On July 26, 2021 ImmunoMet Therapeutics, Inc., a clinical stage biotechnology company targeting metabolism to develop novel anti-fibrotic and anti-cancer therapies, reported that Dr. Revati Shreeniwas has joined the company as Chief Medical Officer (Press release, ImmunoMet Therapeutics, JUL 26, 2021, View Source [SID1234585201]). In this role, Dr. Shreeniwas will manage the clinical development program for ImmunoMet’s lead product candidate, IM156, an investigational Protein Complex 1 (PC1) inhibitor, being evaluated for idiopathic pulmonary fibrosis (IPF) and oncology indications.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Earlier this month we finished dosing our US Phase 1 study of IM156 in healthy volunteers. ImmunoMet is now positioned to advance the clinical development of IM156 in IPF patients. Dr. Shreeniwas brings a wealth of clinical experience to ImmunoMet including extensive IPF clinical experience," said Dr. Benjamin Cowen, President and CEO of ImmunoMet Therapeutics.

Dr. Shreeniwas is a physician certified in internal medicine and pulmonary disease with 17 years of experience in pharmaceutical development. She has designed and implemented more than 50 US and international (Phase 1-4) clinical trials, and been the clinical lead for regulatory interactions with the FDA and EMA. Dr. Shreeniwas has worked on several commercially successful drugs. She has served on the faculty of Stanford University and Columbia Presbyterian Medical Center. Prior to entering pharmaceutical industry Dr. Shreeniwas practiced clinical medicine for 15 years. She is licensed to practice medicine in California. Dr. Shreeniwas graduated from Armed Forces Medical College, India.

"ImmunoMet is positioned to make significant progress in clinical development in IPF and oncology indications. I am especially pleased to be joining the leadership team at this pivotal moment in the company’s history," said Dr. Shreeniwas. "The company’s research to date indicates that IM156 has a unique profile and the potential to offer significant benefit to patients."

About IM156

IM156 is a Protein Complex 1 (PC1) inhibitor that targets the oxidative phosphorylation (OXPHOS) pathway, decreasing the supply of energy and anabolic precursors that are required to drive fibrotic disease and tumor growth. IM156, ImmunoMet’s lead drug candidate, is solely owned by ImmunoMet and is currently in development for the treatment of IPF and selected cancers.

On July 26, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it has entered into a note purchase agreement with a fund of Athyrium Capital Management, LP, a specialized asset management company focused on opportunities in the global healthcare sector, for the issuance of up to $125 million of notes thereunder, subject to funding in two tranches (Press release, Puma Biotechnology, JUL 26, 2021, View Source [SID1234585200]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Puma received gross proceeds of $100 million from the first tranche of notes issued by Puma under the note purchase agreement upon closing on July 23rd and intends to use the funds, together with cash on hand, to retire its existing loan with Oxford Finance LLC. The second tranche of $25 million may be drawn at a later date; if drawn down these proceeds would be used for general corporate purposes and to further support NERLYNX commercial initiatives. Armentum Partners served as the Company’s financial advisor in connection with the note purchase agreement. The notes will become due in July 2026. Additional information on the note purchase agreement will be filed with the Securities and Exchange Commission as a Current Report on Form 8-K.

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma Biotechnology, said, "We are pleased to enter into this note purchase transaction with Athyrium Capital and to have their support with the continued commercialization of NERLYNX. This financing will be used to continue to support NERLYNX commercial activities as well as ongoing research with neratinib."

"We are excited to partner with Puma Biotechnology in supporting NERLYNX in its current indications, as well as its clinical development programs for additional indications," said Laurent D. Hermouet, Partner at Athyrium. "With the Company’s track record of in-licensing successes, we are also thrilled at the potential to help finance inorganic growth activities as they may present themselves to the Company."

