On August 12, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, Aprea, AUG 12, 2024, View Source [SID1234645721]).

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"Aprea continues to make excellent progress advancing its clinical pipeline of therapeutic candidates," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We initiated enrollment in the ACESOT-1051 trial, advancing a second clinical asset in our pipeline, APR-1051. APR-1051 is a next-generation inhibitor of WEE1 kinase which has been designed to limit toxicity. Based on its unique characteristics, we believe it could be best in class. We continue to enroll patients in the ABOYA-119 trial evaluating ATRN-119, our ATR inhibitor. We believe that our ongoing progress positions Aprea at the forefront of synthetic lethality drug development. We remain committed to developing new treatments that have a positive impact on the lives of cancer patients while creating value for our shareholders."

Key Business Updates and Potential Upcoming Key Milestones

ACESOT-1051: A Biomarkers Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051, initiated

APR-1051 is a potent and selective small molecule that has been designed to potentially solve liabilities and may achieve greater clinical activity than other WEE1 programs currently in development. Aprea is advancing APR-1051 as monotherapy in cancers with Cyclin E over expression, as well as other biomarkers that are predicted to be sensitive to WEE1 inhibition. Cancers overexpressing Cyclin E represent a high unmet medical need. Patients with Cyclin E overexpression have poor prognosis and, currently, have no effective therapies.
In June 2024, enrollment commenced in the ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) Phase 1 clinical trial evaluating single-agent APR-1051 in advanced solid tumors harboring cancer-associated gene alterations. The first patient was dosed at NEXT Oncology, San Antonio, Texas, without any dose-limiting toxicities (including myelosuppression) observed to date in the first cohort. A second patient has been enrolled at The University of Texas MD Anderson Cancer Center and has commenced treatment in the second dose cohort.
The primary objectives of the Phase 1 study are to measure safety, dose-limiting toxicities (DLTs), maximum tolerated dose or maximum administered dose (MTD/MAD), and recommended Phase 2 dose (RP2D); secondary objectives are to evaluate pharmacokinetics, preliminary efficacy according to RECIST or PCWG3 criteria; pharmacodynamics is an exploratory objective.
The Company will provide an update on the progress of this clinical study by year end. Open-label safety/efficacy data are expected in the first half of 2025.
In June 2024, Aprea hosted a virtual KOL event to discuss APR-1051. Joseph Vacca, Ph.D., Medicinal Chemistry Expert and Consultant to Aprea, discussed the medicinal chemistry history, strategy-guided selective drug design, and preclinical findings of APR-1051. Eric J. Brown, Ph.D., University of Pennsylvania and Consultant to Aprea, discussed preclinical findings across the WEE1 inhibitor class. A replay of the event (with slides) can be accessed on Aprea’s corporate website here.
APR-1051 was featured in two posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting which took place in April 2024 in San Diego, which summarized the pre-clinical data supporting APR-1051 and the trial design for ACESOT-1051.
ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed to be used in patients with mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. Patients with DDR-related gene mutations have a poor prognosis and, currently, have no effective therapies.
ATRN-119 is currently being evaluated in the open-label Phase 1/2a clinical trial of ABOYA-119 (study AR-276-01) as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes. The first five dose cohorts (50mg to 550mg once daily) have been completed, and patients continue to enroll in additional cohorts in the dose escalation part of the trial.
The primary endpoint of this Phase 1 trial is the tolerability and pharmacokinetics of ATRN-119 when administered orally on a continuous, once-daily schedule. Aprea is planning to amend the study protocol to add a group of patients who will receive ATRN-119 twice a day and to investigate the effect of food on ATRN-119 absorption and drug exposure in blood. Under the current protocol, the Company anticipates the ABOYA-119 Phase 1 readout to be available in the first half of 2025.
An update on the ongoing trial was featured in a poster at the AACR (Free AACR Whitepaper) Annual Meeting this past April. A copy of the AACR (Free AACR Whitepaper) poster can be found here.
For more information, please refer to clinicaltrials.gov NCT04905914.
Corporate

Appointed Nadeem Q. Mirza, M.D., M.P.H. as Chief Medical Officer (CMO), effective May 1, 2024. Dr. Mirza had been a consultant to Aprea since February 2023 and has now assumed a more central role in leading the Company’s development of its expanding clinical pipeline.
Select Financial Results for the Second Quarter ended June 30, 2024

