1stOncology™: Cancer Intelligence Service – Page 7341 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Monrol Is Partnering With Telix Pharmaceuticals, Supplying Lutetium nca Lu 177 for the Manufacturing of Clinical Doses for the Phase II STARLITE 2 Study At MSK and Manufacturing Clinical Doses for Telix’s Phase III ZIRCON Trial

On May 10, 2022 Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) has reported that the first patient has been dosed in the ‘STARLITE 2’ Phase II study of Telix Pharmaceuticals Limited (Telix) investigational renal cancer therapy product, TLX250 (177Lu-DOTA-girentuximab), at Memorial Sloan Kettering Cancer Center (MSK) in New York (Press release, Eczacıbaşı-Monrol Nuclear Products, MAY 10, 2022, View Source [SID1234614128]). Monrol supplied Lutetium (Lu-177 n.c.a) to Telix Pharmaceuticals to manufacture clinical doses of TLX250 for STARLITE 2 Phase II study. This collaboration may offer significant opportunities for clear cell renal cell carcinoma (ccRCC) patients in the future.

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 STARLITE 2 Phase II study (NCT05239533) will assess the efficacy of TLX250 targeted radiation in combination with the anti-PD-11 immunotherapy Opdivo2 (nivolumab) for ccRCC, the most common and aggressive form of kidney cancer. The primary endpoint is to determine the safety and efficacy of combination therapy with TLX250 as assessed by the tumours responding to the Telix therapy versus the current standard of care alone. TLX250 targets carbonic anhydrase IX (CA9),3 a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy.4 The concept is that low doses of targeted radiation can potentially overcome immune resistance – or "immune prime" a tumour and therefore make it more responsive to cancer immunotherapy. Telix’s investigational companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) will also be used in the study to image CA9 expression.

Clinical doses of Telix’s investigational renal cancer companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is also produced by Eczacıbası Monrol in its Istanbul facility for the Phase III ZIRCON clinical trial.

ZIRCON Phase III study ("Zirconium Imaging in Renal Cancer Oncology") is an international multi-centre study at 34 sites in Europe, Australia, Turkey, Canada, and the United States. The study enrolled 30 patients in Turkey. The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth.

Monrol is a company developing, manufacturing, and distributing world-class radiopharmaceutical products, radioisotopes to improve quality of life of cancer patients globally and one of the few producers of Lutetium-177 n.c.a, having uninterrupted worldwide supply capabilities. Monrol Lu-177 n.c.a production process is an exclusive processing technology having cleaner and safer production method with stable isotope enrichment capability.

"Lu-177 n.c.a contributes to our mission to improve quality of life of cancer patients globally. Our new GMP certified facility exclusively designed for theranostic R&D and production with cutting edge technology will enable us to maximize supply of high-quality Lutetium worldwide. We are committed to working closely with Telix to potentially bring new therapeutic radiopharmaceutical agents into market soon to improve patients’ lives having life threatening diseases" said Monrol General Manager Aydin Kucuk".

Telix Chief Medical Officer, Dr. Colin Hayward noted, "The integration of precision nuclear medicine and medical oncology is underway and Telix is at the forefront of this movement to develop personalised products and patient-friendly regimens. We wish to express our gratitude to Dr. Darren Feldman and his clinical team, as well as the patients who will contribute to this ground-breaking study STARLITE 2".

Disclosure: MSK has institutional financial interests related to Telix.

About Lutetium-177 n.c.a

Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients today. Unique properties of Lutetium-177 n.c.a makes it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like Neuro Endocrine Tumors (NET), Prostate cancer and many other clinical development programs are ongoing for other cancers like ccRCC.

In line with the company mission to create hope for a better life for cancer patients, Monrol is establishing strategic partnerships with multinational pharmaceutical companies and constructing a new production facility compliant with FDA 21 CFR Part 211 quality standards which will have an annual production capacity of 60 thousand doses. With its location close to Istanbul, a major transportation hub, the new facility will benefit from a worldwide logistics network and agreements with cargo services to 320 destinations worldwide.

About TLX250

TLX250 (177Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets carbonic anhydrase IX (CA9), a cell surface protein that is highly expressed in several human cancers including ccRCC. High CA9 tumour expression is generally correlated with poor prognosis.

