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Alpha Cancer Technologies Presents New Data from ACT-903, an AFP-Maytansine Conjugate, in Online Publication at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 31, 2023 Alpha Cancer Technologies Inc. (ACT), a biopharmaceutical company focused on developing and commercializing targeted immuno-oncology and immunomodulation therapies based on its proprietary recombinant human Alpha Fetoprotein (AFP) platform, reported details from the company’s abstract published as part of the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Alpha Cancer Technologies, MAY 31, 2023, View Source [SID1234632311]). The ASCO (Free ASCO Whitepaper) meeting will take place in Chicago from June 2-6, 2023.

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"ACT continues to build upon the body of evidence supporting our novel approach of targeting alpha fetoprotein receptors for the treatment of cancer using our truly next-generation ADC technology," said Dr. Igor Sherman, CEO of ACT. "By selectively targeting cancer cells and myeloid derived suppressor cells we can deliver toxins directly to the tumor, leading to enhanced therapeutic efficacy while mitigating many of the side effects associated with traditional ADC treatments. Now across multiple tumor models, we have observed high activity in treatment groups including statistically significant dose-dependent reduction in tumor volume and increased survival. With robust preclinical data demonstrating both safety and efficacy, we look forward to taking ACT-903 into the clinic next year."

The abstract, entitled "Efficacy and safety study of a novel Alpha-fetoprotein (AFP)-Maytansine conjugate in an ovarian xenograft model" was selected by the ASCO (Free ASCO Whitepaper) Scientific Program Committee for publication in the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings, a supplement to the Journal of Clinical Oncology. The research used an ovarian xenograft model compared to control with four dosing regimens of the AFP-maytansine conjugate, ACT-903. Tumor growth, survival, and clinical observations were assessed 62 days following implantation. Separately, organoids were cultured from primary reprogrammed tumor cells from two different patients with high-grade serous ovarian carcinoma and treated with ACT-903 to observe cytotoxicity.

The results in the ovarian xenograft models, consistent with prior research conducted by ACT using colorectal xenograft models, show a statistically significant dose-dependent reduction in tumor volume (p<0.001) and increase in survival (p<0.002) in all treatment groups when compared to the control group. All mice survived to the end of the study (day 62) in Groups 1, 3, and 4, and 6 out of 10 mice survived in the lowest dose group. In the control group, all animals were dead by day 38 due to excessive tumor burden. In the highest dose group, 100% of the mice had complete tumor regression with no regrowth at the end of the study. No signs of toxicity were observed in any treatment group. In the two ovarian organoids, ACT-903 demonstrated a cytotoxic effect over 72 hours similar to that of other known anti-cancer agents, such as paclitaxel and cisplatin.

The results from this study demonstrating the safety and efficacy of ACT-903 in ovarian xenograft models and the cytotoxicity observed in patient-derived cancer organoids support advancement of ACT-903 into clinical studies. ACT plans to submit an Investigational New Drug (IND) application for ACT-903 in 2024.

Yuhan Corporation and J INTS BIO inked a licensing agreement for a New Drug Candidate targeting HER2 NSCLC

On May 31, 2023 Yuhan Corporation (CEO, Wook-Je Cho) reported that it has signed an in-license agreement with J INTS BIO (CEO, Anna Jo) for a Tyrosine Kinase Inhibitor (TKI) targeting HER2, ‘JIN-A04’ (Press release, YuHan, MAY 31, 2023, View Source [SID1234632310]). The total contract size is 325 million dollars, and it includes an upfront payment of 1.9 million dollars and milestone payments according to future development, permits, and sales.

JIN-A04 is an oral TKI targeting non-small cell lung cancer carrying HER2 mutations, and there is currently no approved oral drug approved to date. Preclinical data of JIN-A04 was recently presented at the 2023 edition of the American Cancer Research Association (AACR) (Free AACR Whitepaper) annual meeting in April at Orlando, USA showing strong efficacy in both In-vitro and In-vivo studies.

Yuhan Corporation CEO, Wook-Je Cho said, "We have taken a step forward in the development of the 2nd and 3rd LECLAZA by securing an additional anti-cancer drug pipeline with this contract. We plan to further strengthen our anticancer drug pipeline in the future."

Anna Jo, CEO of J INTS BIO, said, "JIN-A04 is expected to be a hope for NSCLC patients with ‘HER2 Exon20 insertion’ mutations." And it can become the most promising Best-in-Class TKI therapy in this field."

