On July 26, 2022 GEn1E Lifesciences, a next-generation multitarget techbio company developing novel and targeted immunomodulators, reported the company has secured an exclusive, worldwide, all-fields license from the University of Maryland, Baltimore (UMB) for patented next-generation Extracellular Signal-Regulated Kinase 1/2 (ERK1/2) immunomodulators (Press release, GEn1E Lifesciences, JUL 26, 2022, View Source [SID1234656344]). The Company plans to use the newly licensed compounds to advance its portfolio of novel immunomodulators for rare and inflammatory diseases for patients with unmet needs in the areas of pulmonary, oncology and muscle degenerative diseases.

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ERK1/2 is part of the mitogen-activated protein kinase (MAPK) family, an essential signaling pathway that plays a key role in several basic cellular processes, including proliferation and differentiation. Given the ubiquity of the ERK cascade in cellular processes, it shares the pathogenesis of several pulmonary, oncology, and muscle degeneration diseases. ERK1/2’s multiple mechanisms-of-action make it an ideal platform candidate.

"Our ERK1/2 research has unlocked new approaches to selectively inhibit enzyme functions involved in disease, which is different from the current ERK1/2 inhibitors that block all enzyme functions and often result in unwanted toxicities and side effects," said Paul Shapiro, PhD, professor of pharmaceutical sciences at the University of Maryland School of Pharmacy and inventor of the technology. "Our discovery of compounds that target unique substrate binding pockets provides an opportunity to develop novel function-selective kinase therapies that will treat the disease and cause fewer side effects."

The new license builds on the strong working relationship between GEn1E and UMB. In 2019, GEn1E licensed a technology from UMB for developing next-generation p38 immunomodulators. That agreement is bearing fruit today with a lead compound in the clinic and several more novel compounds being accelerated in the pipeline.

"With the addition of ERK1/2 as a new target, the scope of diseases for which we can point our powerful AI-based ‘Platform in a Mechanism’ model expands greatly," said Ritu Lal, PhD, CEO of GEn1E. "The University of Maryland, Baltimore has produced stellar technologies that have the potential to create long-lasting impacts for patients, many of whom are devastated without effective therapies. A proud UMB alum myself, I am thrilled to continue growing a close working relationship with the University."

The power of GEn1E’s platform is evident in the progress the Company has made since graduating from Y Combinator in late 2019. The Company’s lead compound is in clinical stage and GEn1E scientists have developed more than 21 novel next-generation immunomodulators—all using only seed funding. GEn1E has demonstrated an unprecedentedly fast pace and efficiency in drug development using it’s AI platform.

"We are delighted to license additional assets to GEn1E Lifesciences and continue to develop our strong working relationship," said Phil Robilotto, DO, MBA, associate vice president of technology transfer at UMB and director of UM Ventures. "GEn1E’s application of machine learning to accelerate the process of drug development is very exciting and we are thrilled to see the unmet needs of novel and next-generation therapies being fulfilled."

On July 26, 2022 BroadenBio reported the company received the new drug clinical trial approval notice for the Class I investigational new drug BB102 from the Center of Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on July 26th, 2022 (Press release, BroadenBio, JUL 26, 2022, View Source [SID1234640199]). The first-in-human Phase 1 clinical trials for advanced solid tumors in China will be initiated soon.

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BB102 is an innovative small molecule kinase inhibitor discovered and being developed by BroadenBio for the treatment of advanced solid tumors driven by abnormal oncogenic genes. Besides its novel mechanism of action, high selectivity, good safety, and over advantages, BB102 shows promising efficacy to mutation-driven tumors, and is expected to benefit more cancer patients.

July 26, 2022 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported that the first patient was dosed in its Phase 2, AURELIO-04 combination trial of SOT101, an IL-15 superagonist and MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), in patients with selected advanced/refractory solid tumors (Press release, , JUL 26, 2022, View Source [SID1234626214])

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"The initiation of this Phase 2 study is a significant milestone for the clinical development of SOT101," said Richard Sachse, M.D., Ph.D., Chief Medical Officer of SOTIO and Managing Director of SOTIO Biotech in Switzerland. "IL-15 has been widely favored as a promising cytokine in oncology, but IL-15-based approaches to date have fallen short of realizing this promise due to aberrant targeting and adverse events. SOT101 in combination with KEYTRUDA has shown encouraging early clinical efficacy in the AURELIO-03 phase 1 study and we look forward to building upon our findings to advance this innovative therapy for the potential benefit of patients battling cancer."

The Phase 2 trial (NCT05256381) is an open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate efficacy and safety in patients with selected advanced/refractory solid tumors. The initiation of AURELIO-04 is based on encouraging data from the Phase 1/1b AURELIO-03 study of SOT101 which showed encouraging early efficacy signals in combination with pembrolizumab, and as single-agent treatment. The Phase 2 trial will enroll up to 320 patients targeting multiple solid tumor indications across 55 trial sites in Europe and the US. SOTIO entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) last year in December. MSD will supply KEYTRUDA for the study.

The first patient was dosed at the Masaryk Memorial Cancer Institute, Brno, Czech Republic, under the supervision of Peter Grell, M.D., Ph.D., as principal investigator.