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is being developed by Telix for the purpose of determining whether "indeterminate renal masses", typically identified based on CT or MRI imaging, are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer. Telix’s companion investigational diagnostic imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is the subject of a global Phase III trial recruiting (ZIRCON trial, NCT03849118).

AbCellera Reports Q1 2022 Business Results

On May 10, 2022 AbCellera (Nasdaq: ABCL), a technology company with a centralized operating system for next-generation antibody discovery, reported financial results for the first quarter of 2022 (Press release, AbCellera, MAY 10, 2022, View Source [SID1234614127]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

"We entered 2022 with strong momentum that we leveraged to start new drug discovery programs and demonstrate the power of our platform by discovering a panel of CD3 antibodies for use in precision cancer treatments," said Carl Hansen, Ph.D., CEO and President of AbCellera. "With our strong cash position and book of business, we also continued pursuing deal structures that allow us to capture more downstream value and expanded an existing partnership to include the option to co-develop therapeutic programs."

Q1 2022 Business Summary

Earned $317 million in total revenue.
Generated net earnings of $169 million, compared to $117 million in Q1 2021.
Added two programs under contract with an existing partner, resulting in a cumulative total of 158 programs under contract with 36 different partners.
Started discovery on six programs, bringing the cumulative number of program starts to 84.
Confirmed one new molecule advanced into the clinic, bringing the cumulative total to six.
Key Business Metrics

AbCellera added two discovery programs in Q1 to reach a cumulative total of 158 discovery programs as of March 31, 2022 (up from 119 on March 31, 2021), that are either completed, in progress, or under contract with 36 different partners (up from 29 on March 31, 2021). AbCellera started discovery on an additional six programs in Q1 to reach a cumulative total of 84 program starts (up from 54 on March 31, 2021). AbCellera’s partners advanced one additional molecule into the clinic in Q1 2022, bringing the cumulative total to six.

Discussion of Q1 2022 Financial Results

Revenue – Total revenue was $316.6 million, compared to $202.7 million in Q1 2021. Royalties associated with bamlanivimab and bebtelovimab were $307.0 million. The partnership business produced research fees of $9.3 million, compared to $4.0 million in Q1 2021. Licensing revenue was $0.2 million.
Research & Development (R&D) Expenses – R&D expenses were $26.4 million, compared to $12.4 million in Q1 2021, reflecting continuing investments in the capacity and capabilities of AbCellera’s discovery and development platform.
Sales & Marketing (S&M) Expenses – S&M expenses were $2.4 million, compared to $2.6 million in Q1 2021.
General & Administrative (G&A) Expenses – G&A expenses were $14.3 million, compared to $6.4 million in Q1 2021, with the increase driven by investments to support the growth of the company and non-cash stock-based compensation.
Net Earnings – Net earnings were $168.6 million, or $0.59 per share on a basic and $0.54 on a diluted basis compared to $117.2 million, or $0.43 per share on a basic and $0.37 on a diluted basis in Q1 2021.
Liquidity – $786.1 million of cash, cash equivalents, and marketable securities.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

ImmunoGen Announces Webcast of Presentation and Q&A at Upcoming H.C. Wainwright Global Investment Conference

On May 10, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, will present at the upcoming H.C. Wainwright Global Investment Conference (Press release, ImmunoGen, MAY 10, 2022, View Source [SID1234614126]). The presentation will be available on May 24, 2022 at 7:00am ET.

A webcast of the presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the webcast, a replay will be available at the same location.

SQZ Biotechnologies Reports First Quarter 2022 Financial Results and Recent Portfolio Updates

On May 10, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported first quarter 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, MAY 10, 2022, View Source [SID1234614125]).

"Our year is off to an exciting start with the FDA IND clearance to initiate clinical trials of our eAPCs – our multifunctional mRNA-based investigational cell therapy that targets solid tumors by engineering multiple T cell signals simultaneously," said Armon Sharei, Ph.D., Chief Executive Officer and Founder at SQZ Biotechnologies. "We were also delighted by the recent FDA Fast Track Designation for our lead APC clinical candidate, which had promising clinical results in 2021, providing the potential to accelerate its registrational path. We look forward to continued progress on the evolution of our technology platform and unique therapeutic pipeline with anticipated clinical data across our APC, eAPC, and AAC trials in the second half of this year."

First Quarter 2022 and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Granted FDA Fast Track Designation for lead cell therapy candidate SQZ-PBMC-HPV; the designation is designed to accelerate the development and review of treatments for serious or life-threatening diseases
Published peer reviewed preclinical research supporting the development of SQZ APC cancer vaccine therapeutic programs in the Journal of Immunology
Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 trial of SQZ-PBMC-HPV
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Received FDA IND clearance to initiate a Phase 1/2 clinical trial (COMMANDER-001) of the first eAPC therapeutic candidate in patients who have HPV16+ solid tumors
Initiated enrollment of monotherapy stage of the COMMANDER-001 trial
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Continued enrolling and opening additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Published peer reviewed preclinical research in Frontiers in Immunology supporting potential SQZ TAC platform therapeutic development across a variety of complex autoimmune diseases
Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s point-of-care manufacturing system intended to produce clinical batches
SQZ Potential Pipeline Expansion Research

Awarded $2 million grant from the National Institutes of Health that will support the development of cell engineering methods to reprogram immune cells directly into dopamine-producing neurons as a potential novel therapeutic approach for the treatment of Parkinson’s disease
First Quarter 2022 Financial Highlights

Revenue for the quarter ended March 31, 2022, was $2.9 million compared to $5.5 million for the same period in 2021
Research and development expenses for the quarter ended March 31, 2022, were $17.0 million compared to $14.7 million for the same period in 2021; the increase was primarily due to higher development and manufacturing costs associated with our clinical-stage product candidates, as well as increased personnel-related costs to support continued progress with the Company’s pipeline
General and administrative expenses for the quarter ended March 31, 2022, were $6.9 million compared to $6.1 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
Net loss for the quarter ended March 31, 2022, was $21.0 million, compared to $15.4 million for the same period in 2021
As of March 31, 2022, the Company had cash and cash equivalents of $122.9 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023

All of Transgene’s preclinical and clinical assets progressed in line with expectations in Q1 2022

On May 10, 2022 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update for the quarter ended March 31, 2022 (Press release, Transgene, MAY 10, 2022, View Source [SID1234614123]).

Over the first quarter of 2022, all of Transgene’s preclinical and clinical assets progressed in line with expectations. All clinical-stage immunotherapies are slated to deliver data by the end of the year.

Key events of the period and upcoming news flow

TG4050

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 annual meeting, held in New Orleans, LA, April 8-13, Transgene discussed new preliminary positive data on TG4050, its individualized cancer vaccine. These immunological and clinical data highlight the potential of this highly innovative neoantigen vaccine.

A poster on the progress of the two ongoing Phase I trials of TG4050 has been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place in Chicago, IL, June 3-7, 2022. More information will be provided on May 27, 2022, after the release of the abstracts by ASCO (Free ASCO Whitepaper).

An article on the two ongoing trials with TG4050 was also published in the Journal for ImmunoTherapy of Cancer [[1]]. The publication demonstrated that it is possible to develop a patient specific vaccine within a few weeks for patients with a low to moderate tumor mutational burden.

BT-001

Promising preclinical data with BT-001 were presented at AACR (Free AACR Whitepaper) 2022 and published in the Journal for ImmunoTherapy of Cancer [[2]] demonstrating the broad and robust antitumor activity of this Invir.IO oncolytic virus.

Transgene and BioInvent will provide an update on the progress of the clinical trial of BT-001 in Q2 2022. Initial Phase I results will be presented at a scientific conference in H2 2022. These first results aim to establish the tolerability of BT-001 and to determine the dose and administration schedule for further development.

Invir.IO collaboration with PersonGen BioTherapeutics

Transgene announced the launch of a preclinical collaboration with PersonGen BioTherapeutics. This collaboration aims to evaluate the feasibility and efficacy of a combination therapy against solid tumors, combining PersonGen’s CAR-T cell injection with an oncolytic virus from the Invir.IO platform.

Governance

Transgene plans to reinforce its corporate governance by separating the roles of Chairman and CEO. Transgene’s Board of Directors has proposed Dr. Alessandro Riva, MD, as the Non-executive Chairman of the Company. If this nomination is accepted at the upcoming General Shareholder Meeting (May 25, 2022), the roles of Chairman and CEO will be separated. With 30 years of experience in the Life Sciences industry, Dr. Riva will be working closely with Transgene’s CEO Hedi Ben Brahim to realize the potential of the Company’s technology platforms and products to benefit cancer patients.

Transgene’s Board of Directors also proposed the appointment of Prof. Jean‑Yves Blay (subject to the authorization of the public authority to which he reports) and Laurence Espinasse as directors.

Steven Bloom joined Transgene as Vice President, Chief Business Officer (CBO). In this position, he has become a member of the executive committee, leading global business development strategy, alliance management and program management. In particular, he is focused on building the profile of Transgene in the US, where he is based, as part of establishing the Company as a world leader in virus-based immunotherapies.

Transgene also announced that the date of the release of the first half 2022 financial results and of the interim report has been advanced to September 7, 2022.

Summary of key ongoing clinical trials and expected milestones

myvac

TG4050

Phase I

NCT03839524

Targets: tumor neoantigens

ü Codeveloped with NEC

ü New positive data in first patients demonstrating the immunogenicity of the vaccine as well as first signs of clinical activity presented at AACR (Free AACR Whitepaper) 2022

Ü Additional data on the 2 trials expected at ASCO (Free ASCO Whitepaper) (June 2022) and H2 2022

Ovarian cancer – after surgery and first-line chemotherapy

ü Trial ongoing in the USA and in France

ü Patient enrollment progressing in line with forecast

TG4050

Phase I

NCT04183166

HPV-negative head and neck cancer – after surgery and adjuvant therapy

ü Trial ongoing in the UK and in France

ü Patient enrollment progressing in line with forecast

TG4001

+ avelumab
Phase II

NCT03260023

Targets: HPV16 E6 and E7 oncoproteins

Recurrent/metastatic anogenital HPV-positive – 1st (patients ineligible for chemotherapy) and 2nd lines

ü Randomized Phase II trial comparing the combination of TG4001 with avelumab versus avelumab alone

ü Active patient enrollment in Europe (France and Spain), trial initiated in the USA

Ü Results of the interim analysis expected in Q4 2022 (N≈50)

Invir.IO

BT-001

Phase I/IIa

NCT04725331

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

ü Co-development with BioInvent

ü Very encouraging preclinical results presented at AACR (Free AACR Whitepaper) 2022

ü Trial ongoing in France, Belgium and approved in the USA

Ü Update on clinical trial expected in Q2 2022

Ü First Phase I clinical results to be presented at a scientific congress in H2 2022

TG6002

Phase I/IIa

NCT03724071

Payload: FCU1 for the local production of a 5-FU chemotherapy

Gastro-intestinal cancer (colorectal cancer for Phase II) – Intravenous (IV) administration

ü Multicenter trial ongoing in Belgium, France and Spain

ü Proof-of-concept data of the IV administration presented in 2021 (ESMO & AACR (Free AACR Whitepaper))

ü Dose escalation completed to the maximum projected dose (3×109 pfu), confirming the good safety profile. Assessment of this intensified administration schedule ongoing

Ü End of Phase I expected mid-2022

TG6002

Phase I/IIa

NCT04194034

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) administration

ü Multicenter trial ongoing in the UK and in France

ü Ongoing enrollment of patients from the latest dose escalation cohort (109 pfu)

Ü First data expected mid-2022

During the first quarter of 2022, revenue from collaborative and licensing agreements was mainly composed of revenue from the collaboration with AstraZeneca.

As of March 31, 2022, government financing for research expenditures mainly consisted of accrual of 25% of the research tax credit expected for 2022 (€1.7 million in the first quarter of 2022 compared to €1.5 million for the same period in 2021).

Cash, cash equivalents and other financial assets

Cash, cash equivalents and other financial assets stood at €46.8 million as of March 31, 2022, compared to €49.6 million as of December 31, 2021. In the first quarter of 2022, Transgene’s net cash burn was €2.8 million, compared to €7.2 million for the same period in 2021. This decrease is notably linked to the receipt in January 2022 of the $8 million payment from AstraZeneca following the exercise of a first license option in December 2021 for an oncolytic virus developed by Transgene.

The Company holds shares of Tasly BioPharmaceuticals valued at €18.9 million at the end of December 2021.

The Company has a financial visibility through the end of 2023.