On November 12, 2020 VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, reported its financial results for the fiscal 2021 second quarter ended September 30, 2020 and provided an update on its CNS pipeline and business progress (Press release, VistaGen Therapeutics, NOV 12, 2020, View Source [SID1234570839]).

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"We see a significant rise in mental health concerns as the global COVID-19 pandemic continues to impact the daily lives of millions of individuals. We are committed to developing innovative therapies that provide relief to those suffering from anxiety and depression, and we are working diligently towards that goal. We are making significant progress in preparing PH94B for launch of a pivotal Phase 3 study for acute treatment of anxiety in adults with social anxiety disorder in the second quarter of 2021. After reaching consensus with the FDA on the key components of the study design, it will be very similar to the statistically significant Phase 2 study of PH94B in social anxiety disorder. We are also working with the FDA to finalize details for our Phase 2A study of PH94B in adjustment disorder, which we are planning to initiate in early 2021," said Shawn Singh, Chief Executive Officer of VistaGen.

"Millions of people rely on benzodiazepines and other prescription drugs to manage symptoms of stress and anxiety. While some medications are safe and effective treatments, many in the current treatment paradigm have limited therapeutic benefits and potentially serious side effects and safety concerns. In Phase 2 clinical studies, PH94B produced rapid onset anti-anxiety effects without requiring systemic uptake and distribution. With its rapid-onset pharmacology, lack of systemic exposure and sedation, and its excellent safety profile in all studies to date, we believe PH94B has the potential to displace benzodiazepines in the drug treatment paradigm for anxiety disorders. In addition to social anxiety disorder, we believe PH94B also has potential as a novel treatment for adjustment disorder, postpartum anxiety, post-traumatic stress disorder, preprocedural anxiety, panic, and other anxiety-related disorders, and we look forward to assessing its potential in various controlled Phase 2 clinical studies in parallel with our Phase 3 program to assess its potential as an acute treatment of anxiety in adults with social anxiety disorder," concluded Mr. Singh.

CNS Pipeline Highlights and Updates:

PH94B

VistaGen reached consensus with the FDA on key study design and execution aspects of the Company’s initial pivotal Phase 3 study of PH94B for acute treatment of anxiety in adults with social anxiety disorder (SAD):
As in the statistically significant (p=0.002) Phase 2 public speaking study of PH94B in SAD, VistaGen’s Phase 3 study will involve a laboratory-simulated anxiety-provoking public speaking challenge.
The Phase 3 study will be a randomized, double-blind, placebo-controlled, parallel comparison study conducted at approximately 15 sites in North America.
The Subjective Units of Distress Scale (SUDS) will be used to assess the primary efficacy endpoint in the study.
Dr. Michael Liebowitz, Professor of Clinical Psychiatry at Columbia University, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), will be the Principal Investigator of the study.
Target enrollment (completed subjects) will be approximately 182 adults with SAD.
Study expected to initiate recruitment in 2Q 2021.
VistaGen is currently preparing for an exploratory Phase 2A clinical study of PH94B for acute treatment of adjustment disorder (AjD), an emotional or behavioral reaction considered excessive or out of proportion to a stressful event or significant life change, occurring within three months of the stressor, and/or significantly impairing a person’s social, occupational and/or other important areas of functioning. Given the diverse impact of the COVID-19 pandemic, including, among other things, fear and anxiety about health and safety, economic loss, unemployment, social isolation, disruption of established education and work practices, VistaGen submitted its preliminary protocol for the study to the FDA through the FDA’s Coronavirus Treatment Acceleration Program (CTAP). Following that submission, the Company has continued its discussions with the FDA’s Division of Psychiatric Products to determine the study’s appropriate next steps, including the final study protocol.
The Company is planning to conduct the proposed Phase 2A study in New York City and enroll approximately 25 to 30 subjects suffering from adjustment disorder-provoking stressors, including, but not limited to, stressors related to the diverse impact of the COVID-19 pandemic and recent civil unrest in the U.S.
The AjD study is expected to initiate patient recruitment in 1Q 2021.
The Company is also planning for additional exploratory Phase 2A studies in postpartum anxiety, post-traumatic stress disorder, and pre-procedural anxiety (pre-MRI).
VistaGen reported new in vitro electrophysiology data demonstrating that the mechanism of action of PH94B, does not involve direct activation of GABA-A receptors, in distinct contrast to the mechanism of action of benzodiazepines, which act as direct positive modulators of GABA-A receptors.
These studies are significant because they indicate that PH94B has no relevant benzodiazepine-like activity, confirming PH94B’s potential to produce rapid-onset benzo-like, anti-anxiety effects, without the risky side effects and safety concerns of benzos.
AV-101