As of June 30, 2024, the Company reported cash and cash equivalents of $28.7 million, compared to $21.6 million at December 31, 2023. The Company believes its cash and cash equivalents as of June 30, 2024, will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the fourth quarter of 2025.
For the quarter ended June 30, 2024, the Company reported an operating loss of $3.8 million, compared to an operating loss of $3.7 million in the comparable period in 2023.
Grant revenue, primarily from the National Cancer Institute of the National Institutes of Health ("NIH") for the three months ended June 30, 2024, and 2023 was approximately $0.6 million and $0.2 million, respectively.
Research and development expenses were approximately $2.6 million for the quarter ended June 30, 2024, compared to approximately $2.2 million for the comparable period in 2023. The increase was primarily due to an increase in expenses related to the initiation of ACESOT-1051, our Phase 1 dose-escalation study evaluating APR-1051, our small molecule WEE1 inhibitor, in the second quarter of 2024.
General and administrative expenses were approximately $1.9 million for the quarter ended June 30, 2024, compared to approximately $1.7 million for the comparable period in 2023. The increase was primarily related to an increase in personnel costs primarily related to severance expense.
The Company reported a net loss of $3.5 million ($0.58 per basic share) on approximately 5.9 million weighted-average common shares outstanding for the quarter ended June 30, 2024, compared to a net loss of $3.3 million ($0.87 per basic share) on approximately 3.7 million weighted average common shares outstanding for the comparable period in 2023.

On August 12, 2024 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported financial results and business updates for the second quarter ended June 30, 2024 (Press release, Adaptimmune, AUG 12, 2024, View Source [SID1234645720]). The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today.

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "On 1 August, we received US FDA approval for Tecelra, the first ever engineered cell therapy for a solid tumor and the first new treatment option for people with synovial sarcoma in more than a decade. We have hit the ground running to make Tecelra available to eligible patients. Patients can start their treatment journey now with healthcare providers able to begin testing and our ordering platform is up and running. Tecelra will be available in 6-10 US authorized treatment centers in the coming weeks. Tecelra is the first product in our sarcoma franchise, and we are planning to commence our rolling BLA submission for lete-cel in 2025 and commercial launch in 2026. We expect our sarcoma franchise to redefine the treatment landscape in advanced soft tissue sarcoma with projected peak US sales of $400 million."

Sarcoma Franchise with Tecelra and lete-cel

● U.S. Food and Drug Administration (FDA) approves Tecelra for the treatment of advanced MAGE-A4+ synovial sarcoma in adults with certain HLA types who have received prior chemotherapy.
● Tecelra is the first engineered cell therapy for solid tumors.
● Tecelra is the first new treatment option for synovial sarcoma in more than a decade.
● Tecelra is a single infusion treatment.
● No Risk Evaluation and Mitigation Strategies (REMS) program was required for BLA approval.
● Patients can start their treatment journey now, with testing approved and available in the United States.
● Sarcoma centers of excellence across the Unites States are being onboarded as Authorized Treatment Centers (ATCs) for Tecelra.
● The approval of Tecelra was based on results of the SPEARHEAD-1 (Cohort 1) trial. The major efficacy outcome was overall response rate (ORR) by independent review and supported by duration of response. Tecelra treatment resulted in an ORR of 43% with a complete response rate of 4.5%. The median duration of response was 6 months (95% CI: 4.6, not reached). Among patients who were responsive to the treatment, 39.0% had a duration of response of 12 months or longer. Data from the pivotal SPEARHEAD-1 trial were previously published in The Lancet earlier this year.

