Syndax Announces Presentation at Stifel 2020 Virtual Healthcare Conference

On November 11, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, will present at the Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020 at 1:20 p.m. ET (Press release, Syndax, NOV 11, 2020, View Source [SID1234570572]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

Surface Oncology Announces FDA Fast Track Designation Granted by U.S. Food and Drug Administration for SRF388 to Treat Liver Cancer

On November 11, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SRF388 for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer, who have been previously treated with standard therapies, such as vascular endothelial growth factor targeted agents and programmed death-ligand (PD-L1) blockade (Press release, Surface Oncology, NOV 11, 2020, View Source [SID1234570571]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Liver cancer is the most rapidly increasing type of cancer in both men and women in the U.S., with incidences tripling since 1980.1 2 There is a significant need to expedite the development of new therapies to treat liver cancer as the five-year survival for patients with unresectable or metastatic liver cancer is less than five percent,"2 said Rob Ross, M.D., chief medical officer. "SRF388 targets IL-27, an immuno-suppressive cytokine that has been found to be elevated in patients with liver cancer, as well as kidney cancer, and we believe SRF388 has the potential to be an effective treatment option for these patients, as monotherapy or in combination with anti-PD-1 therapies."

SRF388 is currently enrolling patients with advanced solid tumors in a Phase 1 monotherapy dose escalation study with planned expansions in liver and kidney cancer to further evaluate SRF388 as a monotherapy and in combination with other cancer therapies.

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs that are being developed to treat serious conditions and fill an unmet medical need. The purpose of the designation is to bring important new drugs to patients earlier across a wide range of diseases.

SRF388 recently received orphan-drug designation for treatment of hepatocellular carcinoma from the FDA.

About SRF388:

SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immuno-suppressive cytokine. Surface Oncology has identified particular tumor types, including liver and kidney cancer, where IL-27 appears to play an important role in the immuno-suppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immuno-suppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies and potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

ProMIS Neurosciences Announces Third Quarter 2020 Results

On November 11, 2020 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and nine months ended September 30, 2020 (Press release, ProMIS Neurosciences, NOV 11, 2020, View Source [SID1234570570]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Over the course of the third quarter of 2020, the value of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities across multiple neurodegenerative diseases and also initiated two new diagnostic

joint venture programs with BC Neuroimmunology Laboratory (BCNI)," stated Eugene Williams, ProMIS’ Executive Chairman. "We look forward to continued progress applying our unique technology platform to the development of disease-modifying antibody therapies, diagnostics and potential vaccines for Alzheimer’s disease, as well as development in the infectious disease setting. We are working to create accurate and sensitive serological assays to potentially detect the presence of neutralizing antibodies that arise in response to the novel corona virus causing COVID-19 infection.

Corporate Highlights

In July 2020, the Company entered into two joint venture Business arrangements (JV) with BC Neuroimmunology Laboratory Inc. (BCNI). The first JV (JV1) will develop and market highly accurate, objective tests for the detection, diagnosis and monitoring of Alzheimer’s disease (AD). JV1 will offer existing blood-based assays for NfL (neurofilament light chain) and P-tau181 (phosphorylated tau181). Further assays will be developed, potentially incorporating our proprietary peptide antigens and tests for additional neurodegenerative diseases. The Company and BCNI each own 50% of JV1.
The second JV (JV2) will provide highly sensitive and specific serological assays for the detection and characterization of antibodies to the SARS-CoV-2 virus that is responsible for COVID-19. The Company and BCNI each own 50% of the JV2.
In September 2020, the Company announced initiation of a program to construct and test a multivalent peptide vaccine for AD. The critical first steps in vaccine development will be carried out by VIDO-InterVac, a global leader in vaccine research and development.
In September 2020, we announced the resignation of Anthony Giovinazzo from our Board of Directors.
Financial Results

Results of Operations – Three months ended September 30, 2020 and 2019

The Company’s net loss for the three months ended September 30, 2020 was $1,562,228, compared to a net loss of $1,637,714 for the three months ended September 30, 2019. Included in the net loss for the three months ended September 30, 2020 were non-cash expenses of $53,844, representing share-based compensation and amortization of an intangible asset, compared to $134,634 for the three months ended September 30, 2019. The decrease in the net loss for the three months ended September 30, 2020 reflects decreased consulting and professional fees, share-based compensation and foreign exchange losses offset by increased contract research organizations for internal programs and increased patent expenses.

