On November 20, 2020 Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH) ("Spring Bank"), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology and inflammatory diseases, reported that at its special meeting of stockholders held earlier today, Spring Bank’s stockholders approved the issuance of shares of Spring Bank common stock to holders of share capital of F-star Therapeutics Limited ("F-star") in connection with its proposed combination with F-star (the "Exchange") (Press release, Spring Bank Pharmaceuticals, NOV 20, 2020, View Source [SID1234571488]). In connection with the Exchange, stockholders also approved a proposal to effect a reverse stock split of all outstanding shares of Spring Bank common stock at a reverse stock split ratio as mutually agreed to be Spring Bank and F-star in the range of one new share for every three to seven shares outstanding (or any number in between). Spring Bank and F-star have agreed that the exchange ratio for the reverse stock split will be one for every four shares of Spring Bank common stock outstanding (the "Reverse Stock Split"). The Reverse Stock Split will be effective for trading purposes as of the commencement of trading on Monday, November 23, 2020. At the special meeting, Spring Bank stockholders also approved a change of the corporate name of Spring Bank from "Spring Bank Pharmaceuticals, Inc." to "F-star Therapeutics, Inc." effective upon closing of the Exchange. It is anticipated that the closing of the Exchange will occur on November 20, 2020.

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As a result of the Reverse Stock Split, the number of issued and outstanding shares of Spring Bank’s common stock immediately prior to the Reverse Stock Split will be reduced into a smaller number of shares, such that every 4 shares of Spring Bank’s common stock held by a stockholder immediately prior to the Reverse Stock Split will be combined and reclassified into one share of Spring Bank’s common stock. No fractional shares will be issued in connection with the Reverse Stock Split. Stockholders of record who otherwise would be entitled to receive fractional shares because they hold a number of pre-split shares not evenly divisible by the number of pre-split shares for which each post-split share is to be reclassified, will be entitled to a cash payment equal to the product of such fraction to which the stockholder would otherwise be entitled multiplied by the closing price of Spring Bank’s common stock on the Nasdaq Capital Market on the last trading day prior to the Reverse Stock Split effective time (as adjusted to give effect to the Reverse Stock Split), rounded up to the nearest whole cent. The Reverse Stock Split will not affect the total number of authorized shares of Spring Bank common stock.

On November 20, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status (Press release, ADC Therapeutics, NOV 20, 2020, View Source [SID1234571466]). The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date of May 21, 2021.

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"The FDA’s acceptance of our BLA and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "We look forward to working with the FDA during its review of our BLA submission for Lonca. Our organization remains focused on robust planning for a successful launch next year."

The BLA submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior therapy. In June 2020, the Company presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). As of the April 6th cutoff date, Lonca demonstrated an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1% (35/145 patients). The tolerability profile was manageable with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), GGT increase (16.6%) and anaemia (10.3%).

Data from subgroup analyses of LOTIS 2 will be presented in a poster (abstract #1183) at the upcoming 62nd American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Saturday, December 5, 2020.

About Loncastuximab Tesirine (Lonca)

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

Lonca, the Company’s lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. Lonca is also being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.

On November 20, 2020 DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, reported that the Phase 2 CAPTIVE study evaluating treatment with DNX-2401 (tasadenoturev) and pembrolizumab in patients with recurrent glioblastoma (GBM) demonstrated a median overall survival of 12.5 months. DNX-2401 is an adenovirus-based immunotherapy that is engineered to selectively kill tumor cells and trigger a robust anti-tumor immune response .

