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Immunis.AI Achieves Development Milestones and Additional Financing

On September 29, 2021 Immunis.AI, Inc., an immunogenomics platform company developing noninvasive blood-based tests to optimize patient care, reported the close of additional financing that brings its total raised to $40 million to date for the ongoing development of its proprietary Intelligentia immunogenomic platform (Press release, ImmunisAI, SEP 29, 2021, View Source [SID1234590483]). The additional funding comes on the heels of successful completion of key development milestones, including three pivotal studies of the Intelligentia platform. Funding will support further validation and commercialization of the company’s first molecular test in prostate cancer and will also be used to expand development of new tests in breast, colon, lung cancer and other cancers.

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The Intelligentia liquid biopsy platform enables a highly sensitive method for the detection and grading of early-stage cancer and other diseases using a single blood sample. The platform is used to identify and interrogate novel disease-specific biomarkers as well as biomarkers indicative of the immune response to the disease.

"Immunis has developed a platform that harnesses the power of the immune system, achieving potent signal enrichment using proprietary methods and advanced machine learning," said Harry Stylli, Ph.D., Executive Chairperson of the Board at Immunis.AI. "With the recently achieved major milestones, the company is poised to deliver on its core mission to improve early detection and patient outcomes."

"We are grateful for the continuing support of our investors, who share our excitement about the potential of our proprietary immunogenomic platform to transform patient care paradigms," said Christopher Thibodeau, President & CEO of Immunis.AI. "We look forward to reporting results from our pivotal studies in prostate cancer and to delivering tests to better aid in the diagnosis and treatment of patients early, when there is the greatest opportunity for cure."

The successful completion of milestones triggered the final tranche of new capital received over the last several months and positions the company to capitalize on the strong performance of the Intelligentia platform, to develop new pan cancer and disease surveillance tests, and to further advance commercial readiness of its lead test for the active surveillance of prostate cancer. The financing was led by Savitr Capital, LLC with participation from existing investors and management.

Syros Announces First Patient in Dose Confirmation Study of SY-2101, a Novel Oral Form of Arsenic Trioxide, in Acute Promyelocytic Leukemia

On September 29, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that the first patient has been dosed in the dose confirmation study of SY-2101, a novel oral form of arsenic trioxide (ATO) (Press release, Syros Pharmaceuticals, SEP 29, 2021, View Source [SID1234590480]). The trial will evaluate the pharmacokinetics (PK), safety, and tolerability of SY-2101 to confirm the optimal dose to advance into a planned Phase 3 clinical trial in newly diagnosed acute promyelocytic leukemia (APL) patients.

"The current standard of care cures most patients but is tremendously burdensome, requiring regular and lengthy infusions of an IV formulation of ATO over nearly a yearlong course of treatment," said Farhad Ravandi, M.D., Professor of Medicine, Chief of Section of Acute Myeloid Leukemia, Department of Leukemia at The University of Texas – MD Anderson Cancer Center. "An oral form of ATO that offers similar efficacy while dramatically reducing the treatment burden would represent a major advance for APL patients. The preliminary Phase 1 data for SY-2101 are very promising, and I look forward to its continued advancement in the current and future studies."

APL is a well-defined subtype of acute myeloid leukemia (AML), which accounts for about 10% of AML cases, with approximately 2,000 APL patients diagnosed annually in the United States and Europe. An intravenously administered formulation of ATO is approved for use in combination with All-Trans-Retinoic-Acid (ATRA) in newly diagnosed APL and, while curative in more than 80% of patients, its administration requires up to 140 infusions over the typical 10-month course of induction and consolidation treatment. In an earlier Phase 1 clinical trial, SY-2101, which is dosed once daily, demonstrated oral bioavailability, PK exposures similar to IV ATO, and a generally well-tolerated safety profile.

"We are thrilled to now be dosing patients in our dose confirmation study of SY-2101," said David A. Roth, M.D., Chief Medical Officer at Syros. "This milestone represents an important step toward delivering a new option for people with APL and a meaningful advance in our efforts to build a leading portfolio of targeted hematology therapies. We believe SY-2101 could quickly become the new standard of care for APL by offering patients similar efficacy with a substantially more accessible and convenient therapy. We plan to move swiftly from our dose confirmation study into a Phase 3 trial next year, with the goal of filing a New Drug Application (NDA) in 2024."

The dose confirmation study is expected to enroll up to 24 patients with newly diagnosed APL and will evaluate safety, tolerability, and PK as well as the effect of food on the absorption of SY-2101. Patients will be enrolled during the consolidation phase of their APL treatment and will receive single doses of SY-2101 in a fasted state, SY-2101 in a fed state, and IV ATO. Patients will then have the option to roll over into a multiple-dose cohort to receive either SY-2101 or IV ATO, which will provide additional data on the steady state PK and safety of SY-2101 in comparison to IV ATO. Syros expects to report data from this study in the first half of 2022.

Based on the results of the dose confirmation study, Syros expects to initiate a Phase 3 clinical trial in newly diagnosed APL patients. Based on input from the FDA, Syros believes molecular complete response rate and event-free survival in comparison to historical control data with IV ATO may support accelerated and full approval, respectively.

Overland ADCT BioPharma Announces First Patient Dosed in China with ZYNLONTA® in Pivotal Phase 2 Clinical Trial for Diffuse Large B-cell Lymphoma

On September 29, 2021 Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics SA (NYSE: ADCT), reported the first patient has been dosed with ZYNLONTA in a pivotal Phase 2 clinical trial in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in China (Press release, Overland ADCT BioPharma, SEP 29, 2021, View Source [SID1234590478]). In April 2021, ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) as the first and only CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with r/r DLBCL after two or more lines of systemic therapy. This local pivotal study mirrors ADC Therapeutics’ ongoing global pivotal Phase 2 clinical trial of ZYNLONTA and its results are intended to support the potential registration of ZYNLONTA in China.

"After receiving early FDA approval of ZYNLONTA in April, we are pleased that our colleagues at Overland ADCT BioPharma have rapidly initiated a pivotal study to potentially benefit patients in China," said Chris Martin, PhD, Chief Executive Officer of ADC Therapeutics. "We are eager for this bridging study to be completed, and we hope that ZYNLONTA will ultimately be available to all patients who can benefit from it globally."

"Dosing the first patient in this pivotal trial is a key milestone for Overland ADCT BioPharma as we collaborate to expand the clinical reach of ZYNLONTA in greater China and Singapore," said Eric Koo, Chief Executive Officer of Overland ADCT BioPharma. "With many patients in China affected by r/r DLBCL, we remain committed to addressing this unmet medical need and delivering promising antibody drug conjugates for underserved patients around the world. Together with ADC Therapeutics, we look forward to the continued development and commercialization of ZYNLONTA in Asia."

ZYNLONTA, Overland ADCT BioPharma’s lead product candidate, is an ADC composed of a humanized monoclonal antibody directed against human CD19 and conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. In clinical trials, ZYNLONTA has demonstrated significant single-agent clinical activity across a broad population of patients with r/r DLBCL, mantle cell, and follicular lymphomas.

The China Phase 2, multi-center, open-label, single-arm study will evaluate the efficacy and safety of ZYNLONTA used as monotherapy in patients with r/r DLBCL.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

Avacta Group plc: Achievement of Pre-clinical Development Milestone in LG Chem Life Sciences Partnership

On September 29, 2021 Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that a pre-clinical development milestone has been achieved in the multi-target therapeutics development partnership with LG Chem Life Sciences ("LG Chem"), the life sciences division of the South Korean LG Group, triggering an undisclosed milestone payment (Press release, Avacta, SEP 29, 2021, View Source [SID1234590477]).

Avacta and LG Chem have a multi-target therapeutics development agreement to develop Affimer therapeutics in several disease areas. As part of the agreement, LG Chem has the exclusive rights to develop and commercialise, on a world-wide basis, Avacta’s Affimer PD-L1 inhibitor with Affimer XT serum half-life extension.

LG Chem has successfully completed certain pre-clinical in-vivo models in the PD-L1/XT programme leading to the selection of a pre-clinical candidate for further development towards the clinic and triggering an undisclosed milestone payment.

The partnership also provides LG Chem with rights to develop and commercialise other Affimer and non-Affimer biotherapeutics combined with Affimer XT half-life extension for a range of indications and Avacta could earn up to $55m in milestone payments for each of these new products. In addition, under the agreement Avacta will earn royalties on all future Affimer XT product sales by LG Chem.

Dr. Alastair Smith, Chief Executive of Avacta Group, commented: "I am delighted with the progress in our important strategic partnership with LG Chem. LG Chem is a world-class drug development partner with excellent biologics manufacturing and clinical development capabilities and a pioneering vision to develop innovative drugs.

"I am particularly pleased that we have achieved this significant milestone with a novel Affimer bispecific product, which highlights the tremendous promise of the Affimer platform."

About Affimer XT

Affimer XT is a system for extending the time a drug spends in the circulation ("serum half-life extension"). Affimer XT comprises an Affimer that binds to a large blood protein called Serum Albumin that is too large to be cleared rapidly from the circulation. Half-life extension can be achieved by linking Affimer XT to a small drug such as an Affimer PD-L1 inhibitor to make a bispecific drug molecule. A small drug that might otherwise be cleared through the kidneys in a matter of hours, will remain in the circulation for many days if attached to Serum Albumin via Affimer XT. A long serum half-life increases the exposure of a tumour to the drug and potentially therefore improves the therapeutic effect.

NOXXON to Participate in Biotech and Health-Tech Conferences in October 2021

On September 29, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that Aram Mangasarian, CEO of NOXXON, will participate in HealthTech Innovation Days and the Biotech in Europe Forum in early October (Press release, NOXXON, SEP 29, 2021, View Source [SID1234590475]).

HealthTech Innovation Days, October 4-5, Paris
HealthTech Innovation Days, organized by France Biotech, aims to bring together European healthcare stakeholders and promote the transformation of an integrated ecosystem. Mr. Mangasarian will be available for in-person investor meetings at the conference. More information about the event can be found here.

Annual Biotech in Europe Forum, October 7-8, digital conference
Mr. Mangasarian will participate in a panel discussion at the event organized by the Sachs Associates. The session entitled "Immuno-Oncology BD&L Panel" is scheduled on Friday, October 8, 2021 at 11:20 a.m. CEST and will be chaired by speakers from Locust Walk and Merck. Aram Mangasarian will share the floor with Corinne Venot from BeiGene, Khatereh Ahmadi from MSD and Phil L’Huillier from CatalYm. To request a one-on-one meeting with NOXXON please contact us via the conference platform or at [email protected]. More information about the event can be found here.