On June 1, 2024 Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, reported updated data of a KRAS G12C inhibitor glecirasib (JAB-21822) in combination with a SHP2 inhibitor (JAB-3312) in frontline non-small cell lung cancer (NSCLC) patients harboring KRAS G12C mutation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting as form of oral presentation (Press release, Jacobio Pharmaceuticals, JUN 1, 2024, View Source [SID1234643949]). Jacobio also presented updated data of pivotal phase II study of glecirasib as form of oral presentation at an education session.

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As of April 7, 2024, 194 patients participated in a phase II trial of using glecirasib combined with JAB-3312 (NCT05288205), of which 102 patients were frontline NSCLC. The median follow-up time was 10.1 months.

In the oral abstract session (Abstract No. 3008), Professor Jun Zhao, chief physician of Beijing Cancer Hospital, the principal investigator of glecirasib combined with JAB-3312 study, presented the clinical data. About 102 frontline NSCLC patients have been enrolled in 7 dose groups. The confirmed objective response rate (cORR) was 64.7% (66/102), the disease control rate (DCR) was 93.1% (95/102), and the median progression-free survival (mPFS) was 12.2 months, respectively.

This trial explored a total of 7 different dose cohorts, and the optimal dose group was glecirasib at 800mg daily combined with JAB-3312 at 2mg daily one week on and one week off. The cORR of the optimal dose group was 77.4% (18/31), and 54.8% (17/31) of patients achieved a deep response with tumors shrinking by more than 50%. The mPFS was not yet mature.

Regarding on the safety data, among the 194 patients, the incidence of grade 3 or 4 treatment-related adverse events (TRAE) was 43.8%, and there was no treatment-related death. Common TRAEs treatment-related adverse events include anemia, hypertriglyceridemia, etc. The safety profile in the frontline NSCLC is similar to that of the overall study population, and the overall safety is manageable.

Professor Jie Wang, chief physician of Beijing Cancer Hospital, commented, "from the above data, it can be seen that the combination therapy of glecirasib and JAB-3312 has a good safety profile, and the efficacy data shows positive therapeutic potential. If the combination of the two oral drugs can show superiority to the existing standard therapy (immunotherapy combined with chemotherapy) in subsequent trials, we anticipate that patients can avoid the side effects of chemotherapy or immunotherapy."

The combination therapy of glecirasib and JAB-3312 is being tested in a Phase III clinical trial of frontline NSCLC with KRAS G12C mutation in China. Andrea Gillam-Wang M.D., Ph.D., Chief Medical Officer and Global Head of R&D of Jacobio, said: "Our R&D efforts have been focusing on patient needs. We look forward to testing this novel combination against standard care chemotherapy and immunotherapy in NSCLC, and potentially replace standard care regimen consisted of multiple intravenous agents with two oral agents."

The new drug application (NDA) of glecirasib monotherapy for the second-line NSCLC with KRAS G12C mutation was granted Priority Review designation by China CDE on May 21, 2024 In the education session of ASCO (Free ASCO Whitepaper), Professor Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, updated the data of the Phase II registration trial of NSCLC with KRAS G12C mutation in an oral report.

Jacobio Pharma will hold a data discussion call at 20:00 Beijing time on June 3. Please click the link to register: View Source

About Glecirasib
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

About JAB-3312
JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glecirasib and other agents in China, the United States and Europe. The phase III study in combination with KRAS G12C inhibitor Glecirasib has been approved by China CDE in Feb 2024.

On June 1, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that it has released updated data of its novel drug candidate AGP-2449, a FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI), in patients with non-small-cell lung cancer (NSCLC) in a poster presentation at the 60th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL (Press release, Ascentage Pharma, JUN 1, 2024, View Source;ascentage-pharma-releases-updated-data-of-fakalkros1-inhibitor-apg-2449-in-patients-with-nsclc-302161192.html [SID1234643948]). This is the third consecutive year in which clinical data from this study of APG-2449 were selected for presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting.

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The ASCO (Free ASCO Whitepaper) Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community. Presenting clinical development progress at the ASCO (Free ASCO Whitepaper) Annual Meeting for the seventh consecutive year, Ascentage had four clinical studies of three of the company’s proprietary drug candidates selected for presentations, including an oral report, at ASCO (Free ASCO Whitepaper) 2024.

Results presented this year reaffirmed the therapeutic potential of APG-2449 in NSCLC, with data demonstrating preliminary efficacy in patients with NSCLC who were TKI naïve and resistant to second-generation ALK TKIs, as well as early antitumor activity in brain metastases. Biomarker analysis showed that, in patients with NSCLC resistant to second-generation ALK TKIs, phosphorylated FAK (pFAK) expression levels in tumor tissue at baseline and reduction in pFAK levels in peripheral blood mononuclear cells (PBMCs) were correlated with responses to APG-2449.

"APG-2449 is an effective multitargeted inhibitor that acts on FAK/ALK/ROS1. Compared to the data released at last year’s ASCO (Free ASCO Whitepaper) Annual Meeting, the latest results presented this year continued to show manageable safety and favorable antitumor activity in patients with NSCLC," said Prof. Li Zhang, the principal investigator of this study from Sun Yat-sen University Cancer Center. "We are very encouraged by the preliminary efficacy observed in patients with resistance to second-generation ALK TKIs, as it suggests that multitargeted inhibition on FAK and ALK may offer a new strategy for the management of patients with NSCLC resistant to second-generation ALK TKIs. We hope that Ascentage Pharma will conduct further studies on APG-2449 and allow more patients to benefit from this novel therapeutic agent as soon as possible."

"These data of APG-2449 in patients with NSCLC revealed a connection between resistance to ALK inhibitors and the FAK pathway, thus suggesting that the multitargeted FAK/ALK/ROS1 TKI APG-2449 may bring renewed hope to patients with NSCLC who are resistant to second-generation ALK inhibitors. This finding is indeed very encouraging," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "Remaining committed to the mission of addressing unmet clinical needs in China and around the world, we will press forward with this clinical development program in order to bring a safe and effective new treatment option to patients in need."

Highlights of these data presented at ASCO (Free ASCO Whitepaper) 2024 are as follows:

Updated study results of novel FAK/ALK/ROS1 inhibitor APG-2449 in patients (pts) with non-small-cell lung cancer (NSCLC) resistant to second-generation ALK inhibitors.

Abstract#: 3124

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Date and Time: June 1, 2024, Saturday, 9:00 AM – 12:00 PM (Central Time)

First Author: Yuxiang Ma, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.

Highlights:

Background: ALK inhibitors increase FAK pathway gene expression in ALK+ NSCLC cell lines, with the highest induced expression in drug-tolerant persister cells. This suggests that FAK pathway activation is involved in the mechanism that leads to ALK TKI resistance in ALK+ NSCLC. APG-2449 is an orally active FAK inhibitor and a third-generation ALK/ROS1 TKI that has shown potent antitumor activity in preclinical models. This poster reports further safety and efficacy data of APG-2449.

Patient enrollment and methods:

This study comprises dose-escalation and dose-expansion portions. 1,200 mg daily (QD) was determined as the RP2D. There were two cohorts in the dose-expansion portion: Cohort 1 included patients with NSCLC who were resistant to second-generation ALK TKIs; Cohort 2 included patients with NSCLC who were ALK or ROS1 TKI naïve.
As of April 2, 2024, a total of 144 patients with NSCLC, mesothelioma, or ovarian cancer were treated with APG-2449 at doses ranging from 150 – 1,500 mg. The median (range) age of patients was 53 (21-78) years, and 53.5% were female.
Efficacy results:

The ORRs of APG-2449 in patients with ROS1+ and ALK+ TKI-naïve NSCLC (n=36) were 68.2% (15/22) and 78.6% (11/14), respectively. Of the 22 patients with NSCLC resistant to second-generation ALK inhibitors and without targetable bypass gene mutations (e.g., KRAS G12C, BRAF V600E), 10 achieved PRs (10/22; 45.5%). Among the patients treated at RP2D, 12 had brain metastasis at baseline, 9 of whom achieved intracranial PR, resulting in an intracranial ORR of 75.0%.
Biomarker analysis found that, in patients with NSCLC that was resistant to second-generation ALK TKIs, responses to APG-2449 were correlated with pFAK levels in tumor tissues at baseline and reductions in pFAK levels in PBMCs.
Safety results: A total of 129 (89.6%) patients had treatment‑related adverse events (TRAEs), the most frequent (≥10%) of which were elevated serum creatinine (49.3%), increase in alanine aminotransferase (42.4%), increase in aspartate aminotransferase (36.1%); nausea (28.5%); vomiting (23.6%); diarrhea (22.9%); decreased leukocyte count (22.2%), decreased neutrophil count (17.4%) and rash (13.2%). In all, 20 (13.9%) TRAEs were grade ≥ 3.

Conclusions: APG-2449 demonstrated preliminary efficacy in patients with NSCLC whose disease was TKI naïve and resistant to second-generation ALK inhibitors, especially in brain metastases. Biomarker analysis showed that, in patients with NSCLC resistant to second-generation ALK TKIs, responses to APG-2449 PFS were correlated with pFAK levels in tumor tissues at baseline and reductions in pFAK levels in PBMCs.

*APG-2449 is an investigational drug that has not been approved in any country and region.

Appendix: The four clinical studies of Ascentage Pharma’s three drug candidates, including lisaftoclax, presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting.

Drug Candidates

Abstract Title

Abstract #

Format

Olverembatinib
(HQP1351)

Updated efficacy results of
olverembatinib (HQP1351) in patients
withtyrosinekinase inhibitor (TKI)-
resistantsuccinatedehydrogenas
e (SDH)-deficientgastrointestinal
stromal tumor (GIST)and
paraganglioma

#11502

Oral
Report

Lisaftoclax
(APG-2575）

Safety and efficacy of lisaftoclax, a
novel BCL-2 inhibitor, in combination
withazacitidine in patients with
treatment-naïve or relapsed
or refractory acute myeloid leukemia

#6541

Poster
Presentation

Updated efficacy and safety results of
BCL-2 inhibitorlisaftoclax (APG-2575)
alone or combinedwithibrutinibor
rituximab in patients (pts)with
Waldenströmmacroglobulinemia
(WM)

#7078

Poster
Presentation

APG-2449

Updated study results of novel
FAK/ALK/ROS1 inhibitor APG-2449 in
patients (pts) with non-small-cell lung
cancer (NSCLC) resistant tosecond-
generationALK inhibitors

#3124

Poster
Presentation

On June 1, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company pioneering the design and development of a new class of custom-built protein drugs known as DARPin therapeutics, reported it had presented the final data from its Phase 1 dose-escalation study of MP0317 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024, held in Chicago, IL, USA (Press release, Molecular Partners, JUN 1, 2024, View Source [SID1234643939]). MP0317 is a CD40 agonist designed to activate immune cells specifically within the tumor microenvironment (TME) by anchoring to fibroblast activation protein (FAP) which is expressed in high amounts around tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

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"The Phase 1 data for MP0317 demonstrate the ability of the FAP x CD40 DARPin to avoid the systemic toxicities of CD40 agonists while showcasing truly promising modulation of the tumor microenvironment," said Philippe Legenne, MD, MBA, Molecular Partners’ acting Chief Medical Officer. "This further deepens the clinical evidence supporting DARPins’ ability to deliver multi-specific candidates with enhanced capabilities in oncology including localized activation of powerful immunostimulatory molecules. We will continue discussions with potential partners towards clinical evaluation of MP0317 in combination with complementary approaches."

Mechanistic data & clinical response
The final analysis of this phase 1 dose-escalation study included 46 patients with advanced solid tumors and confirms earlier reported interim analysis findings. MP0317 treatment resulted in target occupancy in tumor biopsies with evidence of TME remodeling as characterized by increases in dendritic cells (DC), T follicular helper cells and plasma cells, as well as IFNγ downstream activation and DC maturation gene signature score increases. These findings were further supported by observed elevation of serum levels of CXCL10, a pro-inflammatory downstream effector of the IFNγ signaling.

In terms of clinical response, one patient achieved an unconfirmed partial response and stable disease was observed in 14 additional patients. The data support further clinical evaluation of MP0317 in combination with complementary anticancer therapies. Dose-response analyses of the final trial data propose MP0317 at dosages of 1.5mg/kg or above as providing an optimal benefit-risk profile, with adjustable dosing frequency to match a combination dosing scheme.

