On July 18, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported the appointment of Aaron Rosenberg as Chief Financial Officer, effective July 22 (Press release, BeiGene, JUL 18, 2024, View Source [SID1234644949]). Mr. Rosenberg will succeed Julia Wang, who is departing to pursue external opportunities and will stay with the Company through August to support the transition.

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"We are thrilled to welcome Aaron amid a transformational year for BeiGene as we became a top 15 global oncology innovator by revenue with sustained progress to profitability and one of the most prolific and innovative pipelines in our industry including a plan to have at least 10 new molecular entities this year. Aaron’s financial leadership and impressive track record at Merck & Co. will be invaluable as we continue to responsibly scale our business and look to reinforce our global leadership in hematology as well as build future franchises in other highly prevalent cancers, including lung, breast and gastrointestinal," said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. "We extend our deep gratitude to Julia for her many significant contributions including scaling our financial capabilities to support our growth from 4,000 to over 10,000 employees across five continents, contributing to the launch of BRUKINSA, which is one of the most successful global drug launches in oncology, raising billions of dollars in capital from the global equity markets and helping drive financial excellence to improve operational efficiency. We wish Julia well in her future endeavors."

Mr. Rosenberg is a global finance executive with more than 20 years of experience at Merck & Co., Inc, known as Merck Sharp & Dohme outside of the United States and Canada. He was most recently Senior Vice President and Corporate Treasurer of Merck from 2021.

"I’m honored to join BeiGene at an inflection point in the Company’s growth with the opportunity to further strengthen this resilient global financial organization," said Mr. Rosenberg. "I deeply believe in BeiGene’s mission to develop and deliver innovative cancer medicines to more patients around the world, and I’m excited to be a part of this growing company and its experienced leadership team."

Prior to his role as Corporate Treasurer, Mr. Rosenberg served as Senior Vice President of Corporate Strategy and Planning at Merck from 2018 to 2021 with responsibilities including leading the enterprise-wide business transformation team and acting as Head of Financial Planning & Analysis. Mr. Rosenberg was Vice President and Finance Lead of Merck Animal Health from 2015 to 2018, leading a global team of 120 colleagues. He joined Merck in 2003 in ascending leadership roles in the global finance organization.

Mr. Rosenberg received a Bachelor of Science in Finance from the Warrington College of Business at the University of Florida and a Master of Business Administration from the Leonard N. Stern School of Business at New York University.

On July 18, 2024 Boehringer Ingelheim, a leading research-driven biopharmaceutical company, reported significant progress in its pipeline across key therapeutic areas as it reached major milestones in the first half of the year (Press release, Boehringer Ingelheim, JUL 18, 2024, View Source [SID1234646116]).

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"We are stepping up our investments in R&D beyond our plans announced in April," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "The data read-outs that we received in MASH and will receive for oncology, mental health, and pulmonary fibrosis give us reason to accelerate our launch preparedness for these late-stage assets. We are pleased to see our pipeline developing at such pace."

Boehringer advanced its pipeline across clinical phases with five new phase I, II, or III initiations in cardiometabolic diseases, mental health, and oncology, and achieved two additional fast track designations for programs in inflammation. At the same time, the company announced nine R&D partnership agreements, significantly bolstering its human pharma portfolio across all therapeutic areas and tech platforms.

"As our pipelines continue to expand, both in depth and breadth, we need to apply a rigorous focus where we allocate our resources," said Frank Hübler, Member of the Board of Managing Directors with responsibility for Finance. "We want to accelerate our pipeline where we can, to deliver innovative medicines to patients ever faster."

Net sales rose by 7.4%* year-on-year to EUR 12.9 billion in the first six months of 2024, driven by ongoing high patient demand for Boehringer’s medications, especially for the JARDIANCE product family and OFEV in Human Pharma, and NEXGARD in Animal Health.

Human Pharma
As Boehringer prepares for its future portfolio and ongoing and upcoming launches, the past months were marked by developments across all focus therapy areas. For the remainder of the year, more news is expected across the portfolio with data read-outs in oncology (Zongertinib), mental health (Iclepertin) and pulmonary fibrosis (Nerandomilast).

