Scilex Holding Company, a Sorrento Company, Announces Exclusive Product Distribution Agreement with CH Trading Group LLC to Expand Commercialization of ZTlido® across certain designated territories including Middle East and North Africa

On August 17, 2022 Scilex Holding Company ("Scilex"), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, reported the signing of a Product Distribution Agreement ("Agreement") for certain designated territories with CH Trading Group LLC ("CH Trading"), an international import, export and trading company focused on the Middle East and North Africa (MENA) Region and other markets, to distribute Scilex’s lead non-opioid commercial pain management product, ZTlido (Press release, Sorrento Therapeutics, AUG 17, 2022, View Source [SID1234618457]). Scilex is a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento").

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"Our Agreement with CH Trading is another significant step in our continuing efforts to expand our global presence with our portfolio of innovative non-opioid pain management products, to address unmet medical needs. We are extremely pleased to collaborate with CH Trading, whose deep expertise and relationships will help us build a solid foundation in key MENA Region and other markets," said Henry Ji, Ph.D., Executive Chairman of Scilex and Chairman and Chief Executive Officer of Sorrento.

"We are pleased to work with CH Trading to help support us through the processes of obtaining global Halal certification as well as regulatory approval in the overseas designated territories, so that we may continue to fulfill our mission to address patient pain management needs with ZTlido," said Jaisim Shah, Chief Executive Officer of Scilex.

"We are delighted to work with a non-opioid pain management leader like Scilex for distribution of ZTlido into these markets," said Elsayed Zayan, CEO of the CH Group family of companies, which include CH Trading. "Our mission is to promote healthy, ethical and productive lifestyle, including bringing innovative products to people throughout the OIC countries and the GCC and MENA Regions. Aligning with Scilex’s global ambitions means that together we can help more patients, partners, and public health systems collectively benefit."

Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) ("Vickers"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, have entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock and warrants to purchase common stock are expected to be listed on Nasdaq under the ticker symbol "SCLX" and "SCLXW," respectively. The boards of directors of each of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of Vickers’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

NuCana Reports Second Quarter 2022 Financial Results and Provides Business Update

On August 17, 2022 NuCana plc (NASDAQ: NCNA) reported that financial results for the second quarter ended June 30, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, AUG 17, 2022, View Source [SID1234618456]).

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As of June 30, 2022, NuCana had cash and cash equivalents of £46.5 million compared to £52.6 million as of March 31, 2022 and £60.3 million at December 31, 2021. NuCana continues to advance its various clinical programs and reported a net loss of £3.9 million for the quarter ended June 30, 2022, as compared to a net loss of £9.1 million for the quarter ended June 30, 2021. Basic and diluted loss per share was £0.07 for the quarter ended June 30, 2022, as compared to £0.17 per share for the quarter ended June 30, 2021.

"During the first half of the year, we have remained focused on the rapid and efficient implementation of our development plans," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "In the past few months, we initiated two studies: NuTide:323, a randomized Phase 2 trial of NUC-3373 in combination with other agents for the treatment of second-line patients with colorectal cancer; and NuTide:303, a Phase 1b/2 study of NUC-3373 in combination with other agents including the PD-1 inhibitor pembrolizumab, for the treatment of patients with solid tumors. We also continue to enroll patients in the Phase 1b/2 NuTide:302 study of NUC-3373 in patients with colorectal cancer and the Phase 2 monotherapy part of the NuTide:701 study of NUC-7738 in patients with solid tumors, which will expand to include combination with pembrolizumab."

Mr. Griffith continued: "From a corporate perspective, we recently announced that the Regional Court of Dusseldorf issued a judgement that Gilead’s sofosbuvir infringes our European composition-of-matter patent. We will continue to defend our patent rights and the foundational work of our late Chief Scientific Officer, Professor Chris McGuigan. Additionally, we regained compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market."

Mr. Griffith concluded: "We have provided multiple data updates for both NUC-3373 and NUC-7738 that demonstrate the potential of our ProTides to offer more effective and safer treatment options for patients with cancer. These data have highlighted the compelling anti-cancer activity and favorable safety profiles and pharmacokinetic properties of our product candidates. With an anticipated cash runway into 2025 and through numerous key milestones for both NUC-3373 and NUC-7738, we remain on track to provide a number of data updates over the coming year as we continue to advance our pipeline."

