On December 2, 2021 Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care, reported the closing of a $109 million Series C financing round led by Digital Mobile Venture and other new and existing investors (Press release, Acepodia, DEC 2, 2021, View Source [SID1234596391]). The funds will be used to further validate the company’s ACC technology and advance its pipeline of antibody cell effector (ACE) therapies for patients with cancer with limited treatment options. Concurrent with the financing, Samuel Chen, Director at Digital Mobile Venture, will join the Acepodia Board of Directors. Mr. Chen is also the largest shareholder of Polaris Pharmaceuticals.

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"This significant capital raise paves the way for us to deliver on our mission of bringing innovative, effective and affordable cell therapies to the broadest possible population of cancer patients," said Patrick Y. Yang, Ph.D., chairman and co-founder of Acepodia.

Acepodia has raised $166 million to date in venture capital financing, including a $47 million Series B round completed in March 2021. Investors have included Ridgeback Capital Investments, 8VC, DEFTA Partners, CDIB Capital Healthcare, Maxpro, E-Sun Venture, BioEngine Venture, Samuel Chen, Yahoo founder Jerry Yang, and Foxconn founder Terry Gou.

"We are pleased by the strong support and confidence of our investors as we initiate additional research and development programs and continue our clinical trial expansion in the U.S. in the coming years," said Sonny Hsiao, Ph.D., chief executive officer, president and co-founder of Acepodia. "We are also honored to welcome visionary technology investor Samuel Chen to our board of directors, who shares our mission of building a next-generation platform of cell therapies for cancers with high unmet needs."

Acepodia is developing a first-in-class pipeline of ACE therapies that use its ACC technology to link tumor-targeting antibodies to immune cells, such as natural killer (NK) cells or gamma delta T cells. Unlike CAR-based cell therapies that require viral vector-delivered gene transductions or genetic engineering, this technology combines the precision of targeted monoclonal antibodies and cancer-killing immune cells into a potent cell therapy.

On December 2, 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 hosted a Key Opinion Leader (KOL) event with Frank A. Giordano, M.D. on November 23, 2021, to discuss the combination of NOX-A12 and radiotherapy in brain cancer (glioblastoma, GBM) (Press release, NOXXON, DEC 2, 2021, View Source [SID1234596409]). Dr. Giordano is Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany, and lead investigator of the ongoing NOX-A12 Phase 1/2 study GLORIA in glioblastoma.

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"I have been involved in research and treatment of glioblastoma for many years, and we’ve not seen major changes in the management of this terrible disease for almost two decades. Although the development of an effective treatment for glioblastoma has proved extremely challenging, the data from the GLORIA study are very promising and, if confirmed in a pivotal clinical study, could be transformational for patients affected by this devastating disease," commented Dr. Frank Giordano.

"Dr. Giordano is a research pioneer and expert in precision radiation therapy and intraoperative irradiation of malignant tumors. He has brought together an exceptional team around the GLORIA study which was evident from the data presentation at SNO. His leadership of the trial will ensure that all the insights we can derive will be put to use in future trials of NOX-A12," commented Aram Mangasarian, CEO of NOXXON.

Glioblastoma is a devastating disease affecting 23,000 new patient each year in the US and Europe. The median overall survival for this patient population is only 14 months, and even lower in the MGMT unmethylated (chemotherapy refractory) patient subpopulation. The KOL webinar highlighted data from the Phase 1/2 GLORIA study presented at the Society for Neuro-Oncology (SNO) Annual Meeting, where tumor shrinkage for patients in the study was significantly stronger compared to those of a historic matched cohort that received standard of care. Eight of 9 MGMT unmethylated glioblastoma patients (89%) receiving NOX-A12 demonstrated tumor size reductions, while only 1 of 13 patients from a matched cohort (8%) showed any tumor shrinkage.

During the KOL event, Dr. Giordano emphasized several other important points, summarized in the Annex to this press release.

On 2 December 2021 Oncology One Pty Ltd, reported a partnership with WEHI (Walter and Eliza Hall Institute of Medical Research) to develop new drugs for the treatment of cancer, in collaboration with Curtin University (Press release, Oncology One, DEC 2, 2021, View Source [SID1234629324]).

