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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

On September 29, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that members of the Company’s management team will be attending the upcoming virtual Sachs 21st Annual Biotech in Europe Forum (BEF) on October 7th and 8th 2021, and will be available for 1×1 meetings from Monday, October 4th through Friday, October 8th (Press release, OncoNano Medicine, SEP 29, 2021, View Source [SID1234590472]). Those registered for the event can request a meeting with Onconova through the Sachs Event’s portal.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On September 29, 2021 Kintara biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal year ended June 30, 2021 and provided a corporate update (Press release, Kintara Therapeutics, SEP 29, 2021, View Source [SID1234590471]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

Entered into securities purchase agreements with healthcare-focused institutional investors to raise approximately $15 million in gross proceeds (September). Funding from this registered direct offering, which was priced at a premium to market, was consummated on September 28, 2021, and provides cash for ongoing clinical studies and corporate working capital needs.
Bolstered patient enrollment opportunities in the U.S. by activating additional clinical trial sites for glioblastoma (GBM) patients for the VAL-083 arm of the GBM AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR).
Announced initiation of patient recruitment at first site (January)
Reported activation of 15 clinical sites for the GBM AGILE study (May)
Updated site activation to 26 clinical sites (August)
The GBM AGILE study is a revolutionary, patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. VAL-083 currently represents the only therapeutic agent being evaluated in all subgroups of GBM AGILE (newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent patients). The study will enroll up to 150 patients in the initial evaluation (labeled ‘stage 1’) for the VAL-083 arm of the study at over 40 sites in the U.S. and Canada, with potential to increase to 65 clinical trial centers worldwide. The Company is forecasting that the recent financing will provide sufficient funding through stage 1, which could result in graduation to the final confirmatory stage, the potentially NDA enabling portion of the GBM AGILE study.

Reported topline results from the Phase 2 study conducted at the MD Anderson Cancer Center that affirm the safety and efficacy of VAL-083 in two different GBM patient subtypes and support continued evaluation of VAL-083 in the GBM AGILE registrational study.
In September, topline Phase 2 clinical study results for VAL-083 as adjuvant therapy for newly-diagnosed GBM patients were reported demonstrating progression free survival (PFS) and overall survival (OS) of 10.0 months and 16.5 months, respectively, in efficacy evaluable patients
In July, topline Phase 2 clinical study results for VAL-083 for recurrent GBM were reported demonstrating median overall survival (mOS) for the 48 efficacy evaluable patients initially receiving the GBM AGILE treatment dose of 30 mg/m2/day of 8.0 months.
Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of our 15-patient lead-in CMBC study.
Joined the Russel Microcap Index effective June 28, 2021. Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s U.S. Indexes.
Enhanced leadership team by appointing Tamara A. Seymour to the Board of Directors (April). Ms. Seymour is a corporate finance veteran with three decades of experience in biotech and life sciences including roles as a Chief Financial Officer and Board member of publicly-listed companies.
"As we embark on a new fiscal year with a strengthened cash position from our recent financing, I’m extremely pleased with where the Company is positioned on the clinical and corporate development fronts," commented Saiid Zarrabian, Kintara’s President and Chief Executive Officer. "Moving forward, our diversified, late-stage pipeline has multiple, significant near-term milestones, highlighted by the GCAR GBM AGILE study. We believe this registration study represents an extraordinary opportunity for the Company as it provides an optimal clinical path given its highly accelerated program as evidenced by the initiation of patient enrollment at 26 sites in less than eight months, and from a cost savings standpoint through an FDA approved registrational trial which provides Kintara the unique opportunity to enroll three separate GBM patient subtypes. We are entering a pivotal juncture in the Company’s development, and I wish to extend gratitude to our longstanding shareholders for their continued support."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED JUNE 30, 2021

At June 30, 2021, the Company had cash and cash equivalents of approximately $10.5 million. For the year ended June 30, 2021, the Company reported a net loss of approximately $38.3 million, or $1.60 per share, compared to a net loss of approximately $9.1 million, or $0.87 per share, for the year ended June 30, 2020. The increase in loss for the year ended June 30, 2021 compared to the year ended June 30, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the acquisition of Adgero Biopharmaceuticals Holdings, Inc. and an expanded rate of expenditures with the initiation of the GCAR study and REM-001 development.