On August 24, 2022 Sonoma Biotherapeutics, Inc., a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, reported that it has entered into a lease agreement to develop an approximately 83,000 square-foot Research and Development (R&D) and Manufacturing Center to expand its operations in Seattle and complement its existing R&D enterprise in South San Francisco (Press release, Sonoma Biotherapeutics, AUG 24, 2022, View Source [SID1234618617]). The state-of-the-art Center will support the R&D and manufacturing of Sonoma Bio’s pipeline of gene-modified Treg therapies for autoimmune and inflammatory diseases at scale.

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"Sonoma Bio is at the forefront of developing Treg therapies to treat autoimmune and inflammatory diseases by restoring balance to the immune system, and we are establishing robust and nimble infrastructure from end-to-end to deliver these cellular products," said Heidi Hagen, Chief Technical Officer of Sonoma Biotherapeutics. "Through the integration of our R&D engine with next-generation process development and cell therapy production tools, we will have the ability to quickly and efficiently deliver potentially transformative therapies to patients in need."

This R&D and Manufacturing Center will include the development and use of cutting-edge technologies and capabilities from cell selection and genetic modification to intelligent manufacturing automation and information technology systems. The integration of this infrastructure and scientific expertise will enable Sonoma Bio to move efficiently from molecular target identification to in-house full-scale production for multiple product candidates and indications in Phase 2 clinical trials and beyond. The Center will be located on the Seattle waterfront at 501 Elliott Avenue West, a property owned by Office Properties Income Trust and being redeveloped by The RMR Group into Unison Elliott Bay.

"Seattle has an established legacy of delivering many firsts in the cell therapy field for cancer, and we are building upon those insights to advance our pipeline of engineered Treg therapies for autoimmune and inflammatory diseases," said Jeff Bluestone, Ph.D., Co-Founder and CEO of Sonoma Biotherapeutics. "This Center will create highly-skilled scientific, engineering and manufacturing jobs in the Seattle area, taking advantage of the deep local capabilities and expertise. As we move into the next phase of growth at Sonoma Bio, we want to unite talent across the thriving life science communities of Seattle and San Francisco."

On August 24, 2022 Ranok Therapeutics, a clinical-stage biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancer and other serious diseases, reported the initiation of patient dosing in the U.S. for a Phase 1/2 study of RNK05047 (Press release, Ranok Therapeutics, AUG 24, 2022, View Source [SID1234618616]). The trial, entitled CHAMP-1, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RNK05047 in patients with advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Ranok anticipates preliminary data from the study in the second half of 2023.

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"RNK05047 is Ranok’s first therapy based on our proprietary CHAMP technology, as well as the first BRD4 protein degrader in the pharmaceutical industry to enter clinical testing," said Weiwen Ying, Ph.D., Founder and Chief Executive Officer of Ranok. "RNK05047 is designed to selectively degrade BRD4 protein preferentially in tumors, thereby improving safety and efficacy, which differentiates it from other investigational therapies such as non-selective BET inhibitors."

"The BET bromodomain transcription factor BRD4 is a master regulator of oncogenes involved in diverse cancer types," said Manuel Hidalgo Medina, M.D., Ph.D., Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, Associate Director of Clinical Services at the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and a site Principal Investigator in the trial. "We are pleased to be participating in this trial and are hopeful that RNK05047 will provide a beneficial new therapeutic option for patients."

Additional information on this clinical trial (NCT05487170) can be found at www.clinicaltrials.gov.

About Ranok’s CHAMP platform

Ranok’s proprietary Chaperone-mediated Protein Degradation/Degrader (CHAMP) platform and Chaperone-Tether Library are based on our founders’ extensive backgrounds researching protein homeostasis. CHAMP technology takes advantage of the cellular chaperone network, which regulates the folding and stability of proteins, distinguishing it from other targeted protein degradation approaches. CHAMP has a number of unique advantages, such as the evasion of mechanisms of drug resistance, and is designed to improved safety and efficacy due to the selective targeting of disease tissues.