Stéphane Champiat, M.D., Ph.D., Head of the Inpatient Unit at the Drug Development of Gustave Roussy Cancer Center and coordinating investigator of AURELIO-04 trial commented: "The continued clinical development of SOT101 is crucial as we still face a significant need to provide more effective therapeutic options for patients with solid tumors. Validated by promising Phase 1/1b AURELIO-03 data, AURELIO-04 will aim to confirm safety and demonstrate efficacy of SOT101 in combination with pembrolizumab in additional indications."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About SOT101 and IL-15 Superagonist Technology:

SOT101 is the lead candidate from SOTIO’s technology platform. SOT101 (SO-C101) is a subcutaneously administered IL-15Rβγ superagonist that is fused to the sushi+ domain of the IL-15 receptor α chain. SOT101 has demonstrated strong preclinical in vivo efficacy in various tumor models showing increased long-term survival and tumor regression, as well as a favorable toxicology profile. SOT101 has been shown in pre-clinical models to synergize with checkpoint inhibitors and antibody therapies exerting ADCC.

Along with Interleukin-2 (IL-2), IL-15 activity increases the number of cytotoxic T cells and NK cells, the two most important cells for driving an anti-cancer immune response. This T and NK cell expansion is the result of IL-15 binding to its IL-15 alpha chain receptor in conjunction with binding to its shared IL-2/IL-15 beta gamma receptor on the surface of T and NK cells. SOT101 has been precisely designed and optimized for its use as a potent immunotherapy by addressing two important design issues that limit current IL-2 and IL-15 approaches. These include selectively binding only to cytotoxic T and NK cells, while avoiding other cell types that are associated with adverse events and stimulating T and NK cells through pulses in cytokine concentrations rather than tonic stimulation.

On July 26, 2022 Hanmi reported 2022 second quarter earnings (Presentation, Hanmi, JUL 26, 2022, View Source [SID1234618931]).

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On July 26, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies to enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that after collaboration with the United States Food and Drug Administration ("FDA") on the design of their Phase 2 clinical trial entitled "Open-Label, Dose-Escalation, Phase 2 Safety and Efficacy Study of TSC in Newly Diagnosed Glioblastoma ("GBM") Patients when Administered with Standard of Care ("SOC")" (Press release, Diffusion Pharmaceuticals, JUL 26, 2022, View Source [SID1234617369]). The trial will be designated Study 200-208. The Company expects to initiate the trial by the end of 2022 and anticipates dosing the first patient in the trial in the first quarter of 2023.

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GBM is an aggressive, deadly, and treatment-resistant type of malignant brain tumor, affecting approximately 13,000 newly diagnosed patients each year in the United States. Few treatment options are available for patients with GBM, and none have extended life expectancy beyond a few months. In fact, according to the National Brain Tumor Society, the five-year survival rate for GBM is only 6.8 percent with an average survival time of eight months.

"Effective treatment of GBM remains a significant unmet need and we believe in the potential for TSC to enhance the effectiveness of standard of care therapy for GBM," said Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion. "These tumors are known to be hypoxic, which reduces the effectiveness of radio-, chemo-, and immunotherapeutic approaches and promotes tumor cell metastases. We have previously received Orphan Drug designation from the FDA for treatment of GBM with TSC in conjunction with radiotherapy. With the results of the TCOM and Altitude Trials, we now have better data on TSC dosing compared to the previous GBM trials, and we have used these data to design a unique trial that not only will allow us to evaluate the effects of TSC on key clinical outcomes such as survival, but the use of PET imaging also will enable us to obtain data on the direct effects of TSC on GBM tumor oxygenation well before clinical outcome data is typically available in clinical trials involving GBM patients."

The study will include a dose-escalation phase, enrolling patients in a 3+3+3 design, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TSC at doses of 1.5 mg/kg, 2.0 mg/kg and 2.5 mg/kg administered in combination with concomitant standard of care radiotherapy ("RT") plus temozolomide. An additional 17 subjects will be treated at the highest tolerable dose identified in the dose escalation phase. The primary objective of the study is to evaluate the safety and tolerability of TSC for the treatment of patients with newly diagnosed GBM when administered with SOC. Secondary objectives of the study are to evaluate progression-free survival at six months by magnetic resonance imaging, assessment using Response Assessment in Neuro-Oncology criteria, and to evaluate overall survival at 12 months.

Study 200-208 will vary in a variety of ways from the GBM trials conducted by Diffusion in the past, including three particularly notable differentiators:

The 1.5 mg/kg to 2.5 mg/kg doses of TSC to be administered in the study will be 6-10-fold higher than the 0.25 mg/kg dose used in Diffusion’s prior GBM trials.

TSC will be administered five days each week approximately 30-60 minutes prior to radiotherapy, as compared to the three days per week regimen in Diffusion’s prior GBM trials.

The study trial will incorporate PET scans to directly evaluate the oxygen enhancing effects of TSC on tumor hypoxia using one of two radiotracers, 18F-FMISO or 18F-FAZA, with initial data readouts expected to be available within one year of the study’s initiation.
"For patients with hypoxic tumor microenvironments such as glioblastoma, radiation can be less effective. Diffusion Pharmaceutical’s proposed phase 2 trial of Trans Sodium Crocetinate (TSC) for glioblastoma patients may help to overcome the relative resistance of the hypoxic tumor to ionizing radiation. Improvements in the clinical outcomes for high-grade glioma patients are critically needed," said Dr. Jason Sheehan, MD, PhD, Neurosurgeon at University of Virginia School of Medicine.

"With Glioblastoma Awareness Day on July 20th serving as a stark reminder of the continued unmet need for this disease, our team is incredibly motivated to work with our clinical investigators to get this uniquely designed trial started to explore the potential of TSC to improve outcomes for patients suffering from this devastating diagnosis," noted Chris Galloway, MD, Chief Medical Officer of Diffusion.