On March 23, 2022 Exscientia plc (Nasdaq: EXAI) reported that (Press release, Exscientia, MAR 23, 2022, View Source [SID1234610838])

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Recent advancements in the Company’s pipeline, collaborations and operations as well as financial results for the fourth quarter and full year 2021 are summarised below. In addition, Exscientia will host a conference call on Thursday, March 24 at 12:30 p.m. GMT / 8:30 a.m. ET to provide an overview of the company’s end-to-end technology platform and progress towards automating drug discovery and development.

Recent Highlights

Progressed pipeline led by significant collaborations, expansion, and programme advancement

-Year-over-year pipeline progress with 11 new programmes added, including advancement of three programmes into IND-enabling studies and two programmes to late discovery
-Partnered programmes
oEstablished collaboration with Sanofi in January 2022 focused on development of up to 15 novel small molecule candidates across oncology and immunology, received $100 million upfront cash payment with the potential of $5.2 billion in total milestones plus tiered royalties; several targets have been identified since signing
oCommenced eighth drug discovery project with Bristol Myers Squibb (BMS) in early 2022 for programme against an undisclosed oncology target
oAchieved preclinical proof of concept milestone for a target within Bayer collaboration supporting advancement into late discovery
-Co-owned programmes
oEntered into IND-enabling studies for GTAEXS-617, a CDK7 inhibitor co-owned with GT Apeiron; IND/CTA submission expected by year-end 2022; additional translational data in several tumour types to be presented at the April 2022 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and throughout 2022
oOncology target selected with EQRx, the third in the multi-target collaboration
-Wholly and majority owned programmes
oPhase 1 healthy volunteer top-line data for EXS-21546, A2a antagonist in high adenosine signature cancers, on track for the first half of 2022; translational research on identifying adenosine specific gene signatures for patient selection to be presented at AACR (Free AACR Whitepaper) 2022
oWith support from the Bill & Melinda Gates Foundation, Exscientia has designed an Mpro molecule with pan-coronavirus activity demonstrating 200x greater potency in vitro than a commercially available oral COVID-19 antiviral; ongoing compound development with candidate nomination anticipated in the second half of 2022

Balanced business model has generated meaningful cash flows and strong balance sheet

-$85.3 million cash flow from collaborations in full-year 2021, ending 2021 with $758.9 million in cash and cash equivalents
-2021 net cash outflows from operations of approximately $9.0 million
-$100 million upfront payment from Sanofi collaboration signed in January 2022

Peer-reviewed publications and upcoming scientific meeting presence showcase impact of translational research, clinical impact of precision medicine platform and differentiated technology platform

-Three abstracts accepted for poster presentation at AACR (Free AACR Whitepaper) 2022 highlight the potential of Exscientia’s precision medicine platform and AI capabilities in designing optimised molecules, improving translational research and identifying novel pathways
-EXALT-1 clinical trial results published in Cancer Discovery demonstrate the benefit of the first AI-supported functional precision medicine platform to guide treatment selection and improve outcomes in patients with advanced haematological cancers
-Select peer-reviewed publications describe recent advancements in Exscientia’s technology platform
-Fragment Hotspot Mapping to Identify Selectivity-Determining Regions Between Related Proteins describes a computational method to map protein binding pockets and identify critical regions that can be exploited to generate selective molecules
oDeep generative design with 3D pharmacophoric constraints demonstrates the potential of a new method (DEVELOP) to utilise 3D representations of molecules and generate compounds with improved properties over previous methods
oGenerating property-matched decoy molecules using deep learning showcases a deep learning method for generating molecules to validate and improve virtual screening methods

Strengthened team to position Exscientia for future growth

-Richard Law, D. Phil, has been promoted to Chief Business Officer, effective March 4, with continued focus on driving impactful collaborations across our business models
-Professor Charlotte Deane, Ph.D, joined as Chief Scientist of Biologics AI, from the University of Oxford, focused on the application of AI, machine learning, and the design of protein structures in the discovery and develpment of novel drug candidates
-Significant progress in building out clinical organisation, including clinical operations, to prepare for pipeline expansion and future clinical trials
-Experienced drug discovery team established in Boston, Massachusetts, to focus on wholly owned pipeline

