1stOncology™: Cancer Intelligence Service – Page 5467 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CORMEDIX INC. TO REPORT SECOND QUARTER 2022 FINANCIAL RESULTS AND PROVIDE A CORPORATE UPDATE ON AUGUST 11

On August 1, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the second quarter ended June 30, 2022, before the market open on Thursday, August 11, 2022, and will host a corporate update conference call at 8:30am Eastern Time (Press release, CorMedix, AUG 1, 2022, View Source [SID1234617183]).

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ZepzelcaTM (lurbinectedin) approved in Qatar for the treatment of metastatic Small Cell Lung Cancer (SCLC)

On August 1, 2022 Immedica Pharma AB reported that the MOPH Pharmacy & Drug Control Department has approved ZepzelcaTM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC) (Press release, Immedica Pharma, AUG 1, 2022, View Source [SID1234617182]).

"We are pleased to bring a new treatment choice to patients in Qatar with relapsed SCLC," said Anders Edvell, CEO at Immedica Pharma. "The Qatar MOPH approval of lurbinectedin underscores its potential to fill an unmet need in the SCLC community."

Immedica has a strategic alliance with Pharma Mar, the biopharma company which has successfully developed lurbinectedin. Both companies are committed to bringing innovative therapies to patients worldwide.

The approval of Zepzelca by Qatar MOPH Pharmacy & Drug Control Department is based on results from an open label, multi-center, single-arm clinical trial in 105 adults with relapsed SCLC1. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in relapsed SCLC, monotherapy with lurbinectedin had an overall response rate of 35% and a median duration of response of 5.3 months according to investigator assessments. The FDA approval is based on the same data.

Beam Therapeutics Announces FDA Clinical Hold on BEAM-201 IND Application

On August 1, 2022 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported that on Friday, July 29, 2022, the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the BEAM-201 Investigational New Drug (IND) application for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL) has been placed on clinical hold (Press release, Beam Therapeutics, AUG 1, 2022, View Source [SID1234617181]). BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate. The BEAM-201 IND was submitted at the end of June. The FDA indicated they will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending discussion with the FDA.

Evotec's translational BRIDGE beLAB1407 awards project from Dundee University

On August 1, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that after a successful call for proposals, University of Dundee has been awarded its first funding within the beLAB1407 BRIDGE initiative (Press release, Evotec, AUG 1, 2022, View Source [SID1234617180]). beLAB1407 is a translational BRIDGE collaboration between Evotec and Bristol Myers Squibb, aiming to accelerate translational research from the UK’s academic life science ecosystem.

Building on unique insights into cytokine biology originating from the lab of Dr Ignacio Moraga at the University of Dundee, the selected project will focus on the development of novel biologics for the treatment of inflammatory disorders including inflammatory bowel disease ("IBD"). By promoting the regenerative properties of cytokines while negating the often detrimental inflammatory properties, this method offers a unique approach to treat a variety of conditions. The lab of Dr Mairi McLean at Dundee will provide complimentary expertise in gastrointestinal human tissue organoid cultures.

Using Evotec’s integrated discovery and development platform, beLAB1407 will validate the concept of the approach. beLAB1407 was launched in May 2021 as a translational collaboration between Evotec and Bristol Myers Squibb.

Dr Thomas Hanke, EVP & Head of Academic Partnerships at Evotec, commented: "We are delighted to award and fund a Dundee project within the beLAB1407 BRIDGE. After being initiated in 2021, beLAB1407 makes good progress in supporting a portfolio of competitive drug discovery projects and we are pleased to work on the project aiming to resolve chronic autoimmune processes proposed by Dr Ignacio Moraga and his team."

Anne Muir, Head of IP and Commercialisation at University of Dundee commented: "I am delighted that this first award for Dundee involves the Schools of Life Sciences and Medicine working together. We look forward to more awards from this exciting initiative and to successfully supporting the spinout opportunities that it will enable."

KAZIA PROVIDES PROGRESS UPDATE ON GBM AGILE PIVOTAL STUDY

On August 1, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported a progress update on the GBM AGILE pivotal study (NCT03970447), a global adaptive clinical trial platform designed to evaluate multiple therapies for glioblastoma, to which paxalisib commenced enrolment in January 2021 (Press release, Kazia Therapeutics, AUG 1, 2022, View Source [SID1234617178]).

Kazia has been advised by the Global Coalition for Adaptive Research (GCAR), the sponsor of the study, that the first stage of the paxalisib arm has completed recruitment. The treatment arm did not meet pre-defined criteria for continuing to a second stage, and patients enrolled in the first stage of the paxalisib arm will therefore continue on treatment as per protocol, and in follow-up, until completion of the final analysis, which Kazia anticipates receiving in 2H CY2023, as previously disclosed.

Given that completion of recruitment has now occurred, the study will not open to the paxalisib arm in Germany or China. Kazia will work with its licensing partner to determine the way forward in China, given that country’s general requirement for local data to register a new pharmaceutical product.

All Kazia personnel continue to be blinded to efficacy and safety data from the ongoing study, as required by regulatory authorities, and so the company remains unable to provide analysis or interpretation of the study until follow-up is complete and final data is available.

Kazia CEO, Dr James Garner, commented, "GBM AGILE was designed as an adaptive study, with the potential to follow a range of different paths to completion. Today’s news defines the remaining trajectory of the study, with modestly positive implications for both costs and timelines, and with some specific consequences for regulatory strategy in China. It does not allow us to draw any meaningful inferences about the outcomes of the study, and indeed it is critical for regulatory purposes that we remain blinded to the evolving data. We look forward to reporting final results in 2H CY2023, as currently planned. In the meantime, we are excited by some of the emerging data in diffuse intrinsic pontine glioma (DIPG) and brain metastases, which have become increasingly important areas of focus for the company and look forward to sharing more detail on those activities in due course."