On March 7, 2023 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to reported that it has signed an initial collaboration agreement on the Company’s peptide technology, with Orano SA ("Orano"), a leading international corporation and a key player in the nuclear energy sector (Press release, ImmuPharma, MAR 7, 2023, View Source [SID1234628306]).

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Key points:

Orano has paid a small undisclosed amount to ImmuPharma for a 12-month collaboration to identify suitable radiotherapy candidates for the treatment of cancer.
ImmuPharma has agreed to provide its peptide technology, to explore the potential to allow delivery of a potent radioactive isotope to the core of a cancer cell.
Our team based in Bordeaux, (ImmuPharma Biotech), in conjunction with Orano and the Cancer Research Centre of Lyon (CRCL), will work together to identify molecules that can carry the radioactive entity.
Any potential new cancer therapeutic using ImmuPharma’s peptide technology, discovered as part of the collaboration will be subject to a full licensing agreement between ImmuPharma and Orano in preparation for further development by Orano.
The therapeutic goal is to use ImmuPharma’s peptide technology to deliver a radioactive bullet to the nucleus of cancer cells, killing the cell with minimal impact on surrounding tissue.
The radiopharmaceuticals market is expected to achieve global sales *€8.5bn by 2031. The combination of ImmuPharma’s peptide technology and a powerful radioactive bullet is an exciting new approach with significant commercial potential.
Further details of this development program will be communicated over the next 12 months.

*Source: Transparency Market Research, November 2022.

Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:

"We are delighted to have signed this agreement with Orano. It is the ideal program for our peptide asset given its ability to enter the nucleus of cancer cells. The combination of our peptide as a nuclear targeting vector, combined with the short-range destructive qualities of Orano’s radioactive bullet makes this a logical collaboration for both companies. Furthermore, we potentially create a new product life cycle for our peptide. We look forward to working with Orano and the Cancer Research Centre of Lyon over the next 12 months."

Commenting on the announcement, Guillaume Dureau, Orano’s Director of Research & Development and Innovation said:

"For Orano, it is a real opportunity to evaluate the potential of a highly promising compound, combining one of our new radioisotopes with a promising peptide previously developed by Immupharma. This will enable us to expand and strengthen our pipeline of innovative radiopharmaceuticals."

On March 7, 2023 Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing novel multifunctional biotherapeutics, reported financial results for the fourth quarter and year ended December 31, 2022 and provided a summary of recent business highlights (Press release, Zymeworks, MAR 7, 2023, View Source [SID1234628294]).

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"As I reflect on the past year as Zymeworks’ new Chair and CEO, we made significant progress across all aspects of our business to reset the Company and its R&D strategy on a new path forward to building a successful biotechnology company. We recently outlined our enterprise value framework where we will continue to focus on advancing the business across the five pillars during 2023: our two zanidatamab collaborations with BeiGene and Jazz, our early research and development programs, zanidatamab zovodotin, and our legacy platform licensing portfolio," said Kenneth Galbraith, Chair and CEO of Zymeworks. "With the transformative nature of the completed collaboration with Jazz, we believe we are well positioned to advance all elements of our business during 2023 despite current challenging macroeconomic conditions, with a significantly reduced cash operating burn and expected cash runway extending through 2026."

