On April 20, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported updated positive data from the Phase 1 dose escalation portion of the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant relapsed/refractory (R/R) acute leukemias (Press release, Syndax, APR 20, 2021, View Source [SID1234578249]). SNDX-5613 is the Company’s highly selective, oral menin inhibitor. Information on how to access the live video webcast and accompanying slide presentation can be found below.

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"Data reported today further support the potential for SNDX-5613 to induce clinically meaningful responses in patients with genetically-defined acute leukemias," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, robust clinical activity, including multiple complete responses with no evidence of minimal residual disease (MRD-), were observed in heavily pretreated MLLr and NPM1c patients. We have identified a candidate recommended Phase 2 dose (RP2D) and expect to commence the pivotal Phase 2 portion of the trial by the end of the second quarter."

"Genetically-defined acute leukemias, including those harboring MLLr and NPM1c mutations, represent a disease area with a particularly poor prognosis and few effective treatment options," said Eytan M. Stein, M.D., Assistant Attending Physician and Director, Program for Drug Development in Leukemia, Department of Medicine at Memorial Sloan Kettering Cancer Center, and the trial’s principal investigator. "With five-year survival rates in MLLr and NPM1c mutant acute leukemias of 50% or less, novel treatments that can offer clinically-meaningful benefit are desperately needed. I am excited to present evidence that underscores previous observations that SNDX-5613 has the potential to disrupt the treatment paradigm for this disease."

As of a March 12, 2021 data cutoff date, 43 patients with a median of three prior therapies, such as prior stem cell transplant, venetoclax and chemotherapy, were dosed in the Phase 1 portion of the AUGMENT-101 trial. A total of 31 patients were evaluable for efficacy at the time of the data cutoff date, with the remaining patients either not yet at their initial efficacy assessment (n=4) or not harboring either the MLLr or NPM1c mutation (n=8). The overall response rate1 (ORR) among evaluable patients was 48% (n=15), with 67% (n=10) of these responders achieving MRD negative status, with four of these patients proceeding to receive stem cell transplant. The ORR in evaluable patients harboring an MLL-rearrangement (n=24), was 54% (n=13), and in evaluable patients harboring an NPM1c mutation (n=7), was 29% (n=2).

A candidate RP2D of 226 mg every 12 hours was identified for patients who are not receiving a concomitant strong CYP3A4 inhibitor, and 113 mg every 12 hours for patients on a concomitant strong CYP3A4 inhibitor treatment. Eighteen patients treated at the RP2D were efficacy-evaluable and response results observed at the RP2D were consistent with the overall population.

Across all patients enrolled in the trial as of the data cutoff date (n=43), SNDX-5613 was generally well-tolerated, with no discontinuations due to treatment-related adverse events observed in heavily pretreated patients. The only grade 3 or greater related adverse events occurring in at least 5% of patients were QT prolongation, anemia, and differentiation syndrome. Among all patients treated at the candidate RP2D (n=22) as of the data cutoff date, 9% of patients (n=2) experienced grade 3 QT prolongation.

About AUGMENT-101

AUGMENT-101 is a Phase 1/2 open-label trial designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of orally administered SNDX-5613. The Phase 1 dose escalation portion of AUGMENT-101 was separated into two cohorts based on concomitant treatment with a strong CYP3A4 inhibitor. Arm A enrolled patients not receiving a strong CYP3A4 inhibitor, while Arm B enrolled patients receiving a strong CYP3A4 inhibitor. The pivotal Phase 2 portion of the trial will evaluate efficacy, as defined by complete response rate (per International Working Group response criteria), across three expansion cohorts: MLLr acute lymphoblastic leukemia (ALL), MLLr acute myeloid leukemia (AML), and NPM1c mutant AML.

Conference Call and Webcast Details

The Company will host a conference call and webcast today, Tuesday, April 20, 2021 at 8:00 a.m. ET. The presentation will feature the trial’s principal investigator, Eytan M. Stein, M.D., Assistant Attending Physician and Director, Program for Drug Development in Leukemia, Department of Medicine at Memorial Sloan Kettering Cancer Center.

The live video webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 3129568
Domestic Dial-in Number: (877) 474-0326
International Dial-in Number: (918) 922-6881
Live webcast: View Source

For those unable to participate in the live event, a replay will be available on the Investors section of the Company’s website, www.syndax.com.

