On June 14, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST (Press release, Blueprint Medicines, JUN 14, 2019, View Source [SID1234537093]). Currently, no effective therapy exists for either population. Avapritinib is an investigational, potent and highly selective KIT and PDGFRA inhibitor for patients with advanced GIST.

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Avapritinib has received Breakthrough Therapy Designation from the FDA for the treatment of patients with unresectable or metastatic GIST harboring the PDGFRα D842V mutation, as well as Fast Track Designations for the treatment of patients with GIST harboring a PDGFRα D842V mutation regardless of prior therapy, and patients with GIST who have progressed following treatment with imatinib and a second tyrosine kinase inhibitor.

Blueprint Medicines has requested priority review for the application, which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

"There is an important need for new treatment options that offer durable responses for PDGFRA Exon 18 mutant and fourth-line GIST patients," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "By targeting the underlying molecular drivers of GIST, avapritinib has the potential to help these patients realize the benefits of precision therapy. We plan to work closely with the FDA to bring avapritinib to appropriate GIST patients as quickly as possible."

About GIST

GIST is a sarcoma, or tumor of bone or connective tissue, of the gastrointestinal (GI) tract. Tumors arise from cells in the wall of the GI tract and occur most often in the stomach or small intestine. Most patients are diagnosed between the ages of 50 to 80, and diagnosis is typically triggered by GI bleeding, incidental findings during surgery or imaging and, in rare cases, tumor rupture or GI obstruction.

Most GIST cases are caused by a spectrum of clinically relevant mutations that force the KIT or PDGFRA protein kinases into an increasingly active state. Because currently available therapies primarily bind to the inactive protein conformations, certain primary and secondary mutations typically lead to treatment resistance and disease progression.

In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type. Mutational testing is critical to tailor therapy to the underlying disease driver and is recommended in expert guidelines. Currently, there are no approved therapies for patients with KIT-driven GIST whose disease progresses beyond imatinib, sunitinib and regorafenib. In patients with metastatic PDGFRα D842V-driven GIST, progression occurs in a median of approximately three to four months with available therapy.

About Avapritinib

Avapritinib is an investigational, oral precision therapy that selectively and potently inhibits KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with GIST, including potent activity against activation loop mutations that are associated with resistance to currently approved therapies.

Blueprint Medicines is initially developing avapritinib for the treatment of advanced GIST, advanced systemic mastocytosis (SM), and indolent and smoldering SM. The FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRα D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for avapritinib in the rest of the world.

On June 14, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported updated results from a pivotal Phase 2 study of tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL) in a poster at the 24thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 13-16, 2019 in Amsterdam (Press release, BeiGene, JUN 14, 2019, View Sourcenews-releases/news-release-details/beigene-announces-updated-results-pivotal-phase-2-study" target="_blank" title="View Sourcenews-releases/news-release-details/beigene-announces-updated-results-pivotal-phase-2-study" rel="nofollow">View Source [SID1234537092]).

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"The encouraging clinical results from this study further support our new drug application for tislelizumab in patients with R/R cHL that is currently under priority review in China," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "We hope that this potentially differentiated anti-PD-1 antibody could become a new treatment option for cancer patients in China and across the world."

"Tislelizumab demonstrated high anti-tumor activity in patients with R/R cHL – evidenced by an overall response rate of 87% and a complete response rate of 63%, and was generally well tolerated in these patients," said Yuqin Song, M.D., Ph.D., Associate Professor of Medical Oncology, Deputy Director of the Lymphoma Department at Peking University Cancer Hospital in China, and the presenting author of the study.

Summary of Clinical Results

Abstract Number: PF469

This single-arm, multi-center, pivotal Phase 2 study of tislelizumab as a monotherapy in Chinese patients with R/R cHL (clinicaltrials.gov identifier: NCT03209973) enrolled 70 patients who were either R/R to autologous stem cell transplantation (ASCT), or received at least two prior lines of systemic therapy for cHL and were not candidates for ASCT. Patients were treated with tislelizumab, dosed at 200 mg intravenously every three weeks. The primary endpoint of the trial is overall response rate (ORR) assessed by independent review committee (IRC) according to the Lugano Classification 2014.

