On November 12, 2021 Grey Wolf Therapeutics, a biotechnology company spearheading a new therapeutic approach to immuno-oncology driven by targeted neoantigen generation, reported the presentation of promising preclinical in vivo data on the company’s first-in-class inhibitors of ERAP1 at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Grey Wolf Therapeutics, NOV 12, 2021, View Source [SID1234595491]). The results are featured in a poster presentation (#553) entitled, "First-in-Class Inhibitors of ERAP1 Alter the Immunopeptidome of Cancer, Driving a Differentiated T Cell Response Leading to Tumor Growth Inhibition," at the SITC (Free SITC Whitepaper) conference, being held November 10-14, 2021 in Washington, D.C., as well as virtually.

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Grey Wolf Therapeutics’ first-of-its-kind immuno-oncology approach is centered on dramatically increasing the visibility of tumors to allow for their identification and destruction by the body’s immune system. This is achieved through targeted inhibition of the endoplasmic reticulum aminopeptidases (ERAP1 and ERAP2), causing the generation and presentation of novel and potent neoantigens to the surface of tumor cells. The appearance of these neoantigens uncloaks the tumor cells, illuminating them for the immune system and setting in motion powerful, differentiated T cell responses against the tumor. Importantly, this unique approach is orthogonal to a broad range of other cancer therapy modalities, including, but not limited to, immunotherapy.

The presented findings at the SITC (Free SITC Whitepaper) conference provide compelling evidence for several key elements of the company’s therapeutic hypothesis for ERAP1 inhibition in the treatment of cancer. These include the ability of the company’s ERAP1 inhibitors to drive neoantigen creation, differentiated T cell responses, and tumor growth inhibition.

Key highlights from the company’s presentation include:

Neoantigen Creation

Researchers highlighted study results demonstrating that ERAP1 inhibition triggered clear generation of novel neoantigens, as well as increased expression of existing neoantigens, across various species, cell types and genetic backgrounds in vitro and in vivo. For example, targeted ERAP1 inhibition within the HCT116 colorectal cancer cell line led to increased surface expression of key cancer antigens including MAGE3 and PBK, as well as the generation of an entirely new neoantigen (ATAD2) within the tumor. This neoantigen generation is believed to make the tumor significantly more visible to the immune system, allowing for the desired differentiated T cell response.

Differentiated T Cell Response

Presented findings highlighted three different data sets supporting the ability of ERAP1 inhibition to drive a differentiated T cell response.

First, results demonstrated a statistically significant increase in T cell receptor (TCR) diversity across a range of timepoints following treatment with an ERAP1 inhibitor and an anti-PD-1 antibody in the CT26 tumor model. Second, data demonstrated that the combination of an ERAP1 inhibitor and anti-PD-1 in the CT26 model drove a significant increase in T cell infiltration into the tumor in conjunction with elevated intra-tumoral Granzyme. Finally, the treatment combination led to a significant elevation of a broad range of translationally relevant immune markers that have been shown to correlate with patient response to anti-PD-1 treatment, including CXCL9, CXCL10, IFNg and IL-7R.

It is important to note that this impact on immune markers is tumor-specific as it was only observed within tumors and not in the periphery, suggesting that ERAP1 inhibition is driving an entirely novel, cancer-specific response.

Tumor Growth Inhibition

The ability of ERAP1 inhibition to drive neoantigen creation and the subsequent differentiated T cell response resulted in a meaningful impact on tumor growth. Presented study results demonstrated clear tumor growth inhibition and improved overall survival in multiple syngeneic mouse models following treatment with ERAP1 inhibitors in combination with an anti-PD-1 antibody, as compared to vehicle. Significantly, in the CT26 syngeneic mouse model, each of the findings demonstrating a differentiated T cell response (i.e., TCR repertoire changes, T cell infiltration and upregulation of translationally relevant immune markers) correlates with tumor growth inhibition providing compelling evidence for neoantigen creation driving anti-tumor responses.

"The totality of these presented data provides compelling support for our belief that the generation of novel neoantigens through targeted inhibition of ERAP1 represents a promising, entirely new approach to the oncology drug development space. While we have previously shown the potential of our ERAP1 inhibitors to generate neoantigens that drive anti-tumor responses, these new data presented today clearly demonstrate that the anti-tumor responses are due to a novel and differentiated T cell response," said Peter Joyce, Ph.D., chief executive officer of Grey Wolf Therapeutics. "While these promising results were achieved by combining our ERAP1 inhibitors with an anti-PD-1 antibody, it is important to note that we believe our unique approach will be orthogonal to a broad range of other cancer therapy modalities, including, but not limited to, immunotherapy. Based on these data, we continue to progress our lead ERAP1 inhibitor drug candidate through preclinical development, with the goal of advancing into the clinic in the second half of 2022."

Grey Wolf Therapeutics is developing a portfolio of ERAP inhibitors that it believes represents the first ever application of direct neoantigen generation to the treatment of cancer. GRWD5769, the company’s lead ERAP1 inhibitor development candidate, is expected to enter the clinic in the second half of 2022.

On November 12, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the presentation of new translational preliminary data detailing the differentiated profile of PVRIG compared to TIGIT and PD-1 as a novel checkpoint in the DNAM axis, supporting its potential role as a dominant checkpoint involved in stem-like memory T cells and dendritic cell (DCs) interaction at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held on November 10-14, 2021 (Press release, Compugen, NOV 12, 2021, View Source [SID1234595490]).

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"We believe evidence is growing to consistently demonstrate that PVRIG is a novel and differentiated checkpoint with a potential unique role in cancer immunotherapy" said Eran Ophir, Ph.D., Vice President of Research and Drug Discovery at Compugen. "For cancer immunotherapy to work, T cells are needed at the tumor site and recent studies suggest that early-memory (stem-like) T cells and DCs play an important role in this process. Here we show for the first-time preliminary data demonstrating greater induction of activated DC markers in the serum of two patients responding to our potentially first in class anti-PVRIG antibody, COM701, in combination with nivolumab compared to non-responders, potentially because of DC- T cell interaction. This preliminary data is in line with our recent scientific finding showing that PVRL2, the ligand of PVRIG, is abundantly expressed across DCs types, while PVRIG, measured by both gene and protein expression, is uniquely and dominantly expressed on early memory cells in contrast to TIGIT and PD-1."

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "These new preliminary data further support our earlier findings that PVRIG plays a distinct role within the DNAM axis which we believe is important for triggering robust immune responses in the tumor microenvironment. PVRIG blockade may lead to key mechanistic differences as compared to other DNAM axis members, namely TIGIT and PD-1, with the potential to enhance T cell proliferation and tumor infiltration to address both inflamed and less inflamed tumor types where current checkpoint inhibitors have not shown success. With our potentially first-in-class anti- PVRIG antibody, COM701, we are uniquely positioned to target the DNAM axis in combination with TIGIT and PD-1/L1 inhibitors and look forward to continued translation of these scientific learnings across our ongoing clinical programs."

Key findings from the poster presentation titled, "Novel DNAM-1 axis member, PVRIG, is potentially a dominant checkpoint involved in stem-like memory T cells – dendritic cell interaction," presented by Zoya Alteber PhD, Associate Director, Research and Drug Discovery at Compugen include:

PVRIG is co-expressed with PD-1 and TIGIT on stem-like and exhausted T cells as measured by flow cytometry across multiple tumor types
PVRIG has a unique dominant expression on early memory cells, clustering with markers of early memory T cells. In contrast, TIGIT is strongly associated with PD-1, CTLA-4, and other markers of exhausted T cells
PVRIG protein expression is significantly higher on early memory, CD28+ T cells in contrast to TIGIT and PD-1 which have comparable expression on CD28+ and CD28- cells
PVRL2, the ligand of PVRIG, is dominantly expressed on DC compared to PD-L1 and PVR, the ligand of TIGIT. This dominant expression is observed across DC1, DC2 and activated DC subtypes
Immunohistochemistry across multiple tumor types identified PVRL2 expression in tertiary lymphoid structures, the site of T cell priming, further supporting the PVRIG-PVRL2 interaction as a potentially dominant interaction for T cell activation in the tumor microenvironment
In 2 patients who responded clinically to treatment with the anti-PVRIG antibody COM701 in combination with nivolumab, early data show increased induction of activated DC markers, suggestive of an enhanced T cell – DC interaction, with the potential to enhance T cell proliferation and tumor infiltration.
The poster is available to conference attendees for the duration of the SITC (Free SITC Whitepaper) conference and will be archived on the Publications section of Compugen’s website.

