SillaJen Submits CSR to the US FDA for REN026 Study in Patients with RCC

On March 27, 2024 SillaJen, Inc. (KOSDAQ: 215600) reported that it has submitted CSR to the US FDA on 06 Feb 2024 for REN026, a phase 1b/2a dose escalation and safety/efficacy evaluation study of Pexa-Vec in combination with cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC) (Press release, SillaJen, MAR 27, 2024, View Source [SID1234641525]).

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The study demonstrated an acceptable safety profile and encouraging efficacy of the combination therapy of Pexa-Vec, an engineered oncolytic vaccinia virus, and Libtayo (cemiplimab), anti-PD-1 monoclonal antibody developed by Regeneron Pharmaceuticals Inc. (NASDAQ: REGN).

In 2017, SillaJen began a collaboration agreement with Regeneron for the clinical study of Pexa-Vec in combination with cemiplimab in patients with RCC.

Following the U.S. FDA IND approval in November 2017, SillaJen initiated the trial and 95 patients were enrolled from total of 21 clinical sites in the U.S., South Korea, and Australia. The study ended in February 2023.

The study was conducted in four study arms (A to D) to assess the safety and efficacy of the Pexa-Vec in combination with cemiplimab.

In Arm C, consisting of patients naïve to Immune checkpoint inhibitors (ICIs), Pexa-Vec in combination with cemiplimab showed the overall response rate (ORR) of 23.3% and the median overall survival (OS) of 25.13 months. Both ORR and OS were the highest compared to other study arms.

In Arm D, patients with prior ICI treatment demonstrated ORR of 17.9 %, the second highest of the four arms.

In particular, Arm D included 22 out of 28 patients (78.57%) with the three or more prior systemic regimens in metastatic setting and 5 patients (17.86%) with two prior treatments. Given the typically lower response rates in patients with more prior extensive treatments, the results are considered highly encouraging.

About REN026

1) Background
Pexa-vec (PV) is an oncolytic and immunotherapeutic vaccinia virus engineered to express GM-CSF. The REN026 study assessed the antitumor activity and safety of intravenous (IV) or intratumoral (IT) PV in combination with cemiplimab, anti-PD-1monoclonal antibody, in patients with metastatic or unresectable renal cell carcinoma (RCC).

2) Methods
The study enrolled 95 patients in total, including 6 patients in dose-escalation phase and 89 patients with measurable histologically or cytologically confirmed metastatic or unresectable RCC were randomly assigned to one of four study arms.

Patients naïve to immune checkpoint inhibitors (ICIs) with accessible tumors were randomized into Arm A (IT PV and cemiplimab) or Arm B (cemiplimab monotherapy, addition of IT PV upon disease progression).

Patients naïve to ICIs with non-accessible tumors were placed in Arm C with IV PV and cemiplimab, and those with prior ICIs treatment were assigned to Arm D with IV PV and cemiplimab.

PV was given IT (Arms A and B) administered every 2 weeks or IV (Arms C and D) weekly for 3 or 4 treatments as 1× 109 pfu. cemiplimab IV infusion (all study arms) was administered every 3 weeks, at a dose of 350 mg.

3) Results
Between June 2018 and February 2023, 89 patients were assigned to the study arms as follows: 15 in Arm A, 16 in Arm B, 30 in Arm C, and 28 in Arm D.

The overall response rate (by RECIST 1.1) across the arms were as follows: Arm A – 13.3% (2PR), Arm B – 12.5% (2 PR), Arm C – 23.3% (1 CR, 6 PR) and Arm D – 17.9% (5 PR).

Median progression-free survival and overall survival for the arms were 4.27/22.0 months, 5.65/20.8 months, 4.57/25.1 months and 6.31/18.5 months, respectively.

All patients experienced treatment-related AEs (any grade); 40 (45.5 %) experienced a grade 3 or 4 event.

Pyrexia was the most common treatment-related AE.

No Grade 5 events occurred in any of the study arms.

4) Summary of efficacy results

A (n=15)

B (n=16)

C (n=30)

D (n=28)

ORR (95% CI)-%

13.3 (1.7-40.5)

12.5 (1.6-38.3)

23.3 (9.9-42.3)

17.9 (6.06-36.9)

DCR (95% CI)-%

60.0 (32.3-83.7)

56.3 (29.9-80.2)

63.3 (43.9-80.1)

67.9 (47.6-84.1)

PFS median (mo) (80% CI)

4.27 (2.37-NR)

5.65 (2.07-NR)

4.57 (4.34-15.44)

6.31 (3.29-NR)

OS median (mo) (80% CI)

21.98 (21.98-NR)

20.83 (19.52-NR)

25.13 (22.01-NR)

18.53 (14.75-NR)

5) Conclusions
The combination of IV Pexa-Vec and cemiplimab demonstrated an acceptable safety profile and encouraging efficacy of ORR and survival with durable responses in patients with metastatic or unresectable RCC, regardless of previous ICI treatment.

