On May 10, 2022 NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that Matthew Seavey, Ph.D., MBA, NightHawk’s Vice President of Research will be presenting data on PTX-35, and serving on an expert panel discussing modes of Treg activation, at the 4th Annual Treg Directed Therapies Summit being held on May 17-19th in Boston (Press release, NightHawk Biosciences, MAY 10, 2022, View Source [SID1234614103]).

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PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be utilized to expand regulatory T-cell subsets for auto/inflammatory indications. PTX-35 is the Company’s first antibody-based product and is currently in a Phase 1 clinical trial for the treatment of patients with solid tumors.

Presentation Date/Time: Day-1, Wednesday, May 18th at 4:30 PM ET

Presentation Title: Agonizing Over Treg Expansion to Treat Human Disease: An Update on Our TNFRSF25-Agonist, PTX-35

Expert Panel Date/Time: Day-2, Thursday, May 19th at 11:30 AM ET

Expert Panel Title: Optimizing Routes of Administration & Delivery Mechanisms to Induce Timely Treg Specific Activation

Discussion Highlights:

Describing a clinical-stage Treg immunomodulator with utility in both oncology and auto/inflammation
Demonstrating preclinical efficacy in several possible, clinical indications including transplantation, autoimmunity, and metabolic diseases
Expanding plans for new indications and modalities, as well as opportunities for partnerships
The Hanson Wade 4th Annual Treg Directed Therapies Summit is focused on targeting and translating Treg modifying therapies and brings together executives and leading researchers from large pharma, biotech and academia to discuss developments in Treg therapies.

On May 10, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the first quarter ended March 31, 2022 (Press release, Delcath Systems, MAY 10, 2022, View Source [SID1234614102]).

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Recent Business Highlights

During and since the first quarter, Delcath:

Held a pre-NDA meeting with FDA and announced plans to file an NDA in the third quarter of 2022,
Announced the acceptance of a poster presentation updating results from the FOCUS Phase 3 Trial at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting,
Resumed direct responsibility for sales, marketing, and distribution activities for the CHEMOSAT Hepatic Delivery System in all of Europe,
Achieved medical device regulation (MDR) certification for CHEMOSAT in Europe, which is now regulated as a Class lll device,
Announced that investigators from the University Hospital Southampton published in Melanoma Research results of a single center study on Delcath’s CHEMOSAT Hepatic Delivery System in 81 metastatic uveal melanoma patients with liver dominant disease receiving 250 treatments showing hepatic disease control rate of 88.9%, hepatic response rate of 66.7% and overall response rate of 60.5%, and
Appointed David Hoffman as General Counsel and Chief Compliance Officer and Anthony Dias as Vice President of Finance.
"During and since the first quarter, we held a pre-NDA meeting with FDA and, while we wait for the final meeting minutes from FDA, we do not believe any additional pre-clinical or clinical studies will be required in order to file the NDA. We expect to file the NDA in the third quarter of 2022," said Gerard Michel, CEO of Delcath. "Additionally, the body of published research on the efficacy of our CHEMOSAT system in the European commercial setting continued to grow, we resumed direct sales of CHEMOSAT in Europe, and we strengthened our leadership team. These accomplishments move us much closer to achieving our strategic priorities — filing of the HEPZATO NDA, preparing for the subsequent US launch when approved, and expanding the clinical development of HEPZATO and CHEMOSAT into additional indications of high unmet medical need."

First Quarter 2022 Results

Income Statement Highlights.

Total revenue for the three months ended March 31, 2022 and 2021, was approximately $0.3 million, from primarily sales of CHEMOSAT in Europe. Research and development expenses for the quarter were $4.2 million compared to $3.7 million in the prior year quarter. Selling, general and administrative expenses for the quarter were approximately $3.6 million compared to $3.3 million in the prior year quarter. Total operating expenses for the quarter were $7.9 million compared with $7.0 million in the prior year quarter.

The Company recorded a net loss for the three months ended March 31, 2022, of $8.2 million, compared to a net loss of $6.7 million for the same period in 2021.