Recent Highlights and Current Developments

Completion of Zanidatamab Licensing Agreement with Jazz Pharmaceuticals
During the fourth quarter of 2022, we advanced a significant licensing and collaboration agreement with Jazz Pharmaceuticals plc (Jazz) for the exclusive license to develop and commercialize zanidatamab throughout the world except for those Asia-Pacific territories previously licensed to BeiGene, Ltd. Through December 31, 2022, we received $375 million in upfront payments and are eligible for reimbursement of ongoing zanidatamab-related costs expended after October 19, 2022. We remain eligible to receive up to $525 million upon the achievement of certain regulatory approval milestones and up to $862.5 million in potential commercial milestone payments, for total potential payments of up to $1.76 billion. Pending approval of zanidatamab, we are eligible to receive tiered royalties between 10% and 20% on Jazz’s annual net sales of zanidatamab.
Zanidatamab Continues to Advance with Multiple Upcoming Clinical Catalysts
HERIZON-GEA-01, a global, pivotal study evaluating zanidatamab in 1L HER2-positive GEA, continues to enroll patients with expected top-line data in 2024. Data presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2023 showed 84% overall survival at 18 months in 1L HER2-positive GEA patients treated with zanidatamab and standard chemotherapy. HERIZON-BTC-01, a pivotal study evaluating zanidatamab as monotherapy in previously-treated advanced HER2-amplified BTC patients, reported positive top-line data that 41.3% of enrolled patients with HER2-amplified and -expressing (IHC2+ and 3+) disease achieved a confirmed objective response rate (cORR) and a median duration of response of 12.9 months as assessed by independent central review. In conjunction with Jazz, we expect to present the full data set from HERIZON-BTC-01 at a major medical meeting in the first half of 2023. Zanidatamab was also recently selected for inclusion in the I-SPY platform trials for patients with HER2-expressing tumors in neoadjuvant treatment of locally advanced breast cancer, which continues to explore the potential use of zanidatamab in indications outside of GEA and BTC.
Eleven Abstracts Accepted for Presentation at AACR (Free AACR Whitepaper) Meeting in April
Zymeworks had 11 abstracts accepted for presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting taking place April 14-19 in Orlando, Florida. We look forward to sharing additional information on our preclinical product candidates and zanidatamab zovodotin. Zymeworks plans to host a conference call discussing these data in April after the presentation of all abstracts. Additionally, during 2023 we expect to nominate an additional preclinical product candidate with a goal of an expected IND filing by 2025.
Zanidatamab Zovodotin (ZW49) to Progress in Phase 2 Clinical Trial
With the announcement of the recommended Phase 2 dose (RP2D) of 2.5 mg/kg every three weeks, development of zanidatamab zovodotin continues with multiple Phase 2 studies expected to commence enrollment in 2023. We continue to explore potential development and commercial collaborations prior to undertaking any registrational studies of zanidatamab zovodotin, which are expected to commence before the end of 2025 at the earliest.
5 by 5 Research & Development Strategy

"We have set an ambitious target of generating five novel product candidates to move into clinical studies over the next five years, starting with INDs for both ZW171 and ZW191 in 2024," stated Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "With the capabilities of our platforms and productivity to generate novel antibody drug conjugate or multispecific antibody product candidates, we believe we can form new collaborations and partnerships around additional product candidates in order to advance further potential best-in-class opportunities with new external funding."

ZW171, our lead multispecific candidate, is a 2+1 bispecific antibody designed to co-engage tumor cells and immune cells (T cells) to enable T cell-mediated killing of tumor cells. ZW171 binds to the tumor target mesothelin (MSLN), which is expressed on many different tumors including pancreatic, mesothelioma, ovarian, and other mid to high MSLN-expressing cancers. Our team engineered and optimized the antibody design by layering our complementary technologies, including the use of Azymetric and EFECT.

ZW191, our lead antibody-drug conjugate (ADC) candidate, is engineered to target the folate receptor-alpha protein expressed on a variety of tumors. ZW191 delivers a cytotoxic chemotherapy, topoisomerase-1 inhibitor, to these tumor cells to kill the cancer. Using our Azymetric and Drug Conjugate technologies, our team customized the monoclonal antibody with enhanced internalization characteristics in order to potentially target high, mid, and low levels of folate receptor-alpha expression.

We also continue to have active licensing agreements with key pharmaceutical and biotechnology partners through our portfolio of legacy platform licensing agreements. Through this portfolio, we have received approximately $180 million in the form of non-refundable upfront and milestone payments to date, excluding any amounts received for zanidatamab or zanidatamab zovodotin. During 2023 and 2024, we expect to earn additional milestone payments under certain of these agreements as products continue to advance in development. Further, we continue to evaluate the option of monetizing all of or a portion of our rights to receive future milestone payments and royalties under these legacy agreements, should we need additional non-dilutive funding.

