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VANFLYTA® Approved in the EU as the First FLT3 Inhibitor Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

On November 9, 2023 Daiichi Sankyo’s (TSE: 4568) reported the VANFLYTA (quizartinib) has been approved in the European Union (EU) for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive (Press release, Daiichi Sankyo, NOV 9, 2023, View Source [SID1234637289]).

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VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.

The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet. In QuANTUM-First, VANFLYTA combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; p=0.032]) in patients with newly diagnosed FLT3-ITD positive AML. Median overall survival was 31.9 months for patients receiving VANFLYTA (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.

"This approval of VANFLYTA represents an important advancement for frontline treatment of patients with FLT3-ITD positive acute myeloid leukemia, an aggressive and historically difficult-to-treat subtype," said Richard F. Schlenk, MD, Professor and Head of the Trial Center of the National Center of Tumour Diseases, Heidelberg University Hospital and German Cancer Research Center, Germany. "VANFLYTA is a potent and selective FLT3 inhibitor that significantly improved overall survival when added to standard chemotherapy and it will be a valuable treatment option for newly diagnosed FLT3-ITD positive AML."

"This approval of VANFLYTA is very welcome news for eligible patients diagnosed with FLT3-ITD positive AML each year," said Samantha Nier, Network Director, Acute Leukemia Advocates Network (ALAN). "New medicines and treatment approaches are needed to help patients with this difficult type of leukemia live longer, and we look forward to VANFLYTA becoming available in countries throughout the EU."

The safety profile of VANFLYTA in QuANTUM-First was consistent with previous clinical trials with no new safety signals observed. The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%). QTcF > 500 ms occurred in 2.3% of patients receiving VANFLYTA and 0.8% of patients discontinued VANFLYTA due to QT prolongation. Ventricular arrhythmia events with VANFLYTA were uncommon. Two (0.8%) patients receiving VANFLYTA experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

"With the approval of VANFLYTA in the European Union, patients diagnosed with FLT3-ITD positive acute myeloid leukemia may for the first time receive a targeted therapy developed and approved specifically for their disease subtype," said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. "VANFLYTA is the second innovative medicine from our oncology pipeline approved in the EU and its successful development reflects our commitment to creating new standards of care for patients with cancer."

About QuANTUM-First
QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating VANFLYTA in combination with standard induction and consolidation therapy, including hematopoietic stem cell transplant (HSCT), and as maintenance monotherapy, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 to receive VANFLYTA or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of treatment with single-agent maintenance.

The primary study endpoint was overall survival. Secondary endpoints include event-free survival, postinduction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD measurable residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints including duration of CR also were evaluated.

QuANTUM-First enrolled 539 patients at 193 study sites in 26 countries across Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About FLT3-ITD Positive Acute Myeloid Leukemia
More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.3 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.4,5 In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at 17% for adult patients.6,7

A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common.8 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.1,2 FLT3-ITD mutations occur in about 25% of all AML cases, with frequency reported as high as 30%.1,2

About VANFLYTA
VANFLYTA is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.

VANFLYTA is approved in the EU in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed AML that is FLT3-ITD positive.

VANFLYTA is approved in the U.S. in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDAapproved test. VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

VANFLYTA also is approved in Japan for the treatment of AML that is FLT3-ITD mutation positive, including for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapy for adult patients with newly diagnosed FLT3-ITD positive AML and as a monotherapy for relapsed/refractory AML that is FLT3-ITD positive as detected by an approved test. VANFLYTA is an investigational medicine in all countries outside of Europe, Japan and the U.S.

About the VANFLYTA Clinical Development Program
The VANFLYTA clinical development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3-ITD positive AML in Europe and North America and several phase 1/2 combination studies as part of a strategic collaboration with The University of Texas MD Anderson Cancer Center.

Imfinzi plus bevacizumab met primary endpoint for progression-free survival in liver cancer eligible for embolisation in EMERALD-1 Phase III trial

On November 9, 2023 Astrazeneca reported that Positive high-level results from the EMERALD-1 Phase III trial showed Imfinzi (durvalumab) in combination with transarterial chemoembolisation (TACE) and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolisation (Press release, AstraZeneca, NOV 9, 2023, View Source [SID1234637288]). The trial continues to follow the secondary endpoint of overall survival (OS).

Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death with an estimated 900,000 people worldwide diagnosed each year.1,2 Approximately 20-30% of patients are eligible for embolisation, a procedure that blocks the blood supply to the tumour and can also deliver chemotherapy or radiation therapy directly to the liver.3-9 Despite being the standard of care in this setting, most patients who receive embolisation experience rapid disease progression or recurrence.10-14

Dr. Riccardo Lencioni, Professor and Director of the Cancer Imaging Program in the Department of Diagnostic and Interventional Radiology of Pisa University Hospital in Pisa, Italy, and principal investigator in the trial, said: "Patients with liver cancer eligible for embolisation experience high rates of progression or recurrence and do not have the opportunity for early intervention with effective systemic therapy. These results for durvalumab plus bevacizumab have the potential to reshape the treatment of this complex disease with a poor prognosis by showing for the first time that adding an immunotherapy combination to TACE significantly improves progression-free survival."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These positive results for Imfinzi-based treatment in EMERALD-1 may bring the potential of immunotherapy to patients with earlier stages of liver cancer. We look forward to discussing these data with regulatory authorities and seeing the survival data mature over time, which will be important as we aim to bring this novel treatment option to patients."

The safety profiles for Imfinzi and TACE plus bevacizumab were consistent with the known profile of each medicine, and there were no new safety findings.

The data will be presented at a forthcoming medical meeting and shared with regulatory authorities.

AstraZeneca has an extensive clinical development programme further assessing Imfinzi across multiple gastrointestinal (GI) cancer settings, including in combination with bevacizumab in adjuvant HCC (EMERALD-2) and in combination with Imjudo (tremelimumab), lenvatinib and TACE in embolisation-eligible HCC (EMERALD-3).

Notes

Liver cancer
Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.1-2 Asia holds more than 70% of the world’s new liver cancer cases.15 About 75% of all primary liver cancers in adults are HCC.1 Between 80-90% of all patients with HCC also have cirrhosis.16 Chronic liver diseases such as cirrhosis are associated with inflammation that over time can lead to the development of HCC.16 Immunotherapy is a proven treatment modality in HCC with approved options available for patients in later-line settings.17

EMERALD-1
EMERALD-1 is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial of Imfinzi plus TACE concurrently, followed by Imfinzi with or without bevacizumab until progression versus TACE alone in a total of 616 patients with unresectable HCC eligible for embolisation.

The trial was conducted in 157 centres across 18 countries, including in North America, Australia, Europe, South America and Asia. The primary endpoint was PFS for Imfinzi and TACE plus bevacizumab versus TACE alone, and secondary endpoints include PFS for Imfinzi plus TACE, overall survival, patient-reported outcomes and objective response rate.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo (tremelimumab) in unresectable HCC in the US, EU, Japan and many other countries based on the TOPAZ-1 and HIMALAYA Phase III trials, respectively.

In addition to its indications in GI cancers, Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small-cell lung cancer (SCLC) based on the CASPIAN Phase III trial. Additionally, Imfinzi is approved in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial. Imfinzi is approved in previously treated patients with advanced bladder cancer in a small number of countries.

Since the first approval in May 2017, more than 200,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer and other solid tumours. In 2023, AstraZeneca announced positive results for Phase III trials including combinations with Imfinzi in ovarian (DUO-O) and endometrial (DUO-E) cancers, as well as in resectable NSCLC (AEGEAN).

In addition to the EMERALD programme across multiple liver cancer settings, AstraZeneca has ongoing registrational trials investigating Imfinzi in resectable gastric and gastroesophageal junction cancers (MATTERHORN) and in locally advanced oesophageal cancer (KUNLUN). In June 2023, Imfinzi added to standard-of-care neoadjuvant chemotherapy met a key secondary endpoint of pathologic complete response in the MATTERHORN Phase III trial.

Immutep Completes Enrollment in TACTI-003 Phase IIb Trial of Efti and KEYTRUDA® in First Line Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

On November 9, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported the completion of patient enrollment in the TACTI-003 (KEYNOTEPNC-34) Phase IIb trial evaluating eftilagimod alpha (efti), its proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (Press release, Immutep, NOV 9, 2023, View Source [SID1234637287]).

The Phase IIb trial enrolled 171 patients at over 30 centres across the United States, Europe, and Australia to evaluate the safety and efficacy of efti in combination with pembrolizumab in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumors (Cohort A) and in patients with PD-L1 negative tumors (Cohort B).

A total of 138 patients with recurrent or metastatic HNSCC whose tumours express PD-L1 (CPS ≥1) have been enrolled into the 1:1 randomized Cohort A of the trial evaluating the safety and efficacy of 30mg of efti in combination with 400mg of KEYTRUDA given every six weeks compared to 400mg of KEYTRUDA alone. Patients in Cohort A whose tumors express PD-L1 (CPS >1) are also stratified by CPS 1-19 and CPS >20, and the clinical results for these three CPS groups will be evaluated.