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"We are excited by the promising activity seen in patients with recurrent GBM, which is a notoriously difficult-to-treat cancer with a high mortality rate," said Jeffrey Knapp, chief executive officer of DNAtrix. "The median overall survival of 12.5 months achieved with DNX-2401 and pembrolizumab compares very favorably against historical benchmarks for standard of care agents, lomustine and temozolomide, where our meta-analysis indicates the median overall survival achieved with either of these therapies is on the order of 7.2 months. We look forward to advancing this treatment regimen into a global, randomized Phase 3 study. Additionally, we are also evaluating DNX-2401 in a Phase 1 study for the treatment of diffuse intrinsic pontine glioma, where we have received FDA Fast Track and Rare Pediatric Disease designations. Beyond DNX-2401, we are poised to begin a Phase 1 study in patients with colorectal and other cancers with liver metastases with our second product candidate, DNX-2440, an armed oncolytic virus that induces the expression of OX40 ligand on tumor cells."

Gelareh Zadeh, M.D., Ph.D., FRCS(C), FAANS, professor and dan chair of Neurosurgery at the University of Toronto, head of the Division of Neurosurgery at Toronto Western Hospital, and president of Society-of-Neuro-Oncology added, "My clinical and research focus has been in neuro-oncology, and I have seen the devastating impact of recurrent GBM first-hand. The data we have from the Phase 2 CAPTIVE study are very promising, demonstrating prolonged survival unlike what we have seen with available therapies. I can say that having seen some of the long- responders in my own patients genuinely has me very excited about the promise this therapy holds for GBM, in particular the subset who respond well. If successful, this could represent an important treatment for patients who are in desperate need of additional therapeutic options."

The Phase 2 multicenter CAPTIVE trial studied DNX-2401 in combination with the anti-PD-1 antibody, pembrolizumab, in 49 patients with GBM at first or second disease recurrence. In the study, patients were given a single dose of DNX-2401 followed by 200 mg pembrolizumab infusions every three weeks. The median treatment duration with pembrolizumab was seven cycles. The first part of the study evaluated escalating doses of DNX-2401, and the highest dose evaluated was selected for advancement into the dose expansion phase of the study.

The median overall survival for patients treated with the full dose DNX-2401 and pembrolizumab (n=42) was 12.5 months, and the survival rate at 18 months was 20.2%. Four patients, all of whom have survived more than 23 months, continue to be followed for survival. Five patients (11.9%) had confirmed responses, including two durable ongoing complete responses and 3 partial responses. The median duration of response has not been reached. The most commonly reported adverse events were headache, fatigue, and brain edema, which were primarily mild to moderate and manageable. Detailed results were presented at a late-breaking session during SNO’s 25th Annual Scientific Meeting and Education Day.

About DNX-2401 (Tasadenoturev)

DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and directly kill cancer cells, as well as elicit a broader anti-tumor immune response. DNX-2401 is currently being evaluated as a potential treatment for highly aggressive brain tumors, including recurrent glioblastoma in adults and newly-diagnosed diffuse intrinsic pontine glioma (DIPG) in children. Clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 has been granted Fast Track and Orphan designation by the FDA and PRIME and Orphan designation by the EMA.

About DNX-2440

DNX-2440 is an oncolytic adenovirus expressing the immune modulator OX40 ligand, a powerful costimulatory molecule known to enhance T cell responses directed to tumors. DNX-2440 is in Phase 1 clinical testing following the demonstration of anti-cancer activity in preclinical studies, including tumor reductions, immune memory, and abscopal effect.

On November 20, 2020 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported it will present positive results from the Phase 3 portion of the randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral XPOVIO (selinexor) versus matching placebo in patients with liposarcoma at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020) (Press release, Karyopharm, NOV 20, 2020, View Source [SID1234571490]). As previously reported, the SEAL study met its primary endpoint of a statistically significant increase in median progression-free survival (PFS) in patients with advanced unresectable dedifferentiated liposarcoma following at least two prior therapies.

