On September 24, 2019 LIDDS has reported preliminary data from the LPC-004 study that aimed to determine the tolerability of Liproca Depot and the Prostate-Specific Antigen (PSA) effect at month 5 on patients in part II of the study (Press release, Lidds, SEP 24, 2019, View Source [SID1234555904]).

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The PSA reduction for part II patients was in line with the expected pattern for Liproca Depot’s sustained release and maximum PSA reduction (PSA nadir) occurred during months 2-4. The patients in part II showed a strong PSA decrease and a continued PSA reduction at month 5 as well as over the full study period of six months, confirming the NanoZolid technology’s sustained release profile.

67 % of patients receiving 16 ml dose were determined as responders. A responder is defined as a patient experiencing a PSA decrease of 15% or more. 90% of patients who received a 16 ml injection experienced a PSA decrease during their Liproca Depot treatment.

The positive preliminary results show Liproca Depot’s ability to reduce PSA levels over a period of six months, proving the NanoZolid technology´s suitability for local cancer treatment. The study also confirms the technology’s favorable toxicity and tolerability profile.

All patients in the study were under Active Surveillance with low or intermediate risk of cancer progression and these patients currently receive no treatment.

– Patients under Active Surveillance have a risk of cancer progression which places additional stress on them. Liproca Depot could provide an option for physicians to address an unmet medical need, says Anders Bjartell, Professor and Senior Consultant at the Department of Urology, Skåne University Hospital, and LIDDS Board Member.

– Liproca Depot was well tolerated without the hormonal side effects associated with anti-androgen therapies and a majority of patients in the study were positive to receiving a second injection. Administering Liproca Depot is similar to performing a prostate biopsy, says Professor Laurence Klotz, a world leading expert and one of the study investigators and Professor at the University of Toronto Division of Urology.

– These results validate the continued clinical development of Liproca Depot. LIDDS has already signed a license agreement for China with the pharmaceutical company Jiangxi Puheng which plans to conduct and finance a Phase III study. LIDDS will now continue the commercial activities in order to sign further licensing agreements in other major markets, says Monica Wallter, CEO, LIDDS.

Professor Klotz will present the Phase IIb study results in detail at the 11th European Multidisciplinary Congress on Urological Cancers (EMUC19) in Vienna, Austria, on November 16, 2019. A paper reporting the results of the Phase IIb study will be submitted to leading scientific journals for publication.

For more background information about the Phase IIb Liproca Depot clinical trial, please see enclosed file.

About prostate cancer and the market:
Of the 1.2 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and placed on ‘Active Surveillance’ where they are monitored regularly. There is no standard drug treatment for these cancer patients and many treating doctors see an unmet need.

According to market research firm GlobalData, the global market for prostate cancer drugs is expected to grow to USD 8.3 billion annually by 2023. Liproca Depot’s target group is an untapped market potentially exceeding USD 3 billion per year.

On Spetember 24, 2019 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research in immuno-oncology announced today that it has signed a licensing agreement with Hanmi Pharmaceutical Co., LTD (Hanmi), a well-known global player in the biopharmaceutical field, for the development of bi- and/or multi-specific antibodies for immuno-oncology applications (Press release, Hanmi, SEP 24, 2019, View Source;board_id=INFORMATION_ENGLISH_NEWS [SID1234573788]). Under the terms of the agreement, Hanmi will evaluate and license antibody sequences against an undisclosed target from Phanes and use them in multiple projects under the Pentambody platform, a proprietary bispecific antibody technology developed by Hanmi’s subsidiary in Beijing.

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Under the terms of the agreement, Hanmi will be responsible for the discovery, development, manufacturing and commercialization of the bi- and/or multi-specific antibodies and has exclusive worldwide commercial rights to the molecules for any cancer indications. Phanes will receive upfront and milestone payments plus royalty fees. The details of the financial terms were not disclosed.

"Phanes is an emerging leader in innovative discovery research in the immuno-oncology area and we have demonstrated significant differentiations that we believe will be clinically meaningful in multiple internal programs. We are extremely excited about partnering with Hanmi in the bi- and multi-specific antibodies area with the ultimate goal of providing cancer patients with new treatment options. We have clearly demonstrated the differentiation between our lead mAb and competitor molecules with respect to its mechanism of action. It has great potential to resolve the issues we are facing in the clinic," said Dr. Ming Wang, PhD, MBA, CEO of Phanes Therapeutics, "At Phanes, our mission is to become a source of innovation in the biopharma industry and we are fully committed to delivering robust therapeutic molecules to patients. But we can’t do it alone; we will continue to leverage partnerships with companies that have capabilities complementary to ours."

"Through the collaboration with Phanes, we are planning to expand the potential of the Pentambody platform in innovative immuno-oncology field and generate new treatment options for patients suffering from cancers." said Sechang Kwon, President and CEO of Hanmi pharmaceuticals.

On September 24, 2019 Foundation Medicine, Inc. and Natera, Inc. (NASDAQ: NTRA) reported a partnership to develop and commercialize personalized circulating tumor DNA (ctDNA) monitoring assays, for use by biopharmaceutical and clinical customers who order FoundationOneCDx (Press release, Foundation Medicine, SEP 24, 2019, View Source [SID1234539735]). The initial focus of the partnership will be to enable ctDNA monitoring in biopharmaceutical trials in 2020 to establish the clinical utility for these novel assays. Following these studies, a monitoring product will be made available to clinical customers.

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"We are excited to develop monitoring products based on Foundation Medicine’s genomic insights, and we believe that partnering with Natera, a leader in personalized ctDNA monitoring, offers the potential to significantly advance personalized medicine," said Cindy Perettie, Chief Executive Officer of Foundation Medicine. "Cancer monitoring is an important part of patient care and developing innovative and more efficient diagnostics for physicians to identify disease progression and therapy resistance earlier is critical."