Leadership Appointments

During January, we made two key appointments in the clinical development organization with Jeff Smith, M.D., FRCP, appointed as Senior Vice President, Early-Stage Development, and Elaina Gartner, M.D., appointed as Vice President, Late-Stage Development. Dr. Smith has more than 30 years of drug development experience working for pharmaceutical, biotechnology and contract research organizations in Europe and North America, and is based in our new office in Dublin, Ireland. Dr. Gartner has more than 20 years of clinical research experience, and has been working with Zymeworks since 2019 located in our Seattle office.

Financial Results for the Year Ended December 31, 2022

Revenue was $412.5 million in 2022 compared to $26.7 million in 2021. Revenue for 2022 included $375.0 million for license and technology transfer fees from Jazz, $24.3 million in development support payments from Jazz, a $5.0 million upfront fee from Atreca, and $8.2 million from our other partners for research and development support under cost-sharing arrangements. Revenue for 2021 included $8.0 million from BeiGene for a development milestone, $8.0 million from Janssen for two development milestones, $5.0 million from Iconic for partner revenue, and $5.7 million from our partners for research and development support under cost-sharing arrangements.

Research and development expense was $208.6 million in 2022 compared to $199.8 million in 2021. Research and development expenses in 2022 included a non-cash stock-based compensation expense of $2.4 million comprised of a $3.2 million expense from equity classified awards and a $0.8 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified awards. Excluding stock-based compensation expense and restructuring, research and development expense increased on a non-GAAP basis by $16.2 million in 2022 compared to 2021. The increase related primarily to higher manufacturing expenses of zanidatamab for process performance qualification activities and clinical trial expenses for zanidatamab. These were partially offset by a decrease in expenses related to preclinical activities as well as a decrease in expenses related to clinical activities for zanidatamab zovodotin.

We expect research and development expenditures to increase over time, subject to periodic fluctuations that are in line with the advancement, expansion, and completion of the clinical development of our product candidates, as well as our ongoing preclinical research activities. As of October 19, 2022, Zymeworks is entitled to reimbursement from Jazz for expenses related to ongoing clinical studies of zanidatamab under the terms of the collaboration.

General and administrative expense was $73.4 million in 2022 compared to $42.6 million in 2021. In 2022, general and administrative expense included a non-cash stock-based compensation expense of $1.2 million comprised of a $4.1 million expense from equity-classified equity awards and a $2.9 million recovery from the non-cash mark-to-market revaluation of certain historical liability-classified equity awards. Excluding stock-based compensation expense and restructuring, general and administrative expense increased on a non-GAAP basis by $20.7 million in 2022 compared to 2021. This increase was primarily due to an increase in consulting fees, professional fees, and depreciation expenses as well as a non-recurring sales tax refund recognized in 2021, which partially offset expenses in the same period in 2021. The increase in expenses during 2022 were partially offset by a decrease in salaries and benefits expense as a result of a decrease in headcount due to our restructuring program.

Net income was $124.3 million in 2022 compared to net loss of $211.8 million in 2021. The increase in net income was primarily due to revenue from our collaboration agreement with Jazz, which was partially offset by both higher research and development expense and general and administrative expense as well as an increase in income tax expense.

"2022 was a very exciting year for Zymeworks as we reported annual net income of approximately $124 million, a substantially improved financial position, and a runway that allows for sufficient flexibility to fund our research and development and operating activities until at least 2026 and potentially beyond," said Chris Astle, Ph.D., Senior Vice President and Chief Financial Officer of Zymeworks. "We will continue to take a measured and cautious approach to our operating spend as we develop an exciting and broad portfolio of product candidates over the coming years. With continued R&D expenses for zanidatamab subject to reimbursement from Jazz, the vast majority of our net R&D spending going forward is related to the preclinical product portfolio with an additional staged investment in Phase 2 clinical studies for zanidatamab zovodotin."

