Category: Health

Monday, September 21, 2020

Onconova Therapeutics Inc. (ONTX)

CDK4/6 Program Advances into Clinic in China

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Trial initiation in China by research partner Hanx. Onconova announced the commencement of trial of its CDK4/6 and ARK5 inhibitor ON 123300 in China by its partner, HanX Biopharmaceuticals. Hanx and Onconova established the research collaboration in 2017.


What else is there for Onvonova?  The company anticipates filing for the investigational new drug (IND) application to evaluate ON 123300 in the United States in Q4 2020 for this program. We believe this will be…










Click to get the full report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Monday, September 21, 2020

Onconova Therapeutics Inc. (ONTX)

CDK4/6 Program Advances into Clinic in China

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Trial initiation in China by research partner Hanx. Onconova announced the commencement of trial of its CDK4/6 and ARK5 inhibitor ON 123300 in China by its partner, HanX Biopharmaceuticals. Hanx and Onconova established the research collaboration in 2017.


What else is there for Onvonova?  The company anticipates filing for the investigational new drug (IND) application to evaluate ON 123300 in the United States in Q4 2020 for this program. We believe this will be…










Click to get the full report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

The Roles of Notch Pathways and Notch Signaling in Cancers

Notch signaling regulates a diverse array of functions in the hematopoietic system and other tissues, including lineage commitment, differentiation, cell cycle progression, and maintenance and self-renewal of stem cells. The Notch receptor was first identified by Thomas Hunt Morgan in 1917 with the observation of a Drosophila strain, then cloned by Spyros Artavanis-Tsakonas and Michael Young decades later in 1980. Notch plays an important role in many types of cancer, particularly in the regulation of stem and progenitor cells.

The effect of Notch signaling is highly context-dependent. It is capable of acting as an oncogene or tumor-suppressor gene dependent on the presence of other genetic lesions and other factors. Multiple mutations in Notch genes are identified in a broad spectrum of cancers. They reflect various roles for Notch in different cancer contexts. Remarkably, functional studies implicate the importance of Notch signaling in all of the hallmarks of cancer (Exhibit 1), roles that range from oncogenic to tumor suppressive depending on cancer type.

Exhibit 1. Cancer hallmarks potentially in?uenced by Notch signaling. Positive (oncogenic) effects (green) and tumor-suppressive effects (red) are shown.

 Notes: ACC, adenoid cystic carcinoma; breast Ca, breast carcinoma; CLL, chronic lymphocytic leukemia; SCCa, squamous cell carcinoma; T-ALL, T cell acute lymphoblastic leukemia; TIC, tumor-initiating cell.

Source: Annu. Rev. Pathol. Mech. Dis. 2017. 12:245–75

Notch pathway activation has been implicated in cancer (solid tumor and hematological cancers) and associated with more aggressive cancers. Gamma secretase is a protease (a type enzyme) complex responsible for Notch activation via cleavage of numerous transmembrane proteins, including amyloid precursor protein (APP), Notch, HER4, E-cadherin, N-cadherin, BCMA, and CD44. These substrates have been associated with a variety of diseases, including cancer and Alzheimer’s diseases. Hence, these provide a foundation and rationale for evaluating gamma-secretase and Notch as a therapeutic target.

Exhibit 2. Notch signaling and strategies for pharmacological targeting of this pathway

Source: Moore G. et al. Cells 2020, 9, 1503

There are numerous strategies to pharmacologically target Notch signaling, including Notch receptor monoclonal antibodies, ligand-targeted antibodies (e.g., DLL-4 antibodies), gamma-secretase inhibitors (GSIs), and Notch transcript complex small molecules. Among the multiple gamma-secretase/Notch inhibitors:

• Ayala Pharmaceuticals (AYLA)’ pan-Notch/gamma-secretase inhibitor AL101 is being assessed in an open-label Phase 2 clinical trial (Accuracy) for the treatment of recurrent/metastatic adenoid cystic carcinoma (R/M ACC) for patients bearing Notch-activating mutations.
• SpringWorks Therapeutics (SWTX)’ gamma-secretase inhibitor nirogacestat is evaluated in a registrational Phase 3 (DeFi) clinical trial for the treatment of desmoid tumors.
• Cellestia Biotech (Private)’s pan-Notch inhibitor CB-103 is evaluated in a Phase 1/2A study in adult patients (pts) with advanced or metastatic solid tumors and hematological malignancies characterized by alterations of the Notch signaling, including breast cancer, colorectal cancer, cholangiocellular carcinoma, sarcoma, desmoid tumor, adenoid cystic carcinoma, non-Hodgkin lymphoma, and malignant glomus tumor.

