On May 31, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported the acceptance of its Clinical Trial Application (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to allow expansion of its VERSATILE-002 study of PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) to the UK (Press release, PDS Biotechnology, MAY 31, 2022, View Source [SID1234615250]). The MHRA is among several regulatory agencies that PDS Biotech is seeking approval from to expand the trial into various site outside of the United States PDS Biotech anticipates that enrollment in the UK could begin during the third quarter of 2022.

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"The acceptance of this CTA marks another important regulatory milestone for PDS Biotech. Initiation of our global expansion is a key advancement to expedite enrollment into the VERSATILE-002 clinical study," stated Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "Additionally, this expansion allows PDS to expose global regulators to our novel molecularly targeted immunotherapies."

Chris Curtis, Chief Executive Officer of the UK-based charity group, The Swallows, stated "The reported preliminary safety data of PDS0101 in combination with pembrolizumab is highly encouraging, and we are pleased that European patients will be able to enroll in this promising clinical study of an HPV-targeted immunotherapy with standard of care, pembrolizumab."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On May 31, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that it has appointed Marshelle Smith Warren, M.D. as Chief Medical Officer (Press release, SQZ Biotech, MAY 31, 2022, View Source [SID1234615267]). Dr. Warren will report to the CEO and lead the company’s clinical development, clinical operations, translational medicine, and regulatory affairs functions.

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"Marshelle has tremendous experience in cell-based therapeutic development and will provide complementary expertise as we seek to rapidly advance our clinical programs," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "Her proven leadership, extensive global clinical trial experience, and broad clinical development background will strengthen our ability to execute on our mission to drive patient impact across disease areas."

Dr. Warren brings over 25 years of clinical development industry experience to the company, including a particular focus on viral malignancies and T cell-directing therapeutics. Previously, she was Chief Medical Officer and Senior Vice President of R&D at Viracta Therapeutics, where she led the development of investigational therapeutics for the treatment of Epstein-Barr virus associated lymphoid malignancies. Her prior experience also includes clinical development positions at Allovir, Atara Biotherapeutics, Ionis, Gilead Sciences, Amgen, and AstraZeneca Pharmaceuticals. Dr. Warren has also recently served as a senior advisor on Phase 2 and Phase 3 clinical research programs for investigational T cell therapies targeting cancer, autoimmunity, and viral infections.

"I am very excited to be joining a dedicated team focused on developing a new generation of impactful cell therapies for diseases with significant unmet need," said Marshelle Smith Warren, M.D., Chief Medical Officer at SQZ Biotechnologies. "I look forward to supporting our clinical team and working with my fellow leaders at SQZ to realize the broad potential of our cell therapy platforms to benefit patients around the world."

During her career, Dr. Warren has made significant contributions to approved immunology products including blockbuster Enbrel (rheumatoid arthritis) and Accolate (asthma). She has led the development of successful investigational new

Empowering Cells to Change Livesimg61662729_0.jpg

drug applications for a range of therapeutic types and has overseen regulatory authority negotiations and advisory meetings.

Dr. Warren, who is board certified in internal medicine and clinical immunology, received a BS in biology with honors from Baylor University, and an MD from the University of Nebraska Medical Center College of Medicine. She performed her residency in internal medicine at St. Joseph’s Hospital in Colorado and completed a clinical immunology fellowship at the National Jewish Center for Immunology and Respiratory Medicine.

SQZ Biotechnologies’ cell therapy programs seek to generate activating or tolerizing target-specific immune responses with potential impact across many diseases. The company’s first disease targets include Human Papillomavirus positive solid tumors and celiac disease.

On May 31, 2022 Median Technologies (Paris:ALMDT) reported that the company is expanding its portfolio of services with Imaging Lab, a new entity whose mission is to leverage AI, data mining, and radiomics technologies to exploit imaging data from clinical trials in oncology (Press release, MEDIAN Technologies, MAY 31, 2022, View Source [SID1234615284]).

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The creation of Imaging Lab materializes the convergence of iCRO’s activities for image management in the development of new oncologic drugs and iBiopsy’s activities for the development of software as medical device targeting early diagnosis of cancers, especially lung cancer.

"We are seeing a paradigm shift of pharmaceutical companies towards new drug candidates targeting patients with early-stage cancers," said Fredrik Brag, CEO and founder of Median Technologies. "The synergy between our iCRO and iBiopsy businesses is perfect to respond to this change: iBiopsy develops software as medical device, integrating AI technologies, which allow the diagnosis of diseases at a very early stage, when patients are still asymptomatic. At the same time, iCRO has extensive knowledge of image processing and its management in clinical trials. The cross-fertilization of our two businesses will enable us to leverage imaging data in conjunction with other clinical information in an unparalleled way and provide biopharmaceutical companies with tools for Go/No-Go decisions in trials," adds Fredrik Brag.