As of December 31, 2022, Zymeworks had $492.2 million in cash resources consisting of cash, cash equivalents and short-term investments. Based on current operating plans, we expect to have cash resources to fund planned operations through at least the end of 2026, and potentially beyond. Further, with a substantially improved financial position and reduced cash burn rate, we have provided additional financial guidance to allow for an improved understanding of our future planned spending. For the calendar year 2023, we expect a net operating cash burn of between $90 million and $120 million, including planned capital expenditures of approximately $15 million.

On March 7, 2023 SOPHiA GENETICS SA (Nasdaq: SOPH), a cloud-native software company in the healthcare space, reported financial results for its fourth quarter and full fiscal year ended December 31, 2022 (Press release, Sophia Genetics, MAR 7, 2023, View Source [SID1234628293]).

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Recent Highlights

Revenue for the full-year 2022 was $47.6 million, representing year-over-year growth of 18% on a reported basis. 2022 constant currency revenue growth excluding COVID-19-related revenues was 39%
Revenue was $13.4 million for the fourth quarter, representing a 22% increase on a reported basis over the corresponding period of 2021. Constant currency revenue growth excluding COVID-19-related revenues was 44%
Gross margins reached a record 72% on a reported basis and 75% on adjusted basis for the fourth quarter of 2022
Operating losses moderated in the fourth quarter to $15.1 million on a reported basis and $12.1 million on an adjusted basis, marking the third consecutive quarter of improvement
2023 reported revenue growth guided to at or above 30%; 2023 constant currency revenue growth guidance excluding COVID-19 related revenues initiated at 30% to 35% vs. prior year comparable levels
Expanded strategic partnership with AstraZeneca to apply multimodal technology and expertise to the AstraZeneca oncology portfolio
Entered into an expanded agreement with Memorial Sloan Kettering Cancer Center ("MSK"), which allows SOPHiA GENETICS’ global network of healthcare providers access to MSK’s proprietary comprehensive liquid biopsy and tumor sequencing tests such as MSK-ACCESS and MSK-IMPACT, powered with SOPHiA DDMTM ("Data Driven Medicine")
Entered into agreement with Qiagen to pair QIAseq reagent technology with the universal SOPHiA DDMTM platform to enhance cancer and rare disease analysis for next-generation sequencing ("NGS") applications
CEO Commentary

"SOPHiA GENETICS delivered an acceleration of constant currency ex COVID revenue growth in each subsequent quarter of 2022, finishing the year with 44% year-over-year growth in the fourth quarter. Full year 2022 constant currency revenue growth was 32%, within our long-term growth guidance of 30-35%, however excluding the impact of expected COVID revenue declines, growth was a robust 39% driven by continued execution of our land and expand strategy across our clinical base, particularly the strong adoption of HRD, at triple-digit growth, and increased traction in our BioPharma business. This performance reflects the relevance of our unique market offering," said Jurgi Camblong, PhD., Chief Executive Officer and co-founder of SOPHiA GENETICS. "To be able to deliver in a time of global uncertainty speaks to the strength of our platform and our operating expense reductions are a demonstration of our fiscal discipline. Looking into 2023, on the heels of recent announcements with AstraZeneca, MSK, and Qiagen I could not be more excited about the opportunities that lie ahead and SOPHiA GENETICS’ ability to capitalize."

Ecosystem Update

In February, SOPHiA GENETICS announced an important expansion of its AstraZeneca partnership. SOPHiA GENETICS and AstraZeneca’s initial focus was targeting expanding worldwide access to homologous recombination deficiency ("HRD") testing. Now the companies will build on this by collaborating on how SOPHiA GENETICS’ multimodal approach might help AstraZeneca further their capabilities and elevate precision oncology, currently driven by genomic-based biomarkers, into a truly multimodal connected health ecosystem, specifically around discovery, by accelerating clinical trials.