The company’s efforts to advance holistic cardiovascular, renal and metabolic (CRM) health met some major milestones. Positive Phase II data for survodutide in metabolic dysfunction-associated steatohepatitis (MASH) showed groundbreaking results in liver disease due to MASH, with 83.0% of adults treated with survodutide achieving significant improvements versus 18.2% for placebo (response difference: 64.8%; CI 51.1%-78.6%, p<0.0001). Also, a sub analysis demonstrated that up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of MASH vs placebo, 25.9% [response difference: 38.6% (95% CI 18.1% – 59.1%), p=0.0005].1

The company initiated a Phase III trial in chronic heart failure for its novel selective aldosterone synthase inhibitor (ASi) in combination with empagliflozin. In an upcoming Phase III trial in chronic kidney disease for ASi, Boehringer will collaborate with Oxford Population Health.

Boehringer has joined a multi-year sponsorship of the American Heart Association’s Cardiovascular-Kidney-Metabolic Health Initiative. The initiative, which was announced recently, will allow the company to better understand the burden of people affected by diseases in these interconnected areas and enable better care.

Boehringer is committed to re-entering oncology with targeted investments. Phase Ia/Ib trial of Zongertinib, a HER2-specific tyrosine kinase inhibitor in patients with HER2 aberration-positive solid tumors, showed that Zongertinib was well tolerated and demonstrated promising efficacy. 2 The Brightline-1 trial investigating Brigimadlin in dedifferentiated liposarcoma did not meet its primary endpoint, though the benefit-risk assessment remains positive. Data for both oncology trials will be presented at conferences in the coming months.

In the first six months of 2024, the Human Pharma business grew by 9.3%* year on year. Net sales stood at EUR 10.3 billion. Growth was driven primarily by the JARDIANCE family and OFEV. To meet growing demand, the company continues high investments in its production and supply network. In January, Boehringer announced a further expansion and upgrade of its plant in Koropi, Greece. With an investment of EUR 120 million, the company will increase the manufacturing capacity of new and existing medications, some of them in the late-stage development.

Animal Health
In livestock, the VAXXITEK portfolio of poultry vaccines continues to expand and grew by 15.9%*. The company launched BULTAVO 3, a new vaccine that protects cattle and sheep against bluetongue virus serotype 3 (BTV-3). It is the first BTV-3 vaccine that prevents clinical signs and mortality. BULTAVO 3 has been licensed for emergency use in the Netherlands, Belgium, and Germany. Recent outbreaks of BTV-3 in the three countries caused severe losses for farmers and are threatening neighboring countries.

In the Animal Health business, growth was slower than expected in the first six months, with sales up 0.9%* compared to the same period last year to EUR 2.5 billion. This was primarily due to lower-than-expected sales in the U.S. pet business and challenging market conditions in China, especially impacting the swine vaccine business. Most other markets delivered solid growth.

With the recent launches of NEXGARD PLUS for dogs and NEXGARD COMBO for cats, sales of the NEXGARD parasiticides brands grew by 15.9%*. FRONTPRO, the first approved over-the-counter chewable tablet against ticks and fleas for dogs, is now available in most countries in Europe and continues to drive growth in the region. In pet therapeutics, sales of VETMEDIN, indicated for use in dogs with congestive heart failure, grew by 16.1%*.

Pipeline Outlook
Looking ahead, the company aims for up to 25 new treatment launches in Human Pharma until 2030. In Animal Health, 20 additional launches are expected across markets until 2026, including product updates, indication expansion and new products.

On JuChampions Oncology, Inc. (Nasdaq: CSBR), a leader in the development of advanced preclinical oncology solutions, reported its financial results for the fiscal year and fourth quarter ended April 30, 2024 (Press release, Champions Oncology, JUL 18, 2024, View Source [SID1234644950]).

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Fourth Quarter Financial Highlights:
•Fourth quarter revenue increased 7% to $14 million
•Adjusted EBITDA fourth quarter income of $884,000
•Fourth quarter gross margin on pharmacology services of 49%

Fiscal Year 2024 Financial Highlights:
•Annual revenue of $50.2 million, a decrease of 7% year-over-year
•Fiscal Year 2024 adjusted EBITDA loss of $3.9 million
•Fiscal Year 2024 gross margin on pharmacology services of 42%

Ronnie Morris, CEO of Champions, commented, "As we discussed over the year, we’d be facing hurdles during fiscal 2024 due to the challenging funding environment in the biotech sector and a range of spending patterns from our larger pharmaceutical companies, leading to a slowdown in sales growth and an increase in cancellations. As we head into our fiscal 2025, the overall market sector is showing some signs of recovery and we feel we’ve turned a corner as we close out the year." Morris added, "With regards to our wholly owned subsidiary, Corellia, AI, we remain actively engaged with investors in an effort to raise capital while also carefully managing its expenses and the impact to our bottom-line results."