● Data presentations:
o Data from the pivotal IGNYTE-ESO trial of lete-cel (letetresgene autoleucel), an engineered cell therapy targeting NY-ESO-1, in synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS) was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) annual meeting. The overall response rate (ORR) of 40% was consistent across both SyS and MRCLS, meeting the primary endpoint success criterion for efficacy. Given the trial’s success, Adaptimmune plans to initiate a rolling Biologics License Application (BLA) submission for lete-cel for the treatment of advanced or metastatic MRCLS and synovial sarcoma during 2025. Lete-cel will bolster Adaptimmune’s sarcoma franchise by expanding the addressable patient population to NY-ESO-1 positive MRCLS and SyS solid tumors.
Clinical pipeline

● Adaptimmune recently announced the company had entered into a clinical collaboration agreement with Galapagos to conduct a clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next-generation engineered TCR T-cell therapy, formerly ADP-A2M4CD8) using Galapagos’ decentralized manufacturing platform in patients with head & neck cancer and potential future solid tumor cancer indications.
● Adaptimmune retains the right to develop, manufacture, commercialize, and otherwise exploit uza-cel for platinum-resistant ovarian cancer.
● Uza-cel is being investigated in the SURPASS-3 Phase 2 clinical trial (NCT05601752) for the treatment of platinum-resistant ovarian cancer. Uza-cel received FDA RMAT designation in 2022 for the treatment of patients with platinum resistant ovarian cancer. The SURPASS-3 trial is currently enrolling patients.
● Screening in the SURPASS Phase 1 trial has stopped and enrolment will cease shortly.

Preclinical pipeline

● Wholly owned allogeneic pipeline progressing; process optimization continues at Adaptimmune’s facility in Milton Park, UK.
● IND-enabling activities continue for ADP-600 (PRAME) and ADP-520 (CD70) programs.

Business and corporate updates

● Under the terms of Adaptimmune and Galapagos’ collaboration agreement, Adaptimmune will receive initial payments of $100 million, comprising $70 million upfront and $30 million of R&D funding of which $15m was received on signing, option exercise fees of up to $100 million, additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales.
● Adaptimmune announced in May entry into a Loan and Security Agreement with Hercules Capital, Inc., for a term loan facility of up to $125.0 million. Following the receipt of FDA approval for Tecelra, the Company is eligible to draw down the Tranche 2 Advance of $25.0 million and is in the process of requesting this Tranche 2 Advance.

Financial Results for the three and six months ended June 30, 2024

● Cash / liquidity position: As of June 30, 2024, Adaptimmune had cash and cash equivalents of $211.8 million and Total Liquidity2 of $214.8 million, compared to $144.0 million and $146.9 million respectively, as of December 31, 2023.
● Revenue: Revenue for the three and six months ended June 30, 2024, was $128.2 million and $133.9 million, respectively, compared to $5.1 million and $52.7 million for the same periods in 2023. Revenue has increased in 2024, compared to the same periods in 2023 primarily due to the termination of the Genentech collaboration in the second quarter of 2023, resulting in the majority of the remaining deferred income for the collaboration being recognized as revenue including a cumulative catch-up adjustment of $101.3 million. This was significantly higher than the impact from the termination of the Astellas collaboration in 2023, which resulted in $42.4 million of revenue being recognized in March 2023.
● Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2024, were $40.4 million and $75.7 million, respectively, compared to $30.0 million and $55.5 million for the same periods in 2023. R&D expenses increase due to an increase in the average number of employees engaged in research and development, increases in subcontracted expenditures, an increase in in-process research and development costs and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
● General and administrative (G&A) expenses: G&A expenses for the three and six months ended June 30, 2024, were $19.1 million and $38.8 million, respectively, compared to $20.1 million and $40.5 million for the same periods in 2023. G&A expenses decreased due to restructuring and charges recognised in the first quarter of 2023 that were not repeated in 2024 and an increase in offsetting reimbursements, offset by an increase in other corporate costs due to an increase in accounting, legal and professional fees in the second quarter of 2024 due to fees relating to business development work and preparation for commercialization.
● Net profit/(loss): Net profit attributable to holders of the Company’s ordinary shares for the three and six months ended June 30, 2024, was $69.5 million and $21.0 million, respectively ($0.05 and $0.01 per ordinary share), compared to losses of $21.3 million and $20.4 million ($(0.02) and $(0.02) per ordinary share), for the same periods in 2023.

Today’s Webcast Details

A live webcast and replay can be accessed HERE. Call in information is as follows: +1-844-763-8274 (US or Canada) or +1-647-484-8814 (International). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

On August 12, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the second quarter of 2024 and recent corporate progress (Press release, Abeona Therapeutics, AUG 12, 2024, View Source [SID1234645719]).

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"Having completed data generation for nearly all of the Chemistry Manufacturing and Controls deliverables outlined in the Complete Response Letter that we received in April 2024, we are on track to resubmit our Biologics License Application for pz-cel this year and, if approved, bring a treatment option to patients with recessive dystrophic epidermolysis bullosa," said Vish Seshadri, Chief Executive Officer of Abeona.

Second Quarter and Recent Progress

Pz-cel for RDEB

● On August 8, 2024, Abeona completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss Abeona’s forthcoming resubmission of its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), its investigational first-in-class, autologous cell-based gene therapy currently in development for recessive dystrophic epidermolysis bullosa (RDEB). In pre-meeting communications and during the Type A meeting, Abeona shared data and reports addressing nearly all of the deficiencies noted in the Complete Response Letter (CRL) and gained the FDA’s preliminary alignment pending formal review. For two remaining outstanding items related to sterility assays and identity assays, validation is currently ongoing under protocols that incorporate FDA feedback. Abeona continues to expect to resubmit the BLA in the second half of 2024. Upon acceptance of the BLA, Abeona expects the FDA to set a Prescription Drug User Fee Act (PDUFA) action date six months from the date of submission.

● In April 2024, Abeona received a CRL from the FDA based on the need for additional Chemistry Manufacturing and Controls (CMC) information. In the CRL, the FDA noted that certain additional information needed to satisfy CMC requirements must be resolved before the application can be approved. The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel.

● In May 2024, new pz-cel long-term safety data with up to 11 years of follow-up were presented during a late-breaker session at the Society for Investigative Dermatology (SID) Annual Meeting. In July 2024, data on wound healing at various anatomical sites after pz-cel treatment were presented at the Society for Pediatric Dermatology (SPD) Annual Meeting.

U.S. commercial launch preparations for pz-cel

● Abeona continues to make progress on key commercial activities in preparation for a potential U.S. launch for pz-cel, including onboarding discussions with epidermolysis bullosa treatment sites, conducting medical and payer engagement, and building supply chain and enterprise capabilities to support the Company’s transition to a commercial stage company.

Pipeline programs

● In July 2024, Abeona announced a non-exclusive agreement with Beacon Therapeutics, under which Beacon Therapeutics will evaluate Abeona’s patented AAV204 capsid for its potential use in AAV gene therapies for select ophthalmology indications.

Corporate highlights

● In May 2024, Abeona closed a $75 million underwritten securities offering with participation from both new and existing investors.

Second Quarter Financial Results and Cash Runway Guidance

Cash, cash equivalents, short-term investments and restricted cash totaled $123.0 million as of June 30, 2024. As of March 31, 2024, cash, cash equivalents, short-term investments and restricted cash totaled $62.7 million. Net cash used in operating activities was $12.7 million for the three months ended June 30, 2024.

Abeona estimates that its current cash and cash equivalents, short-term investments and restricted cash, as well as its $50 million credit facility, are sufficient resources to fund operations into 2026, before accounting for any potential revenue from commercial sales of pz-cel, if approved, or proceeds from the sale of a Priority Review Voucher (PRV), if awarded by the FDA.

Research and development expenses for the three months ended June 30, 2024 were $9.2 million, compared to $8.5 million for the same period of 2023. General and administrative expenses were $8.6 million for the three months ended June 30, 2024, compared to $5.0 million for the same period of 2023. The increase in general and administrative expenses is primarily due to commercial and launch preparation costs. Net income for the second quarter of 2024 was $7.4 million, including a $24.9 million gain resulting from the quarterly remeasurement of the fair value of warrant liabilities. In the second quarter of 2023, net loss was $16.7 million, including an $8.6 million loss resulting from the quarterly remeasurement of the fair value of warrant liabilities.

Conference Call Details

The Company will host a conference call and webcast on Monday, August 12, 2024, at 8:30 a.m. ET, to discuss the quarter results. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 678762 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

On August 11, 2024 Akeso, Inc. (HKEX: 9926.HK) ("Akeso,") reported two upcoming oral presentations of ivonescimab (PD-1/VEGF bispecific antibody) at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer ("WCLC24"), taking place in San Diego, USA from September 7-10, 2024 (Press release, Akeso Biopharma, AUG 11, 2024, View Source [SID1234645701]). Among these is a late-breaking Presidential Symposium presentation featuring results from the HARMONi-2/AK112-303 study, which evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS ≥1%).

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The late-breaking result of HARMONi-2/AK112-303 will be presented by Professor Zhou Caicun, the principal investigator of HARMONi-2 and director in the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University.

Presentations during WCLC 2024

Abstract Title

Presentation Details

Phase 3 Study of Ivonescimab (AK112) vs. Pembrolizumab as First-line Treatment for PD-L1-positive Advanced NSCLC: Primary Analysis of HARMONi-2

Session: PL02 Presidential Symposium 1 (LIVESTREAMED)

Form: Plenary oral

Presenter: Caicun Zhou, MD. Ph.D, China Shanghai Pulmonary Hospital

Abstract release time: embargoed until the presentation day

A Phase 2 Study of Perioperative Ivonescimab Alone or Combined with Chemotherapy in Resectable Non-Small Cell Lung Cancer

Session: Perioperative Strategies 1—Early-Stage Non-Small Cell Lung Cancer

Sunday, September 8, 2024, 11:17 AM-11:27 AM

Form: Oral

Presenter: Xiaoliang Zhao, MD, China Tianjin Medical University Cancer Institute & Hospital

Abstract release time: August 14, 2024

Akeso will also participate as an exhibitor, actively engaging with professionals from diverse fields.

Milestones of ivonescimab:

May 2024:
Ivonescimab was granted marketing approval for the treatment of epidermal growth factor receptor ("EGFR") mutated locally advanced or metastatic non-squamous non-small cell lung cancer ("nsq-NSCLC"), making it the world’s first approved PD-1/VEGF bi-specific antibody.

May 31:
At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

June 01:
Interim result of the Phase III study of ivonescimab combined with platinum-doublet chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR-TKIs treatment (HARMONi-A ), was presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and the study was ranked as the top report on the TOP 10 list of lung cancer at ASCO (Free ASCO Whitepaper) by OncoAlert, an international cancer support organization. On the same day, the research findings were also published simultaneously in the JAMA journal.

July 25:
Akeso’s partner, Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit,") announced a strategic five-year collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson) for the purpose of accelerating the development in certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer.

July 29:
The supplemental New Drug Application (sNDA) for ivonescimab as a monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC), has been accepted by the China National Medical Products Administration (NMPA). This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study.

August 02:
The supplemental New Drug Application (sNDA) for ivonescimab monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic NSCLC was accepted by China NMPA with priority review.

About Ivonescimab (AK112/SMT112)
Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics’ license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 5 Phase III trials including 2 global MRCTs and 4 registrational trials versus anti-PD-1 therapeutics. The Company is also conducting multiple clinical trials of ivonescimab covering 16 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.

On August 9, 2024 C&Cure (CEO Min Jeong-jun and Park Jung-gon), an anticancer drug development company in Gwangju Metropolitan City, reported the company has developed a new concept of immunotherapy using bacteria for treating cancer (Press release, CNCure, AUG 9, 2024, View Source [SID1234649035]).

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According to C&Cure on the 9th, the company created bacteria for treating cancer by genetically engineering salmonella, E. coli, and Vibrio.

The independently developed salmonella strain has removed more than 70 genes that are harmful to the human body, reducing toxicity by more than 1 million times.

The company explains that this non-toxic salmonella has a strong affinity for cancer tissue.

When injected into the body, it has the characteristic of overproliferating in cancer tissue by more than 100,000 times more than in normal tissue.

The C&Cure research team genetically engineered the non-toxic salmonella to produce cytolysin A, a cell-lytic protein of E. coli, and flagellin B, a flagellar protein of Vibrio, in cancer tissue.

A company official said, "As a result of experiments on mouse models transplanted with various types of cancer, the fused salmonella dramatically changed the cancer immune microenvironment and caused an anticancer immune effect," adding, "It suggested that it can effectively treat not only primary cancer but also metastatic cancer."

With this technology, C&Cure is going through the clinical trial new drug approval process with the U.S. Food and Drug Administration ( FDA ). It is also conducting mammalian toxicity tests in accordance with standards. CEO Min Jeong-jun, director of Chonnam National University Hospital in Hwasun, and Professor Hong Young-jin of Chonnam National University College of Medicine, chief technology officer, conducted this research with support from the Ministry of Science and ICT’s Immunotherapy Innovation Platform Project and mid-level research project.