Memorial Sloan Kettering Cancer Center, considered one of the most prominent cancer centers in the United States, entered into an agreement with SOPHiA GENETICS in January. The collaboration allows SOPHiA GENETICS’ global network of healthcare providers access to MSK’s proprietary comprehensive liquid biopsy and tumor sequencing tests such as MSK-ACCESS and MSK-IMPACT, powered with SOPHIA DDMTM. Additionally, the collaboration agreements will combine MSK’s rich precision oncology data with the SOPHiA CarePathTM module to enable the acceleration of actionable insights from data to improve patient outcomes.

In March, SOPHiA GENETICS announced a partnership with Qiagen N.V. to enhance the analysis of data generated from QIAseq reagent technology in cancers and rare diseases on the SOPHiA DDMTM platform. The partnership will allow customers to order combined QIAseq panels with the SOPHiA DDMTM platform from Qiagen directly. The goal is to allow customers to use SOPHiA GENETICS’ Set-Up Program, an efficient and reliable process that establishes and demonstrates the analytical performance of any test prior to it being carried out. This will enable customers to better and more efficiently design new workflows using QIAseq technologies.

Fourth Quarter 2022 Financial Results

Total revenue for the fourth quarter of 2022 was $13.4 million compared to $10.9 million for the fourth quarter of 2021, representing year-over-year growth of 22% on a reported basis. Constant currency revenue growth was 36%, and constant currency revenue growth excluding COVID-19-related revenue was 44%.

Platform analysis volumes were 71,066 for the fourth quarter of 2022 compared to 65,595 for the fourth quarter of 2021. The 8% year-over-year growth was attributable to strength in our core platform analysis volume, offset by the continued decline of our COVID-19-related analysis volume. Excluding COVID-19-related volumes, platform analysis volumes were 67,679 for the fourth quarter of 2022 compared to 57,204 in the fourth quarter of 2021, representing growth of 18% year-over-year in the period.

Gross profit for the fourth quarter of 2022 was $9.6 million compared to gross profit of $6.8 million in the fourth quarter of 2021, representing year-over-year growth of 41%. Gross margin was 72% for the fourth quarter of 2022 compared with 62% for the fourth quarter of 2021. Adjusted gross profit was $10.0 million, an increase of 42% compared to adjusted gross profit of $7.1 million in the fourth quarter of 2021. Adjusted gross margin was 75% for the fourth quarter of 2022 compared to 65% for the fourth quarter of 2021.

Total operating expenses for the fourth quarter of 2022 were $24.7 million compared to $27.8 million for the fourth quarter of 2021. Total adjusted operating expenses were $22.1 million compared to $24.6 million in the fourth quarter of 2021.

R&D expenses for the fourth quarter of 2022 were $6.8 million compared to $6.4 million for the fourth quarter of 2021.

Sales and marketing expenses for the fourth quarter of 2022 were $4.2 million compared to $8.6 million for the fourth quarter of 2021. The reduction in expenses was attributable in part to reallocation of headcount and related expenses to R&D and general and administrative.

General and administrative expenses for the fourth quarter of 2022 were $13.9 million dollars compared to $13.0 million for the fourth quarter of 2021.

Operating loss for the fourth quarter of 2022 was $15.1 million, compared to $21.0 million in the fourth quarter of 2021. Adjusted operating loss for the fourth quarter of 2022 was $12.1 million, compared to $17.6 million for the fourth quarter of 2021.

Net loss for the fourth quarter of 2022 was $14.0 million or $0.22 per share compared to $21.4 million or $0.33 per share in the fourth quarter of 2021. Adjusted net loss for the fourth quarter of 2022 was $11.0 million or $0.17 per share, compared to $17.9 million or $0.28 per share for the fourth quarter of 2021.

Full Year Fiscal 2022 Financial Results

Total revenue for full year 2022 was $47.6 million compared to $40.5 million for full year 2021, representing growth of 18% on a reported basis. The growth in revenue was primarily driven by increased usage rates across our existing customers, favorable mix shift to higher priced applications, and strength in HRD and our BioPharma offerings. Constant currency revenue growth was 32%, and constant currency revenue growth excluding COVID-19-related revenue was 39%.