David Miller, CFO of Champions added, "In response to the challenges encountered over the course of the year, we’ve strategically implemented cost cutting measures and operational efficiencies to improve our bottom line. We began to see results from these efforts in the fourth quarter with adjusted EBITDA income of $884,000 and we believe we’re back on track to delivering profitable results on a consistent basis into fiscal 2025 and beyond."

Fourth Quarter Financial Results

Total revenue for the fourth quarter of fiscal 2024 was $14.0 million, an increase of 7%, compared to $13.1 million for the same period last year. The increase in revenue was primarily due to the operational improvements implemented over the year positively effecting our revenue conversion. Total costs and operating expenses for the fourth quarter of fiscal 2024 were $14.2 million compared to $15.6 million for the fourth quarter of fiscal 2023, a decrease of $1.4 million or 9%.

For the fourth quarter of fiscal 2024, Champions reported a loss from operations of $190,000, which includes $263,000 in stock-based compensation, $457,000 in depreciation and amortization, and a $354,000 loss on the disposal of lab equipment, compared to a loss from operations of $2.5 million, inclusive of $209,000 in stock-based compensation, $583,000 in depreciation and amortization, and an $807,000 asset impairment charge in the fourth quarter of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, and the disposal of equipment loss, Champions reported adjusted EBITDA income for the quarter of $884,000, compared to an adjusted EBITDA loss of $922,000 in the prior year period.

Cost of oncology solutions was $7.3 million for the three months ended April 30, 2024, a slight decrease of $87,000, or 1% compared to $7.3 million for the three months ended April 30, 2023. For the three months ended April 30, 2024, gross margin was 48% compared to 44% for the three months ended April 30, 2023. The margin expansion resulted from the improved revenue conversion while maintaining a generally stable cost structure.
Research and development expense was $2.0 million for the three months ended April 30, 2024, a decrease of $804,000, or 28%, compared to $2.9 million in the prior year. The decrease was primarily due to a decrease in compensation and lab supply expenses as we carefully monitored our R&D spend in both our core business and target discovery program. Sales and marketing expense for the three months ended April 30, 2024 was $1.8 million, a slight decrease of $73,000, or 4%, compared to $1.8 million for the three months ended April 30, 2023. The decrease was the result of a decrease in compensation expense offset by an increase in marketing opportunities. General and administrative expense was $2.8 million for the three months ended April 30, 2024 compared to $2.7 million for the three months ended April 30, 2023, an increase of $16,000, or 1%.

Net cash used in operating activities for the quarter was approximately $1.8 resulting primarily from an operating loss and changes in our working capital accounts in the ordinary course of business including, but not limited to, an increase in accounts receivable and a decline in deferred revenue. There were no investing activities for the quarter. Net cash used in financing activities for the quarter was $37,000 for the payment of financing leases. The Company ended the quarter with a cash position of $2.6 million and no debt.

Year-to-Date Financial Results

Total revenue for fiscal year 2024 was $50.2 million, a decrease of 7%, compared to $53.9 million for fiscal year 2023. The decline in revenue was primarily from customer cancellations in fiscal year 2023 resulting in lower study revenue during fiscal year 2024. Total operating expenses decreased 3% to $57.5 million for fiscal year 2024, as compared to $59.1 million for the prior year.

For the twelve months ended April 30, 2024, Champions reported a net loss from operations of $7.4 million, inclusive of $1.1 million in stock-based compensation expense, $1.9 million in depreciation and amortization expenses, and a $435,000 loss on the disposal of lab equipment, compared to a net loss from operations of 5.3 million, inclusive of $864,000 in stock-based compensation expense, $2.2 million in depreciation and amortization expenses, and an asset impairment charge of $807,000 for the prior year. Excluding stock-based compensation, depreciation and amortization, and an equipment disposal loss, Champions reported an adjusted EBITDA loss of $3.9 million for fiscal year 2024 compared to an adjusted EBITDA loss of $1.3 million in the prior year.