On July 26, 2021 Da Volterra, a late-stage biopharmaceutical company developing novel intestinal microbiome-protective therapies, and COMBACTE-NET, a public-private partnership co-funded by Innovative Medicines Initiative to stoke the pharmaceutical pipeline in Europe, reported that the first patient had been randomized in the MICROCARE Phase 3 clinical trial (Press release, Da Volterra, JUL 26, 2021, View Source [SID1234585199]). This follows the authorizations obtained from 7 regulatory authorities in Europe, including France, Germany, Spain and Denmark.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The MICROCARE trial is evaluating DAV132, a first-in-class and strongly innovative microbiome protector, and shall enroll 900 patients newly-diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndrome treated with intensive chemotherapy in approximately 80 centers worldwide.

"We believe that protecting the microbiome of patients with acute myeloid leukemia is a clinically meaningful goal, as patients with disrupted microbiome have more life-threatening complications and a lower survival rate", said Fabien Vitry, M.D., Chief Medical Officer of Da Volterra. "This study is a stepping stone for microbiome-oriented therapies and could pave the way to new treatment options for all patients with cancer."

MICROCARE is a randomized, placebo-controlled, parallel-group trial. Its overarching objective is to demonstrate that DAV132 contributes to decreasing the occurrence of life-threatening complications and to reducing the mortality of patients with hematologic malignancies undergoing several cycles of chemotherapy.

"With all my team, we are glad to have recruited the first patient in MICROCARE.", said Dr. Christine Robin, principal investigator at the Henri-Mondor Hospital (Creteil, France).

The primary endpoint will be the occurrence of Clostridioides difficile infection, a severe and life-threatening complication which is triggered by the disruption of the intestinal microbiome. The study will also assess the efficacy of DAV132 in protecting intestinal microbiome diversity, preventing intestinal colonization with potentially pathogenic bacteria, preventing bloodstream infections and improving Overall Survival.

"The MICROCARE trial offers an opportunity for change for patients and physicians alike, and it is also the proof that the clinical network of COMBACTE-NET, bolstered by IMI support, is up to the challenge of performing high-stake clinical studies." commented Prof. Marc Bonten, M.D., Ph.D., Academic Coordinator of COMBACTE-NET. "All the partners of COMBACTE-NET are committed to making MICROCARE a real success for all stakeholders."

On July 26, 2021 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that it has received notification that the United States Patent and Trademark Office has granted additional patent claims related to the Company’s metabolomic technology platform (Press release, TYME, JUL 26, 2021, View Source [SID1234585198]). The patent, U.S. Patent No. 11,058,638, involves a targeted delivery of therapeutics to cancer cells.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tyme has developed a technology by which the tyrosine isomer racemetyrosine (α-methylparatyrosine) can be fused with a second therapeutic agent in a manner that creates a fusion compound that may allow targeted delivery to the cancer cells in a novel manner. This method of delivery, is predicated on the metabolic phenomenon in which cancer cells consume higher quantities of non-essential amino acids, including tyrosine, from their surrounding environment to support their growth because they cannot make enough of these amino acids.

"This technology could provide Tyme an opportunity to expand its current cancer-metabolism based approach with a drug delivery platform that’s aimed to deliver toxic therapies in a targeted manner that could offer improved safety and efficacy for a range of anticancer drugs." said Steve Hoffman, Tyme’s Chief Scientific Officer.

"This delivery technology is another example of our innovative spirit at Tyme. Even though this approach is still in its early stages, if proven, it has the potential to be a broadly leveraged platform technology." said Richie Cunningham, CEO of Tyme.

The delivery technology is an investigational method of drug delivery in the pre-clinical phase of development that is not approved in the U.S. for any disease indication and requires further studies, which the Company plans to initiate this year.

On July 26, 2021 The Board of Directors of McKesson Corporation (NYSE:MCK) reported that a regular dividend of $0.47 per share of common stock, a 12% increase from $0.42 per share in the prior quarter (Press release, McKesson, JUL 26, 2021, View Source [SID1234585197]). The dividend will be payable on October 1, 2021, to stockholders of record on September 1, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!