On April 3, 2024 Vopec Pharmaceuticals and Agastiya Biotech reported topline results from the Phase 1 study of AB001, an investigational small molecule, PDL1 immunotherapy for patients with metastasized and locally advanced solid tumors (Press release, Agastiya Biotech, APR 3, 2024, View Source [SID1234641730]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Unlike current standard of care immuno- and chemotherapy drugs AB001’s novel immunotherapy mechanism of action selectively destroys tumors without harming healthy cells.

Study Design

A total of 33 patients [3+3 Design], 7 with breast cancer, 5 with ovarian cancer, and 21 with other solid tumors, received AB001. AB001 was administered orally twice daily (at BID doses ranging from 40 to 800 mg) in patients with advanced or metastatic solid tumors. The study’s primary and secondary objectives were safety and efficacy. Safety parameters include MTD, PK, and other standardized toxicology protocols. The efficacy study included investigator-evaluated anti-tumor activity (PD) and biomarker responses correlated with pre- and post-treatment PET-CT and mRNA expression studies.

Toxicity Study

The Phase 1 study showed that AB001 was well-tolerated. The adverse events (AEs) were mild to moderate in severity. No dose-limiting toxic (DLT) effects or treatment-related deaths were reported. Treatment-related adverse events occurred in 9 patients at an instance rate of 2.9%; the most common adverse events were 5 patients with diarrhea (1%), 3 patients with vomiting (1%), and 1 patient with fatigue. Six adverse events were graded as mild in severity, and 3 adverse events were found to be moderate in severity. On investigation, the AEs were determined to be of unrelated causes to the treatment drug and resolved with medications, including over-the-counter medicines.

Efficacy Study

AB001 met secondary efficacy endpoints and demonstrated clinical benefit. The 14-day dose escalation studies showed notable improvements at all dosages in tumor biomarkers, immune markers, and tumor size, as confirmed by 21-day PET SCANs. Among patients with solid tumors, a favorable response was observed in 63.64%, a stable response in 19.39%, and disease progression in 16.36%. Partial responses (PR) were also observed in patients with other solid tumors. Serial assessment of tumor biomarkers showed a significant reduction from baseline. CA19.9 showed a 42% reduction (p=0.2), compared to a 38.4% drop in the CA125 markers (p=0.9), and the overall CEA markers revealed a reduction of 58.6% (p=0.6). mRNA studies showed significant changes in the expression of immunomodulation genes and Treg genes, which were associated with the anti-tumor response of AB001.

The superfast treatment impact within 21 days is attributed to the femto-scale metabolism and tumor DNA damage. MiRNA ad mRNA degradation add to the efficacy of the drug.

AB001 is the first Anti-cancer molecule to be released in India by Vopec Pharmaceutical with R&D and clinical collaboration with US-based Agastiya Biotech. Phase 2 is anticipated to begin in May 2024 in India.

The US FDA has awarded Orphan Drug Designation for AB001 for pancreatic, glioblastoma multiforme (GBM), and acute myeloid leukemia (AML) cancer indications. The companies will present the AB001 Phase 1 data at a future scientific forum.

On April 2, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the European Commission (EC) has expanded approval of Reblozyl (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) (Press release, Bristol-Myers Squibb, APR 3, 2024, View Source [SID1234641720]). This approval of Reblozyl covers all EU member states.*

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With this approval for Reblozyl as a first-line treatment for anemia in adults with lower-risk MDS, more patients in the EU will have the potential to become transfusion independent for longer periods of time compared to current options available," said Monica Shaw, M.D., senior vice president and head of European Markets, Bristol Myers Squibb. "This milestone underscores our ongoing commitment to developing new options for patients with disease-related anemia."

The approval is based on the pivotal Phase 3 COMMANDS study, in which Reblozyl demonstrated superior efficacy compared to epoetin alfa, an erythropoiesis stimulating agent, in the study’s primary endpoint of concurrent red blood cell transfusion independence and hemoglobin increase. Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population. Reblozyl is also approved in the United States and Japan for the first-line treatment of anemia associated with lower-risk MDS.

"In the treatment of lower-risk MDS, few patients experience a lasting response to erythroid stimulating agents, leaving a critical need for more effective treatment options to address the burden of their anemia," said Matteo Giovanni Della Porta, M.D., study investigator and head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy. "Results from the COMMANDS study underscore the clinical value of Reblozyl as an initial treatment for anemia in patients with low- to intermediate-risk MDS, and this approval represents a significant milestone towards improving treatment practice and offering better outcomes for patients."

