On November 16, 2020 Q BioMed Inc. (OTCQB: QBIO), reported that it has received a patent from the U.S. Patent and Trademark Office for its Uttrocide-B molecule (Press release, Q BioMed, NOV 16, 2020, View Source [SID1234571182]). The Patent is titled "Uttroside-B and Derivatives Thereof as Therapeutics for Hepatocellular Carcinoma". Q BioMed has the exclusive rights to the technology through an agreement with the Rajiv Gandhi Centre for Biotechnology, an Autonomous Institute under the Department of Biotechnology, Government of India and the Oklahoma Medical Research Foundation. The Method Of Use patent covers the use of a novel pharmaceutical for the treatment of hepatocellular carcinoma. International and additional U.S. claims are currently under prosecution for the technology which addresses a severe unmet need for a safe and effective drug to treat hepatocellular carcinoma (HCC), the most common form of liver cancer.

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"This patent allowance in the U.S. comes at an opportune time as we are scaling up manufacturing and preparing Uttroside-B for an investigational new drug (IND) application with the U.S. FDA. Upon the FDA’s clearance, we anticipate initiating proof of concept studies by the end of next year," stated Q BioMed CEO Denis Corin.

Uttroside-B has shown ten times the potency against HCC as compared to the current standard of care drug in early pre-clinical investigation. Currently, there are only two approved first-line therapies for HCC. Challenges with current treatments include patients becoming resistant to the specific drugs, adverse side effects, and high costs. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9 billion by 2027.

On November 16, 2020 PharmAbcine Inc. (KOSDAQ: 208340ks) reported that the company will present the final results of the Phase IIa clinical trial of Olinvacimab for rGBM (recurrent glioblastoma multiforme) patients at SNO (Society of Neuro-Oncology) 2020 (Press release, PharmAbcine, NOV 16, 2020, View Source [SID1234571180]).

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The clinical study was conducted in Australia from 2016- 2017. In the study, 25% of the patients had stable disease and 40% of the patients had relief from brain edema. The data from the study suggested the possibility of using Olinvacimab for rGBM patients who no longer respond to Avastin in treating severe brain edema.

In 2017, PharmAbcine received approval from the US FDA (Food and Drug Administration) for the Phase II clinical study of Olinvacimab for Avastin-refractory rGBM patients. Furthermore, Olinvacimab received Orphan Drug Designation (ODD) from both the US FDA and the Korean MFSD (Ministry of Food and Drug Safety) in 2018. Beginning in 2019, the Phase II clinical trial is currently on-going.

Glioblastoma multiforme (GBM) is the most common and malignant primary brain tumor with a fast growth rate. Recurrent glioblastoma multiforme (rGBM) is a disease in which the GBM recur after surgery and drug/radiation therapy. It is known that rGBM has an average life expectancy of about 4 months and causes extensive brain edema.

About Society of Neuro-Oncology Annual Meeting

Society of Neuro-Oncology Annual Meeting is the world’s largest neuro-oncology society held every year. This year marks 25th event with more than 2600 researchers and experts participating from more than 40 countries around the world. Through this event, many global pharmaceutical companies will present various cutting-edge technologies and advance their academic and research efforts in the field of neuro-oncology. SNO 2020 will be held virtually from November 19 to 21.

On November 16, 2020 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") reported financial results for the third quarter ended September 30, 2020 and provided an update on its business (Press release, Titan Pharmaceuticals, NOV 16, 2020, View Source [SID1234571179]).

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Third Quarter 2020 and Recent Highlights

In September 2020, the Company completed a registered direct offering, resulting in net cash proceeds of approximately $2.4 million.
In October 2020, Titan announced a strategic restructuring, where it will focus on ProNeura-based product development; and discontinue its U.S. Probuphine implant sales and wind down Probuphine commercialization activities.
In October 2020, Kate DeVarney, Ph.D., was promoted from the position of Executive Vice President and Chief Scientific Officer to President and Chief Operating Officer. In addition, Sunil Bhonsle stepped down from his executive role. Dr. Marc Rubin, Titan’s Executive Chairman, together with Dr. DeVarney, will oversee the Company’s product development activities.
In October 2020, Titan completed a public offering resulting in net cash proceeds of approximately $5.7 million.
In October 2020, the Company settled all of its debt obligations with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A and Horizon Credit LLC II.
In October 2020, Titan acquired JT Pharmaceuticals, Inc.’s kappa opioid agonist peptide, JT-09, for use in combination with Titan’s ProNeura long-term, continuous drug delivery technology, for the treatment of chronic pruritus.
"Subsequent to the end of the third quarter, Titan began an important, focused restructuring to position the Company for future growth," said Dr. DeVarney. "We believe that our ProNeura platform, which has the potential to provide continuous drug delivery over extended periods of up to six to 12 months, offers potential key value-generating opportunities. These include the platform’s application to the recently-acquired JT-09, for which we plan to establish proof-of-concept as a treatment of chronic pruritus in the first half of next year. In addition, we remain committed to helping individuals impacted by the opioid epidemic through our ongoing, National Institute on Drug Abuse-funded nalmefene implant development program, with plans to file an investigational New Drug Application with the U.S. Food and Drug Administration in the first half of 2021."