Imaging Lab will provide new answers in four areas that determine the success of clinical trials: selection of patients included in trials, especially inclusion of patients diagnosed at early stages of disease thanks to AI technologies, prediction of response to therapy, measurement of disease progression, and evaluation of the safety of drug candidates. The goal is to optimize development plans, including facilitating Go/No-Go decisions to increase the success rate of clinical trials. This rate is especially low in oncology, generating an average development cost of $2.8 billion to take a new molecule to market, compared with an average of $1 billion per new molecule brought to market for other therapeutic areas1.

"Our experience of image management in clinical trials has shown that trial data is vastly underutilized. We can extract much more information from images through the widescale use of data mining, AI, and radiomics and use these technologies to better support our customers and biopharmaceutical partners in their clinical developments," says Nicolas Dano, COO iCRO of Median Technologies.

The Imaging Lab team will be present from June 4-6 (exhibition dates) at the ASCO (Free ASCO Whitepaper) Annual Conference in Chicago , Median’s booth #2098, Exhibit Hall A, to meet the pharmaceutical community.

On May 31, 2022 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for mocravimod in combination with allogeneic Hematopoietic Stem Cell Transplant (HSCT) for post remission therapy of Acute Myeloid Leukemia (AML) patients (Press release, Priothera, MAY 31, 2022, View Source [SID1234615302]). FDA’s Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.

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Priothera is working to initiate the MO-TRANS global Phase 2b/3 study in Europe, US and Japan, to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult AML patients undergoing allogeneic HSCT. The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.

Karen Von Graevenitz, Head of Regulatory Affairs at Priothera, commented: "The Fast Track designation grant for mocravimod in combination with allogeneic HSCT is an important milestone and underlines the significant unmet need in AML patients undergoing HSCT, a serious disease where currently no available therapy exists. The designation means mocravimod will be eligible for expedited review and we will work closely with the US FDA to advance the global Phase 2/3 trial which is due to start in the second half of 2022."

Florent Gros, Co-Founder and CEO of Priothera, added: "Following being granted orphan drug designations for mocravimod in the US and Europe, we are pleased to have been granted Fast Track designation for this highly promising compound. This important regulatory milestone moves us a step closer to bringing mocravimod to patients with AML and other hematologic malignancies."

About mocravimod

Mocravimod (also known as KRP203), is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogeneic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR modulator’s unique mode of action to maintain anti-leukemia activity – graft-versus leukemia (GVL) while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogeneic HSCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.

On May 31, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported upcoming abstract presentations at three key medical conferences taking place in June, which highlight TAVNEOS (avacopan), an orally administered selective complement 5a receptor (C5aR) inhibitor, and its role in ANCA-associated vasculitis and potential application in C3 glomerulopathy, as well as the immuno-oncology potential of CCX559, an orally administered small molecule PD-L1 inhibitor (Press release, ChemoCentryx, MAY 31, 2022, View Source [SID1234615357]).

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European Alliance of Associations for Rheumatology (EULAR), June 1-4, Copenhagen

Effect of Avacopan on Relapse Rates and Relapse-Free Time in Patients with ANCA-Associated Vasculitis: Results of the Phase 3 ADVOCATE Study

Oral Presentation: OP0180
Time: June 2, 2022, at 10:35 – 10:45 AM CEST
Session: Vessels glowing in the dark
Location: Congress Hall A2
Differences Between Avacopan & Prednisone Treatment of ANCA-Associated Vasculitis at Different Thresholds of Glucocorticoid Toxicity

Poster: POS0833
Available: June 1, 2022, 08:00 AM CEST
Poster View 5: June 1, 2022, 01:20 – 01:28 PM CEST
Relapse Rates in Newly Diagnosed and Established Patients with Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis

Poster: POS0835
Available: June 1, 2022, 08:00 AM CEST
Poster View 5: June 1, 2022, 01:36 – 01:44 PM CEST
American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 3-7, Chicago

Results From an Ongoing Phase 1 Dose-Escalation Study of CCX559, an Orally Administered Small Molecule PD-L1 Inhibitor, in Patients With Advanced Solid Tumors

Poster: 248 (Abstract: 2593)
Time: Sunday, June 5 at 8:00 – 11:00 AM CDT
Session: Developmental Therapeutics – Immunotherapy
European Society for Pediatric Nephrology (ESPN), June 22-25, Ljubljana, Slovenia

Safety and Efficacy of Avacopan (CCX168) in a Pediatric Patient with C3 Glomerulopathy

E-Poster Available: June 22, 2022
INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Serious hypersensitivity to avacopan or to any of the excipients

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.

ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased and paresthesia.

DRUG INTERACTIONS

Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

About TAVNEOS (avacopan)

TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS’s selective inhibition of only the C5aR is believed to leave the beneficial C5a pathway through the C5L2 receptor functioning normally.

ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), severe hidradenitis suppurativa (HS) and Lupus Nephritis (LN). The US Food and Drug Administration granted TAVNEOS orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for TAVNEOS for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), as well as for C3G. TAVNEOS has not been approved for indications discussed as in development, and the safety and efficacy of those uses has not been established.

About ANCA-Associated Vasculitis

ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.