Annualized revenue churn rate was 4% of total full year revenue for 2022, as compared to the historic low of 3% seen in 2021 as a result of pent-up demand due to the pandemic. Average revenue per platform customer for the full year was approximately $93,700 compared to approximately $92,000 for the prior year period, despite negative impact from significant currency headwinds. Net dollar retention for the year decreased to 102% from 142% in 2021, also negatively impacted by significant currency headwinds. Constant currency net dollar retention excluding COVID-19-related revenue was 123% as compared to 132% in 2021. Total recurring platform customers grew to 390 as of December 31, 2022, up from 382 as of December 31, 2021, and 383 as of September 30, 2022.

Gross profit for the full year 2022 was $31.3 million, an increase of 24% compared to a gross profit of $25.2 million for full year 2021. Gross margin was 66% for full year 2022 as compared with 62% for full year 2021. Adjusted gross margin was 68% as compared with 64% for the full year 2021.

Total operating expenses for full year 2022 were $119.1 million compared to $96.7 million for full year 2021. Total adjusted operating expenses for the full year 2022 were $104.3 million compared to $87.3 million for 2021.

R&D expenses for full year 2022 were $35.4 million, compared to $26.6 million for full year 2021.

Sales and marketing expenses for full year 2022 were $28.3 million, compared to $28.7 million for full year 2021.

General and administrative expenses for full year 2022 were $55.8 million, compared to $41.5 million for full year 2021.

Operating loss for full year 2022 was $87.8 million, compared to $71.5 million for full year 2021. Adjusted operating loss for full year 2022 was $72.0 million, compared to $61.5 million for full year 2021.

Net loss for full year 2022 was $87.4 million or $1.36 per share, compared to $73.7 million or $1.33 per share for full year 2021. Adjusted net loss for the full year 2022 was $71.6 million or $1.12 per share, compared to $62.3 million or $1.13 per share for full year 2021.

Cash and cash equivalents were $178.6 million as of December 31, 2022.

Full Year 2023 Outlook

Based on current business conditions, business trends and other factors, for the full year ending December 31, 2023, the Company initiates guidance of:

reported revenue growth expected to be at or above 30%;
full year constant currency revenue growth excluding COVID-19-related revenue to be between 30% and 35%; and
2023 operating losses to be below 2022 levels.
Constant currency revenue growth excluding COVID-19-related revenue is a non-IFRS measure. See "Presentation of Constant Currency Revenue and Excluding COVID-19-Related Revenue" below for a description of its calculation. The Company is unable to provide a reconciliation of forward-looking Constant currency revenue growth excluding COVID-19-related revenue to Revenue, the most comparable IFRS financial measure, due to the inherent difficulty in forecasting and quantifying the impact of foreign currency translation.

Webcast and Conference Call Information

SOPHiA GENETICS will host a conference call and live webcast to discuss the fourth quarter and full year 2022 financial results as well as business outlook on Tuesday, March 7, 2023, at 8:00 a.m. Eastern Time / 2:00 p.m. Central European Time. The call will be webcast live on the SOPHiA GENETICS Investor Relations website. The conference call can also be accessed live over the phone by dialing 1-866-652-5200 (United States) or 1-412-317-6060 (outside of the United States). Additionally, an audio replay of the conference call and webcast will be available on the SOPHiA GENETICS website after completion.

On March 7, 2023 Exscientia plc (Nasdaq: EXAI) reported a new collaboration with Charité – Universitätsmedizin Berlin (Charité) to utilise Exscientia’s AI-driven precision medicine platform in haematological cancers (Press release, Exscientia, MAR 7, 2023, View Source [SID1234628292]).