VistaGen reported positive new data from the Company’s second preclinical study of its oral investigational drug, AV-101, combined with probenecid, an FDA-approved drug for treatment of gout used adjunctively to increase the therapeutic benefit of numerous antibacterial, anticancer and antiviral drugs.
The results of this new study complement previous preclinical data demonstrating the combination’s potential to substantially increase the brain concentration of AV-101’s active metabolite, 7-Cl-KYN, a potent and selective full antagonist of the NMDA receptor glycine co-agonist site, thereby reducing, rather than blocking, NMDA receptor signaling.
Partnering Activity

VistaGen received a $5 million non-dilutive upfront license payment from EverInsight Therapeutics (now AffaMed Therapeutics), the Company’s strategic partner for Phase 3 development and commercialization of PH94B for anxiety-related disorders in key markets in Asia.
Upon successful development and commercialization of PH94B in the licensed territory, VistaGen is eligible to receive up to $172 million in additional development and commercial milestone payments, plus royalties on commercial sales of PH94B.
Capital Resources

VistaGen completed an underwritten public offering of common stock resulting in gross proceeds of $14.29 million to the Company, before underwriting discounts and commissions and offering expenses.
Financial Results for the Fiscal Quarter Ended September 30, 2020:

Net loss: Net loss attributable to common stockholders for the fiscal quarter ended September 30, 2020 decreased to approximately $3.7 million compared to $5.7 million for the fiscal quarter ended September 30, 2019. For the six-month period ending September 30, 2020, the net loss attributable to common stockholders was approximately $7.1 million, a decrease from approximately $12.2 million reported in the same period last year.

Revenue: Total revenue for the fiscal quarter ended September 30, 2020 was $334,000, representing the revenue recognition related to its agreement with EverInsight Therapeutics (now AffaMed Therapeutics), pursuant to which the Company received a non-dilutive upfront license fee payment of $5.0 million on August 3, 2020. VistaGen recognized $334,000 in sublicense revenue pursuant to this agreement in the six months ended September 30, 2020 compared to no revenue in the six months ended September 30, 2019. The Company expects to continue recognizing revenue pursuant to this payment in future periods during our fiscal year ending March 31, 2021 and thereafter.

Research and development (R&D) expense: Research and development expense decreased from $4.2 million in the quarter ended September 30, 2019 to $2.4 million for the quarter ended September 30, 2020. Research and development expense also decreased from $8.5 million to $4.1 million for the six months ended September 30, 2019 and 2020, respectively, in both cases, primarily due to the completion of the Company’s Phase 2 study of AV-101 as a potential adjunctive treatment of major depressive disorder in the fourth calendar quarter of 2019. Expenses related to that study and other nonclinical activities related to AV-101 decreased by $4.8 million for the six months ended September 30, 2020 compared to similar expense in the six months ended September 30, 2019. Noncash research and development expenses, primarily stock-based compensation and depreciation in both periods, accounted for approximately $391,000 and $607,000 in the six months ended September 30, 2020 and 2019, respectively.

General and administrative (G&A) expense: General and administrative expense totaled $1.3 million for the three months ended September 30, 2020 as compared to $1.2 million for the same period in the year prior. General and administrative expense decreased to approximately $2.7 million from approximately $3.1 million for the six months ended September 30, 2020 and 2019, respectively. Noncash general and administrative expense, $804,000 in the six months ended September 30, 2020, decreased from $1,044,000 in the six months ended September 30, 2019 primarily due to decreases in stock-based compensation and the noncash components of investor and public relations expense attributable to the amortization of the fair value of equity securities granted to service providers.

Cash Position: At September 30, 2020, the Company had cash and cash equivalents of approximately $15.4 million. During the quarter ended September 30, 2020, the Company received net proceeds totaling approximately $17.5 million from (i) the $5.0 million gross non-dilutive upfront license fee payment from EverInsight Therapeutics (now AffaMed Therapeutics), and (ii) the gross proceeds of approximately $14.29 million from the sale of shares of its common stock in an underwritten public offering.

As of November 12, 2020, the Company had 73,998,057 shares of common stock outstanding.

