On February 25, 2020 ExCellThera Inc., a clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, recently reported preliminary data from the Phase 2 trial of its ECT-001 Cell Therapy in patients with high-risk leukemia and myelodysplasia (MDS) (Press release, ExCellThera, FEB 25, 2020, View Source [SID1234554696]). The preliminary data was presented at the 2020 Transplant and Cellular Therapy (TCT) Annual Meeting in Orlando, Florida, and demonstrates excellent leukemia free survival in patients with high-risk leukemia and myelodysplasia.

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ECT-001 Cell Therapy is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative cord blood transplant therapies for patients with hematological malignancies, allowing more rapid engraftment, greatly reduced incidence of transplant-related mortality, low risk of chronic graft-versus-host disease and low risk of relapse, resulting in better outcomes for patients.

"The preliminary data from the ECT-001 Cell Therapy Phase 2 trial suggests excellent leukemia free survival for high-risk patients with leukemias and myelodysplasia; this data is extremely encouraging as these leukemia free survival results are not seen for this high-risk patient population under the current standard or care," said Dr. Guy Sauvageau, CEO and founder of ExCellThera. "This preliminary Phase 2 data in high-risk leukemias and myelodysplasia adds to the body of excellent clinical data for ECT-001, which has been dosed in over 50 patients to date. It further validates the introduction of the cryopreserved ECT-001 product, which will enable us to perform multi-centre trials and eventually provide global patient access to our cell therapy product."

ExCellThera expects that enrolment in Phase 2 trials of its ECT-001 Cell Therapy will be competed in 2020 and intends to continue dialogue with the FDA under the auspices of the RMAT designation on a pivotal registration-enabling study, and to have discussions with the European Medicines Agency for development in Europe.

Data presented at the 2020 Transplant and Cellular Therapy (TCT) Annual Meeting

Presenter: Sandra Cohen, MD, Hôpital Maisonneuve-Rosemont/Université de Montréal

Updated data from Phase 1/2 trial (completed) of ECT-001 Cell Therapy in patients with hematological malignancies:

Clinically viable with a rapid 7-day expansion and small culture volume
Accelerates clinically relevant engraftment (100 neutrophils at D+9.5) regardless of cord blood unit size
Reduced hospitalization length and fever (last day of fever D+7.5)
A single expanded cord is possible for all patients, with better HLA matching
Access to up to 50% of cord blood units in banks for 70kg patient
Low incidence of transplant related mortality (5%)
Excellent chronic GVHD-relapse-free survival (CRFS) of 74% at 33 months
Preliminary Data from Phase 2 trial (ongoing) of ECT-001 Cell Therapy in patients with high-risk leukemia and myelodysplasia

To date, seven (7) high-risk patients dosed with ECT-001 Cell Therapy
Preliminary data suggests excellent leukemia free survival

On February 25, 2020 IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win technology, reported the successful outcome of a scheduled interim analysis of the ongoing Phase 2 trial (IO102-012/KEYNOTE-764) of its lead cancer therapeutic vaccine, IO102, in non-small cell lung cancer (NSCLC) (Press release, IO Biotech, FEB 25, 2020, View Source [SID1234554683]). In this randomized trial, IO102 is being tested in combination with Merck’s anti-PD1 therapy, Keytruda (pembrolizumab) as a first-line therapy in patients with metastatic non-small cell lung cancer. The interim analysis was designed as a futility analysis. The Safety Monitoring Committee has recommended to continue the trial without modifications as the futility boundary was successfully passed.

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"We set a very high hurdle for the futility boundary for the interim analysis in this difficult to treat disease. Specifically, the successful outcome of this interim analysis required the objective response rate in the experimental arm to exceed the futility boundary which was substantially higher than the historical experience with Keytruda monotherapy in this population. We are excited to note that this hurdle has been successfully crossed," said Eva Ehrnrooth, MD, PhD, chief medical officer of IO Biotech. "Through this trial, we expect to get a comprehensive data set that paves the way for a potential pivotal trial of IO102 addressing the unmet medical need in NSCLC and solid tumors."

"The year 2020 will be a transformational year for IO Biotech. We are pleased by the data generated thus far in the ongoing trial of our off-the-shelf subcutaneous injectable treatment for patients with lung cancer. Additionally, the exciting data being generated in the ongoing melanoma trial with our proprietary T-win cocktail that includes IO102 and IO103 (our two clinical lead programs based on targeting IDO and PD-L1) will allow the company to initiate pivotal trials in two indications with two drugs," said Mai-Britt Zocca, PhD, CEO and Founder of IO Biotech. "We continue to demonstrate long term durability of drug effect with a very attractive safety profile for each of our clinical stage candidates, whether alone or in any combination."

IO Biotech’s lead candidate, IO102, is an Indoleamine 2,3-dioxygenase (IDO) derived immune modulating therapy with a dual mode of action – killing both cancer cells and immune-suppressive cells. IO Biotech’s IDO-derived immune modulating therapies previously demonstrated both a favorable safety profile and promising anti-tumor activity in its first human clinical trial of heavily pre-treated patients with NSCLC.

About the Study
IO102-012/KEYNOTE-764 is an Open-label, Randomized, Phase 1/2 Trial Investigating the Safety and Efficacy of IO102 in Combination with Pembrolizumab, with or without Chemotherapy, as first-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer. This global clinical trial is planned to accrue 108 patients across around 20 sites in the U.S. and Europe.

The IO102-012/KN-764 trial is part of a collaborative agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada). The clinical trial is sponsored by IO Biotech. The rights to the study results will be shared, and IO Biotech has retained global commercial rights to IO102.

About NSCLC
According to the American Cancer Society (ACS), lung cancer is the leading cause of cancer death. Each year, more people die of lung cancer than colon, breast and prostate cancers combined. The two main types of lung cancer are non-small cell lung cancer and small cell lung cancer. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all cases. According to the ACS, the five-year survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be six percent.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About T-win Technology Platform
IO Biotech’s proprietary T-win technology platform enables identification of compounds with dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses. The company’s compounds are administered as "off-the-shelf" subcutaneous injections, distinguishing these treatments from many immuno-oncology therapies.

On February 25, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the U.S. Food and Drug Administration has accepted a Biologics License Application (BLA) from Genentech, a member of the Roche Group, for the fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) for subcutaneous administration using Halozyme’s ENHANZE drug delivery technology in combination with intravenous (IV) chemotherapy for the treatment of eligible patients with HER2-positive breast cancer (Press release, Halozyme, FEB 25, 2020, View Source [SID1234554682]).

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"The acceptance of our partner’s BLA submission is an important development for our ENHANZE technology platform," said Dr. Helen Torley, president and chief executive officer. "This will represent the first product utilizing ENHANZE that combines two biologics, Perjeta and Herceptin, in one fixed-dose, subcutaneous administration. We are excited that patients with HER2-positive breast cancer may now benefit from a shorter treatment administration option."

The BLA submission is based on positive results from the global Phase III FeDeriCa study conducted by Genentech, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.(1)

Subcutaneous administration of the fixed-dose combination of Perjeta and Herceptin is approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. Intravenous administration is approximately 150 minutes for the loading dose of Perjeta and Herceptin using standard IV formulations and between 60-150 minutes for subsequent maintenance infusions for the combination. (2,3,4)

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On February 25, 2020 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, reported that the Company’s management team will participate in the following upcoming investor conferences (Press release, Hansa Biopharma, FEB 25, 2020, View Source [SID1234554681]):

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Cowen and Company’s 40th Annual Health Care Conference in Boston on Monday, March 2, 2020, with a presentation at 4:10 PM EST/ 22:10 CET on the same day.
The Carnegie Nordic Healthcare Seminar in Stockholm on Wednesday, March 4, 2020, with a presentation at 8:00 AM CET
A live webcast of the Cowen presentation will be available on the Events & Webcast page of the Company’s website, www.hansabiopharma.com . A replay of the presentation will be available approximately two hours after the event and will be available for two weeks following the presentation.

Calendar 2020

Feb 27-28, 2020

Road Show Cowen, Chicago/Dallas

Mar 2, 2020

Cowen Annual Health Care Conference, Boston

Mar 4, 2020

Road Show Argot, New York City

Mar 4, 2020

Carnegie Nordic Healthcare Seminar, Stockholm

Mar 26, 2020

Kempen Expert Call with Prof. Mårten Segelmark on Anti-GBM

Apr 2, 2020

Annual Report 2019

Apr 21-22, 2020

Kempen Life Sciences Conference, Amsterdam

Apr 28, 2020

Interim Report Jan-Mar 2020

May 5, 2020

Annual General Meeting

May 18, 2020

UBS Global Healthcare Conference, NYC

May 19, 2020

RBC Global Healthcare Conference, NYC

May 26, 2020

ABG Life Science Summit, Stockholm

May 27, 2020

Ökonomisk Ugebrev Life Science Conference, Copenhagen

Jul 16, 2020

Interimn Report Jan-Jul 2020

Sep 16-17, 2020

Bank of America Merill Lynch Global Healthcare Conf., London

Oct 22, 2020

Interimn Report Jan-Sep 2020

CONTACT:

For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269
E-mail: [email protected]

Rolf Gulliksen
Head of Corporate Communications
Hansa Biopharma
Mobile: +46 (0) 733-328 634
E-mail: [email protected]

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On February 25, 2020 KAHR Medical Ltd., a biopharmaceutical company developing a novel drug platform based on bi-functional, immunotherapeutic fusion proteins known as Dual Signaling Proteins ("DSP") reported that it has raised US$18 million from a global syndicate of leading investors (Press release, KAHR Medical, FEB 25, 2020, View Source [SID1234554680]). Completion of the financing round is subject to customary closing conditions and is expected to occur early next month.

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The round was led by Flerie Invest AB, Oriella Limited, Hadasit Bio-Holdings (HBL), Pavilion Capital and Mirae Asset Venture Investment. Proceeds will be used for advancing the Company’s next generation immuno-oncology drug candidates including the clinical development of the Company’s lead product, DSP107, an anti-CD47 therapy for the treatment of solid tumors through a Phase I/II study and the preclinical advancement of additional pipeline projects.

In September 2019, KAHR Medical announced a clinical collaboration with Roche to evaluate KAHR Medical’s lead program, DSP107, a SIRPα-41BBL DSP, in combination with Roche’s PD-L1-blocking checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced NSCLC who are refractory to existing immune checkpoint inhibitors. KAHR Medical expects to begin a Phase I/II trial in H2 2020 at leading sites in the US to evaluate DSP107 as a monotherapy and in combination with atezolizumab, following the filing of an Investigational New Drug (IND) application with the U.S. Food Drug Administration (FDA).

"We are grateful to our existing investors for their continued support and are pleased to welcome Oriella, a prominent private equity and technology investor in Israel, with an expanding focus on life sciences," said Yaron Pereg, Ph.D., CEO of KAHR Medical. "We are also proud to have Pavilion Capital join our investor base. Pavilion Capital brings a track record of success and expertise in the biopharmaceutical sector. We look forward to using this funding for advancing our next-generation immuno-oncology pipeline for the benefit of patients, who are non-responsive or refractory to existing immunotherapies."

"We are excited to lead this financing round for KAHR Medical together with other distinguished investors," said Thomas Eldered, Chairman of Flerie Invest AB. "Despite advances in the treatment of cancer, there is still a clear need for additional therapies to broaden the patient population that will respond to cancer immunotherapies. We look forward to supporting KAHR Medical in developing effective treatments for cancer patients."

Mr Vincent Tchenguiz, a British entrepreneur and beneficiary of the trust that owns Oriella commented, "We recognize the strength of KAHR Medical’s proprietary platform and believe that the company’s products have the potential to offer unique value to patients suffering from cancer. We are keen to work with the Company as it matures, and we look forward to helping it fulfil its mission of bringing new therapies to cancer patients."

Timothy Low, Head of Healthcare Investments, Pavilion Capital, said, "We are delighted to join KAHR Medical’s syndicate of investors, and believe the company has a tremendous opportunity to contribute new targeted therapies to the field of immuno-oncology."

Michel Habib, CEO of HBL, stated, "HBL has been supporting KAHR Medical since its inception and we are very pleased with the company’s impressive development. We are proud to continue to support the company together with other existing and new global investors and look forward with anticipation to the beginning of clinical trials."

About DSP107 and the Phase I/II study
DSP107 targets CD47-overexpressing tumors, simultaneously blocking macrophage inhibitory signals and delivering an immune costimulatory signal to tumor antigen-specific activated T-cells. CD47 is overexpressed on many cancer cells and binds SIRPα on immune phagocytic cells to produce a "don’t eat me" signal. DSP107 binds CD47 on cancer cells, blocking interaction with SIRPα and thus blocking the "don’t eat me signal". Simultaneously, DSP107 binds 41BB on T-cells, stimulating their activation. These activities lead to targeted immune activation through both macrophage and T-cell mediated tumor destruction. In combination with atezolizumab, DSP107 has the potential to enhance anti-tumor immune response.

The planned Phase I/II study will evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of DSP107 in advanced solid tumors. The safety and preliminary efficacy of both DSP107 monotherapy and combination therapy with atezolizumab will be evaluated in patients with advanced NSCLC who are refractory to PD-1/PD-L1 inhibitors. KAHR Medical will be the sponsor of the study and Roche will provide the clinical supply of atezolizumab.