"2021 was a transformational year for Exscientia as we further validated and built-out our differentiated end-to-end AI platform. We executed across our business as shown by new and expanded collaborations, growing our pipeline with eleven new programmes. We significantly expanded our global operations and scaled our capacity. On top of these achievements, we also completed our upsized IPO on Nasdaq," said Andrew Hopkins, DPhil., Exscientia’s founder and CEO. "As we look to the future, we believe we are reaching a tipping point for realising the full potential of AI-driven drug creation. We’ve already seen historic investment across the industry. Exscientia has achieved many of the "firsts" in this field and is well-positioned to lead the way. The sheer scale that our AI systems lend to scientific discovery make it possible to keep pace with breaking science in a way never before seen. This year we are focused on bringing together the team we have built and the technologies we have invented to advance new medicine programmes toward the clinic, working with our pharma and biopharma collaborators toward audacious goals to tackle rare diseases and solve persistent scientific challenges, and to continue building out our one-of-a-kind precision medicine platform to bring truly personalised medicine to patients."

Investor Call and Webcast Information

Exscientia will host a conference call on March 24 at 12:30 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.

Fourth Quarter and Full Year 2021 Financial Results

For the convenience of the reader, the Company has translated pound sterling amounts to U.S. dollars at the rate of £1.000 to $1.350, which was the noon buying rate of the Federal Reserve Bank of New York on December 31, 2021.

Revenue: Revenue for the full year 2021, was $36.9 million, an increase of $23.9 million compared to the full year 2020, primarily due to the achievement of the opt-in milestone on the first candidate in-licensed under Exscientia’s collaboration with BMS.

R&D and cost of drug discovery: Due to various collaboration structures, R&D expenses may be included under multiple accounting line items. The tables below show how these expenses are separated across the accounting categories.

On March 23, 2022 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, reported financial results for the fourth quarter and full year ended December 31, 2021, the design for its pivotal Phase 3 trial for gedatolisib, an investigational pan-PI3K/mTOR inhibitor, and other recent business progress (Press release, Celcuity, MAR 23, 2022, View Source [SID1234610809]).

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The pivotal Phase 3 clinical trial, which is named VIKTORIA-1, will be an open-label, randomized study to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor. Prior to finalizing the Phase 3 trial design, Celcuity conducted two formal meetings with the U.S. Food and Drug Administration (FDA) to obtain their feedback.

The clinical trial will enroll subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PI3KCA mutations (WT) will be randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). Up to 351 subjects who are PIK3CA WT will be enrolled. Subjects who meet eligibility criteria and have confirmed PI3KCA mutations (MT) will be randomly assigned (1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D) or alpelisib and fulvestrant (Arm E). Up to 300 subjects who are PIK3CA MT will be enrolled.

The primary endpoints for this pivotal study are progression free survival (PFS), per RECIST 1.1 criteria, as assessed by blinded independent central review (BICR). The primary PFS endpoints will be evaluated separately in subjects who are PI3KCA WT and PI3KCA MT.

This multi-center, international trial is expected to enroll up to 651 subjects at approximately 175 clinical sites across the U.S., Europe, and Asia. Celcuity expects to initiate the clinical trial in the first half of 2022.

"We are excited to finalize the trial design for our pivotal Phase 3 study following productive meetings with the FDA," said Brian Sullivan, CEO and co-founder of Celcuity. "This design, we believe, provides us with an opportunity to generate data that could support the future submission to the FDA of a New Drug Application for gedatolisib to treat a broad patient population."

"There is an urgent need for better treatment options for HR+/HER2- metastatic breast cancer patients whose disease has progressed after treatment with a CDK4/6 inhibitor and endocrine therapy," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "We are very encouraged by the clinical data for gedatolisib and determined to advance its development for patients as quickly as possible."

Fourth Quarter 2021 Business Highlights and Other Recent Developments

●Celcuity obtained formal feedback from the FDA regarding the design of its proposed Phase 3 clinical trial, and the trial design has been finalized.

●In January, the FDA granted Fast Track designation to Celcuity’s lead drug candidate, gedatolisib, for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy.

●In November 2021, Celcuity and Pfizer entered into a Clinical Trial Collaboration and Supply Agreement. Under this agreement, Pfizer will supply Ibrance for Celcuity’s pivotal Phase 3 clinical trial for gedatolisib at no cost.

