On November 15, 2022 CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, reported the close of an oversubscribed $120 million Series E financing round, co-led by ORI Capital, Longitude Capital and Decheng Capital, with participation from RA Capital Management, Acorn Bioventures, Malin Corporation, Ally Bridge Group and Sirona Capital (Press release, CG Oncology, NOV 15, 2022, View Source [SID1234624115]). The company has secured a total of over $200 million in funding to date. In connection with the financing, Brian Liu, M.D., Principal from Longitude Capital, will join the company’s board of directors.

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The proceeds from the Series E financing will be used to advance the company’s lead clinical programs in bladder cancer towards FDA approval as well as broaden the scope of its pipeline to address unmet medical needs in urologic cancer, such as the first-line setting in Bacillus Calmette-Guérin (BCG)-naïve, intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients.

"We are delighted by the support from leading global investors to help us accomplish our mission of developing innovative therapeutics for patients suffering from urologic cancers," said Arthur Kuan, Chief Executive Officer, CG Oncology. "Our continued clinical progress in bladder cancer is a testament to our lead candidate CG0070 in both monotherapy and combination therapy studies, setting the stage to further expand development across additional urologic oncology indications."

CG0070 is an intravesically delivered oncolytic immunotherapy agent in an ongoing Phase 3 trial (BOND3) with CG0070 as a monotherapy for the treatment of BCG-unresponsive NMIBC, and a fully enrolled combination Phase 2 study (CORE1) of CG0070 with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in the same indication. CG Oncology has a clinical collaboration with Merck (known as MSD outside the United States and Canada) to evaluate the combination of CG0070 with pembrolizumab in CORE1. Interim Phase 2 data for CORE1 announced at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 Annual Meeting on November 10, 2022, continue to show both strong anti-tumor activity and tolerability of CG0070 in combination with pembrolizumab for patients with BCG-unresponsive NMIBC.

"We have strong conviction in CG Oncology which continues to generate compelling data to develop potential bladder-sparing innovative therapeutics for patients suffering from bladder cancer," said Simone Song, Founder and Senior Partner of ORI Capital. "We’ve been strong supporters of the CG Oncology team from an early stage by leading the Series C round, and we are particularly proud to co-lead this round with Longitude Capital and Decheng Capital, as we see tremendous potential for CG0070 to be a game changer for patients with NMIBC."

"In advanced clinical studies CG0070 has continued to demonstrate potentially transformational results in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population," said Brian Liu, M.D., Principal, Longitude Capital. "I am excited to join CG Oncology’s board of directors during this significant expansion trajectory for the company and am looking forward to working with the leadership team to bring this therapy to patients in need."

CG0070 has been administered to over 200 patients for the treatment of bladder cancer. The investigational therapy has exhibited potential best-in-class efficacy and safety in monotherapy as well as strong response rates when combined with checkpoint inhibitors. Given CG0070’s combination results with strong complete response rates in heavily pre-treated BCG-unresponsive, high-risk NMIBC patients, there has been significant demand within the urologic community for CG0070 to also be investigated in the BCG-naïve NMIBC setting, where limited treatment options have been exacerbated by the global BCG shortage impacting both providers and patients. In response, CG Oncology has decided to investigate the activity of CG0070 as a first-line treatment of BCG-naïve, intermediate-risk NMIBC in a Phase 2 study to expand clinical development for additional patients with bladder cancer.

About CG0070

Our lead candidate, CG0070, is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. CG0070 is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO (nivolumab).

On November 15, 2022 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA," "the Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the results of a pre-clinical study of the Company’s lead drug candidate, THIO, in hepatocellular carcinoma (HCC) in vitro and in vivo models. MAIA presented the data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting, held Nov. 8-12 virtually and in Boston (Press release, MAIA Biotechnology, NOV 15, 2022, View Source [SID1234624114]).

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The results indicate that THIO, a first-in-class telomere-targeted agent may enhance the overall therapeutic efficacy of current immune checkpoint inhibitor-based treatments for HCC. In April, MAIA received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for THIO for the treatment of HCC.

Before the study, the researchers hypothesized that telomere-targeting agents may be effective in HCC. The study evaluated the activity of THIO and second-generation analogues in vitro using telomerase-positive HCC cells and in vivo using syngeneic mouse models of aggressive HCC.

The study found that THIO treatment:

Directly killed cancer cells, as it induced replicative stress, followed by cell cycle arrest and apoptosis in telomerase-reactivated HCC cells.
Stimulated anti-tumor immune response, as it activated pathways associated with innate and adaptive immunity and altered the immune-suppressive tumor microenvironment in syngeneic mouse models of aggressive HCC.
Enhanced the response to immune therapy checkpoint inhibitors, yielding complete responses in some HCC model systems with no dose-limiting toxicities.
"In addition to observing complete responses with no recurrence after THIO treatment, we identified immune memory, meaning that the body was able to autonomously target cancer cells when challenged with an influx of even more cancer cells," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "We are thrilled with this latest set of data as all models treated with THIO exhibited curative properties. The projected growth of liver cancer cases illustrates an increasing unmet global medical need for effective HCC therapies and this latest data reaffirms our belief in THIO’s potential to address it. We also strongly believe that the U.S. FDA’s Orphan Drug Designation of THIO for HCC further validates the quality of our data, and we look forward to continuing its clinical development."

About the SITC (Free SITC Whitepaper) 37th Annual Meeting

The SITC (Free SITC Whitepaper) 37th Annual Meeting provides a multidisciplinary educational and interactive environment focused on improving the outcome for current and future patients with cancer by incorporating strategies based on basic and applied cancer immunotherapy. The Annual Meeting consists of cutting-edge research presentations by experts in the field, oral and poster abstract presentations and ample opportunity for structured and informal discussions, including important networking opportunities. In addition, the meeting includes updates on major national and international initiatives coming from academia, government and industry, as well as important society projects. Additional meeting information is available on SITC (Free SITC Whitepaper)’s website.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with cemiplimab (Libtayo), a PD-1 inhibitor developed by Regeneron. Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or higher line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On November 15, 2022 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that its Chief Executive Officer, Zachary Hornby, will participate in a presentation and fireside chat at upcoming investor conferences (Press release, Boundless Bio, NOV 15, 2022, View Source [SID1234624113]):

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Piper Sandler 34th Annual Healthcare Conference

5th Annual Evercore ISI HealthCONx Conference

On November 15, 2022 Exscientia plc (Nasdaq: EXAI) reported that Recent developments in the Company’s pipeline, collaborations, and operations, as well as financial results for the third quarter 2022, are summarised below (Press release, Exscientia, NOV 15, 2022, View Source [SID1234624112]). Exscientia will host a conference call today, November 15, at 1:30 p.m. GMT / 8:30 a.m. ET.

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"At Exscientia, we are working towards the goal of leading the transformation of our industry’s approach to how drugs are created and how we can then specifically match these treatments to patients. Our capabilities in drug design and precision medicine have distinguished us as a pioneer in the field of AI-based drug discovery," commented Professor Andrew Hopkins, D.Phil., Exscientia’s founder and Chief Executive Officer. "Receiving the Prix Galien award in recognition of our integration of AI-driven precision medicine into drug discovery and development is a testament to our innovation. The concept of improving patient selection through our platform is a key tenet of our new strategic collaboration with The University of Texas MD Anderson Cancer Center, where we will combine our AI-driven drug discovery technology with the institution’s deep clinical expertise in oncology to develop treatments for patients. We believe that this partnership, in addition to our recent expansion into biologics, further positions us as leaders in the field as we continue to advance our pipeline and enhance our end-to-end platform."