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"Dedifferentiated liposarcoma is a particularly aggressive cancer that arises in the body’s fat tissue and is typically associated with high rates of metastatic recurrence and mortality. Unfortunately, there are few effective treatment options available for patients with advanced disease," said Mrinal M. Gounder, MD, Attending Physician, Sarcoma Service and Developmental Therapeutics Service, Memorial Sloan Kettering Cancer Center, and lead investigator of the SEAL study. "The data presented at CTOS 2020 demonstrated that patients treated with XPOVIO experienced a statistically significant improvement in median PFS compared to placebo in patients with at least two prior therapies. Extending PFS is an important clinical goal for these patients because the rapid progression of this disease often translates into early mortality."

"We are delighted to share these significant results from the Phase 3 portion of the SEAL study, the first, late-stage clinical data for XPOVIO in a solid tumor indication," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We believe these data strongly support our goal of developing twice-weekly XPOVIO as an effective, convenient, novel oral therapy that can extend PFS for patients with advanced unresectable dedifferentiated liposarcoma. We are especially excited by these data because XPOVIO is the first oral therapy to show activity in patients with previously treated liposarcoma. We look forward to submitting a New Drug Application to the U.S. Food and Drug Administration (FDA) during the first quarter of 2021, requesting approval of XPOVIO to treat the patient population studied in SEAL. If approved, XPOVIO would represent the first oral, non-chemotherapy agent available for patients with dedifferentiated liposarcoma."

Results from the Phase 3 Portion of the Phase2/3 SEAL Study

The median PFS in the XPOVIO arm of the Phase 3 portion of the SEAL study was 2.83 months compared to 2.07 months in the placebo arm (hazard ratio (HR)=0.70; p=0.023). These data indicate that treatment with XPOVIO reduced the risk of disease progression or death by approximately 30%, compared to placebo. The estimated 6-month PFS survival probability was 23.9% on the selinexor arm compared to 13.9% on placebo. Additionally, the 12-month PFS survival probability was 8.4% on the selinexor arm compared to 2% on the placebo arm. Finally, 7.5% of patients on the selinexor arm had a 15% or greater reduction in their disease burden as measured by target lesion size while none of the patients on the placebo arm achieved this level of reduction. The trial allowed patients on placebo with objective progression to cross over to the XPOVIO treatment arm. The median overall survival for patients who received XPOVIO was 9.99 months compared to 9.07 months for patients who never crossed over to the XPOVIO treatment arm (HR=0.69; p=0.122).

The most common treatment-related 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 (81%), decreased appetite (60%), fatigue (51%), and vomiting (49%) and were mostly Grade 1 and 2 events. The most common Grade 3 and 4 treatment-related AEs were anemia (19%), hyponatremia (11%), thrombocytopenia (10%) and asthenia (10%).

XPOVIO is currently approved by the FDA as a treatment for patients with relapsed or refractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). XPOVIO is currently the only XPO1 inhibitor approved by the FDA and has been extensively tested in clinical trials across numerous cancer indications worldwide since 2012. Karyopharm has also submitted a supplemental New Drug Application (sNDA) for XPOVIO that is currently under review by the FDA for the expansion of XPOVIO’s label to include XPOVIO as a treatment for patients with multiple myeloma after at least one prior line of therapy. The sNDA has been assigned an action date by the FDA of March 19, 2021 under the Prescription Drug User Fee Act. The full Prescribing Information for XPOVIO is available at www.XPOVIO.com.

Details for the oral presentation at CTOS 2020 are as follows:

Title: A Phase 2/3, Randomized, Double-Blind, Cross-Over Study of Selinexor Versus Placebo in Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)
Presenter: Mrinal Gounder, MD, Memorial Sloan Kettering Cancer Center
Paper #: 20
Session: 7. Liposarcoma
Date and Time: Friday, November 20, 2020, 10:30 a.m. to 11:30 a.m. ET

Conference Call Information

Karyopharm will host a conference call today, Friday, November 20, 2020, at 12:00 p.m. Eastern Time, to discuss the results from the SEAL study. The call will feature Dr. Gounder and another recognized sarcoma expert Sant P. Chawla, MD, FRACP, Director of the Sarcoma Oncology Center, Santa Monica, CA, along with members of the Karyopharm executive leadership team. To access the conference call, please dial (877) 870-4263 (local) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

