On July 7, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported the timely completion of construction on its expanded current good manufacturing practice (cGMP) manufacturing facility in Houston (Press release, Kiromic, JUL 7, 2022, View Source [SID1234616535]). This significant milestone was accomplished within the timeline established by the Company, specifically June 30, 2022.

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The expanded facility located at Kiromic’s headquarters is one of the conditions required for the Company to begin the activation of its cell therapy clinical trial for the Deltacel product candidate by the end of this year. The completion also addresses a key component in the clinical hold communication the Company received from the U.S. Food and Drug Administration (FDA) in June 2021.

"The on-time completion of our cGMP manufacturing facility is one of the conditions necessary to begin the activation of the Deltacel clinical trial by the end of this year," stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "The facility supports an expanding product pipeline of cell therapies designed to target solid tumors, furthering our commitment to delivering lifesaving treatments to patients with cancer who have limited therapeutic options. We believe our allogeneic, off-the-shelf manufacturing process will result in shorter lead times and lower costs, thereby increasing the availability of these promising cellular therapies for oncology patients."

The expanded 34,000-square-foot facility includes flexible cellular therapy and viral vector suites, a dedicated cGMP microbiology lab, a dedicated cGMP quality control (QC) lab, a research and development laboratory, and an FDA Code of Federal Regulations (CFR-9) compliant vivarium.

On July 7, 2022 Cardinal Health (NYSE: CAH) reported to release fourth-quarter and year-end financial results for its fiscal year 2022 on August 11, prior to the opening of trading on the New York Stock Exchange (Press release, Cardinal Health, JUL 7, 2022, View Source [SID1234616532]). The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

To access the webcast and corresponding slide presentation, visit Cardinal Health’s Investor Relations page. No access code is required. Presentation slides and a webcast replay will be available until August 10, 2023.

On July 7, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard-to-treat cancers, reported it has entered into a manufacturing agreement with Catalent Pharma Solutions LLC ("Catalent"), which will include cGMP manufacturing for the Company’s recombinant protein, Human DNase I (Press release, Xenetic Biosciences, JUL 7, 2022, View Source [SID1234616530]).

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Catalent is the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities.

"We are pleased to be working with a preeminent contract development and manufacturing organization such as Catalent, and to have the opportunity to leverage their broad expertise and successful track record with early-stage development through commercial manufacturing. We are excited to take this step forward on the path to the clinic and look forward to investigating systemic DNase as an adjunctive therapy for locally advanced or metastatic cancers," commented, Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

"This agreement is an important step towards long-term collaboration betweenCatalent and Xenetic," added Vikalp Mohan, Global Vice President, Head of Drug Substance at Catalent Biologics. "We look forward to leveraging Catalent’s proven biomanufacturing expertise at our site in Madison, Wisconsin to support the advancement of Xenetic’s DNase clinical development program and accelerating their path to first-in-human studies."

Xenetic’s interventional DNase based oncology platform is aimed at improving outcomes of existing treatments, including immunotherapies. The Company exclusively licensed intellectual property for uses of DNases in cancer include systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies.

The DNase platform is designed to target neutrophil extracellular traps ("NETs"), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

The Company is working toward its planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.

On July 7, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the Company has added a second, once-a-week dose cohort in its ongoing global Phase 1 clinical trial in both the United States and China with the highly selective CDK9 inhibitor GFH009 for patients suffering from advanced relapsed or refractory lymphoma and acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, JUL 7, 2022, View Source [SID1234616529]).

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SELLAS previously reported that AML patients treated twice-a-week at the 22.5mg dose level experienced no dose-limiting toxicities, including no Grade 3/4 neutropenia (an abnormally low count of neutrophils, a type of white blood cell). The patients in the AML arm of the clinical trial have entered the last twice-a-week 30mg planned dose level. Additionally, enrollment for lymphoma patients at the twice-a-week 15mg dose level cohort has been completed and safety assessments are underway. The twice-a-week dose regimens for both groups will proceed as planned and are on target for completion this year.

Given that both AML and lymphoma patients tolerated all dose levels studied to date with the twice-a-week administration as well as the efficacy signals seen with both AML and lymphoma patients, SELLAS has amended its protocol to introduce an additional single-dose cohort to study GFH009 once-a-week administration starting at the higher dose level of 30 mg.

The new, weekly single-dose cohort regimen is as follows:

Dose levels are 30mg, 45mg and 60mg once per week.
The amended protocol allows SELLAS to further escalate the doses if each level is determined safe for patients.
The new cohort is expected to take approximately one month to enroll patients and another 21 days to complete the safety assessment for each dose level.
"As we continue to evaluate GFH009 with its unique mechanism of action, increasing the dose administered and extending the administration of the dose will allow us to expand our knowledge of the drug’s safety and efficacy profile, including potentially seeing whether there are further increases in efficacy beyond the already observed efficacy for these patients," said Dragan Cicic, MD, Senior Vice President, Clinical Development, SELLAS. "With this additional valuable data on the new dose levels and regimen, SELLAS will be one step closer to discovering the optimal dosage for patients in preparation for the Phase 2 study."

On July 7, 2022 Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) (Theratechnologies), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it will report financial results for its second quarter of fiscal 2022 ended May 31 on Thursday, July 14, 2022 (Press release, Theratechnologies, JUL 7, 2022, View Source [SID1234616524]).

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The conference call will be held on July 14, 2022 at 8:30 a.m. (ET) to discuss the results and recent business updates. The call will be hosted by Paul Lévesque, President and Chief Executive Officer. Joining Mr. Lévesque on the call will be other members of the management team, including Chief Financial Officer Philippe Dubuc and Chief Medical Officer Christian Marsolais, who will be available to answer questions from participants following prepared remarks.

Participants are encouraged to join the call ten minutes in advance to secure access.

The live conference call will be accessible via webcast at: View Source