As of November 26, 2018, 70 patients with R/R cHL were evaluable for efficacy. Thirteen patients received prior ASCT, and the remaining 57 patients were ineligible for ASCT. Patients had a median of three prior lines of systemic therapy (2-11). Results included:

With a minimum of 23.8 weeks of follow-up and a median follow-up time of 13.9 months at the data cutoff, the ORR by IRC was 87.1% (61/70); 44 patients (62.9%) achieved a complete response (CR), and 17 patients (24.3%) achieved a partial response (PR);

The median duration of response (DOR) has not been reached;

Twelve-month progression-free survival (PFS) was estimated at 73.8% and median PFS has not been reached;

The majority of adverse events (AEs) were grade 1 or 2 in severity. The most frequently reported treatment-emergent adverse events (TEAEs) of any grade include pyrexia (57.1%), weight increase (34.3%), upper respiratory tract infection and hypothyroidism (32.9% each), pruritus, white blood cell (WBC) count decreased, and cough (18.6%, each);

Grade ≧3 TEAEs occurred in 30% of patients, with the most frequently reported being hypertension, pneumonitis, neutrophil count decrease, upper respiratory tract infection, and weight increase (2.9%, each); only 2.9% of patients reported grade 4 TEAEs and there were no fatal TEAEs.

Four patients (5.7%) discontinued treatment due to TEAEs, including pneumonitis (n=2), focal segmental glomerulosclerosis (n=1), and organizing pneumonia (n=1); and

Immune-related (ir) TEAEs reported in more than 5% of patients included thyroid disorder (22.9%), skin adverse reactions (8.6%)*, and pneumonitis (7.1%).
Mid-2019 Clinical Data Update Conference Call and Webcast Information:

BeiGene will host a conference call and webcast on Thursday, June 20 at 8:00 a.m. EDT. Investors and analysts are invited to join the conference call using the following dial-in information:

U.S. Toll-Free: +1 (844) 461-9930
U.S. Toll: +1 (478) 219-0535
Hong Kong Toll-Free: +852 800 279 19250
China Toll-Free: +86 800 914 686
Conference ID: 1790069

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

About Classical Hodgkin Lymphoma

Hodgkin’s lymphoma is one of the two major types of lymphoma that begin in the lymph nodes and tissues of the lymphatic system. All other lymphomas are classified as non-Hodgkin’s lymphomas. Classical Hodgkin lymphoma, the most common form representing about 95% of patients with Hodgkin’s lymphoma, is characterized by the presence of very large cells called Reed-Sternberg cells. There were approximately 2,100 diagnosed cases of Hodgkin’s lymphoma in China in 2012.i Although the cancer can occur in both children and adults, it is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 50.

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program, and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is being studied in a broad clinical program. BeiGene has completed a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) classical Hodgkin’s lymphoma (cHL). Ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric cancer (GC); a Phase 3 clinical trial in first-line patients with ESCC; a Phase 3 trial in patients with Stage III NSCLC; a Phase 2 clinical trial in second- or third-line patients with HCC; and a Phase 2 clinical trial in patients with R/R NK/T-cell lymphomas. The aforementioned studies are enrolling patients in multiple countries, including the U.S., Europe, and China.

Additionally, BeiGene is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 3 clinical trial in patients with nasopharyngeal cancer (NPC); a Phase 3 clinical trial in first-line patients with urothelial carcinoma (UC); a pivotal Phase 2 clinical trial in patients with locally advanced or metastatic UC; and a pivotal Phase 2 trial in patients with MSI-H or dMMR solid tumors. These studies are enrolling patients in China.