About the SEAL Study

SEAL (Selinexor in Advanced Liposarcoma) is a Phase 2/3, randomized, double blind, placebo controlled, multicenter study (NCT02606461) designed to evaluate the efficacy and safety of twice-weekly, 60mg fixed dose of XPOVIO (selinexor) in patients with advanced unresectable dedifferentiated liposarcoma following at least two prior therapies. The Phase 2 portion of the study enrolled approximately 57 patients (1:1 randomization) and the Phase 3 portion enrolled approximately 285 patients (2:1 randomization). Patients on the placebo arm with confirmed progressive disease were permitted to cross over to the XPOVIO treatment arm. The primary endpoint of the study is PFS.

About Liposarcoma

Liposarcoma is a rare type of cancer that occurs in the fat cells in the body, most often in the muscles of the limbs or abdomen. Dedifferentiated liposarcoma (DDLS) is a high grade type of liposarcoma that grows more aggressively than a low grade, well differentiated liposarcoma and is associated with poorer prognosis.1 Liposarcoma accounts for approximately 20% of all soft tissue sarcomas2. In liposarcoma, the risk of recurrence and metastasis increases with higher grade disease.3

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 or 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.

On November 20, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular diagnostic assays, products and services designed to provide physicians with clinically actionable information to improve patient outcomes, reported the results of a study analyzing cerebrospinal fluid (CSF) samples in patients with primary lung or breast cancer with either brain or leptomeningeal disease (Press release, Biocept, NOV 20, 2020, View Source [SID1234571492]). The findings indicate that Target Selector CSF assays are a viable and sensitive platform for circulating tumor cell (CTC) detection and molecular analysis compared to the current standard of care, CSF cytology, which is typically used to establish or confirm leptomeningeal disease when imaging findings are suspicious or equivocal. CSF cytology has limited sensitivity and provides no additional information needed for target therapy choice.

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The results were discussed yesterday in a poster presentation by Santosh Kesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences, Director of Neuro-oncology at the Pacific Neuroscience Institute and John Wayne Cancer Institute, at the Society for Neuro-Oncology’s SNO2020 Virtual Conference on November 19, 2020.

"Once a tumor has metastasized to the brain, CTCs and circulating tumor DNA (ctDNA) can be found in the cerebrospinal fluid," said Dr. Kesari. "This prospective study compared the sensitivity of CTC detection and molecular analysis of Biocept’s Target Selector CSF assays to cytology (microscopic examination of conventional CSF cytology slide preps). This study highlights the potential of CSF-based diagnostics for longitudinal monitoring cancers in the central nervous system."

"Our Target Selector testing is a minimally invasive, cost-effective strategy to simultaneously confirm metastasis to the brain, while also assessing cancer biomarkers in order to qualify a patient for potential targeted therapy options," said Michael Nall, President and CEO of Biocept. "Identifying CTCs and actionable biomarkers with Target Selector can help to confirm and monitor central nervous system involvement when clinically suspected, without the risk of complications associated with surgical biopsies, which are often impossible in these cases.

"This the second major scientific conference in less than two months to accept study results from Target Selector testing in cerebrospinal fluid for presentation," added Mr. Nall. "We view neuro-oncology as an area where our technology is uniquely suited to answer questions posed by treating physicians, and we are appreciative of the Society of Neuro-Oncology’s recognition of our Target Selector testing."

About the SNO2020 Virtual Conference

The Society for Neuro-Oncology exists to advance multi-disciplinary brain tumor research, education, and collaboration to drive discovery and improve patient care. Over 2,600 neuro-oncology professionals are expected to register for the SNO2020 Virtual Conference being held November 19-21, 2020. More information can be found at soc-neuro-onc.org.