On November 12, 2021 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, reported the presentation of data on multiple immuno-oncology programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, OncoResponse, NOV 12, 2021, View Source [SID1234595489]).

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Data presented included preclinical findings on three monoclonal antibodies developed utilizing OncoResponse’s proprietary B-cell platform that leverages data from elite responders to cancer immunotherapy in order to rapidly identify fully human therapeutic antibodies.

"OncoResponse is focused on the development of human antibodies that modulate immune cell activity and enhance immunotherapy responses. Our data presented at SITC (Free SITC Whitepaper) highlight three investigational targets that provide initial and compelling data demonstrating immune activity and the ability to modulate the tumor microenvironment," said Kamal Puri, PhD, Chief Scientific Officer of OncoResponse.

Clifford Stocks, OncoResponse Chief Executive Officer, added, "We look forward to the continued evaluation of our lead candidate, OR2805, in an ongoing clinical trial as well as further advancing additional targets toward IND-enabling studies."

Presentation highlights include:

Poster: 271

Development of OR2805, an anti-CD163 antibody derived from an elite responder to checkpoint inhibitor therapy that relieves immunosuppression caused by M2c macrophages

The evaluation of OR2805 alone and in combination with an anti-PD1 or -PD-L1 antibody in various preclinical in vitro and in vivo assays modeling an immunosuppressive tumor microenvironment, demonstrated:

OR2805 binds with high specificity to M2 macrophages and tumor-associated macrophages (TAMs) in human primary non-small cell lung cancer tumors
OR2805 reduces expression of cell-surface markers associated with tumor-promoting M2c macrophages and relieves the immunosuppressive effect on T-cell activation and proliferation in coculture assays
Robust anti-tumor activity was demonstrated in lung cancer xenograft models in humanized NSG-SGM3 mice. Additionally,
OR2805 reduces TAM mediated immunosuppression and enhances anti-tumor immune responses.
Combination with OR2805 restores and amplifies anti-PD-1 and anti-PD-L1 activity in coculture assays
OR2805 toxicology predicts a tolerable safety profile
OR2805 is currently being evaluated in a Phase 1/2 study in patients with advanced cancer
Poster: 262

Preclinical characterization of humanized anti-Siglec-15 antibodies that rescue T cells from macrophage-mediated immune suppression

The identification of novel humanized anti-Siglec-15 antibodies identified using functional screens modeling Siglec-15-mediated immune suppression by M2c macrophages demonstrated:

Ability of antibodies to block the interaction of Siglec-15 with an immune suppressive checkpoint on T cells and restore T-cell effector function.
Rescue of T cell activation and proliferation from M2c macrophage-mediated immunosuppression in M2c/CD8 coculture assays.
Restoration of effector function of activated and exhausted T cells from M2c-mediated immune suppression, with favorable half-life and anti-tumor activity in humanized mouse models.
Data provide a rationale for further development of these antibodies as anti-cancer immunotherapy.
Poster: 276

Discovery and preclinical characterization of anti-LILRB2 antibodies that rescue T cells from macrophage-mediated immune suppression

Identification of anti-LILRB2 antibodies that demonstrate:

Enhanced IFN-γ production by peripheral blood mononuclear cells and TNF-α secretion by macrophages
Relief of CD8+ T cells from M2c macrophage-mediated immunosuppression
Anti-tumor activity in an SK-MEL-5 tumor model in humanized NSG-SGM3 mice with up to 79% tumor growth inhibition and 44% tumor regression
Results support further development of lead anti-LILRB2 antibodies for cancer immunotherapy
Accessing Posters
The OncoResponse posters presented at SITC (Free SITC Whitepaper) are accessible from the Publications & Presentations page of OncoResponse website at View Source

About OR2805
OR2805 is a fully human antibody discovered using B cells derived from an elite responder to checkpoint inhibitor (CPI) therapy. This antibody binds to CD163 which is highly expressed on tumor associated macrophages (TAMs) that create an immunosuppressive tumor microenvironment and inhibit anti-tumor T-cell responses. High frequency of CD163-expressing TAMs generally predicts an unfavorable prognosis in solid tumors. OR2805 is designed to improve anti-tumor T-cell responses, by reversing the immunosuppression of TAMs, as a therapeutic strategy for monotherapy and in combination with CPI.

On November 12, 2021 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported financial results for the third quarter ended September 30, 2021 and provided a clinical and corporate update (Press release, Milestone Pharmaceuticals, NOV 12, 2021, View Source [SID1234595488]).

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"We continue to make meaningful progress across our etripamil PSVT program. We’ve advanced our Phase 3 efficacy and safety studies and completed important patient research which enables a deeper understanding and characterization of the burden experienced by patients," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Additionally, we look forward to presenting data from an analysis of heart rate in patients treated in the NODE-301 trial at the upcoming AHA Scientific Sessions 2021 meeting. We believe these data underscore the potential of etripamil to serve as an important intervention for patients with episodic cardiovascular conditions."

Recent Updates

Milestone Remains on Track to Report Topline Data from Pivotal Phase 3 RAPID Trial in the Second Half of 2022. As previously announced, enrollment continues in the ongoing pivotal Phase 3 RAPID trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT). Milestone is working closely with study investigators to support patient enrollment and continues to activate new centers. The Company remains on track to report topline data in the second half of 2022.

The RAPID trial, which is targeting a total of 180 adjudicated PSVT events, is expected to randomize approximately 500 patients 1:1 to receive either etripamil or placebo. To maximize the potential treatment effect of etripamil, patients will be directed to administer a repeat dose of study drug if they do not experience symptom relief within 10 minutes of the first study drug administration. The primary efficacy analysis for both the RAPID trial and the completed NODE-301 trial will be time to conversion of supraventricular tachycardia (SVT) over the first 30 minutes following initial study drug administration, with a target p-value of less than 0.05 for each trial. The RAPID and NODE-301 trials could potentially serve to fulfill the efficacy requirement for a future New Drug Application (NDA) for etripamil in patients with PSVT.

Heart Rate Data from NODE-301 Study to be Presented at the American Heart Association (AHA) Scientific Sessions 2021. New analyses on the impact of etripamil on heart rate in patients with PSVT, from the NODE-301 Study, will be presented at the upcoming AHA Scientific Sessions 2021 meeting. The presentation, titled "Etripamil Nasal Spray Reduces Heart Rate in Patients with Paroxysmal Supraventricular Tachycardia Prior to Conversion to Sinus Rhythm", will be featured during an ePoster session on November 14, 2021 at 11:00 a.m. ET.

Analysis of Large Longitudinal Patient Reported Outcome Market Research Study Establishes Disease Burden in PSVT and Market Opportunity for Etripamil. In the third quarter, Milestone completed an important patient reported outcomes (PRO) market research study in PSVT. The 247 patients who participated in the longitudinal portion of the study represent the broader PSVT population in terms of age, sex, medical history and time since diagnosis. Patients on average participated for 8.5 months and completed a survey every 12 days. In total, over 5,000 episodes were reported and characterized. Of these episodes, approximately 60% lasted longer than 10 minutes and 35% longer than 30 minutes.

Patients who participated in the study demonstrated a wide range of annual SVT episode frequency (0 to >50), with a median frequency of 12-15 episodes per year. Based on internal analysis, Milestone estimates approximately 60% of patients experience multiple 10+ minute episodes each year characterized as moderate or severe in intensity. In addition, approximately 30% of patients experiencing episodes sought medical care for the episode, the majority of which were treated in the emergency department.