Recent Highlights

Internal pipeline

Exscientia announced novel patient stratification methods and biomarker data supporting development of GTAEXS-617 (‘617) at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Annual Symposium
CTA submission expected by year-end 2022
Anticipate Phase 1/2 study to begin in the first half of 2023 in multiple solid tumour indications, including ovarian cancer
The Company remains on track to initiate "IGNITE-AI," a Phase 1b/2 study of its A2A programme EXS-21546 (‘546) by year-end 2022
Planned clinical study to look at combination therapies, including checkpoint inhibitors
New results outlining a predictive biomarker for patient selection, identified using Exscientia’s precision medicine platform, will be shared on today’s call
Additional data on patient selection modelling to be presented at a medical meeting by year-end 2022
Partnered programmes

Yesterday, Exscientia and MD Anderson, a premier cancer research and treatment centre in the United States, announced a strategic collaboration to develop small-molecule therapies in oncology
The agreement aligns MD Anderson’s drug development expertise with Exscientia’s AI-based patient-first precision medicine and drug discovery platforms
Additional target advanced in Sanofi collaboration for oncology
Continued progress in Bristol Myers Squibb (BMS) collaboration with all programmes from the 2021 expansion currently in the design phase
Expansion into new modality with biologics AI design

Exscientia announced the expansion of its platform for fast and accurate generative AI design of novel antibodies
Produced accurate protein modelling up to 35,000 times faster than Alphafold2
Approach of virtually modelling antibodies enables an evaluation of far more possibilities than laboratory screening, which Exscientia believes will help find the right antibody for a specific target
Exscientia’s deep learning virtual screening methodology for antibodies is now over three times more accurate than the published state-of-the-art
Sequencing paired human antibody data to create better AI models for antibody design
An additional 8,000 square foot laboratory facility in Oxford Science Park will automate the production of proprietary data for each antibody, measuring essential qualities including affinity, immunogenicity, aggregation and stability
The Company’s precision medicine platform is uniquely positioned for the characterisation of biologics in the oncology space with proven preclinical data from development of monoclonal and bi-specific immunotherapies
Next-generation sequencing (NGS) integrated into precision medicine platform

Exscientia’s newly established NGS capabilities enable state-of-the-art bulk and single-cell sequencing technologies, which can now be used across all Exscientia programmes, regardless of phase
The scalable sequencing platform allows time-efficient in-house genomic and transcriptomic profiling of all cancer patient tissue samples as well as the characterisation of the intratumoural heterogeneity, the tumour microenvironment and anti-tumour drug compound response at single-cell resolution
Exscientia recognition and leadership expansion

Awarded the Prix Galien USA 2022 Digital Health Solution for Exscientia’s AI-driven precision medicine platform. The Prix Galien recognises excellence in scientific innovation that improves the state of human health
Exscientia was pleased to welcome Caroline Rowland to the Company’s executive team as Chief People Officer in September. Caroline brings a wealth of deep tech experience in building culture and developing high performing teams
Investor call and webcast information

Exscientia will host a conference call today, November 15 at 1:30 p.m. GMT / 8:30 a.m. ET. A webcast of the live call can be accessed by visiting the "Investors and Media" section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialling +1 (888) 330 3292 (U.S.), +44 203 433 3846 (U.K.), +1 (646) 960 0857 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.

Third quarter and first nine months 2022 financial results

Exscientia consolidates and reports its financials in pounds sterling. For the convenience of the reader, the Company has translated pounds sterling amounts to U.S. dollars at the rate of £1.000 to $1.1134, which was the noon buying rate of the Federal Reserve Bank of New York on September 30, 2022.

Revenue: Recognised revenue for the three and nine months ended September 30, 2022, was $7.0 million and $22.7 million, respectively, compared to $19.6 million and $25.9 million for the three and nine months ended September 30, 2021.

Research and development expenses: R&D expenses for the three and nine months ended September 30, 2022, were $40.9 million and $103.8 million, respectively, as compared to $14.4 million and $28.2 million for the three and nine months ended September 30, 2021. The increase in research and development expenses was in part due to the growth of Exscientia’s internal and co-owned portfolio, in addition to increased headcount and other costs associated with the Company’s continued technology investments. Share-based compensation accounted for $8.1 million for the quarter ended September 30, 2022, as compared to $2.4 million for the same period ended September 30, 2021.