About SNDX-5613

SNDX-5613 is a potent, selective, small molecule inhibitor of the menin-MLL binding interaction that is being developed for the treatment of mixed lineage leukemia rearranged (MLLr) acute leukemias including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), and NPM1c mutant AML. In preclinical models of MLLr acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit. Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple preclinical models of NPM1c mutant AML, which represents the most frequent genetic abnormality in adult AML. SNDX-5613 is currently being evaluated in the Company’s AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias. SNDX-5613 was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with AML.

About Mixed Lineage Leukemia Rearranged Acute Leukemias

Rearrangements of the MLL gene give rise to mixed lineage leukemia rearranged (MLLr) acute leukemias known to have a poor prognosis, with less than 25% of adult patients surviving past five years. MLL rearrangements produce fusion proteins that require interaction with the protein called menin to drive leukemic cancer growth. Disruption of the menin-MLLr interaction has been shown to halt the growth of MLLr leukemic cells. MLLr leukemias, which are routinely diagnosed through currently available cytogenetic or molecular diagnostic techniques, occur in approximately 80% of infant acute leukemias and up to 10% of all acute leukemias. There are currently no approved therapies indicated for MLLr leukemias.

About NPM1c Mutant Acute Myeloid Leukemia

NPM1c mutant acute myeloid leukemia (AML), which is distinguished by point mutations in the NPM1c gene that drive the leukemic phenotype, is the most common type of cytogenetically normal adult AML and represents approximately 30% of all adult AML cases. This subtype of AML has a five year overall survival rate of approximately 50%. Similar to mixed lineage leukemia rearranged (MLLr) leukemias, NPM1c mutant AML is highly dependent on the expression of specific developmental genes shown to be negatively impacted by inhibitors of the menin-MLL interaction. NPM1c mutant AML is routinely diagnosed through currently available screening techniques. There are currently no approved therapies indicated for NPM1c mutant AML.

On April 20, 2021 Janux Therapeutics reported the closing of a $125 million Series B financing led by RA Capital Management and joined by new investors BVF Partners L.P., EcoR1 Capital, Hartford HealthCare Endowment, Janus Henderson Investors, Logos Capital, Samsara BioCapital and Surveyor Capital (a Citadel company) (Press release, Janux Therapeutics, APR 20, 2021, View Source [SID1234578265]). Janux’s existing investors, OrbiMed, Avalon Ventures, and Bregua, also participated. The proceeds of the financing will help support the advancement of Janux’s pipeline of next generation T cell engager immunotherapies, including a PSMA-TRACTr, EGFR-TRACTr, and TROP2-TRACTr, into initial proof of concept clinical trials.

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"This commitment from a world-class syndicate of life science investors will help advance Janux’s proprietary pipeline of potentially transformative immunotherapies into clinical development, while leveraging our powerful TRACTr platform to identify and optimize new drug candidates," said David Campbell, Ph.D., President and CEO of Janux Therapeutics. "We intend to use the proceeds to advance PSMA-TRACTr, EGFR-TRACTr, and TROP2-TRACTr into the clinic as well as attract the talent needed to realize our vision of providing cancer patients with safe and effective drugs that direct their immune system to eradicate tumors to give them the best chance to overcome their disease."

T cell engagers are an emerging class of immunotherapies that bind to a tumor cell and recruit a patient’s T cells to eradicate tumor cells. Janux’s proprietary Tumor Activated T Cell Engager (TRACTr) technology is designed to overcome specific limitations of current T cell immuno-oncology therapies. Although previous therapies utilizing other technologies have displayed substantial anti-tumor activity, they have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s TRACTr technology is designed to overcome these limitations by integrating tumor-specific activation with crossover pharmacokinetics to produce differentiated T cell engager therapeutics.

"RA Capital believes that Janux’s proprietary technology has the potential to unlock the next generation of immunotherapies, and we are excited about the significant potential that this platform holds for a breadth of highly prevalent solid tumors," said Jake Simson, Ph.D., partner at RA Capital Management. "We are impressed with the preclinical data from Janux’s wholly-owned TRACTr drug candidates showing the potential to harness the potent tumor-killing properties of T cells."

In preclinical studies, Janux TRACTr drug candidates have demonstrated comparable anti-tumor activity relative to standard T cell engagers but lack the associated liabilities related to cytokine release, healthy tissue toxicities, or systemic immune activation.

On April 20, 2021 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, reported financial results for the full year ended December 31, 2020, as well as recent clinical progress (Press release, Akari Therapeutics, APR 20, 2021, View Source [SID1234578285]).

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"2020 saw us successfully complete a Phase II study in BP and align with the FDA and the European Medicines Agency (EMA) on a regulatory pathway to initiate a Phase III pivotal study in BP. In addition, we have initiated a Phase III study in HSCT-TMA. We have also seen further positive data support development of our back of the eye and surface of the eye programs," said Clive Richardson, Chief Executive Officer of Akari Therapeutics. "In 2021, we look forward to progressing our Phase III studies and advancing development of our ophthalmology, lung and trauma programs as we continue to leverage nomacopan’s unique bifunctional action as a dual highly specific inhibitor of LTB4 and complement C5."

Full Year 2020 and Recent Clinical Highlights

Akari’s two lead programs – in BP and HSCT-TMA – are in Phase III development. The Company also has early-stage programs addressing ophthalmology, pulmonary diseases and trauma.

PHASE III TRIALS

Phase III clinical trial in patients with BP

Initiation of a multicenter Phase III study of nomacopan for the treatment of BP with nomacopan following opening of FDA IND. Clinical sites expected to open for recruitment mid-2021.
The FDA and EMA have granted orphan drug designation for nomacopan for the treatment of BP.
Phase III clinical trial in pediatric patients with HSCT-TMA

Phase III study in pediatric HSCT-TMA is now open for enrollment at sites in the U.S. and Europe, subject to the ongoing impact of COVID-19 related restrictions.
Akari has FDA fast track and orphan drug designations for pediatric HSCT-TMA patients.
PNH – long term data

Long-term data from 19 PNH patients treated for over 30 cumulative patient-years showed that self-administered nomacopan:
Is well-tolerated with no reported major adverse vascular events and only a single reported serious adverse event (urinary tract infection) in one patient that was considered possibly related to nomacopan.
Induces transfusion independence (defined as at least six months without transfusion) in 79% (n = 14) PNH patients treated with nomacopan for at least six months, who were transfusion dependent prior to treatment. This compares favorably to the treatment of PNH patients on long-term eculizumab therapy where between 50-60% of transfusion dependent patients become transfusion independent in a 12-month period (Brodsky et al., 2008, SHEPHERD study on eculizumab, Hillmen et al 2013) and supports ongoing studies in other hematological diseases where the role of complement is implicated, such as HSCT-TMA.
EARLY-STAGE PROGRAMS

Ophthalmology program

Interim data from a first-in-eye Phase I/II study in atopic keratoconjunctivitis (AKC), a surface of the eye inflammatory disease, showed nomacopan was comfortable and well tolerated. Akari has opened an IND and is looking to expand its program in the surface of the eye.
Recently presented data points to the potential role of nomacopan as a treatment for AMD. This includes recent articles in the journal CELLS and the American Journal of Pathology, which highlights the causative role LTB4 plays in the induction of vascular endothelial growth factor (VEGF) and associated retinal inflammation. Taken together the data supports a potential therapeutic role for long acting PAS-nomacopan, inhibiting both complement and VEGF in sight threatening retinal diseases.
In a model of choroidal neo-vascularization, PAS-nomacopan injected once during the 16-day treatment period was equivalent to Eyelea in reducing neo-vascularization. Work is ongoing to explore the likely human injection frequency for intravitreal (IVT) administration of PAS-nomacopan.
Given the specialist nature of the ophthalmology market, Akari is exploring opportunities to collaborate with potential partners to accelerate the development of these ophthalmology programs.
Lung program

In the UK, recruitment into the COVID-19 observational study is complete and a publication is in preparation. Initial data has identified elevated levels of LTB4 in COVID patients. In addition, other early disease biomarkers have been analyzed, which may allow for the potential to optimize patient selection for treatment with nomacopan.
In the U.S., the FDA has approved a randomized multi-center study in patients hospitalized with COVID-19 pneumonia with a new increased dosing schedule, following experience in Brazil. The clinical study in Brazil, as previously reported has been paused and may potentially now align with the new U.S. program.
Akari is exploring opportunities to expand its lung program to include other inflammatory diseases with exacerbations, limited treatment options and where both complement and leukotriene pathways are implicated. In this context an investigator led severe asthma study is being considered in the U.S.
Trauma