●Updated data from Celcuity’s ongoing Phase 1b clinical trial for patients with HR+/HER2- advanced breast cancer (ABC) was presented at the San Antonio Breast Cancer Symposium in December 2021. Consistent with the previously released results, the addition of gedatolisib to palbociclib and endocrine therapy demonstrated promising antitumor activity in both first and later line settings for HR+/HER2- ABC that compared favorably to published data for available therapeutic options. A significant objective response rate (ORR) was also observed in patients refractory to their last treatment or who had received two or more lines of prior treatment for advanced breast cancer. Gedatolisib was well tolerated with manageable toxicity and a low number of patients discontinued treatment due to an adverse event.

●Celcuity entered into a clinical trial collaboration agreement with the University of Rochester Wilmot Cancer Center and Puma Biotechnology in October 2021.

●Enrollment in the FACT-1 and FACT-2 trials evaluating CELsignia selected patients who have early-stage HR+/HER2- breast cancer was impacted by COVID-19 related delays during the fourth quarter and early 2022. Hospitalizations of patients with COVID-19 increased dramatically during this period which led hospitals to reduce clinical trial related activities. Interim results are now expected to be available in the first half of 2023.

Fourth Quarter and Full Year 2021 Financial Results

Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2021, compared to the fourth quarter and full year ended December 31, 2020.

Total operating expenses were $6.3 million for the fourth quarter of 2021, compared to $2.6 million for the fourth quarter of 2020. Operating expenses for the full year 2021 were $28.4 million, compared to $9.6 million for the full year 2020.

Research and development (R&D) expenses were $5.5 million for the fourth quarter of 2021, compared to $2.1 million for the fourth quarter of 2020. R&D expenses for the full year 2021 were $25.8 million, compared to $7.7 million for the prior year. The approximately $18.1 million increase during the full year 2021, compared to the full year 2020, resulted primarily from a $10.0 million upfront license fee related to the execution of the Pfizer license agreement, which included $5.0 million of non-cash expense for issuance of common stock. The remaining $8.1 million increase primarily resulted from expenses initially associated with the transfer of gedatolisib-related activities from Pfizer to Celcuity and subsequently the continued support and development of gedatolisib.

General and administrative (G&A) expenses were $0.8 million for the fourth quarter of 2021, compared to $0.4 million for the fourth quarter of 2020. G&A expenses for the full year 2021 were $2.6 million, compared to $1.9 million for the prior year. The approximately $0.7 million increase during the full year 2021, compared to the full year 2020, resulted primarily from a $0.4 million increase in compensation related expenses, including approximately $0.3 million of non-cash stock-based compensation.

Net loss for the fourth quarter of 2021 was $6.8 million, or $0.45 per share, compared to a net loss of $2.6 million, or $0.25 per share for 2020. Net loss for the full year 2021 was $29.6 million, or $2.21 per share, compared to $9.5 million, or $0.92 per share in 2020. Non-GAAP adjusted net loss for the fourth quarter of 2021 was $5.6 million, or $0.37 per share, compared to non-GAAP adjusted net loss of $2.1 million, or $0.21 per share, for the fourth quarter of 2020. Non-GAAP adjusted net loss for the full year 2021 was $21.4 million, or $1.60 per share, compared to non-GAAP adjusted net loss of $7.7 million, or $0.75 per share, for 2020. Non-GAAP adjusted net loss excludes stock-based compensation expense, issuance of common stock and non-cash interest. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles (GAAP) in the United States to non-GAAP financial measures, please see the financial tables at the end of this news release.

Net cash used in operating activities for the fourth quarter of 2021 was $6.1 million, compared to $2.1 million for the fourth quarter of 2020.

At December 31, 2021, Celcuity had cash and cash equivalents of $84.3 million, compared to cash and cash equivalents of $11.6 million at December 31, 2020.

Anticipated Milestones

Celcuity expects to achieve the following potential milestones over the next twelve months

●Provide an update on lifecycle development priorities for gedatolisib in the first half of 2022.
●Initiate two Phase 2 clinical trials to evaluate gedatolisib in HR+/HER2- breast cancer patients selected with a CELsignia PI3K Pathway Test.
●Obtain interim results from the FACT-1 and FACT-2 trials in the first half of 2023.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the fourth quarter and full year 2021 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial (877) 407-0784 and international callers should dial (201) 689-8560. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=d9da71b7fd. A replay of the webcast will be available on the Celcuity website following the live event.

On March 23, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported financial results for the fourth quarter and year ended December 31, 2021, and provided clinical development and operational highlights (Press release, Aura Biosciences, MAR 23, 2022, View Source [SID1234610808]).