General and administrative expenses: G&A expenses for the three and nine months ended September 30, 2022, were $11.5 million, or 18.3% of total operating expenses, and $33.6, or 20.5% of total operating expenses respectively. For the third quarter 2022, G&A expenses increased by $1.9 million compared to the third quarter 2021, primarily associated with an increase in personnel costs. Share-based compensation accounted for $3.2 million for the quarter ended September 30, 2022, as compared to $1.4 million for the same period ended September 30, 2021.

Cash inflows: For the first nine months of 2022, Exscientia received $117.3 million in cash inflows from its collaborations as compared to $67.5 million during the first nine months of 2021.

Net operating cash flow and cash balance: For the first nine months ending September 30, 2022, net operating cash outflows were $15.0 million, in comparison to net operating cash inflows of $8.3 million in the nine months of 2021. Cash, cash equivalents and bank deposits as of September 30, 2022, were $624.7 million as compared to $625.9 million as of December 31, 2021.

Includes constant currency mark-to-market foreign exchange impact of negative 9% based on the strength of the USD during the quarter
During the quarter, Exscientia recognised realised foreign exchange gains of $8.3 million
The Company holds its deposits in both GBP and USD intended to match expected operational cash needs in order to limit the impact of exchange rate fluctuations
SELECTED CONSOLIDATED STATEMENT OF OPERATIONS, CONSTANT CURRENCY CONVERSION (unaudited)
($ millions, except per share data, at the rate of £1.000 to $1.1134)

On November 15, 2022 ElevateBio, LLC (ElevateBio), a technology-driven company focused on powering transformative cell and gene therapies, and Affini-T Therapeutics, a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported a partnership to advance Affini-T’s engineered TCR-T therapies focused on KRAS (Kirsten rat sarcoma viral oncogene homolog), one of the most prevalent oncogenic driver mutations in solid tumor cancers (Press release, ElevateBio, NOV 15, 2022, View Source [SID1234624111]). Affini-T will leverage ElevateBio BaseCamp’s LentiPeakTM lentiviral vector technology platform and cell therapy production capabilities to advance its investigational oncogenic driver programs into clinical development. ElevateBio BaseCamp is a purpose-built viral vector and cell therapy center of excellence with end-to-end process development and current Good Manufacturing Practice (cGMP) manufacturing capabilities for research, clinical and commercial cell and gene therapies, and regenerative medicines.

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"Affini-T is pioneering novel T cell therapy approaches to treat solid tumor cancers by striking at the core of tumor biology, which entails leveraging the most advanced tools and techniques in cell engineering," said Kim Nguyen, Ph.D., Chief Technical Officer, Affini-T Therapeutics. "Deep expertise in autologous cellular therapies manufacturing and analytics combined with its scalable platform for suspension-based lentiviral production, make ElevateBio an ideal partner as we progress our oncogenic driver programs into the clinic and work to deliver transformative therapies to patients and their families."

"We are pleased that our LentiPeak platform and cell therapy expertise can enable innovative developers like Affini-T to further accelerate their pipeline and look forward to working together so that we can bring forth these important therapies for difficult to treat solid tumors," said David Hallal, Chairman and Chief Executive Officer of ElevateBio. "At ElevateBio, we’ve combined multiple next-generation technology platforms with industry-leading expertise to transform the current cell and gene therapy development paradigm and provide our partners with a strategic advantage in the development of their therapies, and ultimately improve the speed of novel therapies to patients."

Affini-T’s proprietary platform is designed to select and engineer the right immune cells to orchestrate a durable and coordinated immune response within the immunosuppressive tumor microenvironment. The company is pioneering engineered T cell therapies with cutting-edge synthetic biology and gene editing enhancements to target oncogenic driver mutations at the core of tumor biology. Its engineered cell therapies are designed to overcome the immunosuppressive tumor microenvironment, enhancing T cell function to increase durability, build persistent responses, and augment tumor infiltration. Affini-T’s investigational cell therapies have the potential to offer new treatment options for patients affected by cancer with mutant variants of KRAS, which account for up to 30% of all cancers and are particularly frequent in cancers with high mortality rates, including lung cancer, colorectal cancer, and pancreatic cancer.