Balance Sheet Highlights

On March 31, 2022, the Company had cash, cash equivalents and restricted cash totaling $20.5 million, as compared to cash, cash equivalents and restricted cash totaling $27.0 million on December 31, 2021. During the three months ended March 31, 2022, and March 31, 2021, we used $6.4 million and $4.6 million, respectively, of cash in our operating activities.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

On May 10, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reportd that it is hosting an R&D Symposium today in New York City (Press release, Corvus Pharmaceuticals, MAY 10, 2022, View Source [SID1234614101]). During the event, which will also be available via webcast, the Company plans to provide updates on its three clinical programs: mupadolimab (anti-CD73), ciforadenant (adenosine 2A receptor antagonist) and CPI-818 (ITK inhibitor) .

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"Current therapies for T cell lymphoma have limited efficacy, highlighting the need for new approaches that rely on novel mechanisms of action," said Neel K. Gupta, M.D., Clinical Assistant Professor of Medicine at Stanford University School of Medicine – Division of Oncology. "The monotherapy activity and responses in advanced refractory T cell lymphoma seen with the ITK inhibitor CPI-818 so far is impressive. Its novel mechanism of action and safety provide many opportunities for single agent and combination with other therapies both in front line and relapsed disease settings, giving CPI-818 the potential to be an important new therapeutic option for T cell lymphoma patients."

New CPI-818 Phase 1/1b Data
The R&D Symposium will include a review of patient case studies from the ongoing Phase 1/1b clinical trial of CPI-818 in patients with relapsed T cell lymphomas, including peripheral T cell lymphoma (PTCL), cutaneous T cell lymphoma (CTCL), angioimmunoblastic T cell lymphoma (AITL) and others. In this trial, which was designed to select the optimal dose of CPI-818, doses of 100, 200, 400 and 600 mg taken twice a day were given to successive cohorts of patients. The 200 mg dose was identified as the optimal dose, and at this dose, four of five patients are responding to therapy as follows (with an April 30, 2022 cut-off date):

PTCL patient achieved a complete response lasting 12 months on CPI-818 treatment with complete remission duration extending an additional 7 months with no further therapy (total complete remission duration of 19 months)
PTCL patient achieved a partial response with treatment ongoing
AITL patient that is responding on treatment
CTCL patient achieved nodal complete response with treatment lasting 21 months
In addition, a PTCL patient receiving the 600 mg dose achieved a partial response that lasted for several months; the patient went on to receive a bone marrow transplant
Lab studies on the blood and tumors of responding patients showed:
Evidence for Th1 skewing
Evidence for increase in T effector cells in blood and tumor
Evidence for increase activation of T cells in tumor and blood
Evidence that CPI-818 does not directly kill the cancer cells; rather the effects appear to be mediated by the patient’s immune response against the tumor
Identification of a dose level that drives Th1 cell differentiation without compromising T effector cell function
CPI-818 is a novel compound that Corvus founders invented and developed based on their prior experience and success with the first BTK inhibitor, ibrutinib.

"We have learned a tremendous amount about ITK, T cell biology and potential indications for this therapy from the development of CPI-818," said Richard A. Miller, M.D., Chief Executive Officer & President of Corvus Pharmaceuticals. "The new interim data from our Phase 1/1b study are consistent with our pre-clinical results, and the research of others, which reveal the role of ITK in T cell function, and the exquisite regulation of T cell differentiation by ITK. Based on this, we believe CPI-818 could be used to enhance anti-tumor immunity in T cell lymphoma and solid tumors by stimulating anti-tumor T cells to attack the cancer cells. The mechanism, and preclinical data, also support its role in immune mediated diseases such as allergy and autoimmunity."

"We are expanding our CPI-818 Phase 1/1b study with a focus on the 200 mg BID dose in PTCL. Angel Pharmaceuticals, our Chinese partner, is also enrolling patients, which we anticipate will help accelerate overall development timelines. Our goal is to share additional data from both studies later this year, and if current trends continue, we anticipate initiating a global Phase 2 clinical trial. We will also be evaluating CPI-818’s potential in front line combination therapy with chemotherapy and preparing for clinical studies in autoimmune diseases," added Dr. Miller.