Anticipated Milestones: H2 2022 and H1 2023

• NUC-3373 (a ProTide transformation of 5-FU)

In the second half of 2022, NuCana expects to:

Commence enrollment in the randomized, controlled Phase 2 (NuTide:323) study of NUC-3373 in combination with other agents for the second-line treatment of patients with colorectal cancer;
Commence enrollment in the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents, including the PD-1 inhibitor pembrolizumab, in patients with solid tumors to identify additional indications for development;
Expand the Phase 1b/2 (NuTide:302) study of NUC-3373 in colorectal cancer patients, and evaluate NUC-3373-based regimens in combination with bevacizumab in second-line patients with colorectal cancer;
Announce data from the Phase 1b/2 (NuTide:302) study of NUC-3373 combined with leucovorin, irinotecan and bevacizumab in patients with colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents in patients with solid tumors to identify additional indications for development.
In the first half of 2023, NuCana expects to:

Announce data from the Phase 1b/2 (NuTide:302) study of NUC-3373 combined with leucovorin, irinotecan and bevacizumab in patients with colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents in patients with solid tumors to identify additional indications for development.
• NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In the second half of 2022, NuCana expects to:

Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors;
Commence enrollment in the Phase 2 part of the NuTide:701 study of NUC-7738 in combination with the PD-1 inhibitor pembrolizumab, in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 in patients with solid tumors.

In the first half of 2023, NuCana expects to:
Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 in patients with solid tumors.

Exscientia Business Update for Second Quarter and First Half 2022

On August 17, 2022 Exscientia plc (Nasdaq: EXAI) reported that Recent developments in the Company’s pipeline, collaborations, and operations, as well as financial results for the second quarter and first half 2022, are summarised below (Press release, Exscientia, AUG 17, 2022, View Source [SID1234618455]). In addition, Exscientia will host a conference call Thursday, August 18 at 1:30 p.m. BST / 8:30 a.m. ET to provide an overview of the company’s pipeline and corporate strategy.

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"In the first half of 2022, we delivered on major new and existing collaborations, advanced our pipeline programmes, and marked the 10-year anniversary of Exscientia’s founding. Over the past decade, we’ve pioneered an AI-driven approach to modernising drug discovery and development, and it was fitting that this quarter we also announced topline data from our EXS-21546 programme, one of the first AI-designed molecules to enter clinical trials," said Andrew Hopkins, D.Phil., Exscientia’s founder and Chief Executive Officer. "With over $730 million in cash, we believe we are in a strong position to deliver across our portfolio of drug projects for the long-term. Our strategy creates an agile interplay between our internal pipeline and partnered programmes, enabling us to move candidates between the two depending on the best fit for Exscientia and our partners, as well as how we can best impact the probability of success for patients."

Recent Highlights

Progress across internal and partnered pipeline, leveraging the Company’s precision medicine platform, as well as key components of Exscientia’s technology and operations.

Internal pipeline

Wholly, majority and co-owned programmes focused on areas in which Exscientia believes it can improve the probability of success, including precision oncology

Following topline data in June, the Company remains on track to initiate a Phase 1b/2 study of EXS-21546 (majority owned with Evotec) in the second half of 2022
Phase 1b/2 study will be optimised with simulation-guided clinical trial design principles as well as leverage Exscientia’s precision medicine platform to maximise potential impact to the most relevant patients
GTAEXS-617 (co-owned with GT Apeiron) CTA submission expected by year-end 2022
CTA and IND-enabling studies are ongoing, including translational work to support planned clinical trials expected to start in the first half of 2023
Partnered programmes

Utilising a scalable end-to-end platform to advance a broad pipeline, while also generating significant cash inflows to support advancements

First two targets identified in new Sanofi collaboration for oncology and inflammation & immunity, respectively
First precision medicine project initiated; focused on patient enrichment for a Sanofi biologic in oncology
Advancing Bristol Myers Squibb (BMS) collaboration with continued progress across both BMS1 and BMS2 collaborations
Following the achievement of recent successful drug discovery milestone, Exscientia and Bayer have mutually agreed to end collaboration; Exscientia will retain optionality to develop one of the two targets pursued under the collaboration
The Bayer agreement was the last Exscientia partnership based on AI-only design services, which included lower economics and reduced operational involvement in comparison with more recent partnerships
This update aligns with Company strategy to increasingly focus on programmes where Exscientia’s AI design, experimental biology and precision medicine platforms can be integrated
Recent clinical progress highlights ability of the Company’s advanced, AI-based platform to create novel molecules with high level of translatability to human biology