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Photo: Cancer Cells

Dyadic Announces Collaboration with Jiangsu Hengrui Medicine for Biologic Drug Development

LIANYUNGANG, CHINA & JUPITER, FL / ACCESSWIRE / August 17, 2020 Dyadic International, Inc. (“Dyadic” or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on further applying its proprietary C1 gene expression platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced collaboration with Jiangsu Hengrui Medicine Co., Ltd. (“Hengrui”) (SSE:600276) to apply Dyadic’s C1 technology to the development of selected Hengrui biologic drug(s).

“We are very excited to partner with Hengrui, one of the most innovative and inventive global biopharmaceutical companies. This collaboration also highlights the appeal of C1’s value proposition, producing cell lines at higher expression levels and lower cost, to address global demand for more efficient biomanufacturing processes of biologic vaccines and drugs. We are looking forward to a successful collaboration with Hengrui,” said Dyadic’s CEO, Mark Emalfarb.

Dr. Lianshan Zhang, Hengrui’s R&D President, commented, “We are interested in Dyadic’s C1 technology, which has potential to help us produce biotherapeutics in a more cost-effective fashion. As a result, we are leveraging our combined expertise and working closely with Dyadic as we share their vision of creating biomedicines to benefit patients globally.”

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

Please visit Dyadic’s website at http://www.dyadic.com for additional information, including details regarding Dyadic’s plans for its biopharmaceutical business.

About Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui Medicine Co., Ltd. is a global biopharmaceutical company, headquartered in China, with 24,700 employees devoted to empowering healthier lives through research. With over $3.3 billion in revenue in 2019, Hengrui has 6 new molecular entities approved in China as well as 30 plus programs in clinical development in China, US, EU and Australia across oncology, anesthesiology & analgesics, autoimmune, and metabolic & cardiovascular therapeutic areas. Driven by internal R&D and global licensing and collaboration, Hengrui is committed to bringing high quality products to patients. For more information, please visit http://www.hrs.com.cn/index.html.

Safe Harbor Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at http://www.dyadic.com.

Contact:

Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: [email protected]

Thursday, September 17, 2020

Lineage Cell Therapeutics (LCTX)

Initiating Coverage, Eye of Stem Cell Treatments and Beyond

Lineage Cell Therapeutics, Inc. (NYSE American: LCTX) is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Topline. We like how strategic and forward-looking Lineage has been recently with its pipeline programs. The management team implemented multiple changes in the corporate structure including the acquisition of Asterias Biotherapeutics – prepended two additional cell therapy product candidates, OPC1 and VAC2 in its pipeline. We believe that the value-driving components of the pipeline have been in flux and have not been on investors’ radar. Our analyses show that out of the pipeline, OpRegen and VAC2 may be subject to the largest near and medium-term value inflections which could be transformational for the company and its investors.


The What.  In this report, we highlight the company’s innovative cell therapy pipeline as it begins to yield data. The lead program, OpRegen, is the largest contributor to our valuation with >$0.5B projected sales at peak in the age-related macular degeneration (AMD) market, which is expected to reach $18.7B sales in 2028. The second lead asset, OPC1, is in a small market of acute spinal cord …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Novus Therapeutics Announces Acquisition of Anelixis Therapeutics

Acquisition includes lead clinical-stage compound AT-1501, a next generation anti-CD40L antibody, in development for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases

Senior management team with extensive drug development and commercialization experience, including Dr. David-Alexandre “DA” C. Gros as CEO and Dr. Steven Perrin as President and CSO, to lead Novus