In March 2021, Akari announced CRADA with the USAISR, working to evaluate the potential for use of nomacopan in battlefield trauma. This follows positive pre-clinical data with nomacopan in a range of pre-clinical models.
Trauma is a global burden disease. In the U.S., there are approximately 500,000 trauma hospital discharges a year which are defined as severe and might benefit from early drug intervention to reduce multi-organ dysfunction following trauma. Akari is actively exploring other opportunities in trauma in the civilian population.
New histamine inhibition development program

Akari added to its pipeline a novel tick derived histamine inhibitor ‘votucalis’, which has a similar structure to nomacopan. Votucalis uniquely prevents activation of all four histamine G-protein coupled receptors creating new therapeutic opportunities in pain management. As such, votucalis potentially provides the opportunity to expand the Company’s existing dermatology franchise with other modes of administration (local topical delivery) and into other diseases such as atopic dermatitis.
The histamine program is supported by positive pre-clinical data in neuropathic pain and itch models.
Full Year 2020 Financial Results

As of December 31, 2020, the Company had cash of approximately $14.1 million, compared to cash of $5.7 million as of December 31, 2019.
In June 2020, Akari entered into a securities purchase agreement (Purchase Agreement) with Aspire Capital Fund, LLC (Aspire Capital) whereby Aspire Capital is committed to purchase up to an aggregate of $30 million of the Company’s ADSs. During the year ended December 31, 2020, the Company sold to Aspire Capital a total of approximately $6.0 million of ordinary shares. As of April 15, 2021, approximately $24.0 million of the original purchase commitment remains available for draw down under the Purchase Agreement.
Research and development (R&D) expenses for full year 2020 were approximately $8.8 million, as compared to approximately $8.7 million in 2019.
General and administrative (G&A) expenses for the full year 2020 were approximately $9.2 million, as compared to approximately $8.2 million in 2019. The increase was primarily due to a one-time non-cash financing expense related to the 2020 Purchase Agreement with Aspire Capital.
For the full year 2020, total other income was approximately $899,000 as compared to approximately $117,000 in 2019. This change was primarily due to higher income related to the change in the fair value of warrant liabilities in 2020 than in 2019, and foreign exchange gains in 2020 as compared to foreign exchange losses in 2019.
Net loss for full year 2020 was approximately $17.1 million, as compared to approximately $16.8 million for the prior year. The slight decrease in net income was primarily due to the aforementioned one-time non-cash financing expense related to the 2020 Purchase Agreement with Aspire Capital.
As part of the 2020 audit, the Company discovered an error in its accounting treatment of certain options (RPC options) from 2015 that should have been accounted for as an equity instrument as opposed to a liability. Accordingly, the Company concluded that the financial statements contained in the Company’s Annual Reports on Form 20-F for the years ended December 31, 2015 through 2019, as well as the interim condensed consolidated financial statements contained in the quarterly reports on Form 6-K for each quarter within these years, as well as the quarterly periods ended March 31, 2020, June 2020 and September 2020, should be restated and therefore not relied upon. This is a non cash re-statement and the RPC options do not constitute a legal liability to the Company and will not affect the Company’s financial statements upon settlement. The Company has included restated financial statements and notes thereto and any other appropriate revisions in its Annual Report on Form 20-F for the year ended December 31, 2020 and for more information please refer to Note 3 of our Annual Report on Form 20-F for the year ended December 31, 2020.
A copy of the Company’s Annual Report on Form 20-F for the year ended December 31, 2020 has been filed with the Securities and Exchange Commission and posted on the Company’s website at View Source

On April 19, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported that in March, the first patient was infused in the CD19-Specific Rapid Personalized Manufacturing ("RPM") CAR-T Phase I Trial, being conducted by Eden BioCell, its joint venture with TriArm Therapeutics (Press release, Ziopharm, APR 19, 2021, View Source [SID1234578181]).

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The patient was treated at National Taiwan University Hospital under the direction of lead investigator, Dr. Shang-Ju Wu.

