On August 11, 2021 Immunetune, a preclinical-stage biotech developing next-generation DNA vaccines against cancer and infectious diseases, reported the appointment of Sijme Zeilemaker as Chief Executive Officer (Press release, ImmuneTune, AUG 11, 2021, View Source [SID1234586349]). With his experience in several oncology biotech companies ranging from preclinical to Phase II clinical development and skillset in business development and investor relations, he will be responsible for bringing Immunetune into the next phase of the company.

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"It is great to be joining a biotech working on truly differentiated technologies to bring a potentially best-in-class program into the clinic. Having seen the forefront of innovation in immuno-oncology the last few years, Immunetune has the right approach and results to make a difference. Gerben and his team have done an impressive amount of work and it is such an exciting phase to be joining them," stated Sijme Zeilemaker.

"We are thrilled bringing Sijme on board to strengthen our team at this pivotal point in time. With his experience with both big pharma partners and international life science investors, he knows exactly what data and technologies they will be looking for," says Gerben Zondag, founder of Immunetune, who will take on the role of Chief Operating Officer. "With the rest of the management team in place, we are confident to move our company and programs forward into the clinic."

Sijme Zeilemaker is joining Immunetune having previously acted as Chief Operating Officer, Director Business Development and Head of Investor Relations at Immunicum AB, a clinical-stage biotech developing cell therapies against cancer, publicly listed at the Nasdaq Stockholm. He joined Immunicum in 2017 as part of a small team and supported the growth of the company through a collaboration with Pfizer and Merck KGaA, three financing rounds, and the merger with DCprime. Before Immunicum, Sijme was Director Business Development at InteRNA Technologies, and held business development roles at to-BBB technologies and 2-BBB Medicines, transitioning these companies from preclinical to clinical-stage.

On August 11, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for the second quarter of 2021 and provided a business update (Press release, Diffusion Pharmaceuticals, AUG 11, 2021, View Source [SID1234587026]).

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"We met our key milestones for the first half of 2021, completing and announcing topline results from our COVID-19 Trial and the first of our Oxygenation Trials. Our development plan remains on track. With the positive outcomes of the COVID-19 and TCOM studies, as well as our significant capital raise in the first quarter, we believe we have the data and the financial capacity to execute our clinical development strategy for TSC through Phase 2b. For the remainder of 2021, we are focused on the design and execution of the remaining two Oxygenation Trials to further our understanding of TSC’s mechanism of action and potential, as well as the further development of our regulatory and commercial strategy for TSC," said Robert Cobuzzi, Jr. Ph.D., President and CEO of Diffusion.

TSC Q2 Development Update

In May 2021, Diffusion reported final results from its Phase 1b trial (the "COVID-19 Trial") of trans sodium crocetinate ("TSC") in hospitalized COVID-19 patients. Although the study was not designed or powered to evaluate efficacy, the study’s external safety monitoring committee observed that patients receiving the 1.5 mg/kg dose of TSC had improved outcomes in secondary and exploratory endpoints compared to those receiving lower doses. The final results were consistent with topline results previously announced in February 2021, indicating that TSC was safe and well-tolerated when administered on a more frequent dosing regimen than previously tested in a clinical trial setting.

In June 2021, the Company reported a positive trend in oxygenation from its Phase 1b trial (the "TCOM Trial") evaluating TSC using transcutaneous oxygen monitoring ("TCOM"). The TCOM Trial was designed to evaluate the effect of TSC versus placebo on peripheral tissue oxygenation in healthy normal volunteers. Topline results based upon analyses of primary endpoint data indicated, as compared to placebo, a positive dose-response trend in TCOM readings after TSC administration that persisted through the measurement period with no evidence of hyperoxygenation. TSC was also safe and well-tolerated at all doses tested.

TSC Development Plans for 2021 and 2022

The positive trend observed in the TCOM Trial is being used to guide dose selection in the additional Oxygenation Trials planned for the latter part of 2021 – the Altitude Trial, followed by the ILD-DLCO Trial.

Altitude Trial (formerly known as the Induced Hypoxia Trial): This trial will be a double-blind, randomized, placebo-controlled study which will evaluate the effects of TSC on maximal oxygen consumption, or VO2, and partial pressure of blood oxygen, or PaO2, in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions (i.e., simulated altitude). The study is designed to evaluate the effect of TSC versus placebo on maximal oxygen consumption and partial pressure of blood oxygen. Diffusion anticipates initiating and completing the Altitude Trial in the fourth quarter of 2021, with topline results available within one to two months of study completion.

ILD – DLCO Trial: This trial will be a double-blind, randomized, placebo-controlled study which will evaluate the effects of TSC on the diffusion of carbon monoxide through the lungs ("DLCO") in patients with previously diagnosed interstitial lung disease ("ILD") who have a baseline DLCO test result that is abnormal. DLCO will act as a surrogate measure of oxygen transfer efficiency, or uptake, from the alveoli of the lungs, through the plasma, and onto hemoglobin within red blood cells. The study will be statistically powered to evaluate the difference in effect of TSC versus placebo on improvement in DLCO as well as in a standard six-minute walk test. Diffusion now anticipates initiating the ILD-DLCO Trial in the late fourth quarter of 2021 and completing the trial in the first quarter of 2022, with topline results available within one to two months of study completion.

