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])).

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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.

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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]).

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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.

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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.

On October 15, 2020 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer (Press release, Apexigen, OCT 15, 2020, View Source [SID1234568545]).

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"These orphan drug designations are important regulatory milestones for Apexigen in its mission to treat cancer patients and for APX005M, which has the potential to meaningfully impact the standard of care across multiple types of solid tumors. We are evaluating APX005M in a broad clinical program that includes more than 10 clinical trials in various indications and therapeutic combinations," said Xiaodong Yang, MD, PhD, Chief Executive Officer of Apexigen.

The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor for various development incentives, including tax credits for qualified clinical testing, up to seven years of marketing exclusivity for the orphan indication and waiver of certain FDA fees.

About APX005M

APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.