ReVeRA Phase 2 Proof-of-Concept Trial Continues Recruitment in Patients Experiencing Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR). Recruitment is ongoing in ReVeRA, Milestone’s Phase 2 proof-of-concept study of etripamil nasal spray in patients experiencing AFib-RVR. Patients are being randomized 1:1 to receive either 70 mg of etripamil or placebo. The Phase 2 double blind, placebo controlled, proof-of-concept in-patient study is designed to assess the safety and efficacy of etripamil nasal spray to reduce the ventricular rate in patients with AFib-RVR. The trial is being conducted in Canada in collaboration with the Montreal Heart Institute and other research centers. The primary endpoint will assess reduction in ventricular rate, with key secondary endpoints including the time to achieve the maximum reduction in rate and duration of the effect.
Third Quarter 2021 Financial Results

As of September 30, 2021, Milestone had cash, cash equivalents, and short-term investments of $126.4 million and 29.9 million common shares issued and outstanding and 12.3 million common shares issuable upon exercise of pre-funded warrants outstanding.

Research and development expense for the third quarter of 2021 was $9.7 million compared with $8.2 million for the prior year period. The increase reflects higher clinical consulting fees and contract research organization (CRO) costs due to advancing RAPID Phase 3 efficacy and safety trials in etripamil for the treatment of PSVT along with an increase in clinical personnel related costs. For the nine months ended September 30, 2021, research and development expense was $27.8 million compared with $28.7 million for the prior year period. The decrease was due to a reduction in clinical trial expenses of $2.3 million which was partially offset by an increase of $1.3 million in clinical personnel related costs which included a non-cash share-based compensation expense.

General and administrative expenses for the third quarter of 2021 and 2020 were $3.0 million. For both of the nine month periods ended September 30, 2021 and 2020, respectively, general and administrative expense was $8.6 million.

Commercial expense for the third quarter of 2021 was $1.6 million compared with $0.9 million for the prior year period. The increase is attributable to investment in commercial activities during the three months ended September 30, 2021 in contrast to the three months ended September 30, 2020, a period during which Milestone reduced commercial spending in order to focus efforts on an optimized clinical development pathway for etripamil after issuing topline results of the first part of the NODE-301 in March 2020. For the nine months ended September 30, 2021, commercial expense was $4.8 million compared with $4.6 million for the prior year period. This change was due to an increased investment in commercialization activities.

For the third quarter of 2021, operating loss was $14.3 million compared to $12.1 million in 2020. For the nine months ended September 30, 2021, Milestone’s operating loss was $26.2 million compared to $41.9 million in the prior year period.
About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a condition characterized by intermittent episodes of rapid heart beat that starts and stops suddenly and without warning that affects approximately two million Americans. Episodes of supraventricular tachycardia (SVT) are often associated with palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Adenosine and certain calcium channel blockers have long been approved for the treatment of PSVT. However, these medications must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Atrial Fibrillation with Rapid Ventricular Rate

Atrial fibrillation (AFib) is a common arrhythmia marked by an irregular and often rapid heartbeat. AFib is estimated to affect five million patients in the United States, a prevalence projected by the Centers for Disease Control to increase to twelve million patients within the next 10 years. Atrial fibrillation with rapid ventricular rate (AFib-RVR) is a condition in which patients with AFib experience episodes of abnormally high heart rate, often with symptoms such as palpitations, shortness of breath, dizziness, and weakness. Oral calcium channel blockers and/or beta blockers are commonly used to manage the heart rate in this condition. When episodes do occur, the corresponding symptoms often cause patients to seek care in the acute care setting such as the emergency department, where standard of care procedures include intravenous administration of calcium channel blockers or beta blockers under medical supervision. Milestone’s initial qualitative market research indicates that approximately 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market for etripamil in patients with AFib of approximately two million patients.

About Etripamil

Etripamil, Milestone’s lead investigational product, is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and now a Phase 2 proof-of-concept trial underway in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR).

On November 12, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2021 (Press release, Soligenix, NOV 12, 2021, View Source [SID1234595487]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "There continues to be a great deal of activity across our Specialized BioTherapeutics and Public Health Solutions business segments. We continue to work diligently to prepare the new drug application (NDA) for HyBryte (SGX301 or synthetic hypericin) following the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL). The Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, expanding the treatment population beyond CTCL. Additionally, we announced expansion of synthetic hypericin development into psoriasis, under the research name SGX302, where we plan to initiate a Phase 2a clinical study in the second half of 2022. This decision follows validation of synthetic hypericin’s biologic activity in the FLASH study, as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, a large and underserved market with a significant unmet medical need. Under our Public Health Solutions business segment, we remain focused on developing heat-stable vaccines for global use. Most notably, we announced publication of compelling pre-clinical immunogenicity studies for CiVax (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses in non-human primates (NHPs), including against the Beta, Gamma and Delta variants."