Corvus R&D Pipeline Approach
The R&D Symposium program will cover the scientific rationale, preclinical and clinical data for the Company’s three programs, along with the overarching scientific and clinical strategies driving the Company’s development activities. Key elements of the overarching strategy include:

Corvus’ precision immunotherapy approach focuses on controlling multiple steps in the "tumor-immunity axis," which is comprised of the tumor, lymph nodes (LN) and blood stream. The Company’s product candidates are designed to modulate tumor immunity, target precise molecular structures and have broad clinical applications. Specifically, mupadolimab, ciforadenant, and CPI-818 all interact with distinct and connected components of the tumor-immunity axis to enhance immunity to cancers:
Mupadolimab is designed to induce the activation of B cells involved in antibody production, and antigen presentation in the tumor, blood and in LN
Ciforadenant is designed to block adenosine-induced immunosuppression in tumors and in LN
CPI-818 is designed to induce the activation and expansion of T cell subsets involved in killing cancer cells in tumor, in LN and in blood through the skewing of T cell differentiation to a Th1 helper T cell phenotype. The formation of Th1 cells leads to production of T cells that are capable of killing cancer cells and viral infected cells
Corvus’ clinical development strategy aims to increase clinical development success by first establishing monotherapy activity, followed by potential combinations with other immuno-oncology and standard of care therapies
R&D Symposium Details
The R&D symposium will be webcast live from Corvus’s website at www.corvuspharma.com and a replay will be available for 90 days following the event. A copy of the presentation slides will also be available on Corvus’ website after the conclusion of the event. It will be hosted by Corvus President and CEO Richard A. Miller, M.D., and include speakers from Corvus as well as leading researchers:

Neel K. Gupta, M.D., Clinical Assistant Professor of Medicine at Stanford University School of Medicine – Division of Oncology
Suresh Mahabhashyam, M.D., Vice President of Clinical Development at Corvus Pharmaceuticals
Erik Verner, Ph.D., Senior Vice President of Research at Angel Pharmaceuticals

On May 10, 2022 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, PMV Pharma, MAY 10, 2022, View Source [SID1234614100]).

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"Our priority in 2022 is execution of the ongoing Phase 1/2 trial evaluating PC14586, our investigational first-in-class p53 Y220C reactivator, in patients with solid tumors, as well as continued progress on our pipeline" said David Mack, Ph.D., President, and Chief Executive Officer. "We look forward to presenting initial data from the Phase 1 dose escalation trial at the 2022 ASCO (Free ASCO Whitepaper) annual meeting."

Corporate Highlights:

PC14586 initial data from the dose escalation portion of the Phase 1/2 PYNNACLE study selected for an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) annual meeting on June 7th. For more information on the Phase 1/2 trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).
Poster titled "Small Molecule Reactivators of Y220C Mutant p53 Modulate Tumor Infiltrating Leukocytes and Synergize with Immune Checkpoint Inhibitors" presented at the American Association of Cancer Research Annual Meeting 2022.
Continued progress on research pipeline with WIP1 (Wild-Type p53-Induced Phosphatase) inhibitor and p53 mutant programs.
First Quarter 2022 Financial Results

As of March 31, 2022, PMV Pharma had $294.8 million in cash, cash equivalents, and marketable securities, compared to $314.1 million as of December 31, 2021. Net cash used in operations was $18.0 million for the three months ended March 31, 2022 compared to $12.9 million for the three months ended March 31, 2021.
Net loss for the quarter ended March 31, 2022 was $18.4 million compared to $11.6 million for the quarter ended March 31, 2021.
Research and development (R&D) expenses were $11.8 million for the quarter ended March 31, 2022 compared to $7.5 million for the quarter ended March 31, 2021. The increase in R&D expenses was primarily related to increased headcount and clinical development expenses to advance PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2022, compared to $4.2 million for the quarter ended March 31, 2021. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.
About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information on the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

On May 10, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2022 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 10, 2022, View Source [SID1234614099]).

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"We have continued to progress our clinical programs, including activating multiple clinical sites in our Phase 2b trial of ATI-1777 in subjects with moderate to severe atopic dermatitis," said Dr. Neal Walker, President and CEO of Aclaris. "We look forward to advancing all of our clinical and preclinical programs."

Research and Development Highlights:

Clinical Programs

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
Currently being developed as a potential treatment for immuno-inflammatory diseases

ATI-450-RA-202: This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing.
Aclaris expects topline data in 2023.