"In addition to refocusing our efforts on the ProNeura platform, our recent restructuring significantly reduced operating expenses, while our debt settlements restored our ability to fully capitalize on our IP," said Dr. Rubin. "These, combined with the recent completion of two financings, positions Titan to execute on our new strategy."

Third Quarter 2020 Financial Results

For the three months ended September 30, 2020, Titan reported approximately $1.1 million in revenue, which reflects approximately $0.1 million in product sales and approximately $1.0 million related to the Company’s National Institute on Drug Abuse ("NIDA") grant. This compared with revenues of approximately $0.9 million in the same period in 2019, which was comprised of $0.2 million in product sales and $0.8 million related to the NIDA grant. Product revenue during the three month period ended September 30, 2020 declined from the comparable periods in 2019 due to a substantial decrease in unit sales volumes; increased utilization of patient assistance programs; and the effects of the COVID-19 pandemic and the related shelter-in-place restrictions and clinic closures.

Total operating expenses for the third quarter of 2020 were approximately $5.8 million, compared with approximately $4.8 million from the same quarter in 2019, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses. R&D expenses for the quarter ended September 30, 2020 were approximately $1.6 million, consistent with the same three month period in 2019. SG&A expenses for the 2020 third quarter were approximately $3.5 million, compared with approximately $3.0 million in the same quarter a year ago. Costs of goods sold for the third quarter of 2020 were approximately $0.7 million, compared with approximately $0.2 million the 2019 third quarter.

Net other expense, consisting primarily of interest expense, was approximately $0.3 million in the third quarter of 2020, compared with net other income of approximately $1.1 million in the third quarter of 2019. The increase in other expense, net for the three months ended September 30, 2020 was primarily due to an approximately $1.0 million non-cash gain on changes in the fair value of warrants issued in connection with Titan’s August 2019 offering and an approximately $0.3 million non-cash gain on debt extinguishment related to the modification of Titan’s loan from Molteni.

Net loss applicable to common stockholders in the third quarter of 2020 was approximately $4.9 million, or approximately $0.05 per share, compared with a net loss applicable to common stockholders of approximately $2.8 million, or approximately $0.18 per share, in the same quarter in 2019.

As of September 30, 2020, Titan had cash and cash equivalents of approximately $4.1 million, which the Company believes, along with the proceeds of public offering, is sufficient to fund planned operations into the third quarter of 2021.

Conference Call Details

Titan management will host a conference call today at 12:00 p.m. ET / 9:00 a.m. PT to discuss business developments in the period. The conference call will be hosted by Marc Rubin, M.D., Executive Chairman, and Kate DeVarney, Ph.D., President and Chief Operating Officer.

The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 9502574. The call will also be broadcast live at View Source, and archived on Titan’s website at www.titanpharm.com/news/events.

On November 16, 2020 Today Children’s Hospital of Philadelphia (CHOP) and Gustave Roussy, a cancer-research institute based in France, reported that were awarded a grant from a group of neuroblastoma clinical research charities led by Solving Kids’ Cancer UK and Solving Kids’ Cancer (US) that will support parallel phase 3 clinical trials developed by the Children’s Oncology Group (COG) and The International Society of Paediatric Oncology Europe Neuroblastoma Group (SIOPEN) (Press release, CHOP, NOV 16, 2020, View Source [SID1234571178]). This is the first-ever collaboration between the North American and European pediatric cancer consortia focused on neuroblastoma. The grant, distributed over a four-year period, will be split between CHOP and Gustave Roussy.

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Additional charity partners providing the research funds include Band of Parents, Joining Against Cancer in Kids (J-A-C-K), Ronan Thompson Foundation, Wade’s Army, and Zoé4life.

Yael Mossé, MD, a physician-scientist who focuses on neuroblastoma in CHOP’s Cancer Center, will co-lead this collaboration with COG and Dominique Valteau-Couanet, MD, PhD, the division chief of Pediatric Oncology at Gustave Roussy.

"This exciting collaboration is an important step in developing better treatments for children with neuroblastoma," said Dr. Mossé. "Only one new drug has been approved by the FDA for neuroblastoma in the past 30 years. We hope this collaboration between North American and European researchers will bring more targeted therapies to children newly diagnosed with this disease."

"This collaboration will allow us to evaluate a targeted therapy upfront in combination with the standard treatment developed by COG and SIOPEN for children with high-risk neuroblastoma. It is a unique opportunity to demonstrate the impact of such targeted therapies in this disease," said Dr. Valteau-Couanet. "The collaboration is the result of a confident relationship developed between our two groups during the last decade. This trial is the first step of a collaboration that will help to answer questions that could not be solved otherwise".

Neuroblastoma is the most common pediatric cancer diagnosed in infancy, with approximately 90 percent of children with the disease diagnosed before the age of five. In North America and Europe, some 1,500 children are diagnosed with severely malignant, high-risk neuroblastoma each year, which requires intense and grueling treatment. Fewer than half of those with high-risk disease live more than five years after diagnosis, and those who do survive often suffer lifelong side effects, including hearing loss, learning disabilities, and secondary malignant cancers.

In order to develop a more effective and less toxic treatment for neuroblastoma, clinical trials developed within COG and SIOPEN will target mutations in the ALK oncogene, which are found in 14 percent or more of patients with newly diagnosed neuroblastoma and have recently been implicated in relapses of the disease. Through a partnership with Pfizer Pharmaceuticals and the New Approaches to Neuroblastoma Therapy (NANT), researchers at CHOP led by Mossé’s laboratory have discovered a highly specific and potent ALK inhibitor, lorlatinib, a drug currently used to treat lung cancer that would impede the pro-cancer activities of these ALK mutations and potentially have a significant impact in neuroblastoma patients.

In parallel Phase 3 clinical trials within COG in North America and SIOPEN in Europe, the researchers hope to use lorlatinib to substantially improve the survival for patients with newly diagnosed high-risk neuroblastoma whose tumors harbor an activated ALK gene mutation. The collaboration, known as TITAN: Transatlantic Integration Targeting ALK in Neuroblastoma, will involve simultaneous evaluation of the addition of lorlatinib to both COG’s and SIOPEN’s high-risk neuroblastoma treatment regimens, merging the data with the aim of accelerating lorlatinib approval if the drug is effective.

"This is a landmark step in clinical research for children with neuroblastoma," said Andy Pearson, MD, Chair of the Solving Kids’ Cancer UK Scientific Advisory Board, which managed the grant review and award process. "With pediatric cancer hugely underfunded in comparison to adult cancer, there is an urgent need for breakthrough treatments for the most difficult-to-cure childhood cancers like neuroblastoma. This trial has the potential to accelerate the discovery of a new treatment and lay the foundation for future collaborations of this nature."

On November 16, 2020 Proteostasis Therapeutics, Inc. (Nasdaq:PTI), a clinical stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2020 (Press release, Proteostasis Therapeutics, NOV 16, 2020, View Source [SID1234571176]).

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In August 2020, Proteostasis and Yumanity Therapeutics, Inc. ("Yumanity"), announced the two companies had entered into a definitive merger agreement. If the merger is completed, Yumanity will become a wholly-owned subsidiary of Proteostasis, and the current stockholders of Yumanity will become the majority owners of Proteostasis’ outstanding common stock. Completion of the merger is subject to the satisfaction of certain closing conditions, including approval of the transaction by Proteostasis’ and Yumanity’s stockholders. Upon the satisfaction or waiver of the terms and conditions required under the merger agreement, including receiving the requisite stockholder approvals, the combined company is expected to operate under the name Yumanity Therapeutics, Inc. and trade on the Nasdaq Capital Market under the ticker symbol "YMTX". The transaction is expected to close in the fourth quarter of 2020, subject to approvals by stockholders of each company and other customary closing conditions.

Third Quarter 2020 Financial Results

Proteostasis reported a net loss of approximately $8.2 million for the three months ended September 30, 2020, as compared to a net loss of $12.8 million for the same period in the prior year.

Proteostasis recorded no revenue in the three months ended September 30, 2020 and 2019.

Research and development expenses for the three months ended September 30, 2020 were $1.2 million, as compared to $10.1 million for the same period in the prior year. The decrease in research and development expenses for the three months ended September 30, 2020 compared to the three months ended September 30, 2019 was primarily due to a decrease in clinical-related research activities.

General and administrative expenses for the three months ended September 30, 2020 were $4.5 million, as compared to $3.2 million for the same period in the prior year. The increase in general and administrative expenses for three months ended September 30, 2020 compared to September 30, 2019 was due primarily to an increase in professional fees in connection with the proposed merger with Yumanity Therapeutics.

Restructuring costs were $2.4 million for the three months ended September 30, 2020, consisting primarily of severance-related costs associated with a reduction in force undertaken in connection with the proposed merger with Yumanity Therapeutics. There were no restructuring costs for the three months ended September 30, 2019.

Cash, cash equivalents and short-term investments totaled $40.8 million as of September 30, 2020, compared to $69.5 million as of December 31, 2019. Proteostasis believes that its existing cash, cash equivalents and short-term investments are sufficient to fund its operations for at least 12 months from the date that its consolidated financial statements are issued and through the completion of the proposed merger with Yumanity Therapeutics.