Dr. Schaber continued, "With approximately $29 million in cash, not including our non-dilutive government funding, we anticipate having the necessary capital to achieve our upcoming milestones, including NDA filing and expansion into psoriasis with the conduct of the Phase 2a clinical trial. We are also continuing to actively assess various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On November 8, 2021, the Company announced it had been granted a Pediatric Investigation Plan (PIP) product-specific waiver in the United Kingdom from the Medicines and Healthcare products Regulatory Agency for HyBryte in the treatment of CTCL. To view this press release, please click here.
On November 4, 2021, the Company announced the publication of pre-clinical immunogenicity studies for RiVax (heat stable ricin toxin vaccine) demonstrating enduring protection for at least 12 months post-vaccination. The article titled "Durable Immunity to Ricin Toxin Elicited by a Thermostable, Lyophilized Subunit Vaccine" has been accepted for publication in the journal mSphere. To read the publication, please click here. To view this press release, please click here.
On September 28, 2021, the Company announced the publication of pre-clinical immunogenicity studies for CiVax demonstrating durable broad-spectrum neutralizing antibody responses, including against the Beta, Gamma and Delta variants of concern. The article, titled "Protein Vaccine Induces a Durable, More Broadly Neutralizing Antibody Response in Macaques than Natural Infection with SARS-CoV-2 P.1", has been posted as an accelerated preprint on bioRxiv. To view the publication, please click here. To view this press release, please click here.
On September 16, 2021, the Company announced that following the validation of synthetic hypericin’s biologic activity in the positive pivotal Phase 3 FLASH study in CTCL, as well as PoC demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, the Company will be expanding this novel therapy under the research name SGX302 into psoriasis, a large and underserved market affecting between 60-125 million people worldwide. To view this press release, please click here.
On September 9, 2021, the Company announced that the Office of Orphan Products Development of the U.S. FDA had granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond CTCL as previously granted. To view this press release, please click here.
On August 23, 2021, the Company announced a publication describing the formulation of single-vial platform presentations of monovalent (single antigen), bivalent (two antigens) and trivalent (three antigens) combinations of filovirus vaccine candidates. In collaboration with University of Hawaiʻi at Mānoa (UHM) and University of Colorado co-authors, the manuscript titled "Single-Vial Filovirus Glycoprotein Vaccines: Biophysical Characteristics and Immunogenicity after Co-lyophilization with Adjuvant", has been published in Vaccine. To read the publication, please click here. To view this press release, please click here.
On August 18, 2021, the Company announced positive data demonstrating the efficacy of multiple filovirus vaccine candidates in NHPs, including thermostabilized multivalent vaccines in a single vial platform presentation. Collaborators at UHM describe the potent efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, Sudan, and Marburg Viruses", published in Frontiers in Immunology. To read the article, please click here. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2021

Soligenix’s revenues for the quarter ended September 30, 2021 were $0.2 million as compared to $0.6 million for the quarter ended September 30, 2020. Revenues primarily included payments on grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization platform technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $3.6 million, or ($0.09) per share, for the quarter ended September 30, 2021, as compared to $1.8 million, or ($0.06) per share, for the quarter ended September 30, 2020. This increased net loss was primarily due to a reduction in revenue from the expiration of government contracts, an increase in research and development expenses associated with the continued development of HyBryte and additional interest expense on convertible debt.

Research and development expenses were $2.5 million as compared to $1.3 million for the quarters ended September 30, 2021 and 2020, respectively. The increase in research and development spending for the quarter ended September 30, 2021 was primarily attributable to the increased expenses associated with the continued development of HyBryte.

General and administrative expenses were $0.9 million and $0.8 million for the three months ended September 30, 2021 and 2020, respectively.

As of September 30, 2021, the Company’s cash position was approximately $29 million.