The patient’s T cells, collected from the patient via apheresis, were genetically engineered utilizing the Company’s non-viral Sleeping Beauty transposon transposase system and infused two days after gene transfer.

"We are excited to be conducting this important trial for this experimental treatment," said Dr. Jay Zhang, Chief Executive Officer of TriArm Therapeutics.

The Company and Eden BioCell will provide updates regarding the experimental treatment and other patient data in the second half of the year at appropriate venue(s), including scientific conferences, publications and / or bespoke events that the Company may convene.

About the Trial "Infusion of CD19-Specific Chimeric Antigen Receptor T-cells Produced by Rapid Personalized Manufacture for Patients with Advanced Lymphoid Malignancies"
This is a single center phase I, open-label dose-escalation trial, for patients with relapsed CD19+ leukemias and lymphomas. Up to 24 patients will be enrolled in this trial. The primary endpoint of the trial is to evaluate the safety and tolerability of autologous CD19-specific T cells manufactured using the RPM process.

On April 19, 2021 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC) reported a presentation at AACR (Free AACR Whitepaper)-2021 (American Association for Cancer Research/ Annual Meeting) entitled: Combination therapy of anti-sense oligonucleotide targeting TGF-β2 (TASO) and IL-2 (Proleukin) has anti-cancer effect in solid cancer (Press release, Oncotelic, APR 19, 2021, View Source [SID1234578197]).

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TGF-β (transforming growth factor-beta) is an essential cytokine for tumor proliferation and metastasis. The expression of TGF-Β correlates with malignancy of various cancers and involves immunosuppression and angiogenesis of a tumor. IL-2 is a major cytokine to proliferate T cells and NK cells which are major players of cancer immunity. However, the toxicity of high dose IL-2 limits its use in cancer therapy. Combination treatment of TGF-β inhibitor and IL-2 would have an anti-tumor effect by immune cells through diminishing immunosuppression by TGF-β and enforcement of immune cells by IL-2. Trabedersen is an anti-sense oligonucleotide targeting human TGF-β mRNA. It is shown that Trabedersen is well tolerable in cancer patients and effective reagent to treat pancreatic cancer, melanoma, and glioblastoma. Proleukin is the only approved IL-2 reagent to treat Renal cell carcinoma and Melanoma.

Trabedersen and Proleukin activated human PBMC (Peripheral Blood Mononuclear Cell) are treated to several solid cancer cell lines, such as Breast cancer, Pancreatic cancer, Melanoma, Lung cancer, and Colon cancer to see the cytotoxicity effect of combination therapy of Trabedersen and Proleukin. NSG mouse (NOD Scid Gamma mouse, NOD.Cg-Prkdcscid Il2rgtm1Wjl/SzJ) which are humanized by human PBMC engraftment and the tumor growth of Melanoma and TNBC (Triple Negative Breast Cancer cell) cell line are monitored.

The combination treatment of Trabedersen and low dose Proleukin decreased cancer cell viability in vitro experiment in solid cancer cell lines. Melanoma and TNBC tumor growth was delayed in humanized NSG mouse model by Trabedersen and low dose IL-2 combination therapy and tumor growth delay was statistically significant to Trabedersen alone or IL-2 alone group. Tumor infiltrating lymphocyte population was increased in Trabedersen treated group and FoxP3+ regulatory T cell population in blood and tumor microenvironment was decreased by treatment of Trabedersen.

TGF-β inhibitor (Trabedersen) and low dose IL-2 (Proleukin) combination treatment is expected to be an effective regimen in solid cancer treatment than individual treatment by alteration of tumor environment. Modulation of the dose of Proleukin expects to help reduce the toxicity of IL-2 and increase the anti-cancer effect by combination with Trabedersen.

Oncotelic has previously announced the regulatory approval from the Ministry of Food and Drug Safety of Korea for the phase 1b clinical trial of a patented OT-101/IL-2 combination. This phase 1b clinical trial will confirm the safety and effectiveness of OT-101/IL-2 in solid cancer patients in cooperation with the UK global pharmaceutical company Clinigen Group. The study will be conducted together with Autotelic BIO- a partner of Mateon on OT-101/IL-2 combination.

OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 further demonstrate its utility as adjunct to other immunotherapies. Interleukin-2 (IL-2, Aldesleukin, PROLEUKIN) Immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma.