On November 20, 2020 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that Andrew Robbins, Chief Executive Officer and President, will participate in a virtual fire side chat at the 3rd Annual Evercore ISI HealthCONx Virtual Conference on Wednesday, December 2, 2020 at 10:55 a.m. ET (Press release, Cogent Biosciences, NOV 20, 2020, View Source [SID1234571465]).

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A live audio webcast may be accessed through the "Events" tab on the investor relations section of the Cogent website at: View Source A replay of the webcast will be available for 30 days following the event.

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 19, 2020 Ziopharm Oncology, Inc. ("Ziopharm" or "the Company") (Nasdaq:ZIOP) reported the presentation of new clinical data from three ongoing trials of Ad-RTS-hIL-12 plus veledimex (Controlled IL-12) for the treatment of recurrent glioblastoma (rGBM) and diffuse intrinsic pontine glioma (DIPG) at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting (Press release, Ziopharm, NOV 19, 2020, View Source [SID1234571417]). Data highlights include the first discussion of interim data from the phase 2 study of Controlled IL-12 in combination with cemiplimab for the treatment of rGBM that has recently completed enrollment, updated interim data from the phase 1 study of Controlled IL-12 in combination with nivolumab for the treatment of rGBM and data from the first patient enrolled in the ongoing phase 1/2 study of Controlled IL-12 monotherapy for the treatment of DIPG.

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"Glioblastoma is a highly aggressive tumor and despite advances in oncology over the last few decades, median overall survival for patients with progressive GBM remains less than one year," said Rimas Lukas, M.D., Associate Professor of Neurology at Northwestern Memorial Hospital Malnati Brain Tumor Institute and investigator on the phase 2 trial of Controlled IL-12 in combination with cemiplimab. "Here we report data for the first time from the ongoing phase 2 study of Controlled IL-12 in combination with PD-1 inhibitor cemiplimab, showing activation of the immune system across patients. These data are highly encouraging and underscore the potential of Controlled IL-12 to transform the treatment landscape of recurrent glioblastoma."

"The updated data on combining Controlled IL-12 with nivolumab reveal a subset of patients with rGBM that demonstrate very encouraging survival at 16 months. This observation reveals that immune modulation with IL-12 and anti-PD-1 is well tolerated with an apparent survival benefit that will need further confirmation in upcoming more advanced clinical trials. These survival data in conjunction with previously reported MRIs showing partial responses is consistent with immune-mediated anti-tumor effects," noted E. Antonio Chiocca, M.D., Ph.D., study investigator, Chairman of Neurosurgery at Brigham and Women’s Hospital, Professor of Neurosurgery at Harvard Medical School, and Surgical Director of the Center for Neuro-oncology at Dana-Farber Cancer Institute.

Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm, added, "As we reflect on the growing body of evidence across our efforts utilizing our Controlled IL-12 platform, we are encouraged by the signs of efficacy we are seeing in these very hard-to-treat cancers. Not only are we observing cytokine production, increases in intra-tumoral T cells (cold tumors turning hot), and predictable safety after treatment with Controlled IL-12 as a monotherapy and in combination with PD-1 inhibitors, but we have reported at least one partial response in each rGBM trial we have conducted to date, for a total of six. These MRI data, along with IL-12-driven immune response complement our encouraging survival data and we look forward to future data read-outs in 2021. Further, the initial look at data from the first patient in our phase 1/2 pediatric glioma study supports Controlled IL-12’s safety profile and continued development."

Controlled IL-12 in combination with PD-1 inhibitor cemiplimab is currently being examined in a phase 2 study for the treatment rGBM (NCT04006119). Preliminary data highlights shared in an on-demand presentation titled "Phase 2 Trial of Controlled IL-12 in Combination with PD-1 Inhibitor in Adult Subjects with Recurrent Glioblastoma" (Abstract #901183) and presented by Dr. Lukas, include:

Serum cytokine levels, including IL-12 and downstream IFN-g, were detected following initiation of Controlled IL-12, and sustained longer than previously reported data of Controlled IL-12 as monotherapy
Treatment resulted in activation of the immune system, with a significant increase in circulating killer (cytotoxic) T-cells by Day 28
Serial MRIs showed evidence of an immune-mediated anti-tumor response
• One partial response was confirmed on Week 16 and is ongoing through Week 32
Median overall survival (mOS) has not been reached, with mean a follow-up time of 6.5 months
Controlled IL-12 with cemiplimab was well tolerated
Enrollment was by design biased toward unifocal cases (82.5%) and is now complete with cemiplimab dosing and follow-up ongoing
Most patients received low dose steroids, defined as <= 20 mg cumulative dosing of dexamethasone during veledimex administration
Controlled IL-12 in combination with the PD-1 inhibitor nivolumab is currently being examined in a phase 1 study for the treatment of rGBM (NCT03636477). Interim data highlights shared in an oral on-demand presentation titled "Combination of Controlled Interleukin-12 Gene Therapy with Immune Checkpoint Blockade in Recurrent Glioblastoma: Updated Results of a Multi-Institutional, Open Label Phase 1 Trial" (Abstract #901050) and presented by Dr. Chiocca include:

Results are comparable to Controlled IL-12 monotherapy
• Veledimex plasma and tumor plasma pharmacokinetics demonstrated a dose-response relationship and crossing of the blood-brain barrier
• Serum IL-12 was detected in all subjects following Controlled IL-12 treatment, typically followed by a transient increase in downstream IFN-γ
Pre- and post-treatment biopsies show increased levels of tumor-infiltrating T cells and decreased levels of PD-1
mOS for the cohorts receiving 10 mg veledimex (n=6; 83% unifocal, 67% low dose steroids) was 16.9 months
mOS among all subjects (across both 10 mg and 20 mg veledimex dosing, n=21) was 9.8 months
Most patients (81%) in this substudy received low dose steroids
Drug-related toxicities were comparable to Controlled IL-12 monotherapy, being predictable, dose-related, and promptly reversible upon discontinuation of veledimex
Enrollment is complete; anti-PD-1 administration in one subject and follow-up in six patients is currently ongoing
As a follow up to our prior readout (ASCO 2020) for this combination which reported partial responses by MRI, the two patients had meaningful improvements in survival with one patient on 20 mg veledimex surviving 17.4 months (now deceased) and the other (10 mg veledimex) surviving 21.0 months (in follow up).

Controlled IL-12 monotherapy is being studied in a phase 1/2 dose escalation study (NCT03330197) for the treatment of children with gliomas, including DIPG. Data highlights from the first patient in the study shared in a poster discussion titled "Phase I/II Study of Controlled IL-12 as Immunotherapy for Diffuse Intrinsic Pontine Glioma (DIPG)" (Abstract #901123) and presented by Stewart Goldman, M.D., Division Head Hematology-Oncology, Neuro-Oncology & Stem Cell Transplantation at Lurie Children’s Hospital and investigator in the study, include:

Controlled IL-12 monotherapy was well-tolerated at the initial dose level (10 mg/day veledimex, BSA adjusted)
• High veledimex compliance was reported, with no dose limiting toxicity (DLTs), Serious Adverse Events (SAEs) or suspected unexpected serious adverse reactions (SUSARs) occurring during the active study period
• Adverse Events (AEs) were similar to adult and older pediatric supratentorial brain tumor subjects in being mild to moderate and predominantly reversible upon withholding of veledimex doses
Preliminary evidence of immune system activation
• Although an increase in serum recombinant IL-12 was not detected after initial dosing of veledimex (patient received 5 mg per day), endogenous IFN-γ was detected which peaked at Day 3 consistent with downstream IL-12-driven immune response
• Circulating cytotoxic T-lymphocyte levels increased between Days 7 and 28
• Partial eyebrow loss was observed, suggestive of immune-mediated alopecia areata
Survival of the first subject dosed was within the historical reference range
Enrollment is ongoing with the plan to investigate two dose levels of veledimex (10 to 20 mg, BSA adjusted) as planned per protocol
"It is important to note that these trials, including our previously disclosed monotherapy study now consist of over 125 patients with rGBM. These provide deep learning that is ongoing and is part of the efforts to develop Controlled IL-12 as a potential therapy for brain cancers. We will continue to monitor the data across both the monotherapy and checkpoint inhibitor combination studies in the coming months. We believe there are multiple potential paths to registration for our Controlled IL-12 program, either as a monotherapy therapy or in combination with other agents," concluded Dr. Cooper.

More information about Controlled IL-12 is available on the Company’s website at View Source Additionally, the presentations presented at the SNO 2020 Virtual Meeting will be available on the Company’s website in the "Scientific and Medical Publications" section.