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).

About COMMANDS

COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndromes (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA)-naïve.

The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin (Hb) increase ≥1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥18 years old with lower-risk MDS who require transfusions. Patients were randomized 1:1 to receive subcutaneous Reblozyl (starting dose 1.0 mg/kg, titration up to 1.75 mg/kg) once every 3 weeks or epoetin alfa (starting dose 450 IU/kg, titration up to 1050 IU/kg) weekly for ≥24 weeks.

At the time of the primary analysis (March 31, 2023), 363 patients were randomized 1:1 to Reblozyl and epoetin alfa. Results from the primary analysis of the intent to treat (ITT) population showed:

60.4% (n=110) of patients receiving Reblozyl vs. 34.8% (n=63) of patients receiving epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks with concurrent mean Hb increase of at least 1.5 g/dL within the first 24 weeks (p<0.0001).
HI-E increase of at least 8 weeks was achieved by 74.2% (n=135) of Reblozyl patients vs. 53% (n=96) of epoetin alfa patients (p<0.0001).
RBC-TI of at least 12 weeks was achieved by 68.1% (n=124) of Reblozyl patients vs. 48.6% (n=88) of epoetin alfa patients (p<0.0001).
Duration of response was 128.1 weeks (108.3-NE) for Reblozyl in patients who achieved TI for at least 12 weeks (achieved weeks 1-24) compared to 89.7 weeks (55.9-157.3) for epoetin alfa (Hazard Ratio [HR]: 0.534; 95% Confidence Interval [CI]: 0.330-0.864, p=0.0096).
Safety results were consistent with previous MDS studies, and progression to acute myeloid leukemia and total deaths were similar between both arms of the study. The most common treatment-emergent adverse events in at least 10% of patients were diarrhea, fatigue, COVID-19, hypertension, dyspnea, nausea, peripheral edema, asthenia, dizziness, anemia, back pain and headache. Rates of reported fatigue and asthenia were shown to decrease over time.

About MDS

Myelodysplastic syndromes (MDS) are a group of closely related blood cancers characterized by ineffective production of healthy red blood cells (RBC), white blood cells and platelets, which can lead to anemia and frequent or severe infections. People with MDS who develop anemia often require blood transfusions to increase the number of healthy RBCs in circulation. Frequent transfusions are associated with an increased risk of iron overload, transfusion reactions and infections. Patients who become RBC transfusion-dependent have a significantly shorter overall survival than those who are not dependent on transfusions, partially due to iron overload or to more severe bone marrow disease than in non-transfusion dependent patients.

About Reblozyl (luspatercept)

REBLOZYL, a first-in-class therapeutic option, promotes expansion and maturation of late-stage red blood cells in animal models. Reblozyl is being developed and commercialized through a global collaboration and North American co-promotion with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.

E.U. Indications:

REBLOZYL is indicated in the E.U. for the treatment of:

adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).
adult patients with anaemia associated with transfusion-dependent and non-transfusion-dependent beta-thalassaemia.
A European Summary of Product Characteristics for REBLOZYL is available from the European Medicines Agency website at www.ema.europa.eu.

U.S. Indications:

REBLOZYL is indicated in the U.S. for the treatment of:

anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. In the U.S., REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

U.S. Important Safety Information:

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 11.4% (63/554) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 2% to 9.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In ESA-refractory or -intolerant adult patients with MDS with normal baseline blood pressure, 26 (30%) patients developed SBP ≥130 mm Hg and 23 (16%) patients developed DBP ≥80 mm Hg. In ESA-naïve adult patients with MDS with normal baseline blood pressure, 23 (36%) patients developed SBP ≥140 mm Hg and 11 (6%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Extramedullary Hematopoietic (EMH) Masses

In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study).

In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs. 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

ADVERSE REACTIONS

Beta-Thalassemia

Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML).

Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

ESA-naïve adult patients with Myelodysplastic Syndromes

Grade ≥3 (≥2%) adverse reactions included hypertension and dyspnea.

The most common (≥10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.

ESA-refractory or -intolerant adult patients with Myelodysplastic Syndromes

Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients.

The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.

LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

DRUG ABUSE POTENTIAL

Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.

Please see accompanying U.S. Full Prescribing Information for REBLOZYL.

