On April 14, 2022 AbbVie (NYSE: ABBV) reported that it will announce its first-quarter 2022 financial results on Friday, April 29, 2022, before the market opens. AbbVie will host a live webcast of the earnings conference call at 8 a.m. CT (Press release, AbbVie, APR 14, 2022, View Source [SID1234612216]). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On April 14, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the initiation of two Phase 2 clinical studies evaluating SRF388, a potential first-in-class antibody against IL-27 (Press release, Surface Oncology, APR 14, 2022, View Source [SID1234612214]). The trials include a randomized Phase 2 clinical study evaluating SRF388 in combination with Roche’s atezolizumab and bevacizumab in patients with treatment-naïve hepatocellular carcinoma (HCC) and a Phase 2 monotherapy study in patients with previously-treated non-small-cell lung cancer (NSCLC).

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"While important progress has been made in recent years, unfortunately the prognosis for the majority of patients with hepatocellular carcinoma and previously-treated non-small cell lung cancer remains very poor," said Alison O’Neill, M.D., chief medical officer. "We have generated strong translational and early clinical data supporting a role for IL-27 blockade in these diseases, and we are pleased to be able to evaluate SRF388’s potential to improve patient outcomes in these indications."

Randomized Phase 2 Study in Patients with Treatment-Naive Unresectable or Metastatic Hepatocellular Carcinoma in Clinical Collaboration with Roche
The blinded, randomized Phase 2 study is enrolling approximately 100 patients with treatment-naïve unresectable or metastatic HCC. Patients are randomized to receive either SRF388 or a placebo in combination with atezolizumab and bevacizumab. The study will evaluate the ability of SRF388 to improve progression-free survival in combination with atezolizumab and bevacizumab compared to placebo plus atezolizumab and bevacizumab. Key secondary endpoints will include the safety, overall response rates and duration of response of the combinations. Due to the blinded nature of the study, Surface does not expect to have detailed clinical data prior to study conclusion but anticipates a futility analysis in early 2023 and final data in the first half of 2024.

Single-Arm Phase 2 Study in Patients with Non-Small-Cell Lung Cancer
The single-arm, Phase 2 study is enrolling up to 40 patients with NSCLC who have previously received treatment with one or more lines of therapy, including PD-1 blockade-based regimens or targeted therapies in disease cases with driver mutations. The primary endpoint will be overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) with an anticipated data readout in 2023.

About SRF388
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including liver, kidney and lung cancer, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immunosuppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies including anti-PD-1 therapy, as well as potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping to identify patients most likely to respond to SRF388. In November 2020, Surface announced that SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of hepatocellular carcinoma from the FDA.

On April 14, 2022 CTI BioPharma Corp. (Nasdaq: CTIC) reported that VONJO (pacritinib), its novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK1, has been included as a recommended treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms (Press release, CTI BioPharma, APR 14, 2022, View Source [SID1234612213]).

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"We are grateful that NCCN acted quickly to include VONJO with a Category 2A designation in its Clinical Practice Guidelines in Oncology as a first line treatment for high-risk patients with myelofibrosis with platelet counts <50 x 109/L who are not candidates for transplant. This therapeutic option helps address an unmet medical need for patients who previously have no other treatment options. There is no other FDA-approved first line treatment for these patients with a 2A designation within the NCCN guidelines," said Adam R. Craig, M.D., Ph.D., President, and Chief Executive Officer of CTI BioPharma. "Additionally, VONJO was included as a Category 2A designation as second line treatment for lower-risk and higher-risk patients with myelofibrosis with platelet counts ≥50 x 109/L who are not candidates for transplant. This placement provides additional treatment options for patients with myelofibrosis."

The new NCCN Guidelines are available online at www.nccn.org.

About VONJO (pacritinib)
Pacritinib is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form and FMS-like tyrosine kinase 3 (FLT3), which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Myelofibrosis is often associated with dysregulated JAK2 signaling. Pacritinib has higher inhibitory activity for JAK2 over other family members, JAK3 and TYK2. At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.

VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important VONJO Safety Information
Hemorrhage:
Serious (11%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <100 × 109/L. Serious (13%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <50 × 109/L. Grade ≥3 bleeding events (defined as requiring transfusion or invasive intervention) occurred in 15% of patients treated with VONJO compared to 7% of patients treated on the control arm. Due to hemorrhage, VONJO dose-reductions, dose interruptions, or permanent discontinuations occurred in 3%, 3%, and 5% of patients, respectively.

Avoid use of VONJO in patients with active bleeding and hold VONJO 7 days prior to any planned surgical or invasive procedures. Assess platelet counts periodically, as clinically indicated. Manage hemorrhage using treatment interruption and medical intervention.

Diarrhea:
VONJO causes diarrhea in approximately 48% of patients compared to 15% of patients treated on the control arm. The median time to resolution in VONJO-treated patients was 2 weeks. The incidence of reported diarrhea decreased over time with 41% of patients reporting diarrhea in the first 8 weeks of treatment, 15% in Weeks 8 through 16, and 8% in Weeks 16 through 24. Diarrhea resulted in treatment interruption in 3% of VONJO-treated patients. None of the VONJO-treated patients reported diarrhea that resulted in treatment discontinuation. Serious diarrhea adverse reactions occurred in 2% of patients treated with VONJO compared to no such adverse reactions in patients in the control arm.

Control pre-existing diarrhea before starting VONJO treatment. Manage diarrhea with antidiarrheal medications, fluid replacement, and dose-modification. Treat diarrhea with anti–diarrheal medications promptly at the first onset of symptoms. Interrupt or reduce VONJO dose in patients with significant diarrhea despite optimal supportive care.

Thrombocytopenia:
VONJO can cause worsening thrombocytopenia. VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre–existing moderate to severe thrombocytopenia (platelet count <100 × 109/L). VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre–existing severe thrombocytopenia (platelet count <50 × 109/L).

Monitor platelet count prior to VONJO treatment and as clinically indicated during treatment. Interrupt VONJO in patients with clinically significant worsening of thrombocytopenia that lasts for more than 7 days. Restart VONJO at 50% of the last given dose once the toxicity has resolved. If toxicity recurs hold VONJO. Restart VONJO at 50% of the last given dose once the toxicity has resolved.

Prolonged QT interval:
VONJO can cause prolongation of the QTc interval. QTc prolongation of >500 msec was higher in VONJO-treated patients than in patients in the control arm (1.4% vs 1%). QTc increase from baseline by 60 msec or higher was greater in VONJO-treated patients than in control arm patients (1.9% vs 1%). Adverse reactions of QTc prolongation were reported for 3.8% of VONJO-treated patients and 2% of control arm patients. No cases of torsades de pointes were reported.

Avoid use of VONJO in patients with a baseline QTc of >480 msec. Avoid use of drugs with significant potential for QTc prolongation in combination with VONJO. Correct hypokalemia prior to and during VONJO treatment. Manage QTc prolongation using VONJO interruption and electrolyte management.

Major Adverse Cardiac Events (MACE):
Another Janus associated kinase (JAK)-inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

Thrombosis:
Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated.

Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately.

Secondary Malignancies:
Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding non-melanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

Risk of Infection:
Another JAK-inhibitor has increased the risk of serious infections (compared to best available therapy) in patients with myeloproliferative neoplasms. Serious bacterial, mycobacterial, fungal and viral infections may occur in patients treated with VONJO. Delay starting therapy with VONJO until active serious infections have resolved. Observe patients receiving VONJO for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines.

Interactions with CYP3A4 Inhibitors or Inducers:
Co-administration of VONJO with strong CYP3A4 inhibitors or inducers is contraindicated. Avoid concomitant use of VONJO with moderate CYP3A4 inhibitors or inducers.

