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PAQ Therapeutics Launches with $30 Million Series A to Develop Novel Therapies through Autophagy-Dependent Degradation

On July 15, 2021 PAQ Therapeutics, a biotechnology company pioneering a new approach to restoring heath and curing disease through autophagy, reported the completion of its $30 million Series A financing (Press release, PAQ Therapeutics, JUL 15, 2021, View Source [SID1234649949]). PAQ’s approach and technology expands the therapeutic potential of autophagy – the body’s most versatile mechanism for natural cellular degradation – to target not only disease-causing proteins but lipids, pathogens and other substrates with the goal of restoring health. Sherpa Healthcare Partners led the Series A financing with participation from Huagai Capital, MSA Capital, and MRL Ventures Fund, joined by seed investors, Nest.Bio Ventures and Matrix Partners China.

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PAQ’s novel autophagosome-tethering compounds (ATTECs) are small molecules with the potential to selectively catalyze autophagy-dependent degradation of a wide range of disease-causing substrates, including proteins and non-protein substrates, such as aggregates, mitochondria, lipids and pathogens. PAQ is initially focused on a genetic neurodegenerative disorder, with the potential to expand the breakthrough ATTEC platform to target disease-causing protein and non-protein targets for a range of diseases with limited treatment options. The Series A financing will allow the company to advance its ATTEC platform and progress its pipeline programs.

"PAQ’s team of global experts are working to hijack the powerful autophagy pathway to directly target and eliminate disease-causing substrates from the body," said Nan Ji, Ph.D., PAQ’s Co-founder, President and CEO. "PAQ’s ATTEC technology provides a complementary and differentiated platform to targeted protein degradation (TPD), which works through the ubiquitin-proteosome (UPS) pathway. Our autophagy-dependent approach further supports a pivotal moment in the evolution of drug discovery and design by expanding our ability to target the disease-causing substrates beyond proteins underlying diseases with limited or no treatment options."

Based in Cambridge, Massachusetts, the global PAQ team collectively brings decades of drug discovery experience and significant expertise in autophagy research. Joining Dr. Ji as co-founders are Huaixiang Hao, PhD, Head of Biology and Professor Boxun Lu of Fudan University in Shanghai, China. PAQ’s scientific advisors are distinguished research leaders in autophagy, neuroscience, drug discovery including:

David Rubinsztein, PhD, Professor of Molecular Neurogenetics and a UK Dementia Research Institute Group Leader, University of Cambridge
Jared Rutter, PhD, Distinguished Professor of Biochemistry, Dee Glen and Ida Smith Endowed Chair for Cancer Research, University of Utah
Jin-Quan Yu, PhD, Frank and Bertha Hupp Professor of Chemistry, The Scripps Research Institute
"Dr. Nan Ji has assembled a strong team of leading autophagy researchers and scientific advisors focused on advancing the ATTEC platform," said Cheng Xing, Managing Partner of Sherpa Healthcare Partners. "We see tremendous potential for autophagy-dependent degradation to achieve major therapeutic innovations leveraging the flexibility of small molecules to create cures and overcome serious diseases where therapeutic options are limited for patients."

Curtana Pharmaceuticals Signs Development and Manufacturing Agreement with Catalent for Brain Cancer Drug CT-179

On July 15, 2021 Curtana Pharmaceuticals, a privately-held, preclinical stage biopharmaceutical company, reported that it has signed an agreement with Catalent to support tablet formulation and manufacturing of Curtana’s CT-179, a drug therapy for the treatment of glioblastoma (GBM), medulloblastoma (MB), and other brain cancers (Press release, Curtana Pharmaceuticals, JUL 15, 2021, View Source [SID1234587031]).

CT-179 is a highly potent and selective small molecule inhibitor of OLIG2, a transcription factor that is essential to normal early brain development but is not actively expressed in most normal adult brain cells or in normal tissues outside the brain. However, it is expressed in all diffuse gliomas and it has been shown that OLIG2 drives tumor initiation, tumor growth, invasion into healthy brain tissue, and resistance to chemotherapy and radiation therapy. Studies to-date have demonstrated the viability of CT-179 to markedly prolong survival in numerous, relevant animal models of GBM, MB and other brain cancers. The drug is orally bioavailable, readily crosses the blood-brain barrier, and achieves high concentrations in the brain.

"This is a significant milestone for the company as we move into clinical trials, which are anticipated to commence in the first half of 2022," said Gregory Stein, M.D., M.B.A. and Chief Executive Officer, Curtana Pharmaceuticals. "GBM is a devastating disease with a poor prognosis and a variety of therapeutic challenges. We are excited to bring this easy-to-use oral therapy with the potential to improve quality of life and prolong survival of patients with GBM and other devastating brain cancers."

Formulation development and CGMP manufacturing of the clinical trial product will take place at Catalent’s 98,000 square-foot facility in San Diego, CA. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, CGMP manufacturing, clinical packaging, labeling, and worldwide distribution.

"Catalent is proud to partner with Curtana in the pursuit of a treatment for brain cancer," said Bryan Knox, General Manager of Catalent San Diego. "The Catalent team in San Diego is focused on early-stage development of small molecule and peptide drug candidates, from the bench to the clinic, and our expertise in oral delivery makes us an ideal partner for Curtana on the further development of CT-179."