Cost of oncology solutions was $29.4 million for the twelve months ended April 30, 2024, a decrease of $131,000 or 0.4%, compared to $29.5 million, for the twelve months ended April 30, 2023. Gross margin was 41% for the twelve months ended April 30, 2024 compared to 45% for the twelve months ended April 30, 2023. The lower margin resulted from a decline in revenue against a generally unchanged cost base. Due to some operational inefficiencies, the variable cost component of cost of sales did not decline meaningfully despite the lower study volume.

Research and development expense was $9.5 million for fiscal year 2024, a decrease of $2.0 million, or 17%, compared to $11.5 million for the prior year. The decrease was primarily due to the implementation of cost savings strategies. Sales and marketing expense for fiscal year 2024 was $7.1 million, an increase of $62,000, or 1%, compared to $7.0 million for fiscal year 2023. The increase was primarily due to marketing initiatives, including increased conference attendance. General and administrative expense was $11.1 million for fiscal year 2024, an increase of $827,000, or 8%, compared to $10.2 million for fiscal year 2023. General and administrative expense was primarily comprised of compensation, insurance, professional fees, IT, and depreciation and amortization expenses. The increase in general and administrative expense was primarily due to an increase in compensation related expenses and non-cash depreciation and amortization offset by a decrease in IT expenses.

Net cash used in operations was $6.1 million for fiscal year 2024. Cash used in operations was primarily the result of our net loss. Net cash used in investing activities was $836,000 primarily from investment in additional lab equipment. Net cash used in financing activities was $527,000 resulting from repurchases of our common stock and financing lease payments offset by proceeds from option exercises. The Company has paused its stock repurchase program.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its fourth quarter financial results. To participate in the call, please call 888-506-0062 (domestic) or 973-528-0011 (international) ten minutes ahead of the call and enter the access code 135832. A replay of the call will be available by dialing 877-481-4010 (Domestic) or 919-882-2331 (International) and entering passcode: 50895, or by accessing the investors section of the company’s website within 72 hours.

Full details of the Company’s financial results will be available on, or before, Monday July 22, 2024 and no later than Monday July 29, 2024 in the Company’s Form 10-K at View Source

On July 18, 2024 Ono Pharmaceutical Co., Ltd. reported that Ono Pharma Korea Co., Ltd. ("OPKR"), a Korean subsidiary of Ono, received the additional approval of Opdivo (nivolumab) Intravenous Infusion ("Opdivo"), an anti-PD-1 antibody, in combination with cisplatin and gemcitabine on July 17 from the Ministry of Food and Drug Safety (MFDS) in South Korea, for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma (Press release, Ono, JUL 18, 2024, View Source [SID1234646252]).

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This approval is based on results from the Phase 3 CheckMate -901 study (CA209-901: ONO-4538-56), evaluating Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy, compared to cisplatin-gemcitabine alone, in patients with previously untreated unresectable or metastatic urothelial carcinoma (UC). In this study, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR), compared to chemotherapy alone. The safety profile of the regimens in this study was consistent with the known safety profiles of the individual components of the regimen. No new safety concerns were identified

 With respect to the indication of UC, Opdivo monotherapy was approved in South Korea for the treatment of "locally advanced or metastatic urothelial carcinoma that has progressed on or following platinum-based chemotherapy" in August 2017, and "adjuvant treatment in patients with muscle-invasive bladder carcinoma (MIBC) at a high risk of recurrence after undergoing radical resection" in February 2022.

About CheckMate -901 Study (CA209-901: ONO-4538-56)
 CheckMate -901 is a randomized, open-label Phase 3 study, evaluating Opdivo in combination with Yervoy (ipilimumab) (primary study) or Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (sub-study) compared to standard-of-care cisplatin-gemcitabine alone, in patients with previously untreated unresectable or metastatic urothelial carcinoma.
 In the CheckMate -901 study, cisplatin-eligible patients were randomized to receive either Opdivo 360 mg in combination with cisplatin-gemcitabine every three weeks for up to six cycles followed by Opdivo 480 mg monotherapy every 4 weeks until disease progression or unacceptable toxicity up to a maximum of two years, or cisplatin-gemcitabine alone every three weeks for up to six cycles. The primary endpoints of this study were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR). The OS and PFS outcomes are based on the final efficacy analyses of these endpoints.
 The primary study is ongoing to assess Opdivo plus Yervoy versus standard-of-care chemotherapy.

About Urothelial Carcinoma
 Bladder cancer is the ninth most common cancer in the world, with more than 610,000 new cases diagnosed in 2022 and more than 220,000 people die from it each year. Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but rates of recurrence and disease progression are high. Approximately 50% of patients who undergo radical surgery will experience disease recurrence, especially within the first two to three years after surgical removal of the bladder or kidney. For patients whose disease recurs as metastatic cancer, the prognosis is poor, with a median overall survival of approximately 12 to 14 months when treated with systemic therapy.

About Opdivo
 Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers since the approval for the treatment of melanoma in Japan in July 2014. Opdivo is currently approved in more than 65 countries, including Japan, South Korea, Taiwan, the US and European Union.
 In Japan, Ono launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable, advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell carcinoma in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017, unresectable advanced or recurrent malignant pleural mesothelioma which has progressed after chemotherapy in August 2018, microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy in February 2020, cancer of unknown primary in December 2021, adjuvant treatment of urothelial carcinoma in March 2022, malignant mesothelioma (excluding malignant pleural mesothelioma) in November 2023, and unresectable advanced or recurrent malignant epithelial tumors in February 2024.
 In addition, Ono has been conducting clinical development program including hepatocellular carcinoma, ovarian cancer, etc.

About Ono and Bristol Myers Squibb Collaboration
 In 2011, through a collaboration agreement with Bristol Myers Squibb (BMS), Ono granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to Opdivo except the US at the time. In July 2014, Ono and BMS further expanded their strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agent and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

On July 18, 2024 Exscientia plc (Nasdaq: EXAI) reported it has reached an agreement to acquire GT Apeiron’s share of its oral CDK7 inhibitor programme, gaining full control of GTAEXS617 (‘617) and all related intellectual property (Press release, Exscientia, JUL 18, 2024, View Source [SID1234644953]).

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The monotherapy dose escalation phase of ELUCIDATE is designed to assess the safety, pharmacokinetics and pharmacodynamics of ‘617 in advanced solid tumours. Recruitment for the trial is progressing well with monotherapy dose escalation data on track to readout in the second half of 2024. In late 2024/early 2025, the study will transition to a combination dose escalation phase. The first tumour type to be explored in this portion of the study is expected to be HR+/HER2- breast cancer patients that have progressed on CDK4/6 inhibitors, assessing ‘617 in combination with a selective estrogen receptor degrader (SERD).

"We are excited to have full ownership of this potentially transformative asset," said David Hallett, Ph.D., interim Chief Executive Officer and Chief Scientific Officer of Exscientia. "This underlines our confidence that we have not only used AI to design a potent and selective compound, but one that has balanced overall properties; these include a reversible mechanism of action and an appropriate human half-life to maximise the therapeutic index of this important cellular mechanism. CDK inhibitors are a major class of oncology drugs, and we believe our highly differentiated compound has the potential to greatly expand impact for patients and exemplifies our leadership in technology-driven drug design."

Under the terms of the agreement, Exscientia will own full rights to the intellectual property as well as full control of this CDK7 inhibitor programme. Exscientia will pay GT Apeiron $10 million in upfront cash, $10 million in upfront equity, and take on all existing development costs, in addition to paying single digit royalties if Exscientia or a third party commercializes ‘617. Following the transaction, Exscientia’s cash runway is still expected to extend well into 2027.

About ELUCIDATE

The ELUCIDATE trial is a multicentre, open-label, two-stage clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of ‘617 administered orally as monotherapy and in combination with standard of care therapies. The company is enrolling patients with solid tumours including head and neck cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer(NSCLC), breast cancer and ovarian cancer, who have advanced, recurrent or metastatic disease and have failed standard of care.

Both the monotherapy and combination therapy dose escalation portion of the trial will enrol patients across multiple dose levels to determine the optimal biological dose (OBD). The dose expansion phase of the trial will commence upon identification of the OBD. The primary efficacy endpoint of the expansion phase is objective response rate (ORR).

CDK7 inhibition combines many potential benefits such as transcription inhibition, reduction of aberrant kinome activation, cell cycle inhibition and modulation of estrogen receptor activity. This makes it an attractive target to overcome common resistance pathways associated with CDK4/6 inhibition, which only targets the cell cycle. Exscientia believes ‘617 has the potential to overcome significant safety and efficacy limitations of existing approved treatments due to the underlying biology of CDK7 and our laser focus on maximising therapeutic index through an AI-designed molecule that enables tight control of both extent and duration of target inhibition.