On November 12, 2020 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the results of the Phase 3 BOSTON (Bortezomib, Selinexor and Dexamethasone) study evaluating XPOVIO in patients with relapsed or refractory multiple myeloma were published online in The Lancet (Press release, Karyopharm, NOV 12, 2020, View Source [SID1234570838]). The BOSTON study evaluated once weekly XPOVIO, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with once weekly Velcade (bortezomib) and low-dose dexamethasone against standard twice weekly Velcade in adult patients with multiple myeloma who had received one to three prior lines of therapy.

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"The results from the BOSTON study published in The Lancet demonstrate that the once-weekly regimen of XPOVIO and Velcade, with low-dose dexamethasone (SVd) reduced the risk of disease progression or death by 30% and induced a higher rate of overall and deep responses compared to patients receiving a standard twice-weekly Velcade and low-dose dexamethasone regimen (Vd). This was observed despite approximately 40% less Velcade, 25% less dexamethasone and approximately 35% fewer clinic visits on the SVd arm as compared with the standard Vd therapy arm. Encouragingly, the efficacy of the SVd regimen was consistent and noteworthy across several key subgroups, including patients who were frail or 65 years and older, patients with high-risk cytogenetics, patients with moderate renal impairment and patients who had either prior bortezomib or lenalidomide treatment," said Dr. Paul Richardson, MD, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute and co-senior author of the manuscript.

"Despite the enrollment of 50% of patients with high risk cytogenetics, a particularly difficult to treat population, the SVd regimen demonstrated a 47% improvement in progression-free survival as compared to the Vd regimen and an overall response rate of 76.4%. Additionally, the rate and severity of peripheral neuropathy, a key treatment-limiting side effect commonly seen with Velcade therapy, was significantly lower on the SVd arm compared to the Vd arm and may lead to improved patient quality of life," said Sundar Jagannath, MD, Director of the Center of Excellence for Multiple Myeloma and Professor of Medicine, Hematology and Medical Oncology, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and an investigator in the BOSTON study.

"We are honored to have the Phase 3 BOSTON data selected for publication in such a highly esteemed medical journal and to be shared with the global oncology community," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We believe the successful outcome of this study represents an important advancement for myeloma patients and we are sincerely grateful to all of the patients and investigators who participated in the BOSTON study. While XPOVIO received accelerated FDA approval last year for patients with penta-refractory multiple myeloma, a supplemental New Drug Application requesting approval for XPOVIO as a treatment for patients with multiple myeloma who have received one prior line of therapy has been accepted by the FDA and assigned a PDUFA action date of March 19, 2021. We are working closely with the regulatory authorities in both the U.S. and Europe to make this potential new treatment option, with a completely novel mechanism of action, available to patients as quickly as possible, if approved."

Once-weekly SVd is a novel, effective and convenient triplet therapy that utilizes approximately 40% less Velcade and 25% less dexamethasone and requires approximately 35% fewer clinic visits during the first 24 weeks of treatment compared to the standard Vd regimen. Because Velcade is given as a subcutaneous injection rather than as an infusion, clinic visits may be shorter with the SVd regimen than with other non-Velcade regimens that may be employed to treat relapsed multiple myeloma and require intravenous infusions.

The Phase 3 BOSTON Study Results as Published in the Lancet

The published BOSTON study results are based on the multi-center, Phase 3, randomized study (NCT03110562), which evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly selinexor in combination with once-weekly Velcade (bortezomib) plus low-dose dexamethasone (SVd) versus twice-weekly Velcade plus low-dose dexamethasone (Vd). The primary endpoint of the study was progression-free survival (PFS) and key secondary endpoints included overall response rate (ORR), rate of peripheral neuropathy, and others. Additionally, the BOSTON study allowed for patients on the Vd control arm to crossover to the SVd arm following objective (quantitative) progression of disease verified by an Independent Review Committee (IRC). The BOSTON study was conducted at over 150 clinical sites internationally.

Although the study had one of the highest proportions of patients with high-risk cytogenetics (~50%) as compared with other Velcade-based studies in previously treated myeloma, the median PFS in the SVd arm was 13.93 months compared to 9.46 months in the Vd arm, representing a 4.47 month (47%) increase in median PFS (hazard ratio[HR]=0.70; p=0.0075). The SVd group also demonstrated a significantly greater ORR compared to the Vd group (76.4% vs. 62.3%, p=0.0012). Patients who had received only one prior line of therapy also demonstrated a higher ORR on the SVd arm as compared to the Vd arm (80.8% vs. 65.7%, p=0.0082). Importantly, SVd therapy compared to Vd therapy showed consistent PFS benefit and higher ORR across several important subgroups.

