a CD47-dependent, HER2-driven biology for evorpacept," said Barbara Klencke, M.D., Chief Medical Officer at ALX Oncology. "Going forward, we believe that a biomarker-driven approach incorporating CD47 expression may optimize patient selection for evorpacept combinations with HER2-targeted agents. Additionally, taken together, the data from this trial and the ASPEN-06 clinical trial reinforce our confidence in the ongoing ASPEN-09-Breast Phase 2 trial."

The Phase 1b/2 open-label, multi-center clinical trial (NCT05027139) evaluated the potential of evorpacept in combination with zanidatamab as a novel treatment for patients with previously treated, inoperable, locally advanced, or metastatic HER2-expressing breast cancer and other cancers. The primary trial results, presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), demonstrated that the investigational combination generated promising anti-tumor activity and a manageable safety profile in patients with heavily pretreated HER2-positive breast cancer (median of six prior therapies), including treatment with ENHERTU. Researchers previously reported a 56% (5/9) confirmed objective response rate (cORR) and a median progression-free survival (mPFS) of 7.4 months in the nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination.

The additional exploratory analysis, conducted to identify biomarkers of response to the evorpacept/zanidatamab combination, shows that responses in this trial were largely restricted to patients with higher CD47 expression. This finding reinforces results from the ASPEN-06 clinical trial, which demonstrated that CD47 expression is a predictive biomarker for response and durable benefit from evorpacept among patients with advanced gastric cancer that has retained HER2 expression.

The full biomarker analysis from the Phase 1b/2 clinical trial has been submitted to an upcoming scientific congress for presentation.

(Press release, ALX Oncology, JAN 30, 2026, View Source [SID1234662367])

On January 30, 2026 ALX Oncology Holdings Inc. ("ALX Oncology," Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported the pricing of an underwritten offering of common stock and pre-funded warrants. ALX Oncology is selling 76,979,112 shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 18,574,120 shares of common stock in the offering. The shares of common stock are being sold at an offering price of $1.57 per share, the closing price on January 29, 2026, and the pre-funded warrants are being sold at an offering price of $1.569 per pre-funded warrant, which represents the per share offering price for each share of common stock less the $0.001 per share exercise price for each pre-funded warrant. The gross proceeds to ALX Oncology from this offering are expected to be approximately $150 million, before deducting the underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any pre-funded warrants. All shares of common stock and pre-funded warrants to be sold in the offering are being offered by ALX Oncology. The offering is expected to close on or about February 2, 2026, subject to the satisfaction of customary closing conditions.

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The financing is being led by new investors RA Capital Management and TCGX, with participation from additional new and existing investors, including 5AM Ventures, Blackstone Multi-Asset Investing, Coastlands Capital, Driehaus Capital Management, HBM Healthcare Investments, Marshall Wace, OrbiMed, Redmile Group, venBio Partners and Vivo Capital, among others.

ALX Oncology anticipates using the net proceeds from the offering to fund the continued clinical development of evorpacept and its ALX2004 program and the related clinical trials, and for working capital and other general corporate purposes.

Piper Sandler, UBS Investment Bank, and Wells Fargo Securities are acting as joint lead book-running managers for the offering.

The securities described above are being offered by ALX Oncology pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected]; UBS Securities LLC, Attention: Prospectus Department, 11 Madison Avenue, New York, NY 10010, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Wells Fargo Securities, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, by telephone at 800-645-3751 (option #5) or by email at [email protected].

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.

(Press release, ALX Oncology, JAN 30, 2026, View Source [SID1234662368])