About RNK05047

RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader that was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMP. The bromodomain transcription factor BRD4 is a key regulator of oncogenes such as MYC and BCL2 and is involved in diverse cancer types. CHAMP-1 is a Phase 1/2 trial of RNK05047 currently underway in the U.S. that will assess its safety, tolerability and pharmacokinetics, and also includes measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints. Preliminary data is expected from the trial in the second half of 2023.

On August 24, 2022 Tachyon Therapeutics, Inc. ("Tachyon" or "the Company"), a private biotechnology company developing transformative cancer therapies against novel targets, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to develop TACH101 for the treatment of advanced solid tumors (Press release, Tachyon Therapeutics, AUG 24, 2022, View Source [SID1234618615]).

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"The approval of this IND marks a significant milestone for the Company, as TACH101 will be the first KDM4 inhibitor to enter clinical stage," said Dr. Frank Perabo, CEO of Tachyon. "Based on encouraging preclinical data, we believe that this novel epigenetic drug candidate holds promise to become a safe and effective treatment option for patients with advanced solid tumors, and we look forward to starting a clinical trial later this year."

The first-in-human clinical study of TACH101 is expected to commence in Q4 2022 and will include a Phase 1a open-label, single-arm, dose escalation portion to evaluate the safety and tolerability of orally administered TACH101 in subjects with advanced and metastatic solid tumors. Once the recommended Phase 2 dose (RP2D) is determined, the Phase 1b dose expansion portion is planned to commence in select tumor types including gastrointestinal and colorectal cancers.

On August 24, 2022 Provectus (OTCQB: PVCT) reported that the Company has expanded its sponsored research program with Michio Kurosu, PhD, Professor, Department of Pharmaceutical Sciences at the College of Pharmacy of the University of Tennessee Health Science Center (UTHSC) in Memphis, Tennessee to investigate Provectus’ pharmaceutical-grade rose bengal for the treatment of anti-fungal and anti-oral bacterial infections (Press release, Provectus Biopharmaceuticals, AUG 24, 2022, View Source [SID1234618614]). Provectus’ innovatively-assembled and proprietary rose bengal is the lead member of a class of the Company’s small molecules called halogenated xanthenes.

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As part of this new sponsored research, the Kurosu team plans to evaluate the in vitro activity of Provectus’ rose bengal against different fungal strains and to conduct susceptibility tests against fungal and bacterial mouth microbes.

The Kurosu team has previously shown the favorable tolerability of the Company’s rose bengal as a topical application under different types of normal light, and the molecule’s in vitro activity against a range of different Gram-positive bacteria and against biofilms. These data and conclusions were noted in Kurosu et al.’s 2022 Molecules article entitled "Antibacterial Activity of Pharmaceutical-Grade Rose Bengal: An Application of a Synthetic Dye in Antibacterial Therapies." The Kurosu team is currently developing a journal manuscript of their prior study of the molecule’s in vitro activity against Gram-negative bacteria.

On August 24, 2022 Bavarian Nordic A/S (OMX: BAVA) reported an agreement with the Pan American Health Organization (PAHO) to facilitate equitable access to the Company’s monkeypox vaccine for countries in Latin America and the Caribbean (Press release, Bavarian Nordic, AUG 24, 2022, View Source,Latin%20America%20and%20the%20Caribbean. [SID1234618613]). Deliveries of the vaccines are expected to begin in September .

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The vaccines will be made available to those countries that participate in PAHO’s Revolving Fund for Access to Vaccines – a technical cooperation mechanism established more than 40 years ago to support national immunization programs, pooling resources from participating PAHO member countries across the Americas to procure vaccines and related supplies.

Paul Chaplin, President and CEO of Bavarian Nordic said: "Monkeypox is a global health challenge that has prompted health authorities worldwide to respond, and we are pleased to work with PAHO to ensure access to vaccines for its member states in the Americas. With the agreement, we have now helped to secure access to our vaccine in more than 70 countries globally, representing the vast majority of affected regions outside endemic areas. While the global supply is currently limited, we are working diligently to increase our manufacturing capacity and have taken steps to partner with other companies to rapidly produce more vaccines to help combat the outbreak."

Bavarian Nordic maintains its guidance for 2022 as this order has already been included in the upgraded financial expectations, as communicated on July 18, 2022.