On October 15, 2020 The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) and the Ohio State College of Pharmacy reported that have been awarded a five-year, $7 million competitive Program Project Grant (PPG) renewal from the National Cancer Institute (NCI) (Press release, The Ohio State University, OCT 15, 2020, View Source [SID1234568604]).

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!

This multidisciplinary project grant represents the only PPG funded by the NCI in the nation led by a pharmacy investigator and will allow teams at Ohio State, the University of Illinois – Chicago and University of North Carolina – Greensboro to continue investigating potential anticancer drug leads based on compounds from tropical plants, coastal lichens, cultured cyanobacteria and filamentous fungi.

The grant renewal extends through 2025 and is led by principal investigator A. Douglas Kinghorn, PhD, DSc, professor and Jack L. Beal Chair of the Division of Medicinal Chemistry and Pharmacognosy at the College of Pharmacy. He is also a member of the OSUCCC – James Molecular Carcinogenesis and Chemoprevention Program.

"We are so appreciative of this renewed funding. It will enable us to continue our momentum of discovery in the lab, including further investigation of natural products identified as having potential for anticancer activity," says Kinghorn, noting that, since the grant’s initial funding in 2007, more than 180 peer-reviewed research and review articles have been published based on findings from the three collaborating institutions.

The grant is organized around three projects and three cores:

Project 1 – Isolation Chemistry of Tropical Plants and Biological Evaluation

(Ohio State; Project Leader, Dr. A. Douglas Kinghorn)

Project 1 involves the isolation chemistry of bioactive tropical plants to be collected by Project 2 (see below), inclusive of extraction, dereplication, compound purification, structure elucidation and scale-up isolation stages. More recently, work has begun in screening U.S. coastal lichens and their fungal mycobionts (Dr. H. Liva Rakotondraibe). Biological screening is offered for Projects 1-3 using a selection of secondary cell-based and mechanism-based assays (Drs. Esperanza J. Carcache de Blanco and Jack C. Yalowich)

Project 2 – Isolation Chemistry of Cultured Cyanobacteria and Plant Acquisition

(UIC; Project Leader, Dr. Jimmy Orjala)

Project 2 entails cyanobacterial collection, culturing, genomic evaluation (Dr. Alessandra Eustaquio), extraction and dereplication, as well as plant collections from tropical rainforests (Dr. Djaja D. Soejarto). Extracts from the plants are further investigated in Project 1.

Project 3 – Isolation Chemistry of Filamentous Fungi and Biological Evaluation

(UNCG; Project Leader, Dr. Nicholas H. Oberlies)

Project 3 works on new lead compounds from fungi obtained from Mycosynthetix, Inc. (Hillsborough, NC; CEO/CSO Dr. Cedric J. Pearce), and comprises culturing, extraction, dereplication, compound purification, structure elucidation, scale-up isolation/yield optimization and biosynthetic manipulation. Some biological testing is carried out at Columbia University as part of Project 3 (Dr. Brent R. Stockwell).

Core A – Administrative and Biostatistics Core

(Ohio State; Core Director, Dr. A. Douglas Kinghorn)

Core A carries out overall administrative functions (aided by Dr. Amanda S. MacFarlane) and offers biostatistics support (directed by Dr. Xiaoli Zhang) to Projects 1-3 and Cores A, 1 and 2.

Core 1 – Biological Correlation and Analysis Core

(UIC; Core Director, Dr. Joanna E. Burdette, assisted by Dr. Leslie Aldrich)

Core 1 provides in vitro testing (screening assays using a small cancer cell line panel; HDAC and proteasome inhibition assays) for samples submitted by Projects 1-3. Promising compounds are evaluated mechanistically and evaluated in mouse hollow fiber and xenograft bioassays

Core 2 – Medicinal Chemistry and Pharmacokinetics Core

(Ohio State; Core Director, Dr. James R. Fuchs)

Core 2 conducts medicinal chemistry (synthesis/analogue development, SAR evaluation) and pharmacokinetic-related functions (e.g., solubility, stability, formulation, metabolism, protein binding; supervised by Dr. Mitch A. Phelps and aided by Dr. Chris Coss) for selected compounds of promise from Projects 1-3.

"Our faculty are working tirelessly to advance drug discovery for some of the most pressing medical problems. The work that Dr. Kinghorn and his team have done for the past 13 years is representative of this," says Henry Mann, PharmD, FCCP, FCCM, FASHP, dean and professor of the College of Pharmacy.

"In addition, this grant provides a tremendous continued opportunity to train a future generation of scientists," says Cynthia Carnes, PharmD, PhD, senior associate dean of research and graduate studies at the College of Pharmacy.

Co-investigators from the Ohio State College of Pharmacy include: Esperanza Carcache de Blanco, PhD; Christopher Coss, PhD; James Fuchs, PhD; Mitch Phelps, PhD; H. Liva Rakotondraibe, PhD; and Jack Yalowich, PhD.

On October 15, 2020 Merck is stepping up to the plate to ramp up its production of a potent, life-saving bladder cancer drug. Merck, known as MSD outside the U.S. and Canada, reported they will construct a new manufacturing facility to significantly expand its production capacity for TICE BCG (BCG Live for Intravesical Use) (Press release, Merck & Co, OCT 15, 2020, View Source [SID1234568601])).

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!

Since 2012, Merck has been the only manufacturer of BCG for patients in the U.S. and European markets. They fell into this position not by choice, but after competitor Sanofi unexpectedly suspended production due to manufacturing-quality problems discovered in an FDA inspection of their Toronto facility. The FDA found 58 mold infractions after a flood at the site. The lab was quickly shuttered and shortages began. Sanofi had intended to return to BCG manufacturing but announced in 2016 that all manufacturing efforts would be halted by mid-2017.

BCG is not a new drug. It was first used in humans in 1921 as a vaccine against tuberculosis. There are some rumblings that the TB vaccine may even help make you less unlikely to get seriously ill when infected with COVID, though that is yet to be proven and the ultimate goal is still a vaccine specifically aimed at coronavirus.

Merck’s form of BCG is a freeze-dried drug deposited directly into the bladder through a catheter typically after a tumor resection has occurred to help prevent recurrence. Patients benefiting most are those categorized with high-risk non-muscle invasive bladder cancer. It is used in early stages as it only affects cells inside the bladder and cannot impact cancer cells once they’ve spread beyond the lining.

The underlying issue in supply is that BCG is a complex biologic that takes about 3 months to make, due to the time it takes the bacteria it’s made from to grow. And with a relatively modest price per dose, it’s not a drug most manufacturers are competing to make.

Although Merck’s new North Carolina facility will take around five to six years to build, it is expected to eventually triple their capacity. The move, particularly knowing this is not a bread-winner for those producing BCG, reaffirms Merck’s commitment to getting patients the treatments they need.

"Our commitment to TICE BCG is at the core of Merck’s mission to save and improve lives," said Dr. Julie Gerberding, executive vice president and chief patient officer, Merck. "As demand for this medicine has increased over the last several years, we recognized the need to do more. While this new facility will take a number of years to complete, we look forward to the day when we can meet the needs of all patients whose physicians have prescribed TICE BCG for them."

The new facility will be part of their existing vaccine manufacturing campus in Durham, North Carolina. About 100 new jobs are expected to be created locally.

Until the facility is up and running, Merck will continue to ration out their current supply of TICE BCG based on historical demand within the US and other countries where they are the sole supplier. Meanwhile, the focus on maximizing current output will continue to try to get the drug to the patients who need it and have no other access to this life-saving treatment.

On October 15, 2020 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") reported the closing of an offering by way of private placement (the "Offering") to certain investors in the United States of U.S.$1.2 million principal amount of 8% convertible notes due October 15, 2024 (the "Notes") (Press release, Intelgen, OCT 15, 2020, View Source(TSX%2DV%3AIGX),(the%20%E2%80%9CNotes%E2%80%9D). [SID1234568577]). The Notes will bear interest at a rate of 8% per annum, payable quarterly, and will be convertible into shares of common stock of the Company (the "Shares") beginning 6 months after their issuance at a price of U.S.$0.18 per Share.

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 Company intends to use the proceeds of the Offering for working capital purposes.

In connection with the Offering, the Company paid to an agent a cash commission of approximately U.S.$85,000 in the aggregate and issued non-transferable warrants to the agent (the "Agent’s Warrants"), entitling the holder to purchase 482,000 common shares at a price of U.S.$0.18 per Share until October 15, 2022.

The TSX Venture Exchange (the "TSXV") has conditionally approved the listing of the Shares issuable upon conversion of the Notes, as well as the Shares issuable upon exercise of the Agent’s Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 15 days of the closing of the Offering.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, securities in any jurisdiction where not permitted by law. Any securities described in this announcement have not been registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold in the United States, or to, or for the account or benefit of a "U.S. person" as defined in Regulation S under the U.S. Securities Act, except in transactions exempt from, or not subject to, registration under the U.S. Securities Act and applicable state securities laws.

The Notes were distributed pursuant to the prospectus exemption of section 12 of the Securities Act (Québec) for distribution of securities to persons established outside Québec.

On October 15, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that the U.S. Centers for Medicare & Medicaid Services (CMS) have issued a negative reimbursement proposal in connection with the National Coverage Determination (NCD) of Epi proColon, Epigenomics’ blood test for colorectal cancer screening (Press release, Epigenomics, OCT 15, 2020, View Source [SID1234568567]).

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 proposed NCD is preliminary. According to the statutes, a 30-day public comment period will now begin, which will be used to further convince CMS of the benefits of Epi proColon in the fight against colorectal cancer. The public response during the initial public comment period at the beginning of the NCD was overwhelmingly positive. Following the comment period, CMS will publish their final decision within 60 days. If the final decision is also negative, the Company will take the opportunity to appeal the decision.

On October 15, 2020 Insilico Medicine reported that Taisho Pharmaceutical Co., Ltd. and Insilico have entered into a research collaboration to identify novel therapeutics against aging (Press release, Insilico Medicine, OCT 15, 2020, View Source [SID1234568546]). Insilico Medicine will utilize both the target discovery and generative chemistry parts of its Pharma .AI platform in this collaboration. It will use its proprietary Pandomics Discovery Platform to identify novel targets for senolytic drugs and Chemistry42 platform for a molecular generation. This collaboration brings together Insilico’s state-of-art artificial intelligence (AI) technologies in drug discovery with Taisho’s expertise in drug development, aimed to extend the human healthspan.

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!

Insilico partners with Taisho
"We’re delighted to collaborate with Taisho pharmaceutical, a well-recognized leader in the pharmaceutical industry and healthcare sector. It is believed that aging is a universal phenomenon that we cannot stop. However, emerging scientific evidence has shown that one may be able to reverse some of the age-associated processes. Through this collaboration, we will adopt our AI-powered drug discovery suites together with Taisho’s validation platform to explore the new space of anti-aging solutions," said Jimmy Yen-Chu Lin, PhD, CEO of Insilico Medicine Taiwan, a fully-owned subsidiary of Insilico Medicine

Under the terms of the agreement, Insilico Medicine will receive an upfront payment and milestone payments upon achievement of specified goals. Insilico Medicine will be responsible for early research phase target identification and molecular generation and Taisho will work collaboratively with Insilico in validating the results in various in vitro and in vivo assays. Taisho has the exclusive option to acquire Insilico’s co-ownership of the successfully developed programs under agreed payment.

"It is our great honor to be collaborating with the scientists of Taisho Pharmaceutical, one of the top 100 pharmaceutical companies in the world operating since 1912. The high level of the scientists we are interfacing, and our previous successes in the application of the Pharma.AI platform for discovery of novel targets and molecules in fibrosis, and previous experience in senolytic drug discovery give us confidence that this collaboration will be successful," said Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine.