On April 4, 2022 RS Oncology, LLC, (RSO) a biotechnical company focused on the treatment of patients with malignant pleural effusion and mesothelioma, reported the dosing of the first patient with RSO-021 as part of its first-in-human Phase 1/2 clinical trial (MITOPE) at the University Hospitals of Leicester in the U.K (Press release, RS Oncology, APR 4, 2022, View Source [SID1234611390]). RSO will be evaluating its novel treatment, RSO-021, against a specific mitochondrial enzyme regulating oxidative stress pathways in cancer cells.

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This novel therapeutic approach has proven in pre-clinical studies to significantly reduce tumor burden in malignant mesothelioma and other cancer types by irreversibly binding and inhibiting a key enzyme in the antioxidant signaling network within the mitochondria of malignant cells.

"Our team is excited to begin patient dosing with our novel metabolic therapy. This is a significant milestone in developing a treatment for people suffering from this horrible disease," stated CEO Jarrett Duncan. "We are eager to see activity of our drug in humans following our successful pre-clinical studies in multiple indications," added COO and Head of Business Development, George Naumov, Ph.D.

"Mesothelioma remains a lethal cancer lacking effective treatments, particularly in patients with relapsed disease. This exciting study of a first in class PRX3 inhibitor is hoped to show promising signals that could lead to development of a new approach to tackle this cancer." said the clinical investigator from Leicester Hospital, Professor Dean Fennell, FRCP FRSB.

About MITOPE clinical trial

The MITOPE Phase 1/2 clinical trial is a first-in-human study that will evaluate RSO-021 as a treatment for patients suffering from MPE and mesothelioma. RSO-021 is a novel irreversible inhibitor of a key mitochondrial enzyme (upregulated in cancer cells) regulating oxidative stress pathways. Treatment with RSO-021 will be administered weekly via an intrapleural catheter after routine pleural effusion drainage. The MITOPE trial is planned to open in six UK-based clinical institutions and will be recruiting patients in collaboration with Mesothelioma UK. For more MITOPE information review View Source or contact [email protected]. The study is supported by NIHR.

On April 4, 2022 Scilex Holding Company ("Scilex"), a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, reported an increase of 53% year-over-year preliminary unaudited gross ZTlido sales in March. ZTlido sold $8.1 million in March 2022 compared to $5.3 million in March 2021 (Press release, Sorrento Therapeutics, APR 4, 2022, View Source [SID1234611389]). In 1Q2022, the preliminary unaudited gross sales for ZTlido are approximately $18.4 million, compared to $14.6 million in 1Q2021, representing a growth of 26% .

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"We are pleased with the progress we have made to ensure patient and physician awareness, access, and adoption to ZTlido. Strong year-over-year sales growth continues to be driven by the expanding payor coverage for ZTlido as a cornerstone of topical lidocaine treatment in neuropathic pain related to post-herpetic neuralgia (PHN) where it continues to be used as first-line therapy," said Jaisim Shah, Chief Executive Officer of Scilex. "Importantly, our diversified portfolio of unique, best-in-class programs will increasingly allow us to offer complementary and standalone opioid-sparing outpatient pain management solutions."

The Scilex commercial team has demonstrated success in expanding access and currently has prioritized and targeted select payor accounts representing approximately 200 million of over 300 million covered lives in the US.

Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) ("VCKA"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, 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 is expected to be listed on Nasdaq under the ticker symbol "SCLX". The boards of directors of each of VCKA, 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 VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

On April 4, 2022 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator drug, mocravimod, reported that it has entered a €1.5 million Loan Agreement with the regional Bpifrance in Strasbourg (Grand Est Bpifrance), via Priothera SAS, its French affiliate (Press release, Priothera, APR 4, 2022, View Source [SID1234611386]).

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This R&D innovation loan will be used to further support the clinical manufacture of mocravimod for a European, US and Asian registration-enabling clinical trial with mocravimod in Acute Myeloid Leukemia (AML) patients undergoing allogeneic hematopoietic stem cell transplant (HSCT).

Brice Suire, Co-Founder and Chief Financial Officer of Priothera, said: "This non-dilutive financing, alongside the funding from the European Investment Bank that we announced recently, will play an important role in financing the development of mocravimod. It will allow us to strengthen our local French team and accelerate delivery of the clinical supply of mocravimod needed for our upcoming registration-enabling global clinical trial. We are very pleased with the confidence shown by Grand Est Bpifrance in supporting the Company in its development program."

Alban Stamm, Innovation Manager at Bpifrance Alsace commented: "We believe that Priothera, with its drug candidate mocravimod, has the potential to enable a major breakthrough in preventing transplant rejection which would provide a tremendous benefit to AML patients undergoing a stem cell transplant. The Bpifrance loan will support Priothera’s key objective of establishing human proof of concept and generating registrational data, allowing the company to create significant socio-economic value in France and beyond that for patients globally."

Mocravimod, a sphingosine 1 phosphate (S1P) receptor modulator which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of HSCT in patients with AML. Moreover, it has shown clinically relevant benefits in an early clinical study in patients with hematologic malignancies undergoing HSCT.

On April 4, 2022 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Company’s Management will participate in a fireside chat and one-on-one investor meetings at the 21st Annual Needham Virtual Healthcare Conference, to be held virtually April 11-14, 2022 (Press release, Selecta Biosciences, APR 4, 2022, View Source [SID1234611385]).

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21st Annual Needham Virtual Healthcare Conference
Format: Fireside chat and one-on-one investor meetings
Date: Thursday April 14, 2022
Time: 1:30 p.m. EST
Webcast: Click Here

An archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

On April 4, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s TakeAim Leukemia Phase 1/2a study (NCT04278768) (Press release, Curis, APR 4, 2022, View Source [SID1234611384]). The TakeAim Leukemia study is a Phase 1/2a open-label, single arm dose escalation and expansion study of orally-administered emavusertib (CA-4948) as monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

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While the partial hold is in place, no new patients will be enrolled in the study, and current study participants benefitting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower.

With the partial hold, the FDA is requesting additional data from the study, including data related to the death of a R/R AML patient who experienced, among several conditions, rhabdomyolysis, which has previously been identified as a dose-limiting toxicity of emavusertib. Additionally, the FDA is requesting safety, efficacy, and other data, including data related to rhabdomyolysis and the Company’s determination of the Recommended Phase 2 Dose for emavusertib in this study.

"We are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients’ lives," said James Dentzer, Chief Executive Officer of Curis. "Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with AML or MDS."

Curis expects to provide updated guidance on the timing of discussing the potential for a rapid registrational path for emavusertib with the FDA after the partial clinical hold is resolved and the related impact on the trial can be determined.

While this partial hold does not affect the TakeAim Lymphoma study (NCT03328078), a Phase 1/2 open-label dose escalating clinical trial investigating emavusertib in patients with B-cell malignancies, the Company has decided to pause enrollment of new patients in that study as well, pending resolution of the partial clinical hold in the TakeAim Leukemia study.