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]).

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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]).

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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.

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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]).

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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.

On September 29, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, SEP 29, 2021, View Source [SID1234590470]):

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Chardan’s 5th Annual Genetic Medicines Conference – October 4-5, 2021

October 4, 2021, 4:30 p.m. ET – Vince Anzalone, CFA, Arrowhead’s vice president of investor relations, will participate in a fireside chat presentation

H.C. Wainwright 5th Annual NASH Investor Conference – October 12, 2021

October 12, 2021 – James Hamilton, M.D., MBA, Arrowhead’s senior vice president of discovery and translational medicine will participate in a fireside chat presentation

A copy of the presentation materials and/or live webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.