On September 27, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the initiation of its Phase 3 global registrational study of zilovertamab, ZILO-301 (NCT05431179), for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) (Press release, Oncternal Therapeutics, SEP 27, 2022, View Source [SID1234621466]). The Company obtained its first Institutional Review Board (IRB) approval for the study and expects to promptly begin patient screening and enrollment.

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"The initiation of the first Phase 3 study of zilovertamab, ZILO-301, represents a key milestone for Oncternal, our partners, investors and patients with R/R MCL," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are looking forward to opening between 50-100 sites across the globe to support what we expect to be the first BLA approval of zilovertamab. ZILO-301 also represents the first registrational study for a therapeutic targeting the novel ROR1 pathway, which we believe can help address significant unmet needs in multiple hematological malignancies and other solid tumors."

About ZILO-301
The Phase 3 clinical trial entitled "A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Zilovertamab (A ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in Subjects with Relapsed or Refractory Mantle Cell Lymphoma" (NCT05431179) will evaluate the potential benefit of zilovertamab for patients who have only experienced stable disease (SD) or a partial response (PR) after having received four months of oral ibrutinib therapy (560 mg daily) during the open-label lead-in phase of the study. Patients with such an inadequate response (PR or SD) will be randomized (1:1) to receive zilovertamab (600mg administered by IV every 2 weeks for 3 administrations and then every 4 weeks thereafter) or placebo, while continuing to receive oral ibrutinib. Across 50-100 international sites, the study aims to enroll 365 patients and to randomize approximately 250 patients after the 4-month lead-in phase.

An interim analysis, designed to support submission of a BLA seeking accelerated FDA approval, will be conducted based on an endpoint of Objective Response Rate (ORR) plus Duration of Response (DOR). The final analysis, intended to support regular FDA approval, will be based on a primary endpoint of progression-free survival (PFS). Secondary efficacy endpoints include ORR, DOR, Complete Response (CR) Rate, Overall Survival (OS), and the proportion of subjects experiencing grade 3 or 4 neutrophil count decrease.

On September 27, 2022 Nanoligent SL, a Spanish biotech company specialized in the development of cancer treatments based on unique protein conjugates, reported the completion of a Seed financing round of total € 2.8 M (Press release, Nanoligent, SEP 27, 2022, https://www.nanoligent.com/index.php/2022/09/27/nanoligent-raised-2-8-m/ [SID1234621464]). The final closing of the Seed round consists of € 1 M investment by i&i Biotech Fund I (i&i Bio), an early-stage Life Science fund with teams in Luxemburg and Prague which is backed by the European Investment Fund. i&i Bio joined previous Nanoligent investors, Italian Angels for Growth, the largest network of business angels in Italy, and AVANTECA Partners, a Swiss privately held asset management firm.

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Jaromir Zahrádka, managing partner of i&i Bio, said: "Nanoligent is the fifth investment of our fund and it belongs to a group of targeted oncology therapies in our portfolio. We are excited by deep scientific background and uniqueness of the technology. The platform is developed by highly motivated, experienced, and fully engaged team of scientists and managers. Based on obtained scientific data, the project has a great potential to become an effective treatment for multiple metastatic-cancer types."

Nanoligent is focused on the development of new drugs for the treatment of more than 20 different metastatic cancer types. The lead molecule is based on the targeted elimination of cancer cells overexpressing the CXCR4 receptor, a recognized biomarker for poor prognosis and therapy resistance. Nanoligent is developing a new proprietary nano-technological platform, with the potential to overcome current limitations of Antibody-Drug-Conjugates.

"Less than a third of newly diagnosed metastatic patients respond to current therapies, making metastasis one of the most pressing unsolved challenges in cancer. With the support of i&i Bio together with our existing investors, we secure our current milestone to provide the first drug candidate of our portfolio of metastasis-targeted therapies" said Montserrat Cano, CEO of Nanoligent.

The seed round financing will allow Nanoligent to foster the development of multiple drug candidates and advance the pre-clinical development of its lead candidate in a variety of tumor types.