Company completes private placement financing with proceeds of $108 million to be used to advance AT-1501 Phase 2 clinical trials in up to four indications

Conference call tomorrow at 8:30 a.m. EDT

IRVINE, Calif. & BOSTON–(BUSINESS WIRE)–Sep. 14, 2020– Novus Therapeutics, Inc. (“Novus”) (NASDAQ: NVUS) today announced it has completed the acquisition of Anelixis Therapeutics, Inc. (“Anelixis”), a privately held clinical stage biotechnology company developing a next generation anti-CD40 Ligand (CD40L) antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases. Concurrent with the acquisition of Anelixis, Novus entered into a definitive agreement for the sale of non-voting convertible preferred stock (the “Preferred Stock”) in a private placement to a group of institutional accredited investors led by BVF Partners L.P., with participation from Cormorant Asset Management, Ecor1 Capital, Logos Capital, Fidelity Management and Research Company, Adage Capital Partners L.P., Woodline Partners LP, Ridgeback Capital, Janus Henderson Investors, and Samsara BioCapital, as well as additional investors. The private placement is expected to result in gross proceeds to Novus of approximately $108 million before deducting placement agent and other offering expenses. The proceeds from the private placement will be used to fund the Company’s operations, including to advance Phase 2 clinical trials of AT-1501, a humanized IgG1 anti-CD40L antibody with high affinity for CD40L, in renal transplantation, islet cell transplantation, autoimmune nephritis, and amyotrophic lateral sclerosis (ALS).

“We are excited about AT-1501 and the potential to develop and commercialize the next generation anti-CD40L antibody, a well-validated target with broad therapeutic possibilities,” said Keith A. Katkin, Chairman of the Board of Directors of Novus. “After exploring a range of strategic options to maximize shareholder value, we believe this acquisition represents the greatest value creation opportunity for Novus stockholders, and we are confident that we have the management and scientific leadership team to fully realize this opportunity for patients in need of new treatment options.”

Leadership & Organization

In addition to the strategic acquisition and private placement, Novus announced its Board of Directors has previously appointed David-Alexandre “DA” C. Gros, M.D. to serve as Chief Executive Officer and Director. Dr. Gros joins Novus from Imbria Pharmaceuticals Inc., where he served as Co-Founder, Chief Executive Officer and Director. Prior to Imbria, Dr. Gros was President and Chief Operating Officer of Neurocrine Biosciences, Inc., Chief Business and Principal Financial Officer of Alnylam Pharmaceuticals, Inc., and Chief Strategy Officer of Sanofi, S.A. Before Sanofi, Dr. Gros held leadership positions in healthcare investment banking at Centerview Partners, LLC, and Merrill Lynch, Pierce, Fenner & Smith, Inc., and in healthcare consulting at McKinsey & Company. Dr. Gros earned a Doctor of Medicine from Johns Hopkins University School of Medicine, a Master of Business Administration from Harvard Business School, and a Bachelor of Arts from Dartmouth College.

“I am both thrilled and humbled to join the Novus management team and Board during this new phase of the company’s evolution, as we prepare to initiate multiple Phase 2 trials for AT-1501” said Dr. Gros. “Through this acquisition and financing, we now have the scientific, organizational and financial resources to build upon a deep historical understanding of the CD40/CD40L pathway, as well as Anelixis’ preclinical and Phase 1 data, to address the needs of people undergoing organ or cellular transplantation, or living with autoimmune and neurodegenerative diseases.”

Joining Dr. Gros on the Novus management team and Board of Directors is Steven Perrin, Ph.D., Founder and Chief Executive Officer of Anelixis, who will take on the role of President and Chief Scientific Officer. Dr. Perrin brings 20 years of drug development experience to Novus, having held R&D positions at the Hoechst-Ariad Genomics Center, Aventis Pharmaceuticals, Inc., and Biogen Idec, Inc. Over the past decade, Dr. Perrin has worked with the ALS Therapy Development Institute to develop the world’s largest ALS drug development program, bridging preclinical and clinical programs. Dr. Perrin received a Ph.D. in biochemistry from Boston University Medical Center, where he also started his career as Associate Professor of Medicine, and a Bachelor of Science from Boston College.

