On June 1, 2023 Philogen S.p.A., a clinical-stage biotechnology company focused on the development of innovative medicines based on tumor-targeting antibodies and small molecule ligands, reported that it has entered into a Clinical Trial Collaboration and Supply Agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) (Press release, Philogen, JUN 1, 2023, View Source [SID1234632352]). Under the terms of the supply agreement, MSD provides their anti-PD-1 therapy, KEYTRUDA (pembrolizumab), to be evaluated in combination with Philogen’s immunocytokines L19IL2, L19TNF, and Nidlegy in a randomized Phase II clinical trial. The study provides an opportunity to explore the combination of immunocytokines and PD-1 blockade in stage III and IV unresectable melanoma patients who failed prior checkpoint inhibitor therapies.

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Nidlegy is also investigated in two Phase III randomized clinical trials for the treatment of stage III B/C melanoma in Europe and in the United States, as well as in two Phase II clinical trials in High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

Dario Neri, CEO and CSO of Philogen, commented: "KEYTRUDA has shown impressive response rates and long-term benefits for a substantial number of patients with advanced melanoma. However, only a minor proportion of patients who fail checkpoint inhibitors typically benefit from a subsequent re-challenge with single-agent PD-1 blockade. Clinical experience with intralesional recombinant IL2 has shown encouraging response rates when combined with systemic anti-PD-1 antibodies in advanced melanoma patients who progressed on or are resistant to checkpoint inhibitors. This provides a strong rationale to combine Nidlegy (L19IL2 + L19TNF) with KEYTRUDA in this setting, and we are pleased to partner with MSD, a global leader in immuno-oncology, to explore this opportunity."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Nidlegy is a registered trademark of Philogen S.p.A. of La Lizza 7, 53100 Siena, ITALY

On June 1, 2023 PDS Biotechnology presented its corporate presentation (Presentation, PDS Biotechnology, JUN 1, 2023, View Source [SID1234632351]).

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On June 1, 2023 NuCana plc (NASDAQ: NCNA) reported that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present and host one-on-one meetings at the Jefferies Healthcare Conference (Press release, Nucana BioPharmaceuticals, JUN 1, 2023, View Source [SID1234632350]).

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Event: Jefferies Healthcare Conference
Dates: Thursday, June 8, 2023
Time: 10:30 AM ET
Location: New York, NY

The presentation will be webcast live and available for replay under "Events & Presentations" in the Investors section of the Company’s website at www.nucana.com.

On June 1, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, reported an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, JUN 1, 2023, View Source [SID1234632349]).

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Background on ASTS and Camsirubicin

ASTS is a diverse type of cancer that typically develops in the connective tissue of the body and which has metastasized (spread) or is not amenable to surgery. The average life expectancy from time of diagnosis for patients with ASTS is about 12 to 15 months. Currently, doxorubicin is the first-line standard of care treatment for most types of ASTS.

Doxorubicin is one of the most widely used cancer drugs worldwide with FDA approval in ASTS and 13 additional cancer indications. Unfortunately, although higher doses of doxorubicin are known to be more effective at treating cancer, the risk of irreversible heart damage increases with the cumulative dose and limits the lifetime amount that a patient can receive. As a result, even if patients are responding, they discontinue doxorubicin treatment typically after only 6 to 8 cycles (~6 months or less).

Camsirubicin has been designed to retain the anti-cancer activity while avoiding the irreversible heart damage that is seen with doxorubicin. The hypothesis for camsirubicin is straightforward: modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better efficacy and patient outcomes.

Updates from Currently Enrolling Phase 1b Clinical Trial

One patient at the 520 mg/m2 dose level, unresectable at study entry, was deemed eligible for tumor resection after several cycles of camsirubicin treatment and a corresponding 21% reduction in tumor dimensions. This patient recently underwent surgical resection of the cancer.

100% of patients (3 of 3) at the fourth dose-level (520mg/m2) achieved stable disease, and had either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug.

Phase 1b data continue to show an improvement in median progression free survival from what was observed in the prior camsirubicin Phase 2 trial (265 mg/m2). This is supportive of our dose-response hypothesis with camsirubicin.

Two patients are currently enrolled in the fifth dose-level cohort (650 mg/m2), which is nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial (265mg/m2).

No drug-related cardiotoxicity has been observed in this trial to-date as evaluated by the industry standard left ventricular ejection fraction (LVEF).

As previously reported, this trial continues to show less frequent and less severe hair loss and oral mucositis with camsirubicin compared to what has been seen in recent ASTS clinical trials with doxorubicin.

No dose limiting toxicity (DLT) has been experienced by any patient in the trial to-date.

Camsirubicin Clinical Trial Design and GEIS Collaboration

The purpose of this 3+3 dose escalation Phase 1b trial is to determine the maximum tolerated dose (MTD) of camsirubicin. Once the MTD is reached, Monopar has a clinical collaboration agreement in place with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, or GEIS) to conduct a multi-country randomized Phase 2 clinical trial. The Phase 2 plan is to evaluate camsirubicin head-to-head against doxorubicin in patients with ASTS, with GEIS as the study sponsor with support from Monopar.

Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.

On June 1, 2023 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies ("ETBs"), to create novel therapies with potent differentiated mechanisms of action for cancer, reported that the U.S. Food and Drug Administration ("FDA"), after reviewing safety data on the program, has removed the partial clinical hold on patient enrollment for its MT-0169 trial, allowing Molecular Templates to proceed with its plan to evaluate the efficacy of MT-0169, one of its ETBs, which specifically targets CD38, a validated target in Multiple Myeloma (Press release, Molecular Templates, JUN 1, 2023, View Source [SID1234632348]). The FDA placed the Phase I study for MT-0169 on a partial clinical hold in April 2023, based on previously disclosed asymptomatic and fully reversible cardiac adverse events ("AEs") noted in two patients dosed at 50 mcg/kg which prompted the dose reduction to 5 mcg/kg last year.

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"We are pleased that the FDA has removed the partial clinical hold," said Eric Poma, Ph.D., Chief Executive and Chief Scientific Officer of MTEM. "MT-0169 represents a novel approach to myeloma that is demonstrating good safety with early signs of potential clinical benefit, particularly in the extramedullary setting, where we have seen a stringent Complete Response in a patient who remains on study for 10 months."

MTEM will be focusing development of MT-0169 on extramedullary myeloma, a form of myeloma that is less responsive to current therapies and carries a worse overall prognosis. Up to 20% of patients with relapsed/refractory multiple myeloma have extramedullary disease.

About MT-0169
MT-0169 was designed to destroy CD38+ tumor cells through internalization of CD38 and cell destruction via a novel mechanism of action (enzymatic ribosomal destruction and immunogenic cell death). The MT-0169 study completed the 5 mcg/kg dose escalation cohort (N=4) and the 10 mcg/kg dose escalation cohort (N=3) without any cardiac AEs or dose-limiting toxicities. A stringent Complete Response was seen in a patient with extramedullary IgA myeloma dosed with MT-0169 at 5 mcg/kg. The patient had a marked reduction in IgA serum protein, conversion from immunofixation positive to negative, and resolution of uptake on bone scan of skeletal lesions. The patient’s disease was quad-agent refractory including CD38-targeting, proteosome inhibitor, IMiD, and a BCMA bispecific antibody. The patient continues on study for 10 months. To date, no instances of capillary leak syndrome or other manifestations of innate immunity have been observed with any next-generation ETB.