"We are happy to welcome the i&i Biotech Fund I in Nanoligent. As in previous cases, we have been impressed by the depth of their scientific due diligence and the professionality of their management. They are going to be an important partner for Nanoligent and we are delighted to continue to co-invest with i&i Bio," said Michele Marzola who, together with Alessandro Toniolo, are co-champions from IAG in this investment.

Two of the investors already joined the Nanoligent’s Board which includes: Michele Marzola (IAG), Michael Milos (Avanteca Partners), Manuel Rodríguez (Chairman) and Montserrat Cano (CEO).

"The i&i Biotech Fund I is the right partner for the further development of Nanoligent. They have shown in depth scientific knowledge as well as being well connected within the pharmaceutical network. We all together are looking forward to bringing Nanoligent’s development plan effectively to the next stages," said Michael Milos from AVANTECA Partners.

On September 27, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that it will release its financial results for the third quarter of 2022 before the market opens on Thursday, Oct. 27, 2022 (Press release, LabCorp, SEP 27, 2022, View Source [SID1234621462]). The company will host a conference call and webcast beginning at 9 a.m. ET that day to discuss the results. The earnings press release and accompanying financial information will be posted on the Labcorp Investor Relations website.

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The call will be webcast live on the Labcorp Investor Relations website. Participants may also register for the call by clicking on this link, to receive the dial-in numbers and unique PIN to access the call. The webcast and dial-in are listen-only. It is recommended that participants join 10 minutes prior to the start, although participants may register and join at any time during the call.

A replay of the webcast will be available approximately two hours after the conclusion of the live event, and will be available until Oct. 13, 2023. To access the webcast recording, visit the Labcorp Investor Relations website.

On September 27, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal year ended June 30, 2022 and provided a corporate update (Press release, Kintara Therapeutics, SEP 27, 2022, View Source [SID1234621461]).

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CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

Announced that three posters were accepted for data presentation at the 2022 Society for Neuro-Oncology ("SNO") Annual Meeting. The 2022 SNO Annual Meeting will be held from November 16 through November 20, 2022 in Tampa, Florida (September).
Received a Study May Proceed letter from the United States Food and Drug Administration ("FDA") to begin a 15-patient study evaluating REM-001 Photodynamic Therapy ("PDT") for the treatment of cutaneous metastatic breast cancer ("CMBC"). This study is intended to aid in the design of a planned Phase 3 registrational study (August).
Entered into a purchase agreement with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park has committed to purchase up to $20.0 million of shares of the Company’s common stock, subject to the satisfaction of the conditions contained in the agreement as well certain limitations contained therein (August).
Received notice from the FDA that the Company was granted Fast Track Designation for VAL-083 for the treatment of patients with newly-diagnosed, unmethylated glioblastoma ("GBM") (June).
Received written notification from the Listing Qualification Department of The Nasdaq Stock Market LLC ("Nasdaq") granting the Company’s request for a 180-day extension to regain compliance with Nasdaq’s minimum bid price requirement. The Company has until November 28, 2022 to meet the requirement (June).
Announced that the Company’s first European site, University Hospital Zurich in Zurich, Switzerland, had been activated for the VAL-083 treatment arm in the Global Coalition for Adaptive Research ("GCAR") registrational Phase 2/3 clinical trial for GBM, titled Glioblastoma Adaptive Global Innovative Learning Environment ("GBM AGILE Study") (May).
"This last quarter was a very productive quarter – on the financing side we put in place a $20.0 million equity facility with Lincoln Park to help bolster our balance sheet. On the regulatory front we received our second Fast Track Designation from the FDA for VAL-083 and the GBM-AGILE Study continues to exceed our expectations," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "Moving our REM-001 CMBC program back into the clinic is also an important step for us to deliver on our mission of serving cancer patients where there is a clear unmet medical need. We believe we remain on track to start enrolling patients in the CMBC study around the end of September 2022."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED JUNE 30, 2022

At June 30, 2022, Kintara had cash and cash equivalents of approximately $11.8 million. During the year ended June 30, 2022, the Company completed two registered direct offerings for aggregate net proceeds to the Company of approximately $21.6 million.