On April 3, 2024 Genmab A/S (Nasdaq: GMAB) and ProfoundBio, Inc. reported that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction (Press release, Genmab, APR 3, 2024, View Source [SID1234641710]). ProfoundBio is a privately-owned clinical-stage biotechnology company developing next-generation ADCs and ADC technologies for the treatment of certain cancers, including ovarian cancer and other FRα-expressing solid tumors. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The transaction will further broaden Genmab’s mid- to late-stage clinical pipeline and strengthen and complement Genmab’s already validated suite of proprietary technology platforms. The acquisition will give Genmab worldwide rights to ProfoundBio’s portfolio of next-generation ADCs, which consists of three clinical and multiple preclinical programs including Rina-S, a potential best-in-class, clinical-stage, FRα-targeted, Topo1 ADC, currently in Phase 2 of a Phase 1/2 clinical trial, for the treatment of ovarian cancer and other FRα-expressing solid tumors. In addition, the combination of ProfoundBio’s novel ADC technology platforms with Genmab’s proprietary antibody platforms will potentially create new opportunities to generate and develop new medicines with the potential to transform the treatment of cancer and improve the lives of patients.

The addition of Rina-S to Genmab’s portfolio will enable Genmab to deepen its presence in the gynecologic oncology space and establish a firm foundation in solid tumors. As a potential best-in-class ADC, Rina-S aims to address a broader patient population than first-generation FRα-targeted ADCs. Based on the data from the ongoing Phase 1/2 clinical trial Genmab intends to broaden the development plans for Rina-S within ovarian cancer and other FRα-expressing solid tumors. In January 2024, the U.S. Food and Drug Administration (U.S. FDA) granted Fast Track designation to Rina-S for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

"The proposed acquisition of ProfoundBio firmly aligns with our long-term strategy and our ambitious 2030 vision, to impact the lives of patients through innovative antibody medicines," said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. "We believe that ProfoundBio’s ADC candidates, proprietary technology platforms and talented team will be a great addition to Genmab and that, together, we will be able to accelerate the development of innovative, differentiated antibody therapies for cancer patients."

"Genmab shares our team’s mission of developing novel therapies to improve outcomes for cancer patients. Genmab’s deep expertise in antibody drug development and commercialization makes this a compelling union that will allow us to rapidly develop and realize the full potential of our ADC therapies to benefit patients," said Baiteng Zhao, Ph.D., ProfoundBio’s co-founder, Chief Executive Officer and Chairman of the Board.
Details of the Transaction
The proposed transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the first half of 2024. The closing of the proposed transaction is subject to the satisfaction of customary closing conditions.

Following today’s announcement, Genmab’s operating expenses before expenses incurred by it in connection with the proposed transaction are now anticipated to be at or moderately above the upper end of the previously disclosed guidance range of DKK 12.4 -13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S. Genmab’s revenue guidance is unchanged and expected to be in the previously disclosed guidance range of DKK 18.7 – 20.5 billion. We expect to update our guidance no later than in connection with Genmab’s second quarter 2024 earnings.

Goldman Sachs International is acting as sole financial advisor to Genmab in this transaction and Shearman & Sterling LLP, Simmons & Simmons LLP and Kromann Reumert are its legal advisors.

BofA Securities, Inc. and Morgan Stanley & Co. LLC are acting as financial advisors to ProfoundBio in this transaction and Cooley LLP, Travers Thorp Alberga and Jun He Law Offices are its legal advisors.

Conference Call Details
Genmab will hold a conference call to discuss the transaction today, April 3 at 1:00 PM CEST / 12:00 PM BST / 7:00 AM EDT. To join the call please use the following registration link: https://register.vevent.com/register/BI9da0549848d848cdaa4b6cd96079bafd. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN. To listen to a live webcast of the call please use the following link: View Source An archive of the webcast and relevant slides will be available at View Source

On April 2, 2024 BioInvent International AB ("BioInvent"), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported a clinical trial collaboration and supply agreement with MSD International Business GmbH, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, for a Phase 1/2a study of its monoclonal antibody BI-1910 in combination with KEYTRUDA (pembrolizumab) (Press release, BioInvent, APR 2, 2024, https://www.bioinvent.com/en/press/bioinvent-announces-new-clinical-trial-collaboration-and-supply-agreement-msd-evaluate-bi [SID1234646696]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the supply agreement, MSD will provide its anti-PD-1 therapy KEYTRUDA to be used in combination with BI-1910. The Phase 1/2a trial will be conducted in the US and Europe and has an innovative, adaptive design to allow for ideal dose escalation.

BI-1910 is BioInvent’s second tumor necrosis factor receptor 2 (TNFR2) program to enter clinical development, after BI-1808 currently in Phase 2a. BI-1910 displays a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent’s first-in-class anti-TNFR2 antibody. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent’s proprietary F.I.R.S.T technology platform. The single agent arm of the Phase 1/2a BI-1910 study was initiated in December 2023 and first data is expected by YE 2024.

"We are delighted to enter into another clinical trial collaboration and supply agreement with MSD to investigate the unique features of BI-1910 in combination with KEYTRUDA. This trial will build on our deep understanding of the TNFR2 biology as we move two differentiated monoclonal antibodies through clinical development. This is our fifth product in ongoing clinical trials, demonstrating the capacity of BioInvent’s technology to identify novel, first-in-class therapeutic cancer targets," said Martin Welschof, CEO of BioInvent.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On April 2, 2024 KiraGen Bio, a pioneering biotech company in the field of innovative cellular therapies for solid tumors, is pleased to announce today a strategic partnership with Flash BioSolutions, a leading CDMO providing state-of-the-art lentiviral particles (Press release, KiraGen Bio, APR 2, 2024, View Source [SID1234644884]). This collaboration aims to fully harness the potential of CAR-T (Chimeric Antigen Receptor T-cell) therapies in cancer treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Through this alliance, KiraGen Bio will leverage the advanced expertise of Flash BioSolutions and its flagship technology, LentiCare. This cutting-edge lentiviral platform will be seamlessly integrated into the development of KiraGen Bio’s groundbreaking CAR-T therapies, playing a crucial role in the Proof of Concept stage and beyond.

The revolutionary aspect of this partnership lies in the synergistic combination of KiraGen Bio’s proprietary AI-driven platform, KiraLOGIC, and Flash BioSolutions’ state-of-the-art LentiCare technology. KiraLOGIC employs advanced machine learning algorithms to rationally design CAR-T cells equipped with a combination of highly multiplexed gene edits, rendering them resistant to the immunosuppressive tumor microenvironment. By integrating these AI-powered gene editing capabilities with the high-quality lentiviral vectors provided by Flash BioSolutions, KiraGen Bio is poised to unlock the full potential of CAR-T therapies for solid tumors, addressing a critical unmet need in cancer treatment.

"Our KiraLOGIC platform leverages AI to rationally design CAR-T cells resistant to immunosuppression, unlocking the potential of cell therapies for solid tumors. Partnering with Flash BioSolutions, a leader in lentiviral vector manufacturing, is pivotal in advancing our multiplex gene-edited CAR-T therapies. Their LentiCare technology ensures high-quality lentiviral vectors, essential for generating robust preclinical data and propelling our therapies towards clinical development. Together, we are poised to accelerate scientific progress and deliver transformative treatments to patients in need," stated Ryan Murray, PhD, CSO & Co-Founder of KiraGen Bio.

"At KiraGen, our unwavering commitment is to bring our revolutionary TME-Guard technology to patients as quickly and broadly as possible. Collaborating with Flash BioSolutions is a significant milestone in realizing this vision. Their deep expertise in lentiviral manufacturing will be instrumental as we rapidly advance our innovative cell therapies through preclinical development and into the clinic. This strategic partnership is key to accelerating our lead programs, forging powerful industry and academic alliances, and building a robust and sustainable pipeline. By joining forces with Flash BioSolutions, we are creating a powerful model that can drive transformative impact for patients while generating value for our investors, as we work to establish KiraGen as a pioneer in solid tumor cell therapy," added Aaron Edwards, CEO & Co-Founder of KiraGen Bio.

"Flash BioSolutions is thrilled to collaborate with KiraGen Bio in reshaping the paradigm of CAR-T therapies for solid tumors," stated Jérôme Bédier, CEO of Flash BioSolutions. "Through the potent fusion of our expertise and state-of-the-art technologies, we are steadfast in our commitment to propelling scientific innovation and introducing revolutionary treatment options for patients confronting this formidable disease."

This partnership between Flash BioSolutions and KiraGen Bio embodies the commitment of both companies to push the boundaries of research to improve the lives of cancer patients. Together, they aspire to open new perspectives in the treatment of solid tumors and bring renewed hope to those battling this disease.