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ADC Therapeutics Reports Second Quarter 2020 Financial Results and Provides Recent Business Highlights

On August 18, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported financial results for the second quarter ended June 30, 2020 and provided recent business highlights (Press release, ADC Therapeutics, AUG 18, 2020, View Source [SID1234563786]).

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"ADC Therapeutics progressed rapidly this past quarter, and we are continuing to evolve towards becoming a commercial-stage company, as we prepare to submit a Biologics License Application to the U.S. Food and Drug Administration for Lonca, our lead product candidate, for the treatment of relapsed or refractory diffuse large B-cell lymphoma, later this year and have already submitted the Chemistry, Manufacturing and Controls (CMC) modules to the FDA. To that end, we’re focused on executing a successful launch and growing our talented and experienced commercial, market access, and medical affairs teams. We also presented data at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June that demonstrated the potential of Lonca to be a key part of the treatment paradigm for patients with non-Hodgkin lymphoma, both as a single-agent and in combination with other therapies, deepening our conviction in the potential promise of this program and the hope it may bring to patients and their families," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "We also completed an upsized IPO and expanded our leadership team. With these new resources and expertise in place, we are well-positioned for our next stage of growth."

Dr. Martin continued, "With regard to Cami, our second lead product candidate, we are pleased to have patient enrollment open in our ongoing pivotal Phase 2 trial in relapsed or refractory Hodgkin lymphoma and remain on track to announce interim results in the first half of 2021. We look forward to providing further updates across our pipeline as our programs continue to progress."

Recent Business and Clinical Highlights

Announced first patient dosed in Phase 2 portion of LOTIS 3 clinical trial of Lonca in combination with ibrutinib: In July 2020, the Company announced that the first patient was dosed in the Phase 2 portion of LOTIS 3, a 161-patient Phase 1/2 clinical trial of loncastuximab tesirine (Lonca, formerly ADCT-402) in combination with ibrutinub, which is being evaluated in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). The clinical trial is intended to support the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA).
Announced FDA lifted partial clinical hold on pivotal Phase 2 trial of Cami for relapsed or refractory Hodgkin lymphoma: In July 2020, the Company announced that the FDA had lifted the partial clinical hold on its pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma (HL). The Company continued to treat those patients who could benefit from ongoing treatment during the partial clinical hold, and the clinical trial is now open for enrollment. Interim results from the clinical trial are expected in the first half of 2021, subject to any impact by COVID-19. The clinical trial is intended to support the submission of a BLA to the FDA.
Presented positive data from LOTIS 2 and LOTIS 3 trials of Lonca at the virtual 25th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (EHA25): In June 2020, the Company presented interim data from two clinical trials of Lonca in an oral presentation and e-poster session at EHA (Free EHA Whitepaper)25. Data from the pivotal Phase 2 single-agent LOTIS 2 trial showed Lonca demonstrated an overall response rate (ORR) of 48.3% and complete response rate (CRR) of 24.1% in a broad relapsed or refractory DLBCL patient population, while upholding a manageable safety profile. The most common grade ≥3 treatment-emergent adverse events in ≥10% of patients were: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), GGT increased (16.6%) and anaemia (10.3%). The Company is on track to submit a BLA to the FDA later this year based on these data. Interim data from the Phase 1 portion of the Phase 1/2 LOTIS 3 trial of Lonca in combination with ibrutinib showed an encouraging ORR of 75% and CRR of 58.3% at the Lonca dose of 60 μg/kg, which is the selected dose for the Phase 2 portion of the trial, in combination with ibrutinib (560 mg/day), in patients with relapsed or refractory DLBCL or MCL. The combination has had a manageable toxicity profile, with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being thrombocytopenia (20%) and anaemia (12%). These interim data highlight the potential of Lonca in earlier lines of therapy and in combination.
Completed upsized initial public offering (IPO) and received first tranche of $115 Convertible Credit Facility with Deerfield: In May 2020, the Company completed its upsized IPO of 14,082,475 common shares at a public offering price of $19.00 per share, which included the full exercise of the underwriters’ option to purchase 1,836,844 additional common shares. The total gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $267.6 million. In tandem with the closing of the IPO, the Company also received an initial $65.0 million disbursement of senior secured convertible term loans under its previously announced Convertible Credit Facility with Deerfield Partners, L.P. and certain of its affiliates. Under the Convertible Credit Facility, the Company will receive an additional $50.0 million disbursement upon receipt of U.S. regulatory approval for Lonca.
Appointed Jenn Creel as Chief Financial Officer and Victor Sandor, M.D., to its Board of Directors: In April 2020, the Company appointed Jenn Creel as Chief Financial Officer and Victor Sandor, M.D., to its Board of Directors. Ms. Creel joined ADC Therapeutics from Celgene Corporation, where she served as franchise chief financial officer and corporate vice president of global finance and business planning prior to its acquisition by Bristol Myers Squibb. Dr. Sandor most recently served as Chief Medical Officer of Array BioPharma, which was acquired by Pfizer, where he supported the approval of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of melanoma. Prior to his role at Array BioPharma, Dr. Sandor was Senior Vice President for Global Clinical Development at Incyte Corporation and held positions of increasing responsibility in oncology product development at AstraZeneca.
Anticipated Upcoming Milestones

File a BLA with the FDA for Lonca for the treatment of relapsed or refractory DLBCL in the second half of 2020.
Present data from the Phase 1b trial of Cami in selected advanced solid tumors at a scientific meeting in the second half of 2020.
Initiate a pivotal Phase 2 trial of Lonca in follicular lymphoma (FL) in the first half of 2021.
Report interim results from the pivotal Phase 2 trial of Cami in HL in the first half of 2021.
Continue to accelerate the Company’s pipeline of ADC product candidates for the treatment of hematological cancers and solid tumors, including presenting Phase 1 data for ADCT-602 in acute lymphoblastic leukemia and ADCT-601 in solid tumors. Continue to advance our earlier-stage programs, ADCT-901 and ADCT-701, with IND-enabling studies.
Second Quarter 2020 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $348.6 million as of June 30, 2020 compared to $115.6 million as of December 31, 2019.

Research and Development (R&D) Expenses

R&D expenses were $26.0 million for the quarter ended June 30, 2020, compared to $21.8 million for the same quarter in 2019. The increase was primarily due to an increased number of research and development employees and increased share-based compensation expense.

General and Administrative (G&A) Expenses

G&A expenses were $19.0 million for the quarter ended June 30, 2020, compared to $4.1 million for the same quarter in 2019. The increase was primarily due to increased share-based compensation expense, an increased number of commercial employees, and increased costs due to new commercial activities and the completion of our initial public offering.

Net Loss and Adjusted Net Loss

Net loss was $126.6 million, or a net loss of $2.01 per basic and diluted share, for the quarter ended June 30, 2020, compared to $23.3 million, or a net loss of $0.49 per basic and diluted share, for the same quarter in 2019. The net loss for the quarter ended June 30, 2020 includes a $79.3 million non-cash charge related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The significant increase in fair value was driven by the increase in the Company’s share price during the quarter. In addition, net loss included share-based compensation expense of $12.7 million for the quarter ended June 30, 2020, compared to $0.1 million for the same quarter in 2019.

Adjusted net loss was $32.1 million, or an adjusted net loss of $0.51 per basic and diluted share, for the quarter ended June 30, 2020, compared to $23.3 million, or an adjusted net loss of $0.49 per basic and diluted share, for the same quarter in 2019.

Conference Call Details

To access the call, please dial 646-787-0157 (domestic) or +41 22 5017540 (international) and enter pin code: 773478. A live webcast of the presentation will be available on the Investors section of the ADC Therapeutics website at www.adctherapeutics.com. The archived webcast will be available after the completion of the event and for 30 days following the call.

