On May 24, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release first quarter 2022 results and corporate update on Wednesday, June 1, 2022 (Press release, Affimed, MAY 24, 2022, View Source [SID1234614989]). The Company will host a conference call at 8:30 a.m. Eastern Daylight Time. The conference call will be available via phone and webcast. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference conference ID 4440407 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of the Company’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

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!

On May 24, 2022 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases, reported that it will participate in the following investor conferences during June 2022 (Press release, Myeloid Therapeutics, MAY 24, 2022, View Source [SID1234615006]):

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!

Wells Fargo Private Biotech Symposium, taking place virtually on June 1, 2022
Jefferies Healthcare Conference, taking place in New York, NY, June 8-10th, 2022. Daniel Getts, Ph.D., CEO of Myeloid, will present a company overview on Friday, June 10th, at 12:15 pm ET.

On May 24, 2022 / ENB Therapeutics, Inc., a clinical stage biotechnology company pioneering a new and differentiated class of therapeutics targeting the endothelin B receptor (ETBR) inhibitor, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, ENB-003, for the treatment of pancreatic cancer (Press release, ENB Therapeutics, MAY 24, 2022, View Source [SID1234634068]). This is the second Orphan Drug Designation award for ENB-003, which has also been granted Orphan Drug Designation for melanoma.

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!

"Immune checkpoint therapies have significantly improved the survival of patients with certain cancers; however, there remain a significant percentage of patients that exhibit no response to these therapies," said Sumayah Jamal, MD-PhD, President, Co-founder and CSO of ENB Therapeutics. "This is especially true for pancreatic cancer patients, where only about 3% of tumors are responsive to the leading anti-PD-1 therapy KEYTRUDA (pembrolizumab). We believe that combining our ETRB inhibitor, ENB-003, with pembrolizumab, has the potential to overcome this resistance, and provide much needed additional treatment options for patients in a broader range of pancreatic tumors."

"Our Phase 1/2 trial will exclude patients with pancreatic tumors that have the molecular alterations known as high microsatellite instability (MSI-H) or defective DNA mismatch repair (dMMR). Thus, we are targeting truly pembrolizumab resistant patients to evaluate the potential for a ENB-003 + pembrolizumab combination as a potential treatment for this population with clear and significant unmet need," said Dr. Jamal.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. This designation acts as a stimulus for the development of drugs for rare diseases through several incentives, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and the potential for seven years of post-approval marketing exclusivity after FDA approval.

About ENB-003

ENB-003 is a selective endothelin B receptor (ETBR) inhibitor that, in preclinical studies, enhanced the efficacy of immunotherapies such as anti-PD-1, anti-CTLA-4 and CAR T across multiple cancer types in preclinical studies. In an ongoing multi-center Phase 1/2 clinical trial, early efficacy signals suggest that ENB-003 overcomes resistance to the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in heavily pre-treated drug resistant cancer patients. The Phase 2 portion of the ENB-003 + pembrolizumab combination study is expected to start in the first quarter of 2023. The trial will enroll melanoma patients with innate resistance to anti-PD-1 based immunotherapies, platinum refractory and platinum resistant ovarian cancer patients, as well pancreatic cancer patients that have failed standard of care.

On May 24, 2022 Pierre Fabre and the European Organisation for Research and Treatment of Cancer (EORTC) reported the screening of the first patient with a resected stage II BRAF-mutant melanoma for the phase III study COLUMBUS-AD (NCT05270044; EORTC-2139-MG) (Press release, EORTC, MAY 24, 2022, View Source [SID1234614969]).

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!

COLUMBUS-AD is a pioneering study to evaluate whether the combination of BRAF and MEK inhibitors encorafenib (Braftovi) and binimetinib (Mektovi) can prolong recurrence-free survival (RFS) and improve distant metastasis-free survival (DMFS) and overall survival (OS) as compared to placebo in participants with surgically resected stage IIB-C BRAF V600E/K-mutant cutaneous melanoma.

"Pierre Fabre’s partnership with EORTC is now accelerating with the opening of COLUMBUS-AD", said Dr Deborah Szafir, Executive Vice President, Head of Medical and Patient Consumer Division at Pierre Fabre. "Building on the clinical benefits that our medicines have demonstrated in advanced disease, we are eager for patients with a BRAF-mutated tumour to explore the adjuvant setting in an earlier stage of the disease as the unmet medical need remains high."

Despite the remarkable progress made in the treatment of advanced melanoma activating the BRAF mutation, unfortunately there remains a high unmet need in earlier stages of the disease. It is estimated that 18% of stage IIB and 25% of stage IIC patients die from melanoma within 10 years from diagnosis.

"The screening of patients for COLUMBUS-AD focuses on patients with surgically resected high-risk IIB-C BRAF V600E/K-mutant cutaneous melanoma", said study coordinator assoc. prof. Dr. Alexander C.J. Van Akkooi, MD PhD, from the Melanoma Institute Australia (MIA) and past chairman of the EORTC Melanoma Group. "It is essential to test the tumour as early as possible for BRAF mutation, so that eligible patients can get a chance to participate into COLUMBUS-AD".

Approximately 815 patients will be enrolled in COLUMBUS-AD. More than 160 sites in up to 25 countries worldwide will participate in the study.

Patients included in the study must have undergone resection of a stage IIB-C melanoma with a BRAF V600E/K mutation, confirmed on resected tumour sample by a central laboratory, and a negative result on sentinel node biopsy. Patients must also have fully recovered from the surgery, have a good performance status (ECOG 0/1), and adequate hematologic, hepatic, cardiac, coagulation and renal functions.

Patients will receive encorafenib and binimetinib or placebo for up to 12 months. They will be followed-up monthly during the treatment period, then every 3 months up to year 3, and then at regular intervals. The participants will be followed-up for 10 years in total.

Pierre Fabre has a long-standing commitment to the melanoma community and takes a unique holistic approach to skin health with expertise in oncology, dermatology and dermo-cosmetics. EORTC, a unique academic clinical research organisation uniting clinical cancer research experts across the globe, shares Pierre Fabre’s commitment to improving the standard of cancer treatment for patients.

About Melanoma

Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumours.1 There are about 324,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma.2,3,4 By 2025, the number of cases is expected to increase to over 340,000.5

On May 24, 2022 Knight Therapeutics Inc. (TSX: GUD), a pan-American (ex-USA) specialty pharmaceutical company, reported that it has entered into exclusive license and supply agreements with Rigel Pharmaceuticals granting Knight the rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America (Press release, Knight Therapeutics, MAY 24, 2022, View Source [SID1234614990]).

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!

Fostamatinib is commercially available in the United States under the brand name TAVALISSE (fostamatinib disodium hexahydrate) and in Europe under the brand name TAVLESSE for the treatment of chronic immune thrombocytopenia (ITP). Fostamatinib is also currently being studied in a Phase 3 clinical trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)1 and in two Phase 3 clinical trials for the treatment of hospitalized patients with COVID-19.2,3

Under the terms of the agreement, Rigel will receive an upfront cash payment, with the potential for additional regulatory and commercial milestones, and stepped-up royalties based on tiered net sales. In return, Knight receives exclusive rights to fostamatinib in all potential indications, including chronic ITP, wAIHA, and COVID-19 in Latin America.

"This partnership represents the continued execution of our strategy of leveraging our solid platform and expertise to bring innovative medicines to our markets," said Samira Sakhia, President and CEO of Knight. "We are excited to be working with Rigel to provide access to an innovative, first-in-class treatment option to patients across Latin America with chronic ITP."

"We consider Knight to be the partner of choice in Latin America and look forward to a productive collaboration that further expands TAVALISSE’s global reach to patients in need," said Raul Rodriguez, President and CEO of Rigel. "TAVALISSE is already available in several countries around the world for the treatment of chronic ITP, and we look forward to pivotal readouts from our Phase 3 clinical trials with fostamatinib in wAIHA and COVID-19."

About ITP

In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA

Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that lead to the destruction of the body’s own red blood cells. Warm antibody AIHA (wAIHA), which is the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for wAIHA, despite the unmet medical need that exists for these patients.

About COVID-19 & SYK Inhibition

COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.4 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.5

SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.6,7,8,9 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with COVID-19.