On August 29, 2019 ADCendo, a spin-out from the University of Copenhagen and Rigshospitalet, reported having been accepted into the BioInnovation Institute (BII) Creation House program (Press release, ADCendo, AUG 29, 2019, View Source [SID1234573153]). As part of the program, ADCendo has secured a convertible loan of 10 million DKK for furthering its novel antibody-drug conjugates (ADCs) being developed for treatment of cancers.
In 2017, following publication of scientific proof-of-concept, ADCendo was established as a spin-out from the Finsen Laboratory of Rigshospitalet and the University of Copenhagen, with the purpose of developing a new type of targeted anti-cancer drug, in the form of antibody-drug conjugates (ADCs) directed at a novel target receptor, uPARAP. An approach that potentially enables targeted therapy in several cancer forms where expression of the target has been found to be highly upregulated, including soft-tissue sarcoma, osteosarcoma, glioblastoma multiforme (GBM) and triple-negative breast cancer. Furthermore, recent research suggests that targeting uPARAP-positive stromal cells (healthy cells surrounding a solid tumor) with this approach, may potentially offer opportunities for treating several much more commonly occurring carcinomas, including breast, colon, pancreatic, prostate, ovarian and renal cancers.

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CSO of ADCendo and group leader at The Finsen Laboratory, Niels Behrendt, explains: "Based on our early results obtained at the Finsen laboratory, we were granted a pre-seed grant from Novo Holdings enabling us to make significant improvements to the overall performance of our early ADC candidates. Our results have been very well received by our international ADC network, and with the expanded access to BII, as well as the additional financial support, we are looking forward to furthering the development of our clinical candidate. Having created the scientific basis of the company through many years of basic cancer research, we are of course very excited about this opportunity to take our results further towards clinical utilization, and we are very proud of having been selected for the Creation House program at BII".

Commenting on the ADCendo spin-out, Bo Porse, head of the Finsen Laboratory, notes: "At the Finsen Laboratory, we have a strong focus on the translational aspects, in addition to our basic research. The successful path of ADCendo from basic cancer research by its founders at the Finsen Laboratory, to a spin-out biotech, nicely illustrates how our research strategy may contribute to development of novel, innovative anti-cancer treatments".

ADCendo is, in parallel with furthering its ADCs, preparing pre-clinical and clinical development plans for metastatic soft tissue sarcoma (STS), a serious disease where patients have a median survival of only 12-18 months. Importantly, ADCendo aims to fill the gap following the drug Lartruvo (Olaratumab, an anti-PDGFR-α antibody), which was withdrawn from the STS market in early 2019 following a failed confirmatory phase III study. At launch, Lartruvo was the first new drug to be approved for first-line treatment of STS in 40 years, and the drug was well received and hoped to provide treatment for STS patients with substantial unmet needs. Going forward, ADCendo aims at developing its ADC strategy for STS, based on a development track similar to Lartruvo, which was granted orphan designation, fast track, breakthrough therapy designation, priority review status, and accelerated approval for STS, enabling a faster and more cost-effective clinical development path.

Henrik Stage, CEO of ADCendo explains: "In short, ADCendo’s business strategy is aimed at moving its lead compound into the clinic for STS patients, preferably based on an orphan drug designation, and hopefully receiving conditional approval for the drug to fill the gap after Lartruvo. Having been accepted for the BII program and receiving the convertible loan funding is an important step towards maturing the company, and preparing for the additional investments needed from investors and partners, to enable us to fulfil our ambitions of bringing our novel ADC drug to the market for treatment of patients with an unmet medical need".

Commenting on ADCendo’s acceptance for the BII program, Hervør Lykke Olsen, Senior Scientific Business Developer at BioInnovation Institute, says: "The goal for ADCendo is to develop a new drug for soft tissue sarcoma (STS), which is a heterogenous groups of tumors notorious for their recurrence, overall complexity, and difficulty to treat. Research from the ADCendo team has shown that the novel target, uPARAP, is highly overexpressed on the surface of cancer cells of STS tumors, making it very well suited for targeting with ADCendo’s ADCs. BII’s support on funding and business development can boost ADCendo to succeed in commercialization of the treatment to benefit patients".

On august 29, 2019 Nordic Nanovector ASA (OSE: NANO) reported that it will host a R&D Day in Oslo on Tuesday, 17 September 2019 from 9:30am to 12:30pm CEST (Press release, Nordic Nanovector, AUG 29, 2019, View Source [SID1234553446]). The programme will include presentations from three external experts and by Nordic Nanovector’s senior management team. An update on the median Duration of Response (mDoR) of Betalutin treatment in the LYMRIT 37-01 trial will also be given during the day.

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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

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Venue: Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Auditorium

To register to attend, please e-mail [email protected] by 13 September 2019.

The R&D Day will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media.

The presentations will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/2019.

The preliminary programme is as follows;

09.30-09.50 Nordic Nanovector’s pipeline – Strategic insights Eduardo Bravo, CEO

09.50-10.10 Radioimmunotherapy – Preclinical results with Betalutin and comparison of alpha and beta emitters Dr Jean-Pierre Pouget*

10.10-10.40 Future vision for R&D at Nordic Nanovector Dr Jostein Dahle, CSO

10:40-10:50 Introduction to clinical sessions Dr Lisa Rojkjaer, CMO

10.50-11.20 Unmet medical needs and therapeutic landscape for recurrent follicular and marginal zone lymphoma Prof. Pier Luigi Zinzani*

11:20-11:30 Coffee Break

11.30-12:00 Novel biologic combinations with Betalutin Dr Arne Kolstad*

12.00-12.20 BLA readiness: CMC commercial plans Dr Marco Renoldi, COO

12.20-12.30 Q&A

*The external experts’ speakers are:

Dr J.P. Pouget, PhD, Radiobiology and targeted radiotherapy group Montpellier Cancer Research Institute (IRCM), French National Institute of Health and Medical Research (INSERM).
Prof. P. L. Zinzani, Professor of Hematology, Institute of Hematology "L. e A. Seràgnoli", University of Bologna.
Dr A. Kolstad MD, PhD, senior consultant in Medical Oncology and Radiation Therapy, Dept of Oncology Oslo University Hospital, The Norwegian Radium Hospital.

On August 29, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will participate in three upcoming investor conferences in September (Press release, Ascendis Pharma, AUG 29, 2019, View Source [SID1234551449]). Company executives will provide a business overview and update on the company’s pipeline programs.

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Details

Event 2019 Wells Fargo Healthcare Conference
Location Boston
Date Wednesday, September 4, 2019
Time 2:25 p.m. Eastern Time

Event Morgan Stanley 17th Annual Global Healthcare Conference
Location New York
Date Tuesday, September 10, 2019
Time 2:55 p.m. Eastern Time

Event Bank of America Merrill Lynch Global Healthcare Conference 2019
Location London
Date Thursday, September 19, 2019
Time 10:40 a.m. British Summer Time
A live webcast of the Wells Fargo and Morgan Stanley conferences will be available in the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On August 29, 2019 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the microbiome organ to treat disease and improve human health, reported that management will participate in a fireside chat at the Morgan Stanley 17th Annual Global Healthcare Conference in New York City on Monday, September 9, 2019 at 1:40 p.m. ET (Press release, Kaleido Biosciences, AUG 29, 2019, View Source [SID1234540068]).

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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

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A live audio webcast will be available through the Investors & Media section of Kaleido’s website at View Source An archived replay will be accessible for 90 days following the event.

On August 29, 2019 Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, reported financial results for the second quarter ended June 30, 2019 and recent clinical progress (Press release, Akari Therapeutics, AUG 29, 2019, View Source [SID1234539160]).

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"We are pleased with the progress we have made advancing our BP, HSCT-TMA and AKC programs and are encouraged by the initial data we have received to date in these programs," said Clive Richardson, Chief Executive Officer of Akari Therapeutics. "Both AKC and BP have further planned clinical readouts this year, providing a potential opportunity for advancing both programs into pivotal trials in 2020 and further supporting the novel therapeutic role of combined C5 and LTB4 treatment. In addition, we are planning to start a pivotal clinical trial for HSCT-TMA in the fourth quarter of this year."

Second Quarter 2019 and Recent Business Highlights

Pediatric HSCT-TMA
The Company continues to progress towards a pivotal trial for HSCT-TMA with nomacopan, which is expected to start in the fourth quarter of 2019. This condition has an estimated 80% mortality rate in children with this severe disease, with currently no approved treatments. In a March 2019 meeting, a framework for the trial design was agreed with the U.S. Food and Drug Administration (FDA). In August 2019, the FDA granted Fast Track designation for nomacopan for the treatment of HSCT-TMA in pediatric patients.
Phase II clinical trial in patients with BP
Initial results from the first three patients with mild-to-moderate BP in the ongoing Phase II trial with nomacopan demonstrated a rapid reduction in BP Disease Area Index (BPDAI) score and blistering of 52% and 87%, respectively, by day 42. There were no drug related serious adverse events. The Company anticipates new safety and efficacy data in mild-to-moderate patients from this study to be given as an oral presentation at the the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 10, 2019.
In early August, the Company announced new data demonstrating synergistic benefits of nomacopan’s dual C5 and LTB4 inhibitory activity in pemphigoid disease, generated by Dr. Christian Sadik’s group at University of Lubeck, Germany, and published in the August 2019 edition of JCI Insight [link].
Phase I/II clinical trial in patients with AKC
Successfully completed Part A of TRACKER, a Phase I/II clinical trial evaluating the safety and efficacy of topical nomacopan in patients with moderate-to-severe AKC. Results showed a rapid response and an overall improvement of 55% in the composite clinical score, which was composed of an improvement in symptoms of 62% and signs of 52% by Day 56. Three patients were treated with twice daily nomacopan eye drops in addition to standard of care for up to 56 days, with one patient completing 14 days and then withdrawing for reasons unrelated to the study. All patients had been on maximal topical cyclosporine, the standard of care, for at least three months prior to entry. The nomacopan eye drops were found to be comfortable and well tolerated with no serious adverse events. Enrollment in the Part B placebo-controlled efficacy arm in 16 patients continues to progress, with data read out planned for the fourth quarter of 2019.
Clive Richardson has been appointed permanent Chief Executive Officer of Akari after having served as interim Chief Executive Officer since May, 2018
Upcoming Events and Milestones

HSCT-TMA pivotal clinical trial expected to start in the fourth quarter of 2019.
Mild-to-moderate BP trial data to be presented at EADV Congress, October 10, 2019.
Completion of Part B of AKC Phase I/II trial by the fourth quarter of 2019.
Second Quarter 2019 Financial Results

Research and development (R&D) expenses in the second quarter of 2019 were $3.6 million, as compared to R&D expenses of $5.1 million in the same quarter the prior year. This decrease was primarily due to lower manufacturing expenses as the Company had previously manufactured clinical trial material for supply through 2019, which was slightly offset by higher clinical trial costs and personnel expenses. R&D expenses for the six months ended June 30, 2019 were $1.3 million reflecting the receipt of a Q1 R&D tax credit of $4.9 million.
General and administrative (G&A) expenses in the second quarter of 2019 were $2.4 million, as compared to $2.9 million in the same quarter last year. This decrease was primarily due to lower expenses associated with professional services, personnel and rent, partially offset by higher stock-based non-cash compensation expenses.
Total other income for the second quarter of 2019 was $1.9 million, as compared to total other expense of $43,000 in the same period the prior year. This change was primarily due to $2.0 million of higher income related to the change in the fair value of the stock option liabilities in 2019 compared to 2018, and to higher foreign exchange gains of approximately $39,000 in 2019 as compared to 2018.
Net loss for the second quarter of 2019 was $4.1 million, compared to a net loss of $8.0 million for the same period in 2018. The decrease in net loss in the second quarter of 2019 was due primarily to the change in the fair value of the stock option liabilities and foreign exchange gains previously cited, accompanied by lower operating expenses in the second quarter of 2019.
As of June 30, 2019, the Company had cash of $2.7 million, as compared to cash of $5.4 million as of December 31, 2018. On July 3, 2019, the Company sold to certain institutional investors, accredited investors and an existing shareholder, RPC Pharma Ltd., an affiliated entity of Dr. Ray Prudo, Akari’s Chairman, an aggregate 2,368,392 registered American Depository Shares (ADSs) of Akari at a purchase price of $1.90 per ADS, resulting in gross proceeds of approximately $4.5 million. Additionally, for each ADS purchased by investors, the investors received an unregistered warrant to purchase one-half ADS. The warrants have an exercise price of $3.00 per ADS, were exercisable upon their issuance and will expire five years from the issuance date.
As of June 30, 2019, the Company has sold to Aspire Capital Fund, LLC (Aspire Capital) a total of $2.0 million of ordinary shares. Subsequent to June 30, 2019, the Company sold to Aspire Capital a further $3.5 million of ordinary shares and approximately $14.5 million remains available for draw down under the purchase agreement entered into with Aspire Capital.