About Pexa-Vec and the SOLVE Platform

Pexa-Vec is SillaJen’s representative investigational product from the company’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. 595 cancer patients have been treated with Pexa-Vec as of 31 March, 2023, in multinational clinical trials. Pexa-Vec is engineered to target common genetic defects in cancer cells by deleting its thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration.

GRAIL Presents New Data on Galleri® and Its Methylation Platform at the Annual American Association for Cancer Research (AACR) Meeting

On March 27, 2024 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported that it will present new data on the clinical utility of its Methylation Platform across the cancer continuum, and the impact of multi-cancer early detection (MCED) testing in guiding diagnostic evaluation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, Calif., April 5-10, 2024 (Press release, Grail, MAR 27, 2024, View Source [SID1234641524]).

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"The data we are presenting at AACR (Free AACR Whitepaper) continue to support the potential of GRAIL’s Methylation Platform to transform cancer care and the potential benefits of population-scale asymptomatic (or early) cancer detection," said Jeffrey Venstrom, MD, Chief Medical Officer at GRAIL. "Our longer-term research demonstrates that adding MCED tests like Galleri to guideline-recommended screenings can help direct diagnostic evaluation and underscores the potential value of repeat MCED screening. Additionally, new data from our Methylation Platform suggests the ability to identify relevant cancer subtypes using a single blood test, helping to enable precision medicine and biomarker discovery."

In the MCED setting, GRAIL is honored to present 3 oral presentations at AACR (Free AACR Whitepaper):

Demonstrating the first real-world evaluation of repeat MCED / Galleri testing showing the potential value of adding repeat MCED screening. The timeframe for repeat testing occurred 10-18 months from initial MCED testing.
Exhibiting 4-year overall survival follow-up demonstrating the prognostic significance of detecting cancer with a methylation-based cfDNA platform like Galleri.
Illustrating data demonstrating the power of Galleri to preferentially detect high grade, clinically significant prostate cancer over indolent cases.
In the precision oncology setting, GRAIL will discuss the adaptability of its Methylation Platform in identifying cancer histological and molecular subtypes through blood samples.

Oral Presentations

Title: Early Real-World Experience with Repeat Multi-Cancer Early Detection (MCED) Testing
Abstract Number: #3891
Session Category: Clinical Research
Session Title: Application of Real-World Evidence to Cancer Care
Date/Time: Monday, Apr. 8, 2024 from 2:30 PM – 4:30 PM
Location: Room 6 CF – Upper Level – Convention Center

Title: A Targeted Methylation-Based Multi-Cancer Early Detection Blood Test Preferentially Detects High-Grade Prostate Cancer and Minimizes Overdiagnosis
Abstract Number: #1264
Session Category: Prevention / Early Detection / Interception
Session Title: Multi-Cancer Early Detection Testing: Where Are We?
Date/Time: Sunday, Apr. 7, 2024 from 3:00 PM – 5:00 PM
Location: Room 28 – Upper Level – Convention Center

Title: Prognostic Significance of Blood-Based Multi-Cancer Detection in Cell-Free DNA: 4-Year Outcomes Analysis
Abstract Number: #3895
Session Category: Clinical Research
Session Title: Early Detection and Progression Biomarkers
Date/Time: Monday, Apr. 8, 2024 from 2:30 PM – 4:30 PM
Location: Ballroom 6 B – Upper Level – Convention Center

Poster Sessions

Title: PATHFINDER 2: A Prospective Study to Evaluate Safety and Performance of a Multi-Cancer Early Detection Test in a Population Setting
Abstract Number: #4784
Session Category: Prevention / Early Detection / Interception
Session Title: Population-Based Screening
Date/Time: Tuesday, Apr. 9, 2024 from 9:00 AM – 12:30 PM
Location: Poster Section 32

Title: Identification of Cancer Subtypes with a ctDNA-based Targeted Methylation Assay
Abstract Number: #7566
Session Category: Clinical Research
Session Title: Molecular Biology in Clinical Oncology: Characterizing and Modulating Epigenetics and Gene Expression
Date/Time: Wednesday, Apr. 10, 2024 from 9:00 AM – 12:30 PM
Location: Poster Section 43