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"We have begun 2022 with strong momentum, being on track to advance AU-011 in the clinic in multiple indications with significant unmet medical need. We look forward to initiating the pivotal trial in patients with early stage choroidal melanoma, which is the first indication in our ocular oncology franchise, in the second half of this year," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We are excited to have received Orphan Drug Designation from the European Commission, further validating the important role that AU-011 could play in the treatment of patients with this life-threatening disease globally."

Dr. de los Pinos continued: "We are also excited to expand our pipeline into additional solid tumors by initiating our Phase 1 trial in non-muscle invasive bladder cancer (NMIBC) in the second half of this year. We are encouraged by the NMIBC preclinical data that we presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancer Symposium, which supports this indication, as well as the preclinical data that will be presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting that further supports the broad oncology potential of our VDC platform. Underscoring our pipeline advancement is a solid balance sheet, with our cash position supporting operations into 2024."

Recent Pipeline Developments

•AU-011 is being developed for the treatment of early stage choroidal melanoma (CM), a life threatening rare disease with no approved drugs. Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in CM in the second half of 2022.
oOrphan Drug Designation granted to AU-011 by the European Commission for the treatment of uveal melanoma (includes CM). The European Commission grants Orphan Drug Designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union (EU) and when no satisfactory method of diagnosis, prevention, or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

•Leveraging the broad tumor targeting capabilities of the VDC platform, Aura is planning to pursue clinical development of AU-011 in NMIBC.

oPreclinical data demonstrating applicability of AU-011 in bladder cancer was presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancer Symposium. Preclinical results demonstrated that AU-011’s targeting of bladder cancer cells through heparan sulfate proteoglycans is tumor grade agnostic. Tumor binding and distribution of AU-011 was evident in both ex vivo human bladder cancer tissues and in an in vivo murine bladder cancer model. Collectively, these results support further investigation of the use of AU-011 in patients with NMIBC.

oNMIBC is an area of high unmet need with no approved targeted therapies. The AU-011 mechanism of action supports the opportunity for use as a first-line treatment following initial diagnosis and/or for the treatment of Bacillus Calmette-Guerin (BCG) refractory disease. The planned Phase 1 trial will evaluate the safety and early proof of mechanism, exploring local necrosis and evidence of immune activation, and Aura expects to initiate the trial in the second half of 2022.

•Aura is investigating additional potential indications for AU-011.

oPreclinical data highlighting the ability to target a broad number of tumor types will be presented as part of the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data that will be presented at the AACR (Free AACR Whitepaper) annual meeting support AU-011’s potential use to target modified heparan-sulfate proteoglycans that are overexpressed on the tumor cell surface. Activity was observed in every tumor type tested, indicating that there are numerous solid tumors to be considered for AU-011 in the clinic, particularly those derived from neural or epithelial lineages. The AACR (Free AACR Whitepaper) annual meeting is being held April 8-13, 2022 in New Orleans, LA.

Recent Corporate Updates

•John Maraganore, Ph.D., joins as a strategic advisor. Dr. Maraganore, former founding Chief Executive Officer (CEO) of Alnylam Pharmaceuticals (Alnylam) and biopharma industry leader, has joined Aura as a strategic advisor. Dr. Maraganore served as the founding CEO and a Director of Alnylam from 2002 to 2021, where he built and led the company from an early technology platform based on RNA interference through global approval and commercialization of the first four RNAi therapeutic medicines, ONPATTRO, GIVLAARI, OXLUMO, and LEQVIO. At Alnylam, he also led the company’s value creation strategy, achieving $25 billion in market capitalization, including over 20 major pharmaceutical alliances.

Recent Events

•Aura hosted a virtual Investor Day to discuss AU-011 in ocular oncology on Tuesday, March 22, 2022. The program included an overview of CM, AU 011’s unique mechanism of action, and a summary of the clinical data of AU-011 in CM to date. This was followed by a moderated Q&A with ocular oncology leaders Dr. Carol Shields, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University, and Dr. Hans Grossniklaus, Senior Professor of Ophthalmology and Founding Director of the Ocular Oncology and Pathology Service at Emory University. The webcast is available here.

Full Year and Fourth Quarter 2021 Financial Results

•As of December 31, 2021, Aura had cash and cash equivalents totaling $149.1 million. Aura believes its current cash and cash equivalents are sufficient to fund its operations into 2024.