ATI-450-HS-201: This Phase 2a trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib (50 mg twice daily) in subjects with moderate to severe hidradenitis suppurativa (HS) is ongoing.
Aclaris expects topline data in the first half of 2023.

ATI-450-PsA-201: Aclaris expects to activate clinical sites in the coming weeks in this Phase 2a trial of zunsemetinib (50 mg twice daily) in subjects with moderate to severe psoriatic arthritis.
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor:
Currently being developing as a potential treatment for moderate to severe atopic dermatitis (AD)

ATI-1777-AD-202: Aclaris activated multiple clinical sites in May 2022 in this Phase 2b trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe AD. In this trial, Aclaris will explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777, in patients 12 years and older.
Aclaris expects topline data in the first half of 2023.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor:
Currently being developed as a potential treatment for T cell-mediated autoimmune diseases

ATI-2138-PKPD-101: This Phase 1 single ascending dose (SAD) trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-2138 in healthy subjects is ongoing.
Aclaris expects topline data in 2022.

If the Phase 1 SAD trial is successful, Aclaris currently plans to initiate a two-week Phase 1 multiple ascending dose trial of ATI-2138 in subjects with psoriasis in 2022. Aclaris is also currently exploring alternative indications to the planned indication that are relevant to the mechanism of action.
Preclinical Programs

ATI-2231, an investigational oral MK2 inhibitor compound:
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer

Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long half-life.

IND-enabling studies are underway, and Aclaris expects to submit an IND by the end of 2022.
Discovery Programs

Currently developing oral gut-biased JAK inhibitors with limited systemic exposure as potential treatments for inflammatory bowel disease.
Central nervous system (CNS) kinase inhibitor targets:
Currently engaged in research to identify brain penetrant kinase inhibitor candidates and assess their impact on neuronal pro-inflammatory cytokine production, microglia growth and survival, and neurodegeneration.
Other Highlights

Aclaris continues to expand its senior R&D team and recently appointed Ian Anderson, Ph.D., as Executive Vice President, Translational Research & Development, and Rob Ortmann, M.D., as Vice President, Clinical Development. Dr. Anderson brings more than 30 years of immunology research experience in drug development, from discovery through Phase 2. He previously held senior scientific leadership roles at Flame Biosciences, Janssen Pharmaceutical, MedImmune and Cambridge Antibody Technology. Dr. Ortmann is a board-certified rheumatologist with more than 10 years of clinical research experience in autoimmune-related therapeutic areas. He previously held clinical development positions at Horizon Therapeutics and Eli Lilly and Company.

Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2022, Aclaris had aggregate cash, cash equivalents and marketable securities of $204 million compared to $226 million as of December 31, 2021. Additionally, in April 2022, Aclaris sold approximately 4.8 million shares under its ATM facility for aggregate net proceeds of $73 million.

Aclaris now anticipates that its cash, cash equivalents and marketable securities as of March 31, 2022 in combination with the $73 million in net proceeds from the April 2022 ATM sale will be sufficient to fund its operations through the end of 2025, without giving effect to any additional potential business development transactions or financing activities.

Financial Results

First Quarter 2022

Net loss was $18.8 million for the first quarter of 2022 compared to $28.8 million for the first quarter of 2021.
Total revenue was $1.5 million for the first quarter of 2022 compared to $1.8 million for the first quarter of 2021.
Research and development (R&D) expenses were $14.3 million for the quarter ended March 31, 2022 compared to $7.8 million for the prior year period.
The $6.5 million increase was primarily the result of:
Higher zunsemetinib development expenses, including costs associated with clinical activities for a Phase 2b trial for RA and a Phase 2a trial for HS.
Higher ATI-1777 development expenses related to drug candidate manufacturing and other preclinical activities and start-up costs associated with a Phase 2b clinical trial.
Higher preclinical development activities related to ATI-2231.

General and administrative (G&A) expenses were $6.1 million for the quarter ended March 31, 2022 compared to $4.8 million for the prior year period.
The $1.3 million increase was primarily the result of higher compensation-related costs, including stock-based compensation, due to increased headcount and the impact of new equity awards granted during the first quarter of 2022.
Revaluation of contingent consideration resulted in a $1.2 million credit for the quarter ended March 31, 2022 compared to a contingent consideration charge of $16.4 million for the prior year period.