Ikena Oncology Appoints Dr. Sergio Santillana, MD, MSc, MBA as Chief Medical Officer

On August 18, 2020 Ikena Oncology, Inc., a clinical-stage biotechnology company that discovers and develops patient-directed, biomarker-driven therapies, reported the appointment of Sergio Santillana, MD, MSc, MBA, as Chief Medical Officer (Press release, Ikena Oncology, AUG 18, 2020, View Source [SID1234563785]). Dr. Santillana, a medical oncologist, will be responsible for leading the clinical development strategy, clinical operations, and regulatory affairs for Ikena’s development pipeline of innovative cancer therapeutics, including the recently announced TEAD inhibitor program targeting the Hippo pathway. He brings nearly 30 years of clinical practice and oncology drug development experience to Ikena and has held executive and senior clinical leadership roles at several premier biopharmaceutical companies, including Eli Lilly, GlaxoSmithKline, Takeda, ARIAD Pharmaceuticals, and Merrimack Pharmaceuticals.

"We are delighted to be adding Sergio to the Ikena team. His impressive track record of driving the clinical development of innovative oncology medicines is ideally suited as we progress our clinical-stage immunotherapies and move our discovery-stage and preclinical targeted oncology programs into the clinic. Sergio’s exceptional experience across drug development and as a medical oncologist will help realize the full potential of our novel therapies," said Mark Manfredi, Ph.D., President and Chief Executive Officer of Ikena Oncology. "I would also like to express our sincere thanks to Dr. Jason Sager for the excellent work that he has accomplished as CMO to date. Jason has played a critical role in rapidly advancing our pipeline assets IK-007 and IK-175 into the clinic, and will continue to contribute to the company as a Senior Clinical Consultant."

Dr. Santillana commented, "I am thrilled to join the Ikena Oncology team and believe in the tremendous potential of our pipeline of novel and high-impact targeted therapy and immunotherapy treatments to set new standards in oncology. I look forward to sharing my experiences as an oncologist and drug developer to help bring the right treatments to the right patients at the right time. Ikena is driven by its vision of a world where every cancer patient has a cure, and I’m excited to work with the entire team to build on the impressive progress they have made."

Prior to joining Ikena, Dr. Santillana provided strategic consultancy services to a variety of life science companies, including Ikena Oncology. Prior to founding his consultancy, Dr. Santillana served as Chief Medical Officer at Merrimack Pharmaceuticals and ARIAD Pharmaceuticals, a commercial-stage biotechnology company that was acquired by Takeda. Prior to joining ARIAD, Dr. Santillana served in various oncology clinical development leadership roles at Takeda, GlaxoSmithKline and Eli Lilly. Before entering the biopharma industry, Dr. Santillana was a practicing board-certified medical oncologist for 15 years, including tenure at the National Cancer Institute of Peru (INEN). Dr. Santillana holds an MSc in Experimental Therapeutics from Kellogg College at the University of Oxford and an M.D. and B.S. from the Universidad Nacional Federico Villarreal School of Medicine in Lima, Peru. He also holds an M.B.A. from the MIT Sloan School of Management.

Avacta and LG Chem Life Sciences Expand Partnership

On August 18, 2020 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, reported the expansion of its existing multi-target collaboration and development agreement with LG Chem Life Sciences (LG Chem), the life sciences division of the South Korean LG Group, to include new programmes incorporating Avacta’s Affimer XT serum half-life extension system (Press release, Avacta, AUG 18, 2020, View Source [SID1234563784]).

In December 2018, Avacta and LG Chem entered into a multi-target therapeutics development agreement to develop Affimer therapeutics in several disease areas potentially worth over $300m to Avacta. The companies have today agreed to expand this drug development partnership to include Avacta’s Affimer XT technology, which can be used to control the time a drug spends in the circulation.

The expansion of the partnership includes an undisclosed additional upfront payment, plus near-term pre-clinical milestones and longer-term clinical development milestones totaling $98.5m for two therapeutics to be developed using the Affimer XT technology. Under the terms of the extended 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.

The expanded 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 this expansion to the agreement with LG Chem, with whom we have developed a strong collaborative partnership. LG Chem is a world-class drug development partner with excellent biologics manufacturing and clinical development capabilities and a pioneering vision to develop innovative therapies.

The expansion of our collaboration to develop new therapies for patients with cancer and other diseases is another strong validation of the Affimer technology and its potential as a therapeutic platform to deliver a pipeline of new drugs.

We look forward to developing these new therapies with our partners, LG Chem, and I look forward to updating the market on this and our other drug development and diagnostics progammes in due course."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

Ultimovacs ASA Announces Completion of Patient Enrollment in Phase I Trial in Malignant Melanoma

On August 18, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, reported that patient enrollment has been completed in the ongoing US-based Phase I clinical trial testing Ultimovacs’ lead candidate, UV1, in combination with pembrolizumab as first line treatment in patients with metastatic malignant melanoma (Press release, Ultimovacs, AUG 18, 2020, View Source [SID1234563783]). The study was designed to assess the safety and tolerability of UV1 combined with checkpoint inhibitor pembrolizumab and to explore initial signs of clinical response.

The Phase I trial investigates Ultimovacs’ cancer vaccine, UV1, in combination with PD-1 checkpoint inhibitor, pembrolizumab. Pembrolizumab is standard-of-care therapy for malignant melanoma, improving the ability of immune cells to kill tumor cells. The preliminary safety information obtained from the first 20 patients in the Phase I trial allowed for the exploration of a higher dose of the adjuvant GM-CSF in 10 additional patients. The first 20 patients received 37.5 μg GM-CSF per UV1 vaccination versus 75 μg GM-CSF per UV1 vaccination in the second cohort of 10 patients. GM-CSF is used as an adjuvant together with UV1 to strengthen the ability of UV1 to stimulate the immune system. With 30 patients enrolled and treated as of today, the trial reached its targeted enrollment criteria. No unexpected safety issues related to UV1 have been observed to date and UV1 has generally been well tolerated by the patients.

Carlos de Sousa, Chief Executive Officer at Ultimovacs, commented:
"Early data on the patients enrolled in the Phase I trial of UV1 in combination with pembrolizumab demonstrate a strong safety profile to date and provide further support for Ultimovacs’ approach of combining UV1 treatment with checkpoint inhibitors. The preliminary safety data builds further on a previous Phase I trial in malignant melanoma, where UV1 was combined with the CTLA-4 checkpoint inhibitor ipilimumab. In both combination trials, treatment with UV1 has been well tolerated by patients, providing a solid basis for the triple combination of UV1 with CTLA-4 and PD-1, which is currently investigated in the Company’s Phase II trials INITIUM and NIPU. We are proud of the Company’s progress and would like to thank the patients, their families and healthcare providers for their participation, particularly in the current challenging environment. "

Jens Bjørheim, Chief Medical Officer of Ultimovacs, added:
"We are pleased that we have completed the enrollment of the second cohort in this Phase I trial despite challenging times related to the ongoing pandemic. In September of this year, all patients in the first cohort will have reached their 1-year follow-up period and we look forward to announcing top-line safety and preliminary efficacy data from patients in the first cohort in the fourth quarter of this year, followed by more detailed results at an international medical conference early next year."

About UV1 and the UV1 Phase II Clinical Trials
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen, telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immuno-oncology drugs which require an ongoing T cell response for their mode of action. To date, UV1 has been tested in four Phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

UV1 will be tested in three different randomized Phase II trials:

The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma. Patients will be treated with UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor). The trial will be conducted in the U.S. and Europe, including Norway. The first patient was dosed on 15 June 2020. A total of 154 patients will be enrolled in the study, 77 patients will receive nivolumab and ipilimumab and the second half of the patients will receive nivolumab, ipilimumab and UV1. The primary endpoint for the study is progression-free survival and the planned readout of the primary endpoint is in the second half of 2022.
The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in mesothelioma. Oslo University Hospital is the sponsor of the NIPU study. Bristol-Myers Squibb and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. The first patient was dosed on 15 June 2020. A total of 118 patients will be included in the NIPU study. Half of the patients will be treated with the combination of UV1, ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor), whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at six national hospital centers specialized in treating mesothelioma in four countries (Norway, Sweden, Denmark and Australia). Planned readout of the primary endpoint progression-free survival is the second half of 2022.
A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients). In the collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.
The Phase II clinical program builds on three completed Phase I trials and one ongoing Phase I trial. The Phase II trials will evaluate UV1 in three different indications in more than 400 patients and in collaboration with two big pharma companies. The ongoing and planned clinical trials represent a strong platform for Ultimovacs to advance towards a potential registration of the universal cancer vaccine, UV1.

EDAP Announces Two Publications Highlighting Favorable HIFU Focal Therapy Outcomes in Journal of Urology

On August 18, 2020 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that two papers highlighting successful studies of the Company’s high intensity focused ultrasound (HIFU) technology for the effective ablation of prostate cancer tissue have been accepted for publication in the prestigious peer-reviewed Journal of Urology, the official journal of the American Urology Association (AUA) (Press release, EDAP TMS, AUG 18, 2020, View Source [SID1234563782]). The two studies, scheduled for publication in the September and October paper editions of the journal, detail clinical outcomes from HIFU procedures conducted at the first two hospitals to purchase the Ablatherm device in the US shortly after the FDA clearance at the end of 2015.

Details of the publications are as follows:

High Intensity Focused Ultrasound Hemigland Ablation for Prostate Cancer: Initial Outcomes of a United States Series. Andre Abreu et al., USC Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, California.

This study describes a study of 100 men with a confirmed diagnosis of prostate cancer, 72% of whom were diagnosed with intermediate or high-risk disease. All study subjects underwent hemi-gland ablation with HIFU as primary treatment for prostate cancer between December 2015 and December 2019. Radical treatment was avoided in 91% of men at two years. There were no major complications, and no rectal fistulas occurred. The study found that urinary symptoms returned to near baseline questionnaire scores within 3-6 months and sexual function returned to baseline by 12 months.

"We are pleased to present this first and largest US study on focal therapy with HIFU as primary treatment for prostate cancer," said Andre Abreu, MD, Assistant Professor of Clinical Urology and Radiology, USC Institute of Urology, and first author of the publication. The results observed from these first 100 prostate cancer patients treated with HIFU partial gland ablation in the US are consistent with the very encouraging results from studies conducted in Europe, both in terms of disease control and genitourinary function preservation. After two years of follow-up, 91% of patients avoided radical treatment and its inherently debilitating side effects. Additionally, all patients maintained full continence and there was no significant decline of erectile function and no major adverse events occurred. This reaffirms our commitment to bringing personalized prostate cancer management, incorporating patients’ preference and implementing a risk-adaptive approach, with adequate cancer control and without compromising patients’ quality of life."

Prospective Evaluation of Focal High Intensity Focused Ultrasound for Localized Prostate Cancer. B. Nahar et al., Department of Urology, University of Miami Miller School of Medicine, Miami, Florida, Sylvester Comprehensive Cancer Center.

This paper describes a single-center prospective study of 52 prostate cancer patients who underwent HIFU treatment between January 2016 and July 2018. Sixty seven percent of study subjects were diagnosed with intermediate or high-risk disease (Grade Group 2 or greater). All patients were treated with EDAP’s Ablatherm HIFU device and were followed for a minimum of 12 months post-procedure. Biopsies were performed at 6 or 12 months for high or low/intermediate risk cancers, respectively. Two years post procedure, only one patient (2%) had to undergo radical prostatectomy surgery. No change in continence was observed and sexual function returned to baseline at 12 months.

The full abstract is available online at: View Source

Marc Oczachowski, Chairman and Chief Executive Officer of EDAP, commented: "The very positive results of these two studies – the first published in the United States – add to the significant amount of data demonstrating that our HIFU technology, now led by our latest generation Focal One device, provides unmatched potency and accuracy, thereby eliminating the two most devastating side effects of radical surgery – incontinence and impotence. Importantly, these results are consistent with previously completed European studies that included larger patient cohorts and longer follow-up periods. The fact that these two prestigious academic institutions, based on these early positive clinical results, have both decided to invest in Focal One is a clear sign of the potential of EDAP’s HIFU technology."

"We are encouraged to see the continuous adoption and use of our US installed base of HIFU machines. Seeing some of our prominent reference centers already publishing in top-ranked Journals their results with our HIFU technology is clearly another milestone in our US market penetration strategy," Mr. Oczachowski concluded.