New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted by the China National Medical Products Administration (NMPA, formerly known as CFDA) and the R/R cHL filing has been granted priority review. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

On June 14, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the first presentation of clinical results from the ASPEN trial, a global randomized Phase 3 open‑label trial of its investigational BTK inhibitor zanubrutinib in patients with Waldenström’s Macroglobulinemia (WM) (Press release, BeiGene, JUN 14, 2019, View Sourcenews-releases/news-release-details/beigene-announces-clinical-results-three-posters-zanubrutinib" target="_blank" title="View Sourcenews-releases/news-release-details/beigene-announces-clinical-results-three-posters-zanubrutinib" rel="nofollow">View Source [SID1234537091]). The poster presentation included clinical results from a nonrandomized exploratory cohort of patients with the MYD88WT genotype of WM. In addition, BeiGene announced updated results from the ongoing Phase 1/2 trial of patients with WM; and a pooled safety data analysis of zanubrutinib from six ongoing monotherapy studies in patients with B-cell malignancies. These data were presented in three posters at the 24thEuropean Hematology Association (EHA) (Free EHA Whitepaper) Congress, taking place June 13-16 in Amsterdam.

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"We are excited to announce new data from ongoing zanubrutinib clinical studies at EHA (Free EHA Whitepaper), including the first results of the Phase 3 ASPEN trial from a non-randomized cohort of patients who have WM with the MYD88WT genotype. For these patients, who typically have poorer prognoses with lower response rates, we recognize the real need for a highly potent and selective BTK inhibitor that can sustain BTK inhibition and reduce off-target effects. We are excited that these data have echoed what we saw in earlier trials, with an overall response rate of 81 percent and a major response rate that includes patients with a partial response or better, of 54% including 23% with a very good partial response (VGPR)," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "We will continue to follow these patients to further assess outcomes. Full results from the trial are planned for presentation at a medical congress later this year."

Dr. Huang continued, "In addition, with longer follow-up from the global Phase 1/2 trial of zanubrutinib in patients with WM, we’re seeing high rates of CR/VGPR (42%) that are proving to be durable responses. Separately, the pooled safety data analysis of zanubrutinib continues to affirm its tolerability as a selective BTK inhibitor, in patients with B-cell malignancies. We believe that these data further support zanubrutinib’s potential to become a meaningful treatment option for patients with B-cell malignancies around the world."

Major Responses in Patients with MYD88 Wildtype WM Treated with Zanubrutinib

Abstract Number: PF487

The ASPEN trial, a randomized open-label, multicenter Phase 3 trial (clinicaltrials.gov Identifier: NCT03053440) of zanubrutinib vs. ibrutinib in patients with WM, has enrolled 26 patients who were centrally determined at study entry to have the MYD88WT genotype. These patients were enrolled in the non-randomized cohort and assigned to receive zanubrutinib 160mg twice daily (BID). Responses were assessed using modified IWWM-6 criteria with endpoints of combined rate of complete response (CR) and very good partial response (VGPR), overall response rate (ORR), major response rate (MRR) and safety.

This exploratory analysis included five patients with treatment-naïve (TN) disease and 21 patients with relapsed/refractory (R/R) WM.

As of February 28, 2019, the median follow-up was 12.2 months (range 2.3 – 21.7 months) and 17 patients remained on study. Results included:

The ORR was 80.8%. MRR (partial response or better) was 53.8% and the VGPR rate was 23.1%. One patient achieved a complete response by IgM criteria with normal IgM levels and negative immunofixation;

Median time to first major response (partial response or better) was 2.9 months;

Median progression‑free survival (PFS) and overall survival (OS) have not yet been reached;

Zanubrutinib tolerability was generally consistent with previous reports. Discontinuation due to adverse events (AEs) occurred in 7.7% of patients (n=2). The primary reason for discontinuation was progressive disease;

The most common AEs (in >15% pts) were diarrhea (19%), hypertension (19%), contusion (15%), constipation (15%), muscle spasm (15%), pneumonia (15%), and upper respiratory tract infection (15%);

There were no fatal AEs or atrial fibrillation/flutter events reported; and

Among adverse events of special interest for BTK inhibitors, bleeding was observed in nine patients (34.6%), hypertension was observed in five patients (19.2%), Grade 3 or 4 cytopenias were observed in four patients (15.4%), Grade 3 or 4 infections were observed in three patients (11.5%), and secondary malignancy in three patients (11.5%). Two patients had major hemorrhage (7.7%).
"Zanubrutinib is a highly potent and selective BTK inhibitor with good bioavailability that was generally well-tolerated in this exploratory cohort from the Phase 3 ASPEN trial, said Meletios A. Dimopoulos, M.D., Professor of Hematology and Medical Oncology, Chairman of the Department of Clinical Therapeutics, Rector of the National and Kapodistrian University of Athens, Greece and first author on the poster. "For the patients with wildtype MYD88 genotype, we are excited by these data that support the results we’ve seen previously from Phase 1/2 studies."

Summary of Updated Clinical Results From the Global Phase 1/2 Trial

Abstract Number PF481

This global, open-label Phase 1/2 trial (clinicaltrials.gov identifier: NCT02343120) of zanubrutinib as monotherapy in patients with B-cell malignancies, including a cohort of patients with WM, is being conducted in Australia, New Zealand, the United States, Italy, the United Kingdom and South Korea. As of September 16, 2018, 77 patients with TN (n=24) or R/R (n=53) WM without prior BTK exposure have been enrolled in the trial; the median follow-up time was 23.9 months (4.4-45.7). Seventy-three patients including 24 with TN and 49 with R/R WM, were evaluable for efficacy in this analysis, per modified IWWM-6 criteria. At the time of the data cutoff, 61 patients remained on study treatment. Updated results included:

The ORR by independent review committee (IRC) was 92% (67/73) including MRR of 82% (60/73) and CR / VGPR rate of 42% (31/73).

The estimated PFS rate at 12 and 24 months was 90% and 81%, respectively;

Zanubrutinib tolerability was generally consistent with previous reports in patients with various B-cell malignancies and AEs were predominantly grade 1 or 2 in severity. The most frequent AEs were upper respiratory tract infection (46%), contusion (30%), cough (20%), headache (18%) and diarrhea (17%);

Grade 3-4 AEs occurred in 51.9% of patients. Grade 3-4 AEs of any attribution reported in > 3 patients included neutropenia (10%); anemia (7.8%), basal cell carcinoma (5%) and hypertension (5%); and

With a median follow up 24 months, discontinuation due to AEs occurred in 10.4% of patients, with five fatal events.
"As we continue to follow the Phase 1/2 trial of zanubrutinib, now for more than four years, we are impressed by the tolerability and efficacy of this BTK inhibitor for patients with WM who had not received prior BTK inhibition therapy," said Judith Trotman, MBChB, FRACP, FRCPA, Clinical Professor of Medicine at Concord Repatriation General Hospital, Concord, New South Wales, Australia and first author on the poster.

Pooled Analysis of Safety Data from Monotherapy Studies of Zanubrutinib in B-cell Malignancies

Abstract Number PS1159

Safety results from six ongoing, Phase 1 and Phase 2 clinical trials of zanubrutinib monotherapy, including collectively 682 patients with non-Hodgkin’s lymphoma (NHL), WM, or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), were included in this comprehensive analysis. The majority of patients had R/R disease; almost all patients received zanubrutinib at a dose of 320mg once daily or 160mg twice daily. The median duration of zanubrutinib exposure was 13.4 months (0.1-49.7).

This analysis included an evaluation of the frequency and severity of AEs, AEs of Special Interest (AESIs), and AEs leading to death, dose reduction or treatment discontinuation (d/c).

Ninety-seven percent of patients reported at least one AE, which were primarily grade 1 or 2. The most common AEs of all grades included upper respiratory tract infection (32.4%), neutrophil count decreased (25.2%), diarrhea (19.4%), cough (19.1%), contusion (18.6%), and rash (18%). The most common grade ≥3 AEs included neutrophil count decreased (14.4%), anemia (7.6%), neutropenia (6.6%), pneumonia (4.5%), platelet count decreased (4.3%), and lung infection (4.1%). Serious AEs (SAEs) consisting primarily of infectious complications such as pneumonia/lung infection were reported in 36% of patients.

AESIs such as atrial fibrillation/flutter (1.9%), major hemorrhage (2.5%), and grade ≥3 hypertension (3.4%) were infrequent, and treatment discontinuation due to AEs was uncommon (9.1% overall, including 3.5% for whom the event(s) were treatment-related).

"Zanubrutinib was generally well-tolerated, with less than five percent discontinuation for treatment-related adverse events. These data also demonstrated low safety-related treatment failure rates at doses of zanubrutinib associated with complete and sustained BTK inhibition," commented Constantine S. Tam, M.D., Disease Group Lead for Low Grade Lymphoma and Chronic Lymphocytic Leukemia at Peter MacCallum Cancer Center and Director of Hematology at St. Vincent’s Hospital, Australia, and lead author of the poster presentation.

Mid-2019 Clinical Data Update Conference Call and Webcast Information:

BeiGene will host a conference call and webcast on Thursday, June 20 at 8:00 a.m. EDT. Investors and analysts are invited to join the conference call using the following dial-in information:

U.S. Toll-Free: +1 (844) 461-9930
U.S. Toll: +1 (478) 219-0535
Hong Kong Toll-Free: +852 800 279 19250
China Toll-Free: +86 800 914 686
Conference ID: 1790069

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

About Zanubrutinib

Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, currently the only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.

Zanubrutinib has been granted by the U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of patients with WM, and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy. The New Drug Applications (NDAs) in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review. BeiGene plans to submit its first NDA in the U.S. for zanubrutinib in 2019 or early 2020.

On June 14, 2019 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") reported that senior management will be presenting in the upcoming JMP Life Sciences Conference in New York City (Press release, Sorrento Therapeutics, JUN 14, 2019, View Source [SID1234537088]).

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Sorrento Therapeutics

Speaker: Dr. Henry Ji (Chairman and CEO)

Date/Time: June 20th, 2019 at 11:30 AM

Location: The St. Regis New York, New York

Webcast: View Source

On June 14, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapeutics for a broad range of cancer indications, reported the pricing of an underwritten public offering of (i) 26,367,200 shares of common stock together with common stock warrants (the "common warrants") to purchase 26,367,200 shares of common stock and (ii) 73,632,800 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock, together with common warrants to purchase 73,632,800 shares of common stock (Press release, Sellas Life Sciences, JUN 14, 2019, View Source [SID1234537087]). The shares of common stock (or pre-funded warrants, as applicable) and accompanying common warrants are being sold together at a combined public offering price of $0.15 per share. The common warrants will have an exercise price of $0.50 per share, will be immediately exercisable and will expire five years from the date of issuance. The common warrants also provide that if, during the period of time between the date that is 60 days after issuance and the date that is 15 months after issuance, the weighted-average price of common stock on the trading day immediately prior to the exercise date is lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one share of common stock. SELLAS has granted the underwriters an option to purchase up to an additional 15,000,000 shares of common stock and/or 15,000,000 common warrants to cover over-allotments, if any.

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The gross offering proceeds to SELLAS from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any warrants, are expected to be approximately $15.0 million. The offering is expected to close on or about June 18, 2019, subject to customary closing conditions. SELLAS intends to use the net proceeds from the offering to commence a pivotal Phase 3 trial for its lead clinical candidate, galinpepimut-S ("GPS"), as a monotherapy in acute myeloid leukemia patients following second complete remission and to continue its Phase 1/2 basket type trial of GPS in combination with pembrolizumab, as well as for general corporate purposes and funding its working capital needs.

A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering. Maxim Group LLC is acting as co-manager.

A registration statement on Form S-1 relating to the offering was filed with the Securities and Exchange Commission ("SEC") on May 23, 2019, amended on June 6, 2019 and June 13, 2019 and was declared effective on June 13, 2019. The offering is being made only by means of a prospectus. SELLAS’ SEC filings are available to the public from the SEC’s website at www.sec.gov. Electronic copies of the final prospectus relating to the offering may also be obtained, when available, by contacting A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.