ImmunoGen Announces Conference Call to Discuss Its Second Quarter 2021 Operating Results

On July 15, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, July 30, 2021 to discuss its second quarter operating results (Press release, ImmunoGen, JUL 15, 2021, View Source [SID1234586881]). Management will also provide a brief update on the business.

Conference Call Information

To access the live call by phone, dial (877) 621-5803; the conference ID is 1789134. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

LifeArc and PharmEnable team up to discover novel oral antiviral drugs to treat coronaviruses

On July 15, 2021 PharmEnable, an AI drug discovery company unlocking challenging biological targets, reported that it has entered into a drug discovery collaboration with LifeArc, an independent UK medical research charity, to apply their respective technologies and expertise to discover novel oral antiviral drugs with activity against coronaviruses (Press release, LifeArc, JUL 15, 2021, View Source [SID1234585348]).

The COVID-19 pandemic has not only demonstrated the threat that novel and variant viruses pose, but also the vital role of innovative science to develop vaccines and drugs to combat infection, improving patient health while minimising economic impact. Although vaccines will be invaluable in controlling the pandemic, they are rarely 100% effective. The impact of COVID-19 is showing no signs of abating with the risk of new variants and novel coronaviruses remaining an ever-present threat.

The aim of the risk-sharing collaboration is to produce an oral therapeutic that has broad applicability across SARS-CoV-2 variants and emerging coronaviruses.

PharmEnable’s approach identifies three-dimensional (3D) small molecule drug candidates with improved specificity compared with traditional screening methods. Its proprietary advanced artificial intelligence (AI)-enabled and medicinal chemistry platform allows the company to mine unexplored chemical space to deliver innovative medicines, and has been used to identify and develop novel, highly specific drug leads.

LifeArc plays a vital role in advancing medical research through funding, advice and scientific expertise to translate early discoveries into patient benefit. Since the beginning of the pandemic, LifeArc has contributed £27m to research projects to address the healthcare challenges of COVID-19. Within this collaboration, it will provide resources for the synthesis, optimisation and biological validation of molecules and contribute its expertise in the translation of early-stage science into healthcare treatments.

Dr Hannah Sore, Chief Executive Officer of PharmEnable, said: "We are delighted that PharmEnable was chosen by LifeArc as part of its highly competitive coronavirus initiative. Our platform is proven in its ability to tap unexplored parts of the chemical universe to find novel and specific small molecule candidates for important and challenging targets. Combining our platform with the expertise and experience of LifeArc should enable us to generate several powerful oral drug candidate molecules against SARS-CoV-2 variants and similar viruses.

"We are excited that by working with LifeArc our technology platforms might play a role in expanding the arsenal of treatments available to manage coronavirus-related diseases and save lives."

Dr Justin Bryans, Executive Director, Drug Discovery and Diagnostics at LifeArc added: "We have been actively mobilising our resources and have forged new partnerships to enable us to find ways in which to address the ongoing challenges of COVID-19. This promising new collaboration combines our drug discovery expertise and translational science skills with PharmEnable’s technology to discover novel, anti-viral drug therapies that may be highly effective against evolving coronaviruses."

Entry into a Material Definitive Agreement

On July 15, 2021, Generex Biotechnology Corporation (the "Company") reported that it closed on a funding transaction by entering into a Securities Purchase Agreement with an investor pursuant to which the Company agreed to sell and sold a secured convertible promissory note bearing interest at 8% per annum with a 12-month maturity date (the "Note") in the aggregate principal amount of $1,085,000 (Filing, 8-K, Generex, JUL 15, 2021, View Source [SID1234585012]). The purchase price of the Note was $1,000,000 with $70,000 of principal amount represented original issue discount, along with the issuance of 705,173 shares of the Company’s common stock, as inducement shares. Pursuant to the Securities Purchase Agreement, the Company also sold to the Investor warrants to purchase up to an aggregate 904,167 shares of common stock.

Subject to certain ownership limitations, the Note will be convertible at the option of the holder six months from the issue date into shares of the Company’s common stock at an effective conversion price of the lower of (i) $0.60 and (ii) 75% of the lowest VWAP during the 30 consecutive trading days immediately preceding the delivery of the conversion. Subject to certain ownership limitations, the warrants will be exercisable after the six-month anniversary of the initial exercise date through the fifth anniversary of issuance at an exercise price of $0.60 per share of common stock.

The conversion price of the Note and the exercise of the warrants will be subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. If the Company defaults on a timely repayment, then the conversion price will also be adjusted if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then conversion price, except in the event of certain exempt issuances.

The Company is required to file a registration statement with the SEC by July 26, 2021, and have the registration statement become effective within 90 days of closing.

The Company has the right to prepay the Note at a premium after issuance. If the Note is prepaid within 60 days, the Company will pay 105% of the principal amount; if the Note is prepaid after 60 days but prior to 90 days, the Company will pay 110% of the principal amount. If the Note is prepaid after 90, the Company will pay 120% of the principal amount.

The net cash proceeds to the Company from the sale of the Note, after deducting the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offering, is expected to be approximately $1,000,000.

The Note, warrants, and the shares of common stock underlying the warrants, were offered privately pursuant to Rule 506 of Regulation D under the Securities Act of 1933.