Meanwhile, Yuhan invested 1.5 million dollars in J INTS BIO in 2021 and 2022, respectively, and holds a 14.8% stake in the company.

Asieris’ progress in MIBC receives renewed attention with its inclusion in ASCO 2023

On May 31, 2023 Asieris Pharmaceuticals (688176)， a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported the phase I clinical data of ANTICIPATE Study was published for the first time at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago (e16607) (Press release, Asieris Pharmaceuticals, MAY 31, 2023, View Source [SID1234632309]). This is a study of taking oral APL-1202 in combination with BeiGene’s tislelizumab compared to just taking tislelizumab alone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC).

A total of 9 subjects were enrolled In the Phase I stage of the trial, and the clinical data showed oral APL-1202 in combination with tislelizumab was well tolerated. No dose-limiting toxicities were observed at either 375 mg, 750 mg, or 1125 mg daily dose of APL-1202 and the recommended phase II dose (RP2D) was identified as 1125 mg daily dose. Treatment-related adverse events (TRAE) were observed in 6 patients. All AEs were grade 1, except 1 case of CTCAE grade 2 T wave abnormality on ECG and 1 case of CTCAE grade 3 liver dysfunctions. No grade 4 or 5 related AEs were observed. None of these events resulted in treatment interruptions, dose reductions, or delays in radical cystectomy. Preliminary efficacy signals were observed and pathological downstaging to

The clinical trial of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in MIBC has completed the Phase I dose-escalation stage and entered into Phase II stage in November 2022. The trial is actively recruiting for Phase II with the first patient enrolled in December 2022. In addition, APL-1202 is currently undergoing two pivotal Phase II/III clinical trials：APL-1202 in combination with intravesical chemotherapy in chemo-relapsed intermediate-to-high risk non-muscle-invasive bladder cancer (NMIBC), and APL-1202 monotherapy for untreated intermediate-risk NMIBC.

"ASCO Annual Meeting is the largest international conference in the field of cancer treatment globally." said Dr. Linda Wu, Chief Development Officer of Asieris, "Bladder cancer is one of the focused areas of Asieris Pharmaceuticals. The successful selection of our clinical research demonstrates our research and development capabilities in this focused area and showcases the growing influence of China in the international oncology community. In the future, Asieris will continue to prioritize patient-centered innovation and research, strive to develop more new drugs and bring greater benefits to patients in China and around the world."

QBIOTICS TO PRESENT AT SACHS 9TH ANNUAL IMMUNO-ONCOLOGY INNOVATION FORUM AND THE BIO INTERNATIONAL CONVENTION

On May 31, 2023 QBiotics Group Limited (QBiotics), a clinical stage life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals reported that Richard Godfrey will present to potential partners and investors at the Sachs 9th Annual Immuno-Oncology Innovation Forum and the BIO International Convention, both being held in the US through June 2023 (Press release, QBiotics, MAY 31, 2023, View Source [SID1234632307]).

Mr Godfrey, representing QBiotics in Business Development, Licensing and Partnerships, will provide an update on the Company’s human and veterinary programmes in oncology and wound healing. The presentations will include recent phase I safety and efficacy data with Tigilanol tiglate (TT) in cancer patients and details of two ongoing phase II studies in later stage patients with Head and Neck cancer and Soft Tissue Sarcoma, being treated with TT.

The Sachs 9th Annual Immuno-Oncology Innovation Forum for Business Development, Licensing and investment is at the Waldorf Astoria Chicago Hotel, USA

Presentation time: 2 June 2023, at 11:40 AM Central Daylight Time (GMT-5)).

Venue: The Faulkner Room

Recorded sessions will also be added to the event portal as available on demand during the virtual week, which takes place from 13 – 15 June EDT.

The BIO International Convention takes place at the Boston Convention & Exhibition Center, USA on 5 – 8 June 2023.

Presentation time: 5 June at 12:30 PM Eastern Daylight Time (EDT).

Venue: Session Room 103

Dr Victoria Gordon, CEO of QBiotics commented, "It is an important part of QBiotics’ partner and investor engagement strategy to attend ASCO (Free ASCO Whitepaper) and present at the high-profile satellite SACHS immune oncology forum, as well as presenting our company at the BIO International Convention. We look forward to discussing our lead assets, tigilanol tiglate in the human and veterinary oncology space, and also sharing more information on our second pipeline candidate EBC-1013, which has shown compelling early promise in wound healing."

Any potential partners or investors interested in engaging around QBiotics and its programmes are invited to reach out directly or via the one-on-one conference partnering systems.

KAHR Reports Dose Escalation Results from Phase I Trial of DSP107 in Combination with anti-PD-L1 in Patients with Advanced Solid Tumors

On May 31, 2023 KAHR, a clinical-stage biotech company developing DSP107, a novel, bi-specific CD47x4-1BB targeting immunotherapy that activates innate and adaptive immunity to treat solid tumors and blood cancers, reported positive results from the dose escalation Phase I study of DSP107 in combination with atezolizumab (anti-PD-L1) in patients with advanced solid tumors (Press release, KAHR Medical, MAY 31, 2023, View Source [SID1234632306]). The results will be presented as a poster in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, to be held June 2-6, in Chicago, IL.

Yaron Pereg, Ph.D., Chief Executive Officer of KAHR said, "We are extremely encouraged by the dose escalation data, showing significant tumor shrinkage and durable responses to DSP107 in combination with atezolizumab in patients with microsatellite stable colorectal cancer (MSS-CRC), which is considered a ‘cold’ tumor that usually does not elicit an efficient immune response. The highest dose of DSP107 (10 mg/kg) in the dose escalation phase was selected for the Phase II expansion cohorts in 3rd line MSS-CRC patients and 2nd/3rd line non-small cell lung carcinoma (NSCLC) patients. In light of DSP107’s latest and previously demonstrated favorable safety profile, and the deep and long-lasting responses seen in the combination therapy dose escalation stage of the trial, we believe that DSP107 has the potential to benefit patients who are non-responsive or refractory to existing cancer treatments."

Results of the completed dose escalation part of the study show that DSP107 in combination with atezolizumab was well tolerated (n=19) with no dose limiting toxicities (DLT’s) and no hematological or hepato-toxicities up to and including the highest dose tested (10 mg/kg).

At the highest dose (10 mg/kg) of DSP107, which was selected for the expansion cohorts, the combined treatment demonstrated a disease control rate (DCR) of 57% (4/7 patients with objective response or stable disease). Deep and durable objective responses were observed in 2 of 3 patients with MSS-CRC, with target lesion shrinkage of 73% and 83% including disappearance of pulmonary and hepatic target lesions in one patient and response durability currently standing at 10 and 9 months, respectively. The third MSS-CRC patient achieved stable disease (16% target lesion shrinkage) lasting for 6.5 months until progression. Another patient with adrenal carcinoma from the highest dose cohort also remains stable on treatment after 11 months.

The combination therapy dose escalation phase of the study was an open label, multi-center trial (NCT04440735) that enrolled 19 patients with advanced solid tumors, with a median of 3 prior lines of therapy. Patients were treated weekly with 1, 3 or 10 mg/kg DSP107 infusions and atezolizumab (1200 mg) every three weeks, until disease progression. The primary objective was to determine the safety and tolerability of DSP107 in combination with atezolizumab. The secondary objective was to assess the preliminary efficacy of DSP107 in combination with atezolizumab.

Presentation information
Date: June 3rd, 2023, 8:00 am-4:00 pm
Session: Developmental Therapeutics – Immunotherapy
Abstract #2632
Poster #474

Abstract available on the ASCO (Free ASCO Whitepaper) website.

About DSP107

DSP107 is a dual-targeting fusion protein that activates innate and adaptive immunity by blocking CD47 on cancer cells and utilizing 4-1BB conditional co-stimulatory activation of T-cells. By binding both cancer cells and immune cells, DSP107 combines checkpoint inhibition with tumor localized immune cell activation to bolster anti tumor immunity. DSP107 binds to and inhibits CD47, an immune checkpoint protein overexpressed in many cancers that enables the tumor to evade immune recognition and attack by macrophages. Simultaneously, when anchored to the tumor, DSP107 binds 4-1BB, a co-stimulatory receptor expressed on T-cells, recruits them to the tumor microenvironment and stimulates their activation. These activities result in targeted macrophage and T-cell mediated immune activation and tumor destruction.

DSP107’s phase I monotherapy dose escalation data demonstrated an excellent safety profile (n=23), with no binding to red blood cells and no dose limiting toxicities (DLT’s), hematological or hepato-toxicities in all tested doses up to and including 10 mg/kg. Paired biopsies data demonstrated biological activity including immune cell infiltration in the tumor compartment following DSP107 treatment and 50% disease control rates (11/22) in advanced solid tumor patients.

DSP107 is also being tested in combination with standard of care therapies (azacytidine and azacytidine with venetoclax) for relapsed/refractory AML and MDS patients in a Phase 1b study.