On September 27, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target solid tumors, reported that the FDA has accepted the protocol and given the formal go-ahead to proceed with the planned ONCOS-102 phase 2 trial in melanoma. Study initiation activities are proceeding according to the communicated timeline, with the aim to start enrolling patients in late 2022 or early 2023 (Press release, Targovax, SEP 27, 2022, View Source [SID1234621468]).

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PD-1 CPI refractory advanced melanoma is a major unmet medical need affecting up to 25,000 patients per year globally in the major markets. The diagnosis has poor prognosis and there are currently no approved treatment options available. In a recently reported phase 1 trial, ONCOS-102 demonstrated a highly competitive response rate (ORR) of 35% in this patient population in combination with a PD-1 CPI. Importantly, the strong ORR outcome was corroborated by biomarker data showing significant increase in T-cell infiltration and broad and persistent activation of immune-related gene signatures in responding patients.

Based on these promising early clinical results, Targovax is planning to conduct a larger, phase 2 multi-cohort study to further explore and validate the benefit of ONCOS-102 in PD-1 CPI refractory melanoma. This phase 2 study will be run in collaboration with Targovax’s partner Agenus, who will provide their Fc-enhanced CTLA-4 (botensilimab) and PD-1 (balstilimab) CPIs for combination with ONCOS-102.

In the first part of the study, two groups will evaluate the safety and efficacy of (1) a higher dose of ONCOS-102 to be tested as a monotherapy and (2) the low and new higher dose of ONCOS-102 in combination with the PD-1 CPI balstilimab. Following confirmation of the safety of the increased ONCOS-102 dose, the study will proceed into its second part adding two more groups. In group (3) ONCOS-102 will for the first time be combined with a CTLA-4 CPI (botensilimab) and, ultimately, in (4) the triple combination of ONCOS-102, balstilimab and botensilimab will be tested.

Dr. Lone Ottesen, Chief Medical Officer of Targovax ASA, said: "We are very pleased to get the formal go-ahead from the FDA for our phase 2 melanoma study. With the proposed design, we will answer important clinical questions relating to safety, dosing and contribution of components that are critical to enable subsequent registrational trials. I am particularly excited about the combination with the next generation Fc-enhanced CTLA-4 CPI botensilimab, which is expected to enhance systemic activity and deepen tumor responses. We anticipate that the triple combination of ONCOS-102 with PD-1 and CTLA-4 blockade will boost response rates above the already strong 35% ORR, and firmly establish ONCOS-102 as class-leading candidate in PD-1 CPI refractory melanoma".

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.