“The activation of CD40/CD40L signaling is critical to mediating antibody and cellular inflammatory response. We are developing antibodies to inhibit the activation of this pathway with the hope of offering new treatment modalities for people living with conditions such as autoimmune nephritis and ALS, or those requiring a potentially life-saving transplant,” said Dr. Perrin. “I have dedicated my career to developing better medicines for these patients and their families, and I look forward to working with the team to advance these clinical programs.”

Concurrent with the acquisition, former Anelixis Chairman of the Board Walter Ogier has been appointed to the Novus Board of Directors. Mr. Ogier has more than 30 years of experience developing therapeutic medical products ranging from pharmaceuticals to medical devices, stem and immune cell therapies, and gene therapies. He has served in multiple CEO roles including Genetix Pharmaceuticals, Inc. (now bluebird bio, Inc.) and Acetylon Pharmaceuticals, Inc., which Celgene Corporation acquired in 2016. In addition to Novus, he serves as a director of Biothera Pharmaceuticals, Inc., Thetis Pharmaceuticals, LLC, and Nemucore Medical Innovations, Inc., and as Board advisor to Kodikaz Therapeutic Solutions, Inc., and ME Therapeutics, Inc.

Novus Board members will also include Keith A. Katkin, Chairman of the Board; Gary A. Lyons; and John S. McBride. The company will continue to maintain its executive offices in Irvine, Calif. and will have research and development facilities in Boston, Mass.

About the Transactions

The acquisition of Anelixis was structured as a stock-for-stock transaction whereby all of Anelixis’ outstanding equity interests were exchanged in a merger for a combination of shares of Novus common stock and shares of Preferred Stock. Concurrently with the acquisition of Anelixis, Novus entered into definitive agreements for a PIPE investment with existing and new investors to raise approximately $108 million in which the investors will be issued shares of Preferred Stock at a price of approximately $500 per share (or, $0.50 per share on an as-converted-to-common basis). The PIPE offering is expected to close on September 14, 2020. Subject to stockholder approval, each share of Preferred Stock will, at the option of the holder, be convertible into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. The acquisition was approved by the Board of Directors of Novus and the equity holders of Anelixis.

Ladenburg Thalmann & Co. Inc. is serving as exclusive financial advisor and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Novus. Goodwin Procter LLP is serving as legal counsel to Anelixis. SVB Leerink is serving as financial advisor and lead placement agent for the private placement, and Noble Life Science Partners, a division of Noble Capital Markets, Inc., is acting as co-placement agent.

Additional details are available in an updated corporate presentation that can be found online at www.novustherapeutics.com.

Webcast Details

Novus will host an audio webcast on Tuesday, September 15, 2020, at 8:30 a.m. EDT to discuss the acquisition. The live audio webcast will be accessible through a direct link and the investor section of www.novustherapeutics.com. To access via phone, please dial (833) 614-1390 (toll-free) or (914) 987-7111 (international) and provide the conference ID 4046285. Please visit the investor section of the Novus website at www.novustherapeutics.com for the archived webcast and for more information on the acquisition.

About AT-1501

AT-1501 is a humanized IgG1 anti-CD40L antibody with high affinity for CD40L, a well-validated target with broad therapeutic potential. The CD40/CD40L pathway plays a central role in generating pro-inflammatory responses in autoimmune disease, allograft transplant rejection, and neuroinflammation. In a Phase 1 safety study of healthy volunteers and patients with ALS, AT-1501 was well tolerated at all doses tested.

About Novus Therapeutics

Novus Therapeutics, Inc. is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for people requiring an organ or cell-based transplant, and for people with autoimmune and neurodegenerative disease. Novus is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.novustherapeutics.com.

Follow Novus Therapeutics on social media: @Novus_Thera and LinkedIn.

Notice of Issuance of Inducement Grants

Pursuant to their employment agreements, Drs. Gros and Perrin have been awarded options to purchase a total of 18,279 and 7,857 shares of Preferred Stock, respectively, subject to time-based vesting (the “Inducement Grants”). The Inducement Grants have an exercise price of $500 per share of Preferred Stock, which is equal to the price at which the Preferred Stock is being offered and sold in the PIPE financing and represents (on an as-converted basis) a premium of approximately 30% over the last reported closing price of the Novus common stock prior to grant. The Inducement Grants have been approved by the Novus Board of Directors and the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company’s stockholder-approved equity incentive plans as an inducement grant in accordance with Nasdaq Listing Rule 5635(c)(4).

Forward-Looking Statements

This press release contains forward-looking statements that involves substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward-looking statements include such identifying words. Forward-looking statements include, but are not limited to statements regarding: risks related to market conditions; expectations regarding the timing for the commencement of future clinical trials; expectations regarding the success of clinical trials; the rate and degree of market acceptance and clinical utility of the company’s products; the company’s estimates regarding expenses and cash runway; and the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005852/en/

Amanda Sellers
[email protected]
301.332.5574

Source: Novus Therapeutics, Inc.

Targeting Ovarian and Breast Cancer Through Another Innovative Therapy

The ovarian cancer landscape has experienced a paradigm shift from chemotherapy to targeted therapy with the approvals of Poly (adenosine diphosphate–ribose) polymerase (PARP) inhibitors and other late-stage assets in development. The mechanism of action of PARP inhibitors is based on trapping PARP on DNA at sites, which generates unrepairable DNA breaks. These breaks lead to the accumulation of DNA damage and tumor-cell death in cancer cells due to defective recombination repair systems (e.g., tumors with mutations in BRCA1 or BRCA2 genes). BReast CAncer (BRCA) genes 1 and 2 are linked to high-risk breast and ovarian cancers.

Breast cancer is the most frequently occurring cancer in women worldwide; ovarian cancer is the second most common gynecological cancer in developed countries, including the United States. BRCA1 and BRCA2 tumor suppressor genes are linked to cellular damage through activation of specific DNA repair processes. DNA replication and error-repair are critical components of cancer cell survival. PARP inhibitors are believed to inhibit both PARP1 and PARP2. The suppression of PARP activity prevents the formation of PAR polymers and blocks the binding of NAD+ at the site of DNA damage, ultimately compromising a cell’s ability to defeat DNA-dependent damage. There are currently 4 FDA-approved PARP inhibitors—niraparib (Zejula, PARP 1 and 2 inhibitors), olaparib (Lynparza, PARP 1 and 2 inhibitors), and rucaparib (Rubraca, PARP1, and PARP 3 inhibitor)— to treat patients with ovarian cancer who are refractory or resistant to platinum-based chemotherapy, and talazoparib (Talzenna, PARP 1 and 2 inhibitor) for the treatment of gBRCAm HER2- locally advanced or metastatic breast cancer.

Focusing on ovarian cancer treatment

Astra Zeneca’s (AZN) olaparib is approved in the United States and Europe as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer. SOLO-1, the first pivotal study of a PARP inhibitor in an early-stage setting, showed promising results. The data was presented at ESMO and published in NEJM. In a 391-patient trial, Lynparza was superior to placebo, as demonstrated by a clinically and statistically significant improvement in progress-free survival (PFS). Patients participating in the study were diagnosed with deleterious or suspected deleterious BRCA1 or BRCA2 mutations. Patients treated with Lynparza group did not reach the median PFS at 41 months of follow-up, while the placebo group hit median PFS at 13.8 months. At 36 months of follow up, 60% of patients treated with Lynparza showed progression-free disease compared to 27% in the placebo group. In addition to SOLO-1 study, the company conducted a Phase 3 clinical trial, PAOLA-1, to evaluate Lynparza in combination with Genentech’s Avastin (bevacizumab) as the first-line maintenance therapy for advanced ovarian cancer. In May 2020, Lynparza was approved in the first-line setting based on the results from the PAOLA-1 trial that showed patients treated with Lynparza and bevacizumab lived without disease progression for 37.2 months compared to 17.7 months median for bevacizumab alone.

Tesaro’s (TSRO) Zejula (niraparib) was approved for maintenance use in patients who had a complete or partial response to platinum chemotherapy in March 2017. The Phase 3 PRIMA (NCT02655016) study evaluated Zejula versus placebo as maintenance therapy after frontline chemotherapy in ovarian cancer patients. PRIMA study has enrolled patients regardless of BRCA mutation, while Astra Zeneca’s SOLO-1 trial only includes patients harboring BRCA mutation. Based on PRIMA results, Zejula was approved as monotherapy for women with advanced ovarian cancer beyond those with BRCAm disease in the first line and recurrent maintenance treatment settings, as well as late-line primary treatment settings on April 2020. The results showed that a 57% reduction in the risk of disease progression or death compared to placebo (HR 0.43; 95% CI, 0.31 to 0.59; p<0.0001) in the homologous recombination deficient (HRd) population (biomarker identified), and a 38% reduction in the risk of disease progression or death versus placebo in the overall population (HR 0.62; 95% CI, 0.50 to 0.76; p<0.0001).

Clovis (CLVS) ‘s Rubraca is a PARP1, PARP2, and PARP3 enzyme inhibitor, approved for the maintenance treatment of adult patients with recurrent epithelial ovarian cancer who responded (complete or partial response) to platinum-based chemotherapy. The ARIEL3 clinical trial evaluating Rubraca in 564 patients showed that patients treated with Rubraca have an average of 13.7 months without cancer progression compared to 5.4 months for those who did not receive Rubraca.

The ovarian cancer landscape has evolved to targeted therapy from chemotherapy with the approvals of PARP inhibitors and other late-stage assets in development. Lynparza has emerged first in the market and dominating the market with $982 million in sales, followed by Zejula with $292 million in sales and Rubraca with $143 million. There are multiple other late-stage assets- including ImmunoGen’s mirvetuximab soravtansine, Mersana Therapeutics’s XMT-1536, Fluzoparib Jiangsu Hengrui Medicine’s fluzoparib and others expected to enter into the market in the next several years.

Exhibit 1. Worldwide sales (in millions) of PARP inhibitors in ovarian cancer

Source: Evaluate Pharma

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Thursday, September 03, 2020

Cocrystal Pharma Inc. (COCP)

The High Unmet Need Persists in Influenza

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A late-stage influenza asset development is halted. The Janssen Pharmaceutical announced a strategic decision to discontinue the development of pimodivir, a Phase 3 clinical asset. The study results showed that pimodivir in combination with the standard of care (SOC) was very unlikely to demonstrate improved benefit in hospitalized patients with influenza A compared to SOC treatment alone. The study in both hospitalized patients and outpatients with influenza A was halted.


What does it mean? Cocrystal has two influenza programs: i) CC-42344 in influenza A, and ii) influenza A/B program in collaboration with Merck. CC-42344, influenza A PB2 inhibitor, is an investigational new drug (IND)-enabling stage. Cocrystal’s influenza programs have a large market potential (the worldwide (WW) sales of influenza drugs in the U.S. is expected to reach over $2.5 billion in 2026 …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Cocrystal Pharma Announces Closing of $17.2 Million Bought Deal Including Partial Exercise of Underwriter’s Option to Purchase Additional Shares

BOTHELL, WA, August 31, 2020 – Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics, announced today the closing of its previously announced underwritten public offering of 16,422,813 shares of common stock of the Company, including the partial exercise by the underwriter of the option to purchase an additional 2,137,098 shares of common stock, at a price to the public of $1.05 per share.

H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

The Company had granted to the underwriter a 30-day option to purchase up to an additional 2,142,857 shares of common stock at the public offering price, less underwriting discounts and commissions, of which the option to purchase an additional 2,137,098 shares of common stock has been exercised. The gross proceeds to Cocrystal, before deducting underwriting discounts and commissions and offering expenses, including the partial exercise of the underwriter’s option to purchase 2,137,098 additional shares of common stock, are approximately $17.2 million. The Company intends to use the net proceeds from this offering for the expansion of our COVID-19 and Influenza treatment development programs and general corporate purposes and working capital.

The shares of common stock were offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-237738) originally filed with the Securities and Exchange Commission (the “SEC”) on April 17, 2020, and declared effective by the SEC on May 13, 2020. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at https://www.sec.gov/ and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, hepatitis C viruses, coronaviruses and noroviruses.>

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to our intended use of proceeds and other statements that are not historical fact. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks arising from our reliance on continuing collaboration with Merck Sharp & Dohme Corp. under the collaboration agreement entered into last year, market and other conditions, any impact from the COVID -19 pandemic and its impact on the economy, the availability of products manufactured by third parties, the future results of preclinical and clinical studies, general risks arising from clinical trials, receipt of regulatory approvals, our ability to find and enter into agreements with suitable collaboration partners, unanticipated litigation and other expenses and factors that affect the capital markets in general and early stage biotechnology companies specifically. Further information on our risk factors is contained in our filings with the SEC, including our Prospectus Supplement dated August 26, 2020, our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor and Media Contact:

JTC Team, LLC
(833) 475-8247
[email protected]

Monday, August 24, 2020

Onconova Therapeutics Inc. (ONTX)

INSPIRE Fails, What is Next for Onconova?

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Rigosertib fails to provide survival benefit for MDS patients. Onconova announced data from its pivotal INSPIRE study, assessing rigosertib in the 2nd-line high-risk myelodysplastic syndrome (HR-MDS) patients. The primary endpoint of overall survival was not met in this trial. The results showed that IV rigosertib plus best supportive care to physician’s choice (PC) did not provide any survival benefits in patients compared to PC alone (6.4 months versus 6.3 months (p=0.33), respectively).


What is next for Onvonova? The results were disappointing. However, the company has the capital ($27.2 million as of June 30th, 2020) to advance other agents in…










Click to get the full report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Monday, August 24, 2020

Onconova Therapeutics Inc. (ONTX)

INSPIRE Fails, What is Next for Onconova?

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Rigosertib fails to provide survival benefit for MDS patients. Onconova announced data from its pivotal INSPIRE study, assessing rigosertib in the 2nd-line high-risk myelodysplastic syndrome (HR-MDS) patients. The primary endpoint of overall survival was not met in this trial. The results showed that IV rigosertib plus best supportive care to physician’s choice (PC) did not provide any survival benefits in patients compared to PC alone (6.4 months versus 6.3 months (p=0.33), respectively).


What is next for Onvonova? The results were disappointing. However, the company has the capital ($27.2 million as of June 30th, 2020) to advance other agents in…










Click to get the full report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision. 

Ceapro Inc. Reports 2020 Second Quarter and Six-Month Financial Results and Operational Highlights

Ceapro Inc. Provides Update on Development of an Inhalable Therapeutic for COVID-19

 – First milestone successfully achieved in early stages of the ongoing research project with McMaster University
– Confirmed capability of PGX Technology to optimize and standardize the size and morphology of yeast beta-glucan (PGX-YBG) suitable for lung inhalation
– In-vitro study with human cell lines demonstrated that PGX-YBG obtained from different sources exhibited significant stimulatory effect on human immune response

EDMONTON, ALBERTA – August 18, 2020 – Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today provided an update on its ongoing collaboration with McMaster University to develop an inhalable therapeutic for COVID-19.

The project, entitled “PGX-processed yeast beta-glucans as an inhalable immunomodulating therapeutic for COVID-19 patients,” jointly funded by Mitacs and Ceapro, is under the leadership of Dr. Kjetil Ask, a pulmonary fibrosis expert, and Dr. Todd Hoare respectively from departments of Medicine and Chemical Engineering at McMaster University.

To assess the potential of PGX-processed yeast beta-glucan (PGX-YBG) in practical application for COVID-19, the project was designed with four aims or milestones. The first milestone was to optimize the size and morphology of the best PGX-YBG for immunomodulation while the second milestone was to examine tolerability and safety of inhaled PGX-YBG in naïve animal models. The first milestone of the project was fully achieved, and the second milestone is near completion.