•Research and development expenses increased to $8.0 million and $25.2 million for the three months and full year ended December 31, 2021, respectively, from $3.5 million and $18.0 million for the three months and full year ended December 31, 2020, respectively, primarily due to ongoing manufacturing development costs for AU-011 and higher personnel expenses from growing headcount due to the progression of clinical trials.

•General and administrative expenses increased to $3.6 million and $10.1 million for the three months and full year ended December 31, 2021, respectively, from $1.4 million and $4.2 million for the three months and full year ended December 31, 2020, respectively. General and administrative expenses include $0.9 million and $0.1 million of stock-based compensation for the three months ended December 31, 2021 and 2020, respectively. The increase was primarily related to personnel expenses due to an increase in headcount, as well as general increases in audit, legal, consulting, insurance, regulatory, and facilities expenses related to operating as a public company.

•Net loss for the three months and full year ended December 31, 2021, was $11.6 million and $35.3 million, respectively, compared to $4.9 million and $22.2 million for the three months and full year ended December 31, 2020, respectively.

On March 23, 2022 Kirilys Therapeutics, Inc., a private, preclinical-stage biopharmaceutical company founded by investment firm Catalys Pacific, reported that the Company completed a seed financing led by Lightspeed Venture Partners (Press release, Kirilys Therapeutics, MAR 23, 2022, View Source [SID1234610776]). The company licensed its lead compound, KRLS-017, from Ube Industries, Ltd., a premier Japanese chemical manufacturer. The company also completed a partnership agreement with D2G Oncology, Inc. which uses genetically defined animal tumor models to reveal relationships between cancer genotypes and drug efficacy. This financing round will enable Kirilys to complete all activities through the IND filing of KRLS-017, as well as preparatory work for the Phase 1 clinical development program.

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KRLS-017 is a reversible small molecule inhibitor of Cyclin Dependent Kinase 7 (CDK7). CDK7 has been implicated as a key regulator of both transcriptional addiction and cell cycle dysregulation in tumors and therefore represents an attractive target for therapeutic intervention across a broad range of solid tumors and hematologic malignancies. In preclinical studies, KRLS-017 demonstrated best-in-class potency, selectivity, and anti-tumor efficacy along with very favorable properties for an oral drug.

"Selective inhibition of CDK7 offers a compelling opportunity to bring new therapeutic options to patients suffering from difficult to treat transcriptionally-driven cancers," said Galym Imanbayev, M.D., partner at Lightspeed Venture Partners. "We are excited to back this unique combination of accomplished team, quality of asset, and a proprietary clinical strategy enabled by D2G Oncology."

"We founded Kirilys to combine ground-breaking science in precision oncology from D2G Oncology with excellent drug discovery from Japan," said BT Slingsby, M.D., Ph.D., M.P.H., founder and executive chairman of Kirilys and managing partner, Catalys Pacific. "KRLS-017 holds significant potential for patients worldwide and we are confident in the tremendously experienced Kirilys team to develop KRLS-017 and deliver on that promise."

Joining BT Slingsby and Takeshi Takahashi on the board of directors are Kapil Dhingra, M.B.B.S., who is the former Head of Roche Oncology and Co-Founder of Kirilys, and Galym Imanbayev, M.D., M.B.A., Partner at Lightspeed Venture Partners.

On March 23, 2022 XNK Therapeutics AB ("XNK") reported that the first patient has been treated in a Phase II clinical study using XNK’s leading autologous natural killer (NK) cell-based candidate drug in combination with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab) (Press release, XNK Therapeutics, MAR 23, 2022, View Source [SID1234610775]).

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"Having the first patient treated with NK cells in this clinical study is an important milestone in the clinical development of our leading drug candidate," said Johan Aschan, CMO of XNK Therapeutics. "The study is progressing well, and we look forward to the results."

The present investigator-initiated, open, randomized, controlled, Phase II study ISA-HC-NK (EudraCT: 2020-000994-26) compares XNK’s leading candidate drug combined with Sanofi’s anti-CD38 antibody Isatuximab with Isatuximab alone as a consolidation treatment following autologous stem cell transplantation in patients with newly diagnosed multiple myeloma. The clinical study takes place at the Karolinska University Hospital at its Huddinge site and encompasses at total of 60 patients with 30 patients in each treatment arm.