Research and development expenses for the three months ended September 30, 2020 were $1,048,726, as compared to $1,053,123 in the three months ended September 30, 2019. The decrease in research and development expense for the three months ended September 30, 2020 is primarily attributed to decreased consulting and professional fees and share-based compensation, offset by increased contract research organizations for internal programs and increased patent expenses.

General and administrative expenses for the three months ended September 30, 2020 were $510,264, as compared to $584,602 in the three months ended September 30, 2019. The decrease in general and administrative expenses for the three months ended September 30, 2020 is primarily attributable to a decrease in foreign exchange losses and share-based compensation, offset by an increase in consulting and professional fees.

Results of Operations – Nine months ended September 30, 2020 and 2019

The Company’s net loss for the nine months ended September 30, 2020 was $4,974,365, compared to a net loss of $5,942,821 for the nine months ended September 30, 2019. Included in the net loss for the nine months ended September 30, 2020 were non-cash expenses of $343,892, representing share-based compensation, warrant modification and amortization of an intangible asset, compared to $551,968 for the nine months ended September 30, 2019. The decrease in the net loss for the nine months ended September 30, 2020 reflects decreased costs associated with contract research organizations for internal programs, decreased consultant costs, decreased professional fees, decreased share-based compensation and decreased foreign exchange losses, offset by increased patent expenses.

Research and development expenses for the nine months ended September 30, 2020 were $2,921,199, as compared to $3,866,294 in the nine months ended September 30, 2019. The decrease in the research and development expenses for the nine months ended September 30, 2020 reflects the conservation of cash resources and decreased costs associated with external contract research organizations for internal programs, decreased consulting and professional fees and decreased share-based compensation, offset by increased patent expense.

General and administrative expenses for the nine months ended September 30, 2020 were $2,051,506, as compared to $2,076,463 in the nine months ended June 30, 2019. The decrease for the nine months ended September 30, 2020 is primarily attributable to a reduction in consulting and professional fees and a decrease in foreign exchange losses offset by warrant modification expense.

Outlook

As a prelude to the first PMN310 clinical trial in AD, we will use a novel biomarker approach that may show evidence of slowing of neuronal death as early as the Phase 1 clinical study. As the ability to achieve early detection of AD develops, based on the advent of reliable blood-based biomarkers for AD detection, the need for preventive treatment will grow. Therapeutic vaccines can be used for this purpose. Using our discovery platform, our goal is to devise a safe and effective AD vaccine to induce a specific immune response against toxic oligomers of amyloid beta.

The Company will also continue to characterize the potential benefits of its programs selectively targeting toxic aggregates of TDP-43 in ALS, toxic forms of alpha-synuclein in PD and toxic aggregates of tau in AD and other dementias. Our unique platform produces antibodies that meet a key success factor for the development of therapeutics and vaccines for neurodegenerative diseases: the ability to selectively target the neurotoxic form of a protein implicated as a root cause of disease, while sparing normal forms of the protein.

In the infectious disease setting, we are working to create accurate and sensitive serological assays to potentially detect the presence of neutralizing antibodies that arise in response to a specific infection, such as COVID-19.

Achilles Therapeutics Announces Grant of European Patent Covering Use of Selectively Expanded T cells Targeting Clonal Neoantigens for the Treatment of Cancer

On November 11, 2020 Achilles Therapeutics Limited ("Achilles"), a clinical-stage biopharmaceutical company developing personalised cell therapies targeting clonal neoantigens, a novel class of tumour target, reported the decision by the European Patent Office ("EPO") to grant European patent EP3288581B, which covers the treatment of cancer using T cells that have been selectively expanded to target clonal neoantigens (Press release, Achilles Therapeutics, NOV 11, 2020, https://achillestx.com/achilles-therapeutics-announces-grant-of-european-patent-covering-use-of-selectively-expanded-t-cells-targeting-clonal-neoantigens-for-the-treatment-of-cancer/ [SID1234570569]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The patent is assigned to Cancer Research Technology and licensed exclusively to Achilles in certain fields. The inventors of EP3288581B include three of Achilles’ co-founders, Sergio Quezada, Chief Scientific Officer, Karl Peggs, Chief Medical Officer (effective January 2021) and Professor Charles Swanton, a Royal Society Napier Professor of Cancer and Chief Clinician at Cancer Research UK as well as Group Leader at the Francis Crick Institute and UCL.