Title: Most Cancer Deaths are Unaddressed by Current Screening Paradigms
Abstract Number: #6075
Session Category: Prevention / Early Detection / Interception
Session Title: Biomarker-Based Screening
Date/Time: Tuesday, Apr. 9, 2024 from 1:30 PM – 5:00 PM
Location: Poster Section 31

Title: Association of Circulating Free DNA (cfDNA) Maximum Variant Allele Frequency (mVAF) Levels with Clinical Outcomes in Patients (pts) with Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) Treated with Pembrolizumab (pembro) + Chemotherapy (chemo) in the Phase 2 KEYNOTE-782 Trial
Abstract Number: #LB107
Session Category: Clinical Research
Session Title: Late-Breaking Research: Clinical Research 1
Date/Time: Monday, Apr. 8, 2024 from 9:00 AM – 12:30 PM
Location: Poster Section 51

Syros Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update

On March 27, 2024 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported financial results for the quarter and full year ended December 31, 2023 and provided a corporate update (Press release, Syros Pharmaceuticals, MAR 27, 2024, View Source [SID1234641523]).

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"We are entering 2024 poised for a major transformation," said Conley Chee, Chief Executive Officer of Syros. "We recently completed enrollment of the 190 patients necessary for our primary endpoint analysis in the SELECT-MDS-1 Phase 3 trial, and we remain on track to report pivotal CR data by the middle of the fourth quarter of this year. We are optimistic about this data, which we believe will further reinforce tamibarotene’s potential as a differentiated, biologically targeted approach for the approximately 50% of HR-MDS patients who are positive for RARA overexpression."

Mr. Chee continued, "In addition, we expect to report additional data from SELECT-AML-1 this year. In December, we shared initial results from a prespecified analysis of randomized patients, and we were highly encouraged by the 100% CR/CRi rate observed following treatment with the triplet combination of tamibarotene, venetoclax and azacitidine. We believe the triplet combination could alter the treatment paradigm in AML, with the potential to offer a more effective and well-tolerated option. Following our equity offering in the fourth quarter of 2023, we are well-positioned to execute on our upcoming clinical milestones, while beginning to prepare for our first new drug application filing and planned HR-MDS launch in the United States. We look forward to delivering tamibarotene as a new standard-of-care for the frontline treatment of MDS and AML patients with RARA overexpression in need of better treatments."

UPCOMING MILESTONES

Report pivotal complete response (CR) data from the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression by mid-Q4 2024.
Report additional data from SELECT-AML-1 Phase 2 trial in unfit AML patients with RARA gene overexpression in 2024.
RECENT PIPELINE HIGHLIGHTS

On March 25, 2024, Syros announced the completion of enrollment for the 190 patients in the SELECT-MDS-1 Phase 3 clinical trial necessary to support the CR primary endpoint analysis and subsequent NDA filing in the United States. The trial will continue to enroll up to 550 patients to evaluate overall survival (OS) as a key secondary endpoint.
In December 2023, Syros announced encouraging initial data from the randomized SELECT-AML-1 Phase 2 clinical trial evaluating tamibarotene in combination with venetoclax and azacitidine. Data demonstrated a 100% CR/CRi (complete response/complete response with incomplete hematologic recovery) rate in response-evaluable patients (nine of nine) treated with the triplet regimen of tamibarotene, venetoclax and azacitidine, as compared to 70% among patients (seven of ten) treated with venetoclax and azacitidine alone. The median time to CR/CRi response was rapid; all patients treated with the triplet regimen achieved a CR/CRi by the end of cycle one. Consistent with prior clinical experience, tamibarotene in combination with approved doses of venetoclax and azacitidine was generally well tolerated, and the overall safety profile demonstrated no additive toxicities or new safety signals, and no evidence of increased myelosuppression compared to treatment with the doublet combination of venetoclax and azacitidine. Read more here.
CORPORATE

In December 2023, Syros priced an equity offering of 4,939,591 shares of common stock at an offering price of $4.42 per share, and, in lieu of common stock to investors who so chose, pre-funded warrants to purchase 5,242,588 shares of its common stock at an offering price of $4.419 per pre-funded warrant. Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.
Fourth Quarter and Full Year 2023 Financial Results

Revenues were $0.4 million for the fourth quarter of 2023 and $9.9 million for the year ended December 31, 2023, as compared to negative $0.8 million in the fourth quarter of 2022 and $14.9 million for the year ended December 31, 2022. The decrease for the year ended December 31, 2023 compared to the year ended December 31, 2022 reflects the early termination of our collaboration agreement with Pfizer.
Research and development expenses were $21.5 million for the fourth quarter of 2023 and $108.2 million for the year ended December 31, 2023, as compared to $27.9 million for the fourth quarter of 2022 and $111.9 million for the year ended December 31, 2022. The decrease for the fourth quarter of 2023 compared to the same period in 2022 and the decrease for the year ended December 31, 2023 compared to the year ended December 31, 2022 were primarily due to the restructuring of our operations to prioritize key development and pre-launch activities to advance tamibarotene.
General and administrative (G&A) expenses were $5.9 million for the fourth quarter of 2023 and $28.3 million for the year ended December 31, 2023, as compared to $7.3 million for the fourth quarter of 2022 and $29.3 million for the year ended December 31, 2022. The decrease for the fourth quarter of 2023 compared to the same period in 2022 and the decrease for the year ended December 31, 2023 compared to the year ended December 31, 2022 were primarily due to decrease in facilities costs, consulting and other professional fees.
For the fourth quarter of 2023, Syros reported a net loss of $64.4 million, or $2.18 per share, compared to a net loss of $4.8 million, or $0.17 per share, for the same period in 2022. For the full year ended December 31, 2023, Syros reported a net loss of $164.6 million, or $5.81 per share, compared to a net loss of $94.7 million, or $7.49 per share, for the same period in 2022.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of December 31, 2023, were $139.5 million, as compared with $202.3 million on December 31, 2022.

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second quarter of 2025, beyond pivotal Phase 3 data from the SELECT-MDS-1 trial and additional data from the randomized portion of the SELECT-AML-1 trial.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss the fourth quarter and full-year 2023 financial results and provide a corporate update.

To access the live conference call, please dial (888) 259 6580 (domestic) or (416) 764 8624 (international) and refer to conference ID 21905455. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

METIS Phase 3 Clinical Trial Met Primary Endpoint, Demonstrating a Statistically Significant Extension in Time to Intracranial Progression for Patients with Brain Metastases from Non-Small Cell Lung Cancer

On March 27, 2024 Novocure (NASDAQ: NVCR) reported the phase 3 METIS clinical trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with Tumor Treating Fields (TTFields) therapy and supportive care compared to supportive care alone in the treatment of patients with 1-10 brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery (SRS) (Press release, NovoCure, MAR 27, 2024, View Source [SID1234641522]). Patients treated with TTFields therapy and supportive care exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone for brain metastasis (n=298; hazard ratio=0.67; P=0.016). Median TTFields therapy treatment duration was 16 weeks and median usage was 67%. Consistent with previous studies, TTFields therapy was well-tolerated with sustained quality of life and neurocognitive function. Baseline characteristics were well balanced between arms.

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"Patients with brain metastases from non-small cell lung cancer are frequently treated with radiosurgery but face a high likelihood of rapid brain relapse," said Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida. "In this international, multicenter, phase 3 trial, the use of TTFields therapy significantly delayed time to brain relapse, with associated improvement in quality of life and stable cognition. This is a major benefit and is potentially practice changing."

Preliminary analyses of key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) did not demonstrate statistical significance. Certain secondary endpoints showed positive trends in favor of treatment with TTFields therapy, including time to distant progression and quality of life. Full analysis of secondary endpoints is ongoing.

"Novocure’s willingness to pursue areas of considerable unmet need, like the patient population studied in METIS, is a point of pride for our company," said Asaf Danziger, Novocure’s Chief Executive Officer. "We are so pleased with the positive outcome of this trial and encouraged by TTFields’ performance. I would like to thank everyone involved with METIS, especially our courageous patients and dedicated investigators, for their contributions to the trial and for meaningfully contributing to the evolution of treatment of brain metastases from NSCLC."

Novocure intends to submit these data to regulatory authorities. Novocure also intends to publish these findings in a peer-reviewed scientific journal and share them at an upcoming scientific congress.

Conference Call Details

Novocure will host a conference call and webcast to discuss the METIS topline results at 8:00 a.m. EST today, March 27th. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast and slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

About METIS

METIS [NCT02831959] is a phase 3 trial of stereotactic radiosurgery with or without TTFields therapy for patients with 1-10 brain metastases from NSCLC. 298 adult patients were enrolled in the trial and randomized to receive either TTFields therapy with supportive care or supportive care alone following SRS. Supportive care consisted of, but was not limited to, treatment with steroids, anti-epileptic drugs, anticoagulants, pain control or nausea control medications. Patients in both arms of the study were eligible to receive systemic therapy for their NSCLC at the discretion of their treating physician. Patients with known tumor mutations for which targeted agents are available were excluded from the trial.

The primary endpoint of the METIS trial is time to first intracranial progression, as measured from the date of first SRS treatment to intracranial progression or neurological death (per RANO-BM criteria), whichever occurs first. Time to intracranial progression was calculated according to the cumulative incident function. Patient scans were evaluated by a blinded, independent radiologic review committee. Secondary endpoints include, but are not limited to, time to distant progression, time to neurocognitive failure, overall survival, time to second intracranial progression, quality of life and adverse events. Key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) were planned to be used in labeling claims, if successful. Patients were stratified by the number of brain metastases (1-4 or 5-10 metastases), prior systemic therapy, and tumor histology. Patients were allowed to crossover to the experimental TTFields therapy arm following confirmation of second intracranial progression.

About Brain Metastases

Brain metastases are a secondary tumor formed when cancer cells break away from the primary tumor and travel through the blood or lymph system to form new tumors (or metastases) in the brain. Brain metastasis are a negative prognostic factor in NSCLC and adversely impact neurocognitive function and quality of life. Approximately 25% of patients with NSCLC have brain metastasis at diagnosis, and lifetime risk among patients with NSCLC is approximately 50%. Neurologic symptoms are present in approximately 60-75% of patients with brain metastasis, and seizures, focal neurologic deficits, headaches, and altered mental status are common. Treatment options for patients with brain metastasis from NSCLC are limited to neurosurgery, SRS, whole brain radiation therapy, or combinations of these options. However, given the neurotoxicity and significant decline in cognitive functioning, whole brain radiation therapy (WBRT) is an unfavorable treatment option. New therapeutic options are needed for greater intracranial control while minimizing the risk of neurocognitive adverse events.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

Iambic Therapeutics Announces First Patient Dosed in Phase 1 Clinical Study of IAM1363, a Highly Selective HER2 Inhibitor for the Treatment of Solid Tumors

On March 27, 2024 Iambic Therapeutics, a biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, reported that the first patient has been dosed in its Phase 1 clinical study evaluating IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers (Press release, Iambic Therapeutics, MAR 27, 2024, View Source [SID1234641521]).

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"Using Iambic’s AI platform, we have been able to rapidly discover and advance a candidate that is highly selective for inhibiting HER2 compared to effects on EGFR and other tyrosine kinase receptors that contribute to toxicity in patients. Along with its demonstrated CNS penetrance and potential to inhibit both wild-type HER2 and common HER2 mutants, we believe IAM1363 can be a highly differentiated, best-in-class small molecule for the treatment of HER2-altered cancers," said Iambic’s Chief Medical Officer, Neil Josephson, M.D.

The Phase 1/1b trial, NCT06253871, is an open-label, multi-center, dose escalation and dose optimization study, designed to evaluate tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 as monotherapy and in combination with trastuzumab in patients with advanced HER2 cancers.

IAM1363 is a selective and brain-penetrant small molecule inhibitor of wild-type and oncogenic mutant HER2 proteins, designed to expand the therapeutic index compared to available HER2 inhibitors and to avoid toxicities from off-target inhibition of EGFR, a related receptor tyrosine kinase. In preclinical studies, IAM1363 has demonstrated over 1000-fold selectivity for HER2 compared to EGFR, a promising pharmacokinetic and safety profile, preferential tumor enrichment, and penetrance of the central nervous system. In HER2 tumor models, including intracranial tumor models, IAM1363 has demonstrated favorable efficacy and tolerability compared to benchmark tyrosine kinase inhibitors and HER2-targeted antibody-drug conjugates. IAM1363 was identified using Iambic’s AI-driven discovery platform, which unifies physics-informed machine learning and experimental automation to identify therapeutic candidates with differentiated drug profiles.

"For the patients I see in clinic there remains a significant need to improve therapies for HER2-driven cancers. Even with recent advances in the field we still lack treatments that can provide long-term disease control in multiple tumor types and for disease that has metastasized to the brain. IAM1363 is a promising agent because of its potency and selectivity for HER2, and its ability to readily cross the blood brain barrier. Because of its selective targeting, I see great potential for it to be developed across the entire spectrum of HER2 altered cancers, both as a single agent and in combination with other standard of care therapies," said Dr. Alexander Spira at Virginia Cancer Specialists in Fairfax, Virginia and principal investigator on the Phase 1 study of IAM1363.