For the year ended June 30, 2022, Kintara reported a net loss of approximately $22.7 million, or $0.52 per share, compared to a net loss of approximately $38.3 million, or $1.60 per share, for the year ended June 30, 2021. The decreased net loss for the year ended June 30, 2022 compared to the year ended June 30, 2021 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the Adgero transaction in August 2020.

On September 27, 2022 Ajinomoto Corporation ("Ajinomoto Co."), through its consolidated subsidiary, Ajinomoto Genexine Corporation ("AGX"), reported that it has reached an agreement with JSR Corporation ("JSR"), a leading materials company, to collaborate on the global expansion of its biopharmaceutical culture media business, adding new high-performance media developed by JSR, to Ajinomoto Co.’s product lineup. Sales are scheduled to begin in December 2022 (Press release, JSR, SEP 27, 2022, View Source [SID1234621460]).

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Image is for illustration purposes.

Currently, the global market for culture media, which is essential for cell culture in biopharmaceutical R&D and manufacturing, is growing at an annual rate of more than 10% due to the growing demand for antibody drugs and vaccines and the expansion of cell and gene therapies. Demand is forecast to grow to more than USD15 billion*1 by 2030. Accordingly, demand for CHO cell line culture medium, which has become a mainstream for biomedical use, is expected to increase further.

In this collaboration, Ajinomoto Co. will receive access to the composition of a high-performance culture medium (CELLiSTTM BASAL CHO MX) optimized for JSR’s CHO-M cell line*2, which will be commercialized and manufactured by AGX. AGX will undertake sales in the Asian markets, while JSR will retain exclusive rights to market and sell Basal CHO MX in the U.S. and European markets. In addition to the CHO-M cell line, this product has also been confirmed to exhibit higher antibody productivity in other CHO cell lines than products currently available on the market. (Ajinomoto Co. and JSR research).

Under the Ajinomoto Group Medium-Term Management Plan 2020-2025, the Group is focusing on the biopharmaceutical culture medium business. Ajinomoto Co. has been involved in the development, production, and sale of CHO and other culture media for biopharmaceuticals for more than 30 years. The company’s strengths include bioprocess technologies, which have been cultivated through the supply of amino acids for pharmaceutical and food applications, and the company’s global supply chain of amino acids, which are important raw materials for culture media. Since 2017, Ajinomoto Co. has been selling and marketing biopharmaceutical media under the CELLiSTTM brand, mainly in Asia.

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JSR, through its JSR Life Sciences division, provides materials for downstream bioprocessing including Amsphere A3 protein A resins and others and a full range of drug discovery and development support services.

Both companies will exhibit the CELLiSTTM BASAL CHO MX at BioProcess International 2022, which will be held from September 27-30, 2022 in Boston, Massachusetts, USA.

Michael Lish, General Manager of Amino Science Division, Ajinomoto Co., commented as follows: "Since 2014, we have been supplying high-quality culture media for biopharmaceuticals from our plant in South Korea. We are very honored to have the opportunity to meet the needs of our customers in Europe and the United States through this new market channel. This collaboration is an important measure to grow our culture media business into the second pillar of our amino acid business."

"Ajinomoto is a good fit to commercialize this culture media because of their advanced technology and high quality assurance systems," said Tim Lowery, Senior Officer, General Manager of Life Sciences Div. "JSR is a materials company at our core, and this collaboration expands our ability to bring our expertise to customers, so we are excited to bring the CELLiSTTM BASAL CHO MX to the North American and European markets."

Ajinomoto Co. and JSR will strengthen their biopharmaceutical culture media business through collaboration for global business development. Ajinomoto Co. will continue to contribute to the development of new medicines through the production and marketing of CELLiSTTM, a biomedical medium, with the aim of "solving food and health problems through the action of amino acids." As a state-of-the-art technology company, JSR Corporation promotes the advancement and practical application of science based on its corporate mission of Materials Innovation.