A related patent was granted in Singapore in August 2020 with equivalent applications pending in multiple countries, including the United States. Many patent offices worldwide consider the status of equivalent European cases to be highly relevant to their patent granting decision.

"This is a significant and exciting decision by the EPO," said Dr. Iraj Ali, Chief Executive Officer of Achilles. "We are using Achilles’ innovative platform to rapidly advance our therapies for the treatment of solid tumours and have two ongoing clonal neoantigen T cell (cNeT) clinical trials; the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic malignant melanoma."

Tony Hickson, Cancer Research UK’s Chief Business Officer, said: "Achilles has made significant advances in the development of T cell therapies for cancer, and we are delighted to see the strides that they have taken since they were founded in 2016."

EXUMA Biotech Presents Preclinical Data on Rapid Point-of-Care “rPOC” Subcutaneous CAR-T Platform at the SITC 35th Anniversary Annual Meeting & Pre-Conference

On November 11, 2020 EXUMA Biotech Corp., a clinical-stage biotechnology company discovering and developing CAR-T products and delivery solutions for liquid and solid tumors, reported that preclinical data for the company’s next-generation rapid point-of-care, or "rPOC", subcutaneous (SC) autologous CAR-T platform, are being presented today in an e-poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting and Pre-Conference, November 9-14, 2020 (Press release, EXUMA Biotechnology, NOV 11, 2020, View Source [SID1234570568]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The e-poster presentation titled "Rapid Point-of-Care Subcutaneous CAR-T from Blood Draw to Injection in 4 Hours with Modified LV Encoding CARs and Synthetic Driver Elements Enables Efficient CAR-T Expansion and Tumor Regression" is part of the Cellular Therapies/Chimeric Antigen Receptors (CARs) category and is accessible for attendees within the SITC (Free SITC Whitepaper) virtual meeting platform. Additionally, Abstract #117 is available under the abstract tab at www.sitcancer.org/2020/home. The poster will be presented today, Wednesday, November 11th, from 5:15-5:45 pm EST and Friday, November 13th, from 4:40-5:10 p.m. EST.

EXUMA has developed this novel, viral-based rPOC platform to enable same-day autologous CAR-T administration. The platform is made possible by viral vectors that are engineered to display T cell-activating elements on the viral envelope and to encode "drivers" of T cell engraftment, in addition to chimeric antigen receptors.

Animal models presented at SITC (Free SITC Whitepaper) reveal that exposure of peripheral blood to these viral vectors for just four hours, followed by subcutaneous injection to create a synthetic lymph node, resulted in robust CAR-T cell expansion (>10,000 fold) with regression of established tumors. Interestingly, administration of the same products intravenously in the same animal model did not support significant CAR-T cell expansion or control tumor growth.

"Today’s data represent a snapshot from over four years of internal research and development at EXUMA to mature this technology with the objective of delivering new solutions for speed and accessibility to cancer patients with significant unmet needs," said EXUMA Biotech Chairman and CEO Dr. Gregory Frost, Ph.D. "Through this subcutaneous ‘lymph node’ approach with modified lentiviruses and driver domains, rPOC SC may reduce the complexity of CAR-T, while maintaining the ability of CAR-T cells to expand, persist and exert anti-tumor activity."

EXUMA’s "rPOC" Platform

EXUMA’s next-generation rapid point-of-care or "rPOC" platform is being developed for subcutaneous CAR-T administration in a matter of hours following blood draw, with the potential to make same-day autologous CAR-T a reality for cancer patients. The long-term vision is for rPOC to be administered in the community oncology infusion clinic without the need for lymphodepleting chemotherapy or long-term immunosuppression.