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Under the collaboration, Charité will evaluate the potential of Exscientia’s precision medicine platform to select better treatments and improve outcomes for patients with haematological cancers. Each patient sample will be prospectively evaluated with a broad panel of marketed drugs, including drugs that may not yet be approved for the indication, to determine a comparative response profile, ex vivo.

"Despite major advances in the treatment of haematological cancers, the mortality rate for patients suffering from these conditions remains high. Following the results of the EXALT-1 trial, we believe that this new collaboration with Exscientia may present an opportunity to continue exploring how to meaningfully improve therapy selection and patient outcomes. Simultaneously, it is imperative that we develop a new generation of therapeutics against unexplored targets and biomarkers to improve patient outcomes, and we believe that our newly established biobank will enable Exscientia to move towards this goal," said Prof. Ulrich Keller, M.D., Director Medical Department, Division of Haematology and Oncology at Charité.

This collaboration will expand on the results of the EXALT-1 study, which were previously published in the peer reviewed journal Cancer Discovery. EXALT-1 was a first-of-its-kind prospective trial, which demonstrated significantly improved outcomes for late-stage haematological cancer patients using Exscientia’s deep learning-based high content functional drug testing platform to guide personalised treatment recommendations as compared to physician’s choice of treatment. A post-hoc analysis published in Blood Cancer Discovery showed that combining this technology with new deep learning advancements leveraging cell-specific features in high-content images had the potential to further improve patient outcomes.

Charité will also establish a biobank of viably cryopreserved blood, bone marrow and lymph node tissues to support further technology development and preclinical research projects at both Exscientia and Charité. Unlike conventional biobanks that typically contain dead specimens, this will contain live human tissue samples and therefore be instrumental for clinical and translational research.

"We are really excited to work with Charité to further advance the development and capabilities of our AI-driven functional precision medicine platform. Following the success of the EXALT-1 trial, we believe that AI-guided treatment has the potential to significantly improve patient outcomes, as well as healthcare economics, and we look forward to Charité using this approach in a clinical research setting," said Professor Andrew Hopkins, D.Phil, Founder and CEO of Exscientia. "Charité’s work will contribute to Exscientia’s growing body of evidence supporting our platform’s potential in identifying the right treatment for the right patient. The systematic collection of viable tissue will allow us to further develop the technology as well as advance our clinical and future translational research around novel and better drugs as we seek to modernise the way we guide treatment selection for patients."

On March 7, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported that the first two patients have been dosed in Europe in MAIA’s Phase 2 clinical trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, MAR 7, 2023, MAIA Biotechnology Doses First Patients in Europe in Ongoing Phase 2 Trial (THIO-101) Evaluating THIO for Non-Small Cell Lung Cancer Treatment [SID1234628291]). Following regulatory clearances in Hungary, Poland, and Bulgaria, five clinical sites have been activated in these three European countries.

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The primary objectives of the THIO-101 trial are to evaluate the safety and tolerability, as well as preliminary clinical efficacy of THIO, a first-in-class cancer telomere targeting agent, in patients with advanced NSCLC, who either progressed or relapsed through the initial treatments with an immune checkpoint inhibitor alone, or in combination with chemotherapy. The Company dosed its first patient in the THIO-101 trial in Australia in July 2022 and commenced dosing patients in Europe in March 2023.

"We are very excited to commence enrolling patients in Europe in THIO-101 as five sites are being activated in three countries. THIO represents a potential treatment for patients with Non-Small Cell Lung Cancer, which currently has limited treatment options and continues to be defined by high unmet need and mortality," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We are very pleased with the progress we have made thus far as we are now enrolling patients in Australia and three European countries in this ongoing Phase 2 trial with THIO."

Mihail Obrocea, MD, MAIA’s Chief Medical Officer, added, "The initiation of dosing in MAIA’s Phase 2 clinical trial of THIO-101 in Europe depicts important progress for MAIA towards understanding the pharmacokinetics and safety of this first-in-class investigational medicine, and we very much look forward to potentially sharing the clinical data later this year."

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of an immune checkpoint inhibitor allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed for patients with NSCLC that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.