Safety & tolerability
MP0317 displayed a favorable and manageable safety profile across all nine planned dosing cohorts (0.03–10 mg/kg administered intravenously weekly (Q1W) or every 3 weeks (Q3W). The most frequently observed adverse reactions were fatigue and lower grade infusion-related reactions (grade 1–2). Dose-limiting toxicity was reported in one patient (transient asymptomatic grade 3 elevation of liver enzymes) at the highest planned dose of 10 mg/kg administered Q3W.

Details of the poster presenting the final results from the MP0317 Phase 1 study at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting can be found below. The poster will be made available on Molecular Partners’ website after the presentation.

Title: Effect of MP0317, a FAP x CD40 DARPin, on safety profile and tumor-localized CD40 activation in a phase 1 study in patients with advanced solid tumors

Abstract number (poster board): 2573 (52)

Timing: 1 June 2024; 9:00 am – 12:00 pm PST

On June 1, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment and immune system to overcome tumor immune evasion and drug resistance, reported positive interim data from its randomized, controlled, open label, multicenter Phase 2 study of CM24 in second-line metastatic pancreatic ductal adenocarcinoma (PDAC) presented at a late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Purple Biotech, JUN 1, 2024, View Source;id=308199&p=2326565&I=1206939-c7Z3G6f3m8 [SID1234643938]).

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"These exciting interim data demonstrate the potential of CM24 in combination with nivolumab plus the standard-of-care chemotherapy regimen Nal-IRI/5FU/LV to improve clinical outcomes for advanced metastatic PDAC patients. We are highly encouraged by the meaningful results of our primary endpoint, Overall Survival, as well as by the concordant and consistent improvement in all secondary endpoints including PFS, ORR, DCR and CA19-9" stated Gil Efron, Chief Executive Officer of Purple Biotech.

Michael Cecchini, MD Assistant Professor of Medicine at the Yale Cancer Center, a principal investigator in this study, commented, "As a clinician, it is encouraging to see these interim data in the Nal-IRI arm suggesting the potential for improved clinical outcomes for patients with late-stage metastatic PDAC who are in dire need of new effective therapies. These patients face very limited time with their families, and the prospect of potentially lengthening their lives while delaying their disease progression by approximately two months overall is clinically meaningful. These data justify further investigation of CM24 in combination with nivolumab together with standard-of-care chemotherapy to potentially improve outcomes for patients facing a very poor prognosis from this type of tumor".

The Phase 2 study is evaluating CM24, a novel first-in-class multi-functional anti-CEACAM1 antibody, in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab plus SoC chemotherapy in second-line PDAC patients versus SoC chemotherapy alone. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein responsible for tumor immune evasion and poor tumor response and/or resistance to immune checkpoint inhibitors. The primary endpoint of the study is OS and the secondary endpoints include PFS, ORR and DCR. A Bayesian methodology was used to estimate the magnitude of effect of the experimental arm versus the SoC arm and the study is not powered for hypothesis testing. A total of 63 patients have been enrolled, across 18 centers in the U.S., Spain, and Israel in 2 parallel independent randomized study cohorts (total of 2 arms per cohort). The experimental arms administered patients with CM24 plus nivolumab and a choice of one of two SoC chemotherapies for second-line PDAC, dependent on prior first line therapy regimen; either gemcitabine/nab-paclitaxel or liposomal irinotecan (Nal-IRI)/5-fluorouracil (5-FU) and leucovorin (LV) (Nal-IRI/5FU/LV), while the control arms administered either respective chemotherapy alone. CA19-9 as well as additional exploratory biomarkers are also being evaluated. Of the 63 patients enrolled, 32 were in the gemcitabine/nab-paclitaxel study (experimental and control) and 31 were in the Nal-IRI/5FU/LV study (experimental and control). An analysis of the gemcitabine/nab-paclitaxel study will be performed when the data are sufficiently mature. Topline final data are expected by the end of 2024.

The study interim efficacy results as of the cutoff date of May 8, 2024, are summarized in the following table:

Metric CM24 + Nivolumab + Nal/IRI/5FU/LV Arm
(n = 16) Nal/IRI/5FU/LV Arm
(n = 15)
Hazard ratio for OS 0.74 (95% CI: 0.31-1.77)
Median OS 7.72 months 5.62 months
6 months OS rate 53% 39%
Hazard Ratio for PFS 0.72 (95% CI: 0.33-1.60)
Median PFS 3.8 months 1.9 months
3 months PFS rate 60% 47%
6 months PFS rate 19% 10%
ORR 25% 7%
DCR 63% 40%
A consistent and continuous decrease of CA19-9, a validated and clinically predictive PDAC biomarker, was observed in the experimental arm (61% on average) vs. an increase in the control arm (34% on average).

The CM24+nivolumab+Nal/IRI/5FU/LV regimen was well tolerated, with the most frequent treatment emergent Grade 3 or higher adverse events being diarrhea (19%), fatigue (19%) and anemia (6%).

On June 1, 2024 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported longer follow-up data from the EGFRwt cohort and initial clinical efficacy data from the EGFRmut cohort from the on-going AFM24-102 study in NSCLC (Press release, Affimed, JUN 1, 2024, https://www.affimed.com/affimed-provides-follow-up-data-of-afm24-plus-atezolizumab-showing-durable-responses-in-heavily-pretreated-nsclc-egfr-wild-type-patients-and-positive-initial-data-from-the-nsclc-egfr-mutant-cohort/ [SID1234643937]).

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As of the updated data cutoff on May 13, 2024 for the 17 EGFRwt patients previously reported on, 15 patients were response-evaluable. Four confirmed objective responses were seen: 1 complete response (CR) and 3 partial responses (PR). In addition, 8 patients achieved stable disease (SD), resulting in a disease control rate of 71%. Median progression-free survival was 5.9 months with median follow-up of 7.4 months. Importantly 3 of 4 responses were ongoing for more than 7 months. All responders were resistant to checkpoint inhibitor treatment prior to the study, which supports the hypothesis that combining AFM24 with atezolizumab may provide an alternative strategy to overcome resistance to existing therapies.

As of May 21, 2024, 21 heavily pretreated EGFRmut patients (median of 3 prior therapies) had received the combination therapy of which 13 were response-evaluable. The combination of AFM24 with atezolizumab showed encouraging signals of clinical activity including 1 CR, 3 PRs and 6 patients with SD. As of the data cut-off, all responses were on-going. EGFRmut NSCLC is considered an immunogenically weak subtype where single-agent therapy with immune checkpoint inhibitors have exhibited poor response rates. The data suggests that the combination of AFM24 and atezolizumab could be acting synergistically to improve efficacy outcomes.

AFM24 and atezolizumab combination therapy demonstrated a manageable safety profile. Side effects were consistent with the known safety profiles of these agents. The most frequent side effects observed were mild to moderate infusion related reactions and transient mild to moderate increase in liver enzymes.

"The efficacy of the combination of AFM24 and atezolizumab in these heavily pretreated NSCLC patients is encouraging and supports our hypothesis of a synergistic activity of AFM24 with PD-1/PD-L1 blockade. We believe the durability of the responses in EGFRwt tumors is remarkable and is unlikely driven by PD-1/PD-L1 blockade alone, as all patients with responses had documented progression on their previous PD-1/PD-L1 therapy. In addition, median PFS of atezolizumab, even in checkpoint naïve patients, is only 2.8 months," said Dr. Andreas Harstrick, Chief Medical and acting Chief Executive Officer of Affimed. "This growing body of evidence reinforces our belief that AFM24 in combination with check point targeting can address pressing unmet medical needs in refractory NSCLC patients."

The EGFRwt NSCLC cohort of the study will enroll up to 40 patients and the EGFRmut NSCLC cohort will enroll up to 25 patients. Recruitment in both cohorts is ongoing, and further updates are expected in H2 2024.

Conference Call and Webcast Information

Affimed will host a conference call and webcast for the financial community on June 1, 2024, at 6:00 p.m. CDT / 7:00 p.m. EDT. Dr. Harstrick and Dr. Hye Ryun Kim, Professor at Yonsei University College of Medicine, Seoul, Korea, will review the latest clinical findings and address questions.

The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link:

https://register.vevent.com/register/BIff607338e5d247f99b548240be2ad413, and you will be provided with dial-in details and a pin number.

About AFM24
AFM24 is a tetravalent, bispecific ICE that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.