Announced topline data from EXS-21546 Phase 1a healthy volunteer study in June 2022
The study demonstrated that observed human pharmacokinetics for EXS-21546 were in line with what had been designed for and predicted in preclinical modelling, supporting a twice-daily (BID) dose for continuous A2A receptor inhibition over a dosing interval
EXS-21546 signalled inhibition of A2A receptor was sustained over the BID dosing period, demonstrating a level of lasting target engagement
EXS-21546 was well-tolerated with no CNS adverse events reported in the SAD portion at all doses (30mg, 90mg, 250mg, 400mg) and in the MAD portion at 150mg BID
Exscientia’s approach allows for significant cash inflows to drive the business

$111.0 million cash flow from collaborations in second quarter 2022, including $100.0 million from Sanofi, ending the first half 2022 with $732.0 million in cash, cash equivalents and short-term bank deposits
Includes constant currency mark-to-market foreign exchange impact of negative 8%
During the quarter, Exscientia recognised realised foreign exchange gains net of forward contract settlements of $14.0 million. The Company holds its deposits in both GBP and USD intended to match expected cash needs while limiting the impact of exchange rate fluctuations
Second quarter 2022 net positive cash inflows from operations of $72.9 million
Expanded leadership team in critical growth areas

Eileen Jennings-Brown joined as Exscientia’s Chief Information Officer, reporting to Garry Pairaudeau, Chief Technology Officer, and responsible for overseeing IT and DevOps. Ms. Jennings-Brown brings more than 25 years of experience across IT roles, including most recently heading technology for the Wellcome Trust.
Charlotte Deane, Ph.D., Chief Scientist of Biologics AI, who joined Exscientia in January 2022, was awarded an appointment to the Most Excellent Order of the British Empire (MBE) for leading the UK Research and Innovation’s rapid response call for projects addressing issues arising from the pandemic.
Select peer-reviewed publications and scientific meeting presentations during the quarter

"Coverage Score: A Model Agnostic Method to Efficiently Explore Chemical Space," was published in the Journal of Chemical Information and Modeling in July 2022. This advancement in active learning allows more efficient exploration of chemical space, potentially leading to increased diversity of candidates, faster model improvement and shorter time to candidate identification
"Surface Plasmon Resonance Screening to Identify Active and Selective Adenosine Receptor Binding Fragments," a study which further validates Exscientia’s innovative biosensor approach to screening wildtype GPCR targets to advance drug discovery, was published in the ACS Medicinal Chemistry Letters in June 2022
Three posters presented at the AACR (Free AACR Whitepaper) Annual Meeting in April, highlighting Exscientia’s human tissue precision medicine platform, including potential benefits of Exscientia’s AI-driven design to overcome known issues such as potency, toxicity and selectivity and improve patient outcomes
Investor call and webcast information

Exscientia will host a conference call on Thursday, August 18 at 1:30 p.m. BST / 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.

Second quarter and first half 2022 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 $1.2162, which was the noon buying rate of the Federal Reserve Bank of New York on June 30, 2022.

Revenue: Recognised revenue for the three and six months ended June 30, 2022, was $8.7 million and $17.2 million respectively, representing an increase of $8.3 million and $10.4 million compared to the three and six months ended June 30, 2021, primarily due to delivery on an increased number of projects across our second collaboration with BMS, revenues generated from the extension of the BMS agreement to leverage Exscientia’s precision medicine platform, and recognition of remaining revenues following the termination of the Bayer agreement.

R&D and cost of drug discovery: Due to various collaboration structures, expenditure incurred in relation to research and development activities may be recognised within one of several financial statement captions. The tables below show how these expenses are separated across the accounting categories.

Research and development expenses: R&D expenses for the three and six months ended June 30, 2022, were $40.2 million and $68.8 million respectively, as compared to $9.9 million and $15.1 million for the same period ended June 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 $9.1 million and $12.1 million for the quarter and half year ended June 30, 2022, as compared to $1.6 million and $1.9 million for the same period ended June 30, 2021.

General and administrative expenses: G&A expenses for the three and six months ended June 30, 2022, were $14.7 million and $24.2 million respectively, or 22.3% and 21.9% respectively of total operating expenses. For the three and six months ended June 30, 2022, G&A expenses increased by $5.6 million and $11.1 million compared to the three and six months ended June 30, 2021, primarily associated with an increase in personnel costs and additional costs incurred in relation to the operation of a listed company. Share-based compensation accounted for $3.3 million and $4.6 million for the quarter and half year ended June 30, 2022, as compared to $1.7 million and $2.0 million for the same periods ended June 30, 2021.

Cash inflows: For the second quarter 2022, Exscientia received $111.0 million in cash inflows from its collaborations as compared to $39.5 million during the second quarter 2021.

Cash, cash equivalents and bank deposits: Cash, cash equivalents and bank deposits as of June 30, 2022, were $732.0 million as compared to $683.7 million as of December 31, 2022. This includes a 12-month fixed term deposit of $121.7 million.

Scandion Oncology extends PANTAX trial due to better-than-expected tolerability of SCO-101

On August 17, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it has observed a better-than-expected tolerability of its potential new cancer treatment SCO-101 in the dose-finding PANTAX phase 1b-trial (Press release, Scandion Oncology, AUG 17, 2022, View Source,c3615032 [SID1234618452]). Thus, dosing is now escalated to higher levels than expected based on the initial findings in the CORIST trial, which prompted the amendment of the PANTAX trial design communicated in January 2021.

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The continued dose escalation extends the PANTAX trial meaning it is now expected to read out in the first half of 2023 (previously expected in the third quarter of 2022). Trial execution is strong with good patient recruitment and the trial is progressing well.

PANTAX is a dose-finding phase Ib-trial in patients with unresectable or metastatic pancreatic

cancer who are offered SCO-101 as an add-on therapy to their standard chemotherapy. The good tolerability of SCO-101 observed in this setting supports the overall profile of the compound as well tolerated in vulnerable patients.

"We have been positively surprised by the tolerability of SCO-101 observed in this trial, which further supports our belief in the potential of SCO-101 as a new cancer treatment improving options for patients. Naturally, we continue the dose escalation beyond our expectations in order to find the optimal dose of SCO-101 in this indication and combination, even if this of course postpones the readout from the trial", says Bo Rode Hansen, President & CEO of Scandion.

Scandion is also currently carrying out the CORIST phase 2-trial in which SCO-101 is studied as combination therapy in patients with metastatic colorectal cancer. Topline data from the ongoing second part of this trial is still expected during the third quarter of 2022.

US FDA accepts new drug application for GSK’s momelotinib for the treatment of myelofibrosis

On August 17, 2022 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for momelotinib, a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anaemia (Press release, GlaxoSmithKline, AUG 17, 2022, View Source [SID1234618451]). The US FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.

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The NDA is based on the results from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints, including Total Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate (SRR). The primary analysis data from the MOMENTUM trial were recently presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress.

Momelotinib is not currently approved in any market.

About the pivotal MOMENTUM phase III clinical trial

MOMENTUM is a global, randomised, double-blind phase III clinical trial of momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anaemic and had been previously treated with an FDA-approved JAK inhibitor. The trial was designed to evaluate the safety and efficacy of momelotinib for treating and reducing key hallmarks of the disease: symptoms, blood transfusions (due to anaemia) and splenomegaly (enlarged spleen).

The trial’s primary efficacy endpoint was TSS reduction of ≥50% over the 28 days immediately before the end of Week 24 compared to baseline TSS, using the Myelofibrosis Symptom Assessment Form. Key secondary endpoints included TI rate for ≥12 weeks immediately before the end of Week 24 with haemoglobin levels ≥ 8 g/dL and SRR based on splenic volume reduction of ≥35% at Week 24 from baseline.

Patients were randomised at 2:1 to receive either momelotinib or danazol (n=130 and n=65, respectively). After 24 weeks of treatment, patients on danazol were allowed to crossover to receive momelotinib. Early crossover to momelotinib was available for confirmed splenic progression. The trial enrolled 195 patients across 21 countries.

About momelotinib

Momelotinib is a potential new medicine with a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor, type I (ACVR1).1,2,3,4 Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.1,2,4 Additionally, direct inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anaemia.1,2,3,4

Momelotinib was most recently developed by Sierra Oncology, Inc., which GSK acquired in July 2022, building on GSK’s expertise in haematology and portfolio of specialty medicines and vaccines.

About myelofibrosis

Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signalling and is characterised by constitutional symptoms, splenomegaly, and progressive anaemia. Myelofibrosis affects approximately 20,000 patients in the US, with about 40% of patients already anaemic at the time of diagnosis and nearly all patients estimated to develop anaemia eventually.1,5 Patients will often require transfusions, and more than 30% will discontinue treatment due to anaemia.6 Anaemia and transfusion dependence strongly correlate with poor prognosis and shortened survival.7

GSK in oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates, and cell therapy, either alone or in combination.