Additionally, 33 patients with recurrent or metastatic HNSCC were enrolled into Cohort B to determine the efficacy and safety of the same combination therapy in patients with PD-L1 negative tumours (CPS <1). These patients are not expected to respond to KEYTRUDA monotherapy, with a typical Overall Response Rate of up to 5%, and therefore were not randomized. 1 Due to a higher number of patients with negative PD-L1 expression (CPS <1) who were eligible for and allocated to Cohort B and the number of patients in screening at the time of achieving the trial’s enrollment goal, the trial enrolled 171 patients.

The primary endpoint of the study is Overall Response Rate of evaluable patients according to RECIST 1.1. Secondary endpoints include Overall Survival, Overall Response Rate according to iRECIST, Progression Free Survival, and Duration of Response. The primary analysis according to the trial protocol will be performed after all subjects have completed at least three cycles of treatment (18 weeks in total) or discontinued the trial, and all relevant data for the primary endpoint has been collected, cleaned, and analysed. The Company expects to report data from the trial in H1 CY2024.

Dr. Frédéric Triebel, CSO of Immutep, said: "The completion of patient enrollment in TACTI-003 represents an important milestone in the clinical development of efti. We hope to build upon the encouraging data previously seen combining efti with the anti-PD-1 KEYTRUDA in the second line HNSCC setting. Dr Florian Vogl, our CMO who joined Immutep earlier this year, will oversee the completion of this important trial."

Dr. Florian Vogl, CMO of Immutep, added: "We are very excited to have completed patient enrollment in this randomised, multi-national trial and look forward to sharing data in the first half of 2024. Head and neck squamous cell carcinomas represent a difficult-to-treat, heterogenous cancer and an area of high unmet need. Our results in the second line setting provide optimism for the potential of efti in combination with pembrolizumab in the first-line treatment of these aggressive tumours."

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer by incidence worldwide, with 890,000 new cases and 450,000 deaths reported in 2018.2,3,4 It is an aggressive, genetically complex, and difficult to treat cancer.5 Furthermore, HNSCC is associated with high levels of psychological distress and compromised quality of life (QOL).6 As such, HNSCC patients need improved treatment options.

Eftilagimod alpha was granted Fast Track designation by the FDA in April 2021 for treatment of first-line HNSCC. For more information about the Phase IIb trial, visit clinicaltrials.gov (NCT04811027).

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

About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

Araris Biotech AG Announces Research Collaboration with Taiho Pharmaceutical to Develop Next-Generation ADCs Using Araris’ Proprietary Linker-Conjugation Technology

On November 8, 2023 Araris Biotech AG ("Araris"), a Swiss oncology biotech company developing next-generation antibody drug conjugates (ADCs), reported they have entered a collaboration agreement under which Araris will use its proprietary linker-conjugation platform to generate novel ADCs against undisclosed targets provided by Taiho Pharmaceutical Co., Ltd., a Japanese R&D-driven specialty pharma company with a focus on oncology (Press release, Araris Biotech, NOV 8, 2023, View Source [SID1234651282]).

ADCs delivered by Araris will be further tested and evaluated by Taiho. The financial terms of the collaboration agreement were not disclosed.

"We are proud to enter a collaboration with Taiho Pharmaceutical and look forward to working with the Taiho team to develop next-generation ADCs with improved efficacy and tolerability," said Dragan Grabulovski, Ph.D., acting chief executive officer of Araris.

Philipp Spycher, Ph.D., chief scientific officer of Araris added, "This agreement underlines the potential of our linker-payload platform to deliver novel ADCs with excellent properties, and it positions our company as a highly attractive partner for pharmaceutical companies."

Alloy Therapeutics and Wheeler Bio Announce Preferred Service Offering for Alloy Partners to Accelerate the Translation from Discovery to CMC

On November 8th, 2023 Alloy Therapeutics, Inc., a biotechnology ecosystem company and Wheeler Bio, Inc., an agile contract development and manufacturing organization (CDMO), reported the formation of a non-exclusive, preferred service offering to drive translation from Discovery to CMC development and clinical material supply for ecosystem partners (Press release, Alloy Therapeutics, NOV 8, 2023, View Source [SID1234642128]). The organizations are collaborating to provide a premiere service experience for Alloy partners requiring CMC development services from Wheeler as a high-quality, reliable CMC service provider for development and GMP manufacturing.

Alloy and Wheeler Bio are offering a premium service experience for existing and future ATX-Gx platform users and Alloy Discovery Service partners who also contract Portable CMC development services with Wheeler Bio. This fully integrated offering reflects Alloy’s creative approach to enabling a flexible Insight-to-IND service, connecting partnered antibody projects with Wheeler’s Portable CMC platform to provide a seamless pathway to high quality and affordable lead selection and CGMP material production.

