1stOncology™: Cancer Intelligence Service – Page 6587 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Domain Therapeutics Raises $42m Series A Financing

On May 10, 2022 Domain Therapeutics, a biopharmaceutical company specializing in the research and development of innovative drugs targeting G Protein-Coupled Receptors (GPCRs) in immuno-oncology, reported the closing of a US $42m (€39m) series A financing round co-led by Panacea Venture, CTI Life Sciences and 3B Future Health Fund, and joined by adMare BioInnovations, Schroders Capital, Omnes, Turenne Capital, Theodorus, Viva BioInnovator and existing investor Seventure Partners (Press release, Domain Therapeutics, MAY 10, 2022, View Source [SID1234614129]).

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!

This investment is a significant step forward for the French-Canadian company as it seeks to bring novel therapeutic solutions to cancer patients, aimed at bypassing immunosuppression mediated by GPCRs. Domain Therapeutics will use the proceeds of this financing to i) conduct the clinical development of its EP4R antagonist, DT-9081, ii) advance two additional GPCR programs, including an anti-CCR8 antibody, to the Investigational New Drug application stage, and iii) progress its discovery-stage pipeline of a number of first-in-class assets targeting GPCRs, identified through its proprietary platforms.

"We are pleased to welcome our new shareholders and I thank them all for their commitment at this decisive stage of our company’s growth," comments Pascal Neuville, CEO of Domain Therapeutics. "After having delivered a first GPCR drug candidate for immuno-oncology together with Merck KGaA, Domain is now committed to advance its own treatments reviving the immune system to defeat cancer."

With the expansion of immune checkpoint inhibitor treatments and the understanding of how tumors highjack and escape the immune system, even under immunostimulating treatments, GPCRs have recently emerged as strategic targets responsible of immunosuppression and treatment-resistance mechanisms. Domain Therapeutics is leveraging its insights into GPCR science and technology to develop a robust immuno-oncology pipeline designed to harness the power of immunity and to broaden the impact of immunotherapies. In addition, Domain Therapeutics scientists are hunting for biomarkers, tissue microarray data, genetic mutations and protein expression to select patients who will benefit most from its immunotherapy treatments.

"Panacea Venture foresees in Domain Therapeutics an outstanding potential in terms of value creation in the near future by leveraging the promise of GPCRs to deliver innovative immunotherapies," adds James Huang, Founding Managing Partner of Panacea. "We look forward to contributing to the success and the development of the company."

"We are very proud to co-lead this strategic financial round to support Domain Therapeutics capabilities to innovate and transform the company into a clinical-stage biotech." mentions Laurence Rulleau, Managing Partner at CTI Life Sciences. "The presence of Canadian investors in this Series A reinforces the footprint of Domain in Montreal and will increase the visibility of the company in North America for future financing and clinical development."

"Domain Therapeutics has a unique positioning in GPCR-mediated immunoresistance. The combination of two decades of expertise in GPCR drug discovery and the development of the oncology franchise over the last years holds great promise to deliver innovative immunotherapies to patients and to address high unmet medical needs," remarks Roberto de Ponti, Managing Director and General Partner of 3B Future Health Fund. "We are delighted to support Domain Therapeutics high-performing management team in transforming a comprehensive portfolio of programs into cancer treatments."

The Board of Directors of Domain Therapeutics is now composed of : James Huang (Director, Panacea Venture), Laurence Rulleau (Director, CTI Life Sciences), Roberto de Ponti (Director, 3B Future Health Fund), Emmanuel Fiessinger (Director, Seventure Partners), Youssef Bennani (Chairman of the Board of Directors), Sylvie Ryckebusch (Independent Director), Pascal Neuville (Director and CEO), Katherine Cohen (Observer, Panacea venture), Frédéric Lemaître Auger (Observer, adMare BioInnovations), Erwin Boos (Observer, Schroders Capital) et Guillaume Blavier (Observer, Omnes).

Advisors involved in this operation

Lawyers

Advisors of the company:

Bird & Bird (Paris, France) : Emmanuelle Porte (Partner) and Claire Tanguy (Associate).
Advisors of investors:

BCF (Montreal, Canada): Gino Martel, Julien Lefebvre (Partners), Luka Pavlovic (Associate);
Jones Day (Paris, France): Geoffroy Pineau-Valencienne (Partner) and Jeanne Plé (Associate) ;
Chammas & Marcheteau (Paris, France): Jerôme Chapron (Partner), Pauline Vigneron (Associate) ;
Taylor Wessing (Paris, France): Nicolas De Witt (Partner) ;
McDermott Will & Emery (Paris, France): Emmanuelle Trombe (Partner), Laetitia de Dinechin (Associate).
Intellectual Property

Advisors of the company:

Vossius & Partner (Munich, Allemagne) : Oswin Ridderbusch (European Patent Attorney);
Lavery Avocats (Montreal, Canada): Alain Dumont (Partner).
Advisors of investors:

Goodwin Procter LLP (Boston, United States): Theresa C. Kavanaugh (Partner).
Financial advisors

Advisors of the company:

Agile Capital Markets (Paris, France) : Eric Cohen (Managing Director), Michael Khayat (Associate) ;
CenPonts Healthcare (Paris, France) : Xianding Ma (Partner), Jinlong Yue (Executive Director).

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.

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