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The collaboration centres on the development of novel small molecule drugs to treat solid tumours, initially focusing on breast cancer.

The project will seek to identify small molecule compounds that specifically inhibit a novel target in breast cancer that drives tumour growth. If successful, further work will need to be undertaken to refine these compounds towards candidate therapies, which could enter clinical trials in due course.

Chair of Oncology One’s Scientific Advisory Board, Dr Ian Street, said: "This project represents an important next step for Oncology One in building a pipeline of drug discovery programs that are highly differentiated and address unmet clinical needs. We have made great progress in early breast cancer detection, and this has had a dramatic effect on reducing mortality. However, if early disease is missed and the cancer metastasises, then unfortunately prognosis is poor. We are very much looking forward to a productive collaboration with David and Pieter, and the drug discovery and research teams at WEHI and Curtin".

This transcontinental project originated in the research labs of Professor David Komander at WEHI and Associate Professor Pieter Eichhorn at Curtin University. The objective is to develop a new therapeutic for treating metastatic ER+ breast cancers that have escaped current treatments. The new therapeutic also has the potential to address unmet clinical needs in other cancers such as colorectal and brain.

WEHI Ubiquitin Signalling Division Head, Professor David Komander, said: "The ubiquitin system offers many opportunities for innovative cancer treatments. We are delighted to work with Oncology One on this exciting project and to translate our research to benefit cancer patients. The project was initially born in a collaboration with Curtin University, and we are excited to draw upon our strengths and to work with industry to improve treatments for a disease that continues to impact so many lives."

Breast cancer is the most prevalent form of cancer in women and accounts for over 2 million cases and over 600,000 deaths per year worldwide according to the World Health Organisation (WHO). The emergence of resistance to existing therapies is a major challenge in the treatment of many people with breast cancer, and new treatment modalities are urgently required to improve patient outcomes.

Curtin University Associate, Professor Pieter Eichorn, said: "While breast cancer survival rates have improved, there are millions of patients who don’t respond to current treatments. Through this collaboration drawing on the expertise of WEHI in drug discovery and Oncology One in drug development, we can find the best way to bring our cancer treatment discoveries to patients, and make a real difference to them and to their loved ones and families."

On December 2, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported the first five patients have been treated in the INSIGHT-003 study (Press release, Immutep, DEC 2, 2021, View Source [SID1234596428]).

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No additional safety signals have been observed in the study which is the first time a triple combination therapy consisting of eftilagimod alpha ("efti") and an existing approved standard of care combination of chemotherapy (carboplatin) and an anti-PD-1 therapy has been administered.

Lead investigator, Prof. Dr. Salah-Eddin Al-Batran of the Institute of Clinical Cancer Research IKF said: "The INSIGHT-003 study has commenced well. We are very pleased with the safety of the triple combination so far and all patients are still participating in the study. This is important as it is the first time patients have received a triple combination therapy with efti. Patient recruitment is advancing in line with our projections."

INSIGHT-003 is evaluating a triple combination therapy consisting of efti in conjunction with an existing approved standard of care combination of chemotherapy and anti-PD-1 therapy. The study will continue to recruit up to 20 patients with various solid tumours and additional results are expected in calendar year 2022.

About INSIGHT-003

INSIGHT-003 is an investigator-initiated study conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy consisting of efti in conjunction with an existing approved standard of care combination of chemotherapy (carboplatin) and anti-PD-1 therapy.

Up to 20 patients with solid tumours will be recruited to participate in the trial. Patients will receive 30 mg subcutaneous doses of efti every two weeks in conjunction with standard of care chemotherapy plus anti-PD-1 therapy. The trial will assess the safety, tolerability and initial efficacy of the combination.

On December 2, 2021 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported positive results from the phase 3 FOCUS study (Press release, Delcath Systems, DEC 2, 2021, View Source [SID1234596392]). The FOCUS study’s intent-to-treat (ITT) population was comprised of a total of 102 subjects, across various lines of therapy. Of the ITT group, 91 evaluable patients were administered at least one study treatment.

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Treatment with HEPZATO in the ITT analysis resulted in an objective-response-rate (ORR) of 31.4% [95% CI: 22.55-41.31], including 6.9% of patients with a complete response (CR). Median duration of response was 14 months [95% CI: 8.54, NC], with over half of responders continuing to be monitored for progression events. Disease control rate (DCR) was 65.7% [95% CI, 55.63, 74.81].

On the primary ORR endpoint, the lower bound 95% Confidence Interval (CI) of 22.55% exceeded the FOCUS trial’s prespecified 8.3% upper bound 95% CI threshold for success. This threshold was derived from a meta-analysis of sixteen checkpoint inhibitor publications documenting the treatment of 476 metastatic ocular melanoma patients.

Supportive, predefined, exploratory analyses were conducted comparing patients in the HEPZATO arm versus a BAC group. The BAC arm was comprised of a total of 42 patients, originally randomized in the FOCUS trial prior to its amendment, in consultation with FDA, to a single-arm pivotal study in 2018. The evaluable BAC subjects were treated predominantly with liver-targeted Transarterial Chemoembolization (TACE).

Among patients who received at least one study treatment, patients in the HEPZATO arm had statistically significant improvements over BAC in the following prespecified endpoints:

ORR of 35.2% versus 12.5% for the BAC arm (p=0.0154).
Disease Control Rate of 73.6% versus 37.5% for patients in the BAC arm (p=0.0002).
Median Progression Free Survival of 9.03 months versus 3.12 months for the BAC arm (HR=0.39; p=0.0002).
Enrollment in the FOCUS trial HEPZATO arm ended in late 2020 with overall survival data continuing to mature. Per the statistical plan, a final predefined exploratory survival analysis, versus BAC, will be conducted at 24-months after last patient last treatment.

As of this analysis, survival at 12-months in the evaluable patients was 75% in the HEPZATO arm versus 47% for BAC [HR=0.37, p=0.01]. Delcath will provide future overall survival analysis updates, as patient follow-up continues, and the Kaplan-Meier analysis matures.

In the HEPZATO safety population, the most commonly reported treatment-emergent serious adverse events were anemia (29.7% of patients), thrombocytopenia (26.4% of patients) and neutropenia (19.8% of patients), which were well-manageable. 5.3% of patients experienced treatment-emergent serious cardiac adverse events. In all cases the events resolved with no ongoing complications. There were no treatment-related deaths in the trial.

"Metastatic ocular melanoma is a disease with a dismal prognosis and new therapies are urgently needed. The FOCUS study results, along with the predefined analyses versus a relevant BAC group, clarify HEPZATO overall clinical benefit in this difficult-to-treat patient population," noted Dr. Jonathan Zager MD FACS, global lead investigator of the FOCUS study, senior member and Director of Regional Therapies at Moffitt Cancer Center. "The overall efficacy, coupled with an improved safety profile versus the first-generation product, suggests that HEPZATO would offer a compelling clinical benefit were it approved by FDA."

"We are thrilled by the HEPZATO response rates and duration of response which far exceed that which has been seen with other agents in this difficult-to-treat patient population. Our data further highlights HEPZATO’s potential superiority to other available liver-targeted therapies, which suggests a broader utility for our platform across multiple liver-metastatic tumor types. In addition to re-filing our NDA by mid-2022, Delcath, along with key opinion leaders, intend to study HEPZATO in additional indications in the near future."

The FOCUS trial results will be presented at a comprehensive Investor Update Meeting taking place today from 10:00am EST – 1:30pm EST. In addition to the FOCUS trial, a distinguished panel of physicians will discuss their personal clinical experience with HEPZATO in both the clinical trial setting and the commercial setting in Europe, as well as the potential for HEPZATO to treat liver metastatic tumor types beyond metastatic ocular melanoma.

Event Details:

Event: Delcath Systems Virtual Investor Update Meeting
Date: Thursday, December 2, 2021
Time: 10:00am – 1:30 p.m. EST

To register for this event, please click here.

The live webcast of the event may be accessed through the Events and Presentation page of Delcath’s website, under the Investors section. The archived webcast and presentation will be available on the Company’s website after the event.