Introducing Wheeler’s Phase offering, where partners of both Alloy and Wheeler will receive the following preferred services:

Dollar-for-dollar reductions in Alloy commercial milestones matching Wheeler Portable CMC services contracted for ‘Lead-to-Tox’ and ‘Lead-to-Clinic’ programs.
Free CMC consulting services to advise ecosystem partners on the translation from discovery to CMC development.
Zero charge CHO pool generation for up to 4 leads, for Alloy partners contracting Wheeler’s Lead-to-Tox or Lead-to-Clinic Portable CMC programs.
50% reduction in initial payment for Alloy partners contracting Wheeler Lead-to-Clinic Portable CMC programs.
Zero reservation fee required to hold manufacturing slots for Alloy partners contracting Wheeler full Lead-to-Clinic Portable CMC programs.
"Following every great antibody and bispecific discovery process, CMC becomes the critical path to treating patients. We developed this preferred offering with Wheeler to support Alloy’s partners with the highest quality cell line development and GMP manufacturing process possible," said Errik Anderson, CEO and Founder at Alloy Therapeutics. "Alloy is helping to lower the cost of drug development by reducing our partners’ downstream payments dollar-for-dollar on their path to the clinic. Wheeler’s high-quality, predictable, fit-for-purpose approach increases the probability of success and reduces the time to clinic for these drug programs. Sharing our economics to help align the ecosystem and accelerate the path of new therapies is a win-win for everyone: Our partners, Alloy, Wheeler, and most importantly, patients."

Alloy is a leading provider of antibody discovery platforms and services with over 150 partners to date with a leading team that has collectively put hundreds of antibodies into the clinic. Alloy’s most popular platform, ATX-Gx, is a best-in-class transgenic mouse strain for fully human antibody discovery which has a proven track record of delivering robust immune response and antibody output with diverse affinity and epitopic coverage. On top of this industry leading humanized transgenic mouse platform Alloy has built a full stack of advanced antibody discovery services including advanced technologies for B-cell repertoire mining and sequencing, proprietary integration of AI/ML, as well as protein engineering and functional testing to rapidly move partners from target idea to validated lead candidate in as quickly as 6 months.

Wheeler Bio’s mission is to solve the translational challenges inherent in advancing from discovery to CMC development and clinical trial material supply. To solve these challenges, Wheeler has developed Portable CMC as an open-source process platform and workflow of pre-clinical and clinical development services based around discrete CMC milestones. The Portable CMC platform is designed to align with clients’ fund-raising milestones, providing a very flexible, affordable, and rapid path to clinical supply. With the implementation of its Portable CMC platform for antibodies, Wheeler Bio is helping emerging biopharma companies reduce manufacturing risks in parallel with drug discovery to enable them to progress smoothly and successfully into drug development and first-in-human studies.

Aligned with its open collaboration model, Alloy partners are still free to use any CDMO of their choice. The preferred service offering is designed to guarantee at least one high-quality CDMO partner for each Alloy partner. By bringing together the ecosystem benefits of Alloy’s world-class discovery engine, along with Wheeler’s reliable CMC services, the Wheeler Phase offering will rapidly traverse the translational gap between discovery and material supply to the clinic. This strategic partnership avoids time lost in selecting a CDMO partner and managing the transition of information to a CDMO that does not know the discovery history, thereby eliminating the CDMO selection process via implementation of a de-risked and proven manufacturing platform (Portable CMC). With implementation of the Phase offering, Wheeler Bio is cementing its unique strategy and commitment to linking discovery and CMC, which most service providers overlook in the path to clinic. This Wheeler CRO partnering model can also be applied more broadly with other discovery providers to further bridge the translational gap between discovery and CMC clinical delivery.

"By closely aligning Alloy’s discovery platform with Wheeler’s development and manufacturing platform, our ecosystem clients benefit immensely by skipping the CDMO RFP process while reducing risk in tech transfers," said Jesse McCool, CEO and Co-Founder at Wheeler. "Our bioprocess models are in lockstep with ATX-Gx derived antibodies, so Wheeler services represent the best, most efficient use of CMC capital for Alloy partners."

"We are elated to participate as an early adopter of the Alloy-Wheeler partnership to speed our path from discovery to CMC development and first patient dosing," stated Hemanta Baruah, Co-Founder and CEO at Aakha Biologics. "Both Alloy and Wheeler are laser focused on meeting our needs as a small biotech start-up with specific goals to generate early data to further enable our fundraising efforts, while also providing a rapid path to the clinic."