In addition, the following results favored SVd therapy as compared to Vd therapy:

SVd therapy demonstrated a significantly higher rate of deep responses, defined as ≥ Very Good Partial Response compared to Vd therapy (44.6% vs. 32.4%) as well as a longer median duration of response (20.3 months vs. 12.9 months). Additionally, 16.9% of patients on the SVd arm achieved a Complete Response or a Stringent Complete Response as compared to 10.6% of patients receiving Vd therapy. All responses were confirmed by an IRC.

Data at the time of analysis showed a trend toward an overall survival (OS) benefit associated with SVd therapy with fewer deaths, numerically, reported on the SVd arm (47 vs. 62). Median OS for the SVd arm had not yet been reached as of the data cut-off date of February 18, 2020, while the median OS for the Vd arm was 25.0 months. The median OS for the SVd arm will be reported once it is reached and becomes available.

Peripheral neuropathy (PN) rates were significantly lower on SVd compared to Vd (32.3% vs. 47.1%; p=0.0010). In addition, PN rates of grade ≥2 were also significantly lower in the SVd arm compared to Vd (21.0% vs. 34.3%, P=0.0013).

The most common treatment-emergent adverse events (AEs) were cytopenias, along with gastrointestinal and constitutional symptoms and were consistent with those previously reported from other selinexor studies. Most AEs were manageable with dose modifications and/or standard supportive care. The most common non-hematologic treatment-related AEs were nausea (50%), fatigue (42%), decreased appetite (35%), and diarrhea (32%) and were mostly Grade 1 and 2 events. The most common Grade 3 and 4 treatment-related AEs were thrombocytopenia (39%), anemia (16%), and fatigue (13%).

About Multiple Myeloma

According to the National Cancer Institute (NCI), multiple myeloma is one of the most common types of blood cancer in the U.S. with more than 32,000 new cases each year and over 140,000 patients living with the disease. It is most frequently diagnosed among people aged 65-74 years old. Despite recent therapeutic advances, there is currently no cure and most patients’ disease will typically progress following treatment with currently available therapies. According to the NCI, nearly 13,000 deaths due to multiple myeloma are expected in the U.S. in 2020.

About XPOVIO (selinexor)
XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

IMPORTANT SAFETY INFORMATION
Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma (MM) and developed or worsened in patients with DLBCL.

Thrombocytopenia is the leading cause of dosage modifications. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.

Neutropenia: XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection. Neutropenia and febrile neutropenia occurred in patients with MM and in patients with DLBCL.

Obtain white blood cell counts with differential at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction (AR).

Gastrointestinal Toxicity: XPOVIO can cause severe gastrointestinal toxicities in patients with MM and DLBCL.

Nausea/Vomiting: Provide prophylactic antiemetics. Administer 5-HT3 receptor antagonists and other anti-nausea agents prior to and during treatment with XPOVIO. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.

Diarrhea: Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration, and replace electrolytes as clinically indicated.

Anorexia/Weight Loss: Monitor weight, nutritional status, and volume status at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide nutritional support, fluids, and electrolyte repletion as clinically indicated.

Hyponatremia: XPOVIO can cause severe or life-threatening hyponatremia. Hyponatremia developed in patients with MM and in patients with DLBCL.

Monitor sodium level at baseline and throughout treatment. Monitor more frequently during the first 2 months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review. Interrupt, reduce dose, or permanently discontinue based on severity of the AR.

Serious Infection: XPOVIO can cause serious and fatal infections. Most infections were not associated with Grade 3 or higher neutropenia. Atypical infections reported after taking XPOVIO include, but are not limited to, fungal pneumonia and herpesvirus infection.

Monitor for signs and symptoms of infection, and evaluate and treat promptly.

Neurological Toxicity: XPOVIO can cause life-threatening neurological toxicities.

Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity.

Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until the neurological toxicity fully resolves. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes. Institute fall precautions as appropriate.

Embryo-Fetal Toxicity: XPOVIO can cause fetal harm when administered to a pregnant woman.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

ADVERSE REACTIONS

The most common adverse reactions in ≥20% of patients with MM are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

The most common ARs, excluding laboratory abnormalities, in ≥20% of patients with DLBCL are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3-4 laboratory abnormalities in ≥15% of patients included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in ≥5% were thrombocytopenia, lymphopenia, and neutropenia.

In patients with MM, fatal ARs occurred in 9% of patients. Serious ARs occurred in 58% of patients. Treatment discontinuation rate due to ARs was 27%. The most frequent ARs requiring permanent discontinuation in ≥4% of patients included fatigue, nausea, and thrombocytopenia.

In patients with DLBCL, fatal ARs occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal AR was infection (4.5% of patients). Serious ARs occurred in 46% of patients; the most frequent serious AR was infection. Discontinuation due to ARs occurred in 17% of patients.

USE IN SPECIFIC POPULATIONS

In MM, no overall difference in effectiveness of XPOVIO was observed in patients >65 years old when compared with younger patients. Patients ≥75 years old had a higher incidence of discontinuation due to an AR than younger patients, a higher incidence of serious ARs, and a higher incidence of fatal ARs.

Clinical studies in patients with relapsed or refractory DLBCL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

The effect of end-stage renal disease (CLCR <15 mL/min) or hemodialysis on XPOVIO pharmacokinetics is unknown.

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On November 12, 2020 SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, reported that it has signed a commercial supply agreement with Lantheus Holdings, Inc. (the parent company of Progenics Pharmaceuticals, Inc. (Progenics)) to manufacture and distribute Lantheus’ lead investigational prostate cancer imaging agent, PyL (18F-DCFPYL) (Press release, Sofie Biosciences, NOV 12, 2020, View Source [SID1234570837]).

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Following U.S. Food and Drug Administration ("FDA") approval, Lantheus will have a critical need for dependable and scalable manufacturing and distribution partners to support PyL. Under the commercial supply agreement, SOFIE will roll out PyL via its national network, which has manufactured PyL for Progenics during the clinical trials. SOFIE’s network will help meet the expected commercial demand for PyL by leveraging its expertise, experience, and distribution capabilities to achieve widespread availability and market coverage.

SOFIE’s CEO, Patrick Phelps stated, "Our relationship with Progenics, and now Lantheus, as well as our network capabilities have been greatly refined over the years we’ve worked on PyL. With over 500 doses previously manufactured for Progenics’ clinical trials, SOFIE is committed to delivering the doses needed, for widespread use post-FDA approval." SOFIE’s Chief Technical Officer, Dr. Melissa Moore, added, "Solidifying our relationship with Lantheus via this commercial agreement is the next step in the evolution of our Radiopharmaceutical Contract Manufacturing Organization. SOFIE believes that PyL will be an important next generation prostate cancer diagnostic tool and will offer new opportunities to those suffering from this common form of cancer."

Paul Blanchfield, Lantheus Chief Commercial Officer commented, "We are delighted to partner with SOFIE as we work toward FDA approval to bring PyL to the U.S. prostate cancer community. Consistent, reliable, and on-time delivery of diagnostic PET imaging agents is critical to meeting our supply demands and we look forward to our continued partnership with SOFIE to help patients gain access to PyL."

On November 12, 2020 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported members of the executive team will present during upcoming virtual investor conferences (Press release, Kezar Life Sciences, NOV 12, 2020, View Source [SID1234570836]). The details of the presentations are as follows:

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Jefferies Virtual London Healthcare Conference
Wednesday, November 18, 2020, 1:10pm EST (Fireside Chat)
Presenters: John Fowler, Chief Executive Officer; Christopher Kirk, PhD, Chief Scientific Officer, and Noreen R. Henig, MD, Chief Medical Officer

2020 Evercore ISI HealthCONx Conference
Thursday, December 3, 2020, 1:00pm EST (Presentation)
Presenter: John Fowler, Chief Executive Officer

The presentations will be webcast live and may be accessed in the "Investors and News" section of the Company’s website at www.kezarlifesciences.com. Kezar Life Sciences will maintain an archived replay of the webcasts on its website for 90 days after the conference.

On November 12, 2020 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported that company management will participate at three upcoming conferences (Press release, Xencor, NOV 12, 2020, View Source [SID1234570835]):

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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

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Jefferies Virtual London Healthcare Conference
Conference Dates: November 17-19, 2020
Presentation Date: Thursday, November 19, 2020
Presentation Time: 5:00 p.m. GMT / 9:00 a.m. PST
SVB Leerink Oncology Day
Conference Date: Thursday, November 19, 2020
Piper Sandler 32nd Annual Virtual Healthcare Conference
Conference Dates: November 30 – December 3, 2020
Presentation Available: Monday, November 23, 2020
Webcasts of the Jefferies and Piper Sandler presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. A replay of the live Jefferies presentation will be posted on the Xencor website approximately one hour after the live event. Both presentations will be available for at least 30 days.