Drug interruptions due to an adverse reaction occurred in 27% patients who received VONJO 200 mg twice daily compared to 10% of patients treated with BAT. Dosage reductions due to an adverse reaction occurred in 12% of patients who received VONJO 200 mg twice daily compared to 7% of patients treated with BAT. Permanent discontinuation due to an adverse reaction occurred in 15% of patients receiving VONJO 200 mg twice daily compared to 12% of patients treated with BAT.

Please visit View Source for full Prescribing Information and the Medication Guide.

On April 14, 2022 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) reported that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") for toripalimab, a PD-1 inhibitor, for the treatment of small cell lung cancer ("SCLC") (Press release, Coherus Biosciences, APR 14, 2022, View Source [SID1234612212]). ODD is granted to drugs intended to treat rare diseases with a patient population less than 200,000 in the United States. The designation provides incentives to advance development and commercialization of drugs that have the potential to provide benefit to patients with rare diseases.

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SCLC is an aggressive tumor characterized by rapid disease progression, low expression of PD-L1 and low levels of tumor infiltrating immune cells, as well as a high degree of immunosuppression. Efficacy of cancer immunotherapy has been limited in SCLC. No PD-1 inhibitors are currently approved in the United States for SCLC. Prognosis for SCLC patients is poor, with five year survival rates of approximately 20% and less than 5% for patients with extensive stage SCLC.

The JUPITER-08 study (NCT04012606) is an ongoing, randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial evaluating PD-1 inhibitor toripalimab in combination with chemotherapy (cisplatin or carboplatin + etoposide) compared to placebo in combination with chemotherapy as the first-line treatment of extensive stage SCLC. Enrollment in this trial has been completed. The co-primary endpoints of the study are overall survival and progression free survival as assessed by the investigator.

"Toripalimab in combination with chemotherapy has demonstrated robust antitumor immunity and survival benefit in multiple tumor types including in tumors with low PD-L1 expression. This differentiated clinical activity may result from toripalimab’s unique binding epitope and internalization properties," said Dr. Theresa LaVallee, Chief Development Officer at Coherus. "SCLC patients have a particularly poor prognosis, and new and better treatment options are clearly needed for patients with this aggressive cancer. We are pleased to be working closely with our partner, Junshi Biosciences, to evaluate toripalimab in this underserved patient population and look forward to topline data from the pivotal first line SCLC clinical trial expected later this year."

"Lung cancer is the second most prevalent malignant tumor and has the highest mortality rate. However, there is a disparity in the development of new treatments for different subtypes of lung cancer, non-small cell lung cancer ("NSCLC") and SCLC. For NSCLC without oncogenic mutations, multiple immuno-oncology drugs, including toripalimab, have been shown to improve survival when added to chemotherapy as compared to chemotherapy alone, whereas treatment options for SCLC patients are limited to chemotherapy with one of two PD-L1 inhibitors," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We appreciate the FDA’s recognition of our endeavors to develop new therapies for SCLC patients and, based on experience in other cancers, are hopeful that toripalimab may provide a significant advance over chemotherapy in the JUPITER-08 study."

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are four approved indications for toripalimab in China:

unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma NPC after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.
The first three indications have been included in the National Reimbursement Drug List ("NRDL") (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.

In addition, two supplemental New Drug Applications ("NDAs") for toripalimab are currently under review by the National Medical Products Administration ("NMPA") in China:

in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic ESCC.
in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic NSCLC without EGFR or ALK mutations.
In the United States, the FDA has granted priority review for the toripalimab BLA for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which has no FDA-approved immuno-oncology treatment options. The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") target action date for April 2022 for the toripalimab BLA. The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug Designation for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and SCLC. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

On April 14, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, reported that the Company will report first quarter 2022 financial results on Thursday, April, 21, 2022, after market close (Press release, Cytori Therapeutics, APR 14, 2022, View Source [SID1234612199]). Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.

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A live webcast will be available at ir.plustherapeutics.com/events

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: 866-342-8591
International dial-in: 203-518-9713
Conference ID: PSTVQ122
Conference Call Name: Plus Therapeutics Q1 2022 Earnings
Following the live call, a replay will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call.