Diffusion expects to announce in the fourth quarter of 2021 the initial indication in which TSC will be studied to support the planned pathway for regulatory approval and to initiate a controlled, clinical outcome study evaluating TSC in the chosen indication during the first half of 2022, funded with cash-on-hand.

Operating and Leadership Team Developments

During the second quarter, Diffusion enhanced its operating team with the addition of new employees in the areas of administration, quality assurance, clinical operations, and finance. In addition, in connection with the Diffusion’s annual meeting of stockholders in June 2021, Jane H. Hollingsworth was elected as the new chair of the Company’s board of directors and Diana Lanchoney, M.D. and Eric Francois were newly elected to the board of directors. The Company believes these organizational additions have already had a significant, positive impact on its ability to develop, implement and execute on its corporate strategy and development plans, and position the Company well to build shareholder value through its next stage of growth.

2Q21 Financial Results

Research and development expenses in the second quarter were $2.0 million compared to expenses of $2.2 million in the prior year period. The decrease was attributable to the wind-down of the Company’s clinical trial evaluating TSC in glioblastoma multiforme brain cancer and its COVID-19 Trial completed in February 2021. These decreases were offset by increased headcount and costs related to the TCOM Trial.

General and administrative expenses were $1.8 million during the second quarter of 2021 versus $1.5 million in the comparable quarter last year. The increase compared to the prior year period was primarily attributable to increased salaries, wages, stock-based compensation, and professional fees related to increased headcount and costs associated with the separation of former employees that will not recur in future years.

As of June 30, 2021, Diffusion had cash and cash equivalents of approximately $43.3 million as compared to $18.5 million as of December 31, 2020.

On August 11, 2021 Cytocom, Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported that the company will participate at the Empowering the Kingdom through Business Conference hosted by the Liberty University School of Business on August 10-12, 2021 (Press release, Cytocom, AUG 11, 2021, https://www.cytocom.com/2021/08/11/cytocom-inc-announces-participation-at-liberty-universitys-empowering-the-kingdom-through-business-conference/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-inc-announces-participation-at-liberty-universitys-empowering-the-kingdom-through-business-conference [SID1234586287]). Cytocom President and CEO, Mike K. Handley, will participate live as a featured panelist in the Healthcare Breakout session moderated by Dean Joseph Johnson on August 11, 2021.

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On August 11, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the second quarter 2021 (Press release, Cyclacel, AUG 11, 2021, View Source [SID1234586333]). The quarter’s business highlights included an update on the Company’s progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively.

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"After announcing In July that the first patient had been dosed with oral fadraciclib, two additional patients with advanced solid tumors have been treated, completing enrolment of the first dose level," said Spiro Rombotis, President and Chief Executive Officer. "We are encouraged by investigator interest in our fadraciclib 065-101 solid tumor study. In earlier clinical studies fadraciclib has demonstrated single-agent activity, including durable PR. We believe that fadraciclib is a leading, transcriptionally-active CDK inhibitor with a differentiated product profile. Pipeline momentum will continue to build with the planned opening of protocol 065-102, an oral fadraciclib study in patients with hematological malignancies, and later with the initiation of two similar protocols in solid tumors and hematological malignancies for our novel PLK1 inhibitor, CYC140. The second half of 2021 is an exciting period for Cyclacel, as we expand our clinical programs and increase our visibility as an oncology leader focused on cell cycle inhibition for the treatment of cancer. We look forward to reporting further updates as data from these studies become available."

Key Corporate Highlights

Oral fadraciclib – First three patients with advanced solid tumors dosed in the 065-101 Phase 1/2, registration-directed trial. The study includes multiple cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in MCL1, MYC and/or cyclin E amplified cancers. The cohorts include breast (metastatic, hormone receptor positive, post-CDK4/6 inhibitor; HER-2 refractory; or triple negative), cholangiocarcinoma, colorectal (including KRAS mutant), endometrial, hepatocellular, ovarian cancers and certain lymphomas. The study design also includes a basket cohort which will enroll patients with relevant biomarkers to the drug’s mechanism regardless of histology. Previously single agent, intravenous fadraciclib has demonstrated durable suppression of MCL1 and other mechanistically-related proteins, including cyclin E and MYC, at tolerated doses.

Oral CYC140 – continued progress with IND-directed activities and manufacturing of clinical trial supplies. Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition. The Company expects to begin a study in patients with solid tumors in the second half of 2021. Similar to the fadraciclib clinical program, the CYC140 Phase 1/2 study will be a registration-directed trial using a streamlined design that will first determine the recommended Phase 2 dose (RP2D) for single-agent CYC140. Once the RP2D has been established, the trial will immediately enter into a proof-of-concept, cohort stage, using a Simon 2-stage design, where single agent CYC140 will be administered to patients across multiple cohorts based upon those histologies thought to be sensitive to the drug’s mechanism of action.
Key Near-Term Business Objectives and Expected Timeline

2H 2021

First patient to be dosed with oral fadraciclib in 065-102 Phase 1/2 leukemia study
FDA clearance of IND filing; begin oral CYC140 Phase 1/2 advanced solid tumor study
1H 2022

First patient to be dosed with oral CYC140 in Phase 1/2 leukemia study
Phase 1 data with oral fadraciclib in advanced solid tumor 065-101 study
Financial Highlights

As of June 30, 2021, cash and cash equivalents totaled $43.6 million, compared to $47.8 million as of March 31, 2021. The decrease of $4.2 million was primarily due to net cash used in operating activities. The Company estimates that the cash resources will fund currently planned programs through early 2023.

Research and development expenses were $4.1 million for the three months ended June 30, 2021 as compared to $1.2 million for the same period in 2020. Research and development (R&D) expenses relating to fadraciclib increased by approximately $1.9 million for the three months ended June 30, 2021 with the start of the CYC065-101 study of fadraciclib in solid tumors and preparations for opening the 065-102 study of fadraciclib in leukemias. Additionally, R&D expenses related to CYC140 increased $1.0 million for the quarter as IND-directed activities are approaching completion and clinical trial supplies are being manufactured.

General and administrative expenses for the three months ended June 30, 2021 were $2.0 million, compared to $1.3 million for the same period of the previous year due to costs of approximately $0.4 million related to exiting a long-term facility lease, increased legal and professional expenses and recruitment costs.

United Kingdom research & development tax credits were $1.0 million for the three months ended June 30, 2021, as compared to $0.3 million for the same period in 2020 due to the increase in R&D expenditure.

Net loss for the three months ended June 30, 2021 was $5.1 million, compared to $2.2 million for the same period in 2020.

On August 11, 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 the first patient has been dosed in its Phase I multicentre trial evaluating AVA6000, a novel pro-drug of Doxorubicin (Press release, Avacta, AUG 11, 2021, View Source [SID1234586350]).

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AVA6000 is Avacta’s first therapeutic based on its proprietary pre|CISION technology. The platform incorporates a substrate that is specifically cleaved by the protease fibroblast activation protein alpha (FAPα), which is upregulated in most solid tumours and at low background levels in healthy tissue, providing an activation mechanism to ensure localised release of chemotherapeutic agents from their pro-drug form. By activating chemotoxins only within the tumour microenvironment, systemic exposure to healthy tissues is limited, improving the safety and therapeutic potential of these cancer therapies.

Incorporating the pre|CISION platform, AVA6000 is a tumour-activated form of Doxorubicin. Anthracyclines such as Doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 2024, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity, particularly cardiotoxicity. Avacta’s pre|CISION pro-drug approach is designed to reduce the systemic exposure of healthy tissues to the active chemotherapy, leading to improved safety and therapeutic index, potentially resulting in improved dosing regimens, better efficacy and better outcomes for patients.

The AVA6000 study is a dose-escalation Phase I study in patients with locally advanced or metastatic selected solid tumours, known to be FAP-positive. These cohorts will receive ascending doses of AVA6000 to determine the maximum tolerated dose and establish a recommended Phase II dose. The second part of the study is an expansion phase where patients receive AVA6000 to further evaluate the safety, tolerability and clinical activity at this recommended Phase II dose across selected tumour types. For more information visit www.clinicaltrials.com (NCT04969835)

The first patient has received their first dose of AVA6000 at The Royal Marsden NHS Foundation Trust, London. The Phase I study is being initiated across a small group of leading UK oncology centres with an established reputation for early clinical research in cancer. The dose escalation phase is anticipated to complete by Q2 2022 followed by completion of the dose expansion phase by Q2 2023.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:

"The initiation of the first in human Phase I clinical study for AVA6000 marks the transformation of Avacta Life Sciences into a clinical stage biopharmaceutical company. It is an outstanding achievement by the team and we are extremely proud of what has been achieved since we established the collaboration with Professor William Bachovchin at Tufts University Medical School to develop the pre|CISION technology for tumour targeting.

"We are delighted to be working on the AVA6000 study with global key opinion leaders in oncology drug development at world-class oncology clinical trial sites in UK on this important pro-drug approach to improving the safety and efficacy of chemotherapies.

"If the study shows that the pre|CISION technology is effective in reducing systemic toxicity of Doxorubicin in humans, then that will open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION pro-drug chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 2027.

I look forward to further updating the market when key clinical development milestones are achieved."

Neil Bell, Chief Development Officer, Avacta Life Sciences commented:

"The initiation of this AVA6000 Phase I trial is a significant and transformational milestone for Avacta . AVA6000 offers an opportunity to improve upon the current doxorubicin treatment paradigm for patients, either as a monotherapy or in combination. We look forward to the results from our AVA6000 first-in-human clinical trial as we strive to improve therapeutic index of doxorubicin for patients."

AVA6000 Principal Investigator Professor Udai Banerji, Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust commented:

"I am delighted that the first patient has now received AVA6000 in the first-in-human study. This drug harnesses our understanding of the tumour microenvironment to enhance drug delivery – targeting potent anticancer therapies to tumours and potentially sparing patients debilitating side effects. It is fantastic that efforts are being made to discover and develop smarter, kinder treatments."

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