In order to derive the best and most suitable PGX-YBG product, the PGX Research and Development (R&D) Team at Ceapro worked very diligently to source, fractionate, and modify the PGX demo unit to process yeast beta glucan obtained from various sources. Surface area, surface morphology and particle size distribution measurements conducted by Ceapro and the research team at McMaster confirmed that, unlike the yeast beta-glucan currently available on the market, the PGX-processed YBG particles consistently generated from the retained raw material are small enough for effective inhalation.

“We are excited that we have been able to fabricate particles that have the targeted properties for inhalation, enabling the effective delivery of the particles to patients’ lungs pending the safety and efficacy animal trials now underway. As this project continues, our confidence in the potential of Ceapro’s materials to treat late-stage COVID-19 patients
and make a real-time impact on preserving lives during the pandemic continues to build,” reported Dr. Todd Hoare.

Dr. Kjetil Ask added, “If this size optimized PGX-YBG passes the tolerability, safety and therapeutic animal tests that we have already initiated, this material could quite quickly contribute as an immune modulator and anti-fibrotic treatment option for the most severe COVID-19 patients. Additionally, and equally exciting, the possibility of using PGX-YBG as an inhalable carrier of other drugs, would potentially allow the direct delivery of additional treatment options and increase their bioavailability in the lung, while reducing potential side effects.”

In parallel to the animal studies conducted at McMaster University, Ceapro also outsourced an in-vitro study to assess the immune response of the PGX-YBG on human receptors. The activity of PGX-YBG was tested on two human Dectin isotypes (Dectin-1a and Dectin-1b) involved in the modulation of the innate human immune response. The conclusion of this in-vitro study was that PGX-YBG exhibited significant stimulatory effect on human Dectin-1a and Dectin-1b receptors. Due to the results seen in the in-vitro study, the Company expects that PGX-YBG will stimulate the human immune response once inhaled into the lungs and potentially prevent reactions like the cytokine storm. The results demonstrated in the in-vitro study were also consistent with results seen in the preliminary biological study where PGX-YBG was found to modulate the immune system without causing the undesirable side-effects associated with other yeast beta-glucan.

“We are very proud of the work that has been conducted so far and believe we are well-positioned to offer an additional tool in the fight against COVID-19, which is having devastating effects worldwide. With the expected completion of the third and fourth goals related to tolerability, safety and efficacy studies with both naïve and pre-clinical animal models as early as mid-October, our teams are positioning us to be ahead of schedule. Hoping for favorable pre-clinical results, preparations of a Phase 1/2 clinical trial protocol will be commenced immediately and planned to be submitted to Health Authorities during Q4 2020. Given that yeast beta-glucan is already approved as a pharmaceutical additive, we expect to quickly develop PGX-YBG as a fast-acting inhalable stand-alone therapeutic and/or delivery system to treat severe inflammation observed in COVID-19 patients and other fibrotic end-point disease in the lung,” commented Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro. “We look forward to providing continued updates as we progress through the next milestones of this study.”

About Pressurized Gas eXpanded Liquid Technology (PGX)

Ceapro’s patented Pressurized Gas eXpanded (PGX) is a unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value, fine-structured, open-porous polymer structures and novel biocomposites. PGX is ideally suited for processing challenging high-molecular-weight, water-soluble biopolymers. It has the ability to make ultra-light, highly porous polymer structures on a continuous basis, which is not possible using today’s conventional technologies. PGX was invented by Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta (U of A) along with Dr. Bernhard Seifried, now Senior Director of Engineering Research and Technology at Ceapro. The license from U of A provides Ceapro with exclusive worldwide rights in all industrial applications.

About McMaster University

McMaster University, one of four Canadian universities listed among the Top 100 universities in the world, is renowned for its innovation in both learning and discovery. It has a student population of 23,000 and more than 175,000 alumni in 140 countries.

About Mitacs

Mitacs is a national, not-for-profit organization that has designed and delivered research and training programs in Canada for 20 years. Working with over 100 post-secondary institutions, 6,000 companies, and both federal and provincial governments, Mitacs builds partnerships that support industrial and social innovation in Canada.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions.

For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

Issuer:

Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

This press release does not express or imply that the Company claims its product has the ability to eliminate, cure or contain the SARS-2-CoV-2 (COVID-19) at this time.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.