The companies will leverage Foundation Medicine’s FoundationOne CDx as the baseline test to define a set of unique variants that will subsequently be monitored utilizing a co-developed assay that includes components of Natera’s Signatera platform. While the initial focus is to develop personalized cancer monitoring assays that are compatible with FoundationOne CDx as the baseline test, Foundation Medicine may also elect to expand the scope of the partnership to develop monitoring assays that utilize genomic data generated from Foundation Medicine’s FoundationOneLiquid test for solid tumors utilizing ctDNA and/or FoundationOneHeme test for hematologic malignancies and sarcomas.

Foundation Medicine has the exclusive right to commercialize the co-developed monitoring assays. Natera will continue to exclusively offer Signatera testing based on whole exome sequencing of tumor and matched normal DNA.

"We are thrilled to partner with Foundation Medicine on this landmark opportunity," said Steve Chapman, Natera’s Chief Executive Officer. "This partnership accelerates Natera’s progress towards making personalized ctDNA monitoring the global standard of care for evaluating patient response to cancer therapy."

Foundation Medicine’s tests are ordered by physicians for more than 100,000 patients per year, and the company has more than 50 active biopharma partnerships.

On September 24, 2019 Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, reported the closing of a $62 million Series C financing (Press release, Amphivena Therapeutics, SEP 24, 2019, View Source [SID1234539751]). The round was co-led by NanoDimension and Qiming Venture Partners USA, and included new investors Clough Capital, Aju IB, Korys Merieux, Kaitai Capital, Industrial Investors, Nawton Limited and insiders MPM Capital, funds managed by Tekla Capital Management LLC and Franklin Berger.

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"AMV564 is a T cell engager that selectively eliminates myeloid-derived suppressor cells (MDSC) in cancer patients while sparing normal neutrophils and monocytes. Its unique activity and excellent safety profile positions AMV564 well, as monotherapy or in combination with other agents, for the treatment of hematologic malignancies and solid tumors," said Jeanmarie Guenot, Ph.D., Amphivena Chief Executive Officer and President.

"The Series C financing is an endorsement by new and existing investors of our leadership in the evolving T cell engagement space," said Peter Van Vlasselaer, Ph.D., Executive Chairman. "This funding enables us to study the therapeutic impact of selective MDSC removal in both hematologic and solid cancers and to advance AMV564 and our novel T cell engagement portfolio to the forefront of immuno-oncology."

About AMV564

AMV564 is a bivalent, bispecific (2:2) T cell engager that binds CD33 and CD3. To date, over 50 patients have received AMV564 in two Phase 1 clinical trials for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is currently being evaluated in a First-in-Human Phase 1 trial in patients with relapsed/refractory AML at Washington University School of Medicine, MD Anderson Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, Fred Hutchinson Cancer Research Center, The Ohio State University Wexner Medical Center, University of Pennsylvania Medical Center, Northwestern Memorial Hospital, and The Johns Hopkins Hospital.

The safety, efficacy and selectivity of AMV564 was highlighted most recently at both the 24th European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam (Abstract S877) and at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, CA last December. Amphivena believes that AMV564 has demonstrated novel clinical activity by rapidly and selectively eliminating leukemic blasts and rare immature, granulocytic and monocytic MDSCs while sparing normal CD33-expressing cells, including neutrophils and monocytes.

AMV564 is also being evaluated in a Phase 1 solid tumor study which is currently open to enrollment.

On September 24, 2019 AIM ImmunoTech (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, reported the U.S. Department of Defense (DoD) has granted $8.32 million in funding in another "Breakthrough Award (Press release, AIM ImmunoTech, SEP 24, 2019, View Source [SID1234539736])". This award is to Moffitt Cancer Center for a Phase 2 clinical study of a combination of therapies, including the Company’s drug Ampligen, in patients with brain-metastatic breast cancer (BMBC).

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The funding is through the DoD’s Breast Cancer Research Program, which started the Breakthrough Awards to support research that has the potential for a major impact and to accelerate progress toward ending breast cancer. As recently announced, Roswell Park Comprehensive Cancer Center (Roswell Park) reported receipt of its own DoD-funded Breakthrough Award of $6.42 million to study Ampligen in the treatment of BMBC. Together, these separate but parallel proposed clinical trials are receiving approximately $15 million in DoD funding to study Ampligen as a tumor microenvironment modulating agent component of a dendritic cell vaccine approach in the treatment of brain-metastatic breast cancer, which include both brain parenchyma and leptomeningeal sites of metastasis.

The grant to Moffitt Cancer Center was made possible by the unique complementary preclinical and clinical expertise of the teams of Dr. Brian Czerniecki of Moffitt Cancer Center and Dr. Pawel Kalinski of Roswell Park. The researchers hypothesize that vaccination with HER2/HER3-loaded dendritic cells (alpha-DC1s) combined with tumor-selective chemokine modulation (CKM) will be clinically effective and may enhance antitumor efficacy of PD-1 blockade when treating BMBC. Ampligen is a component of CKM therapy.

"Treatment of brain metastasis to the central nervous system is a large need for women with metastatic breast cancer and this novel immunotherapy offers promise to this group of patients," said Dr. Czerniecki, chair of the Department of Breast Oncology at Moffitt Cancer Center.

The researchers’ submitted impact statement highlights this need: "The current treatments, such as surgery or radiotherapy (whole-brain radiation or stereotactic radio-surgery), or intrathecal (I.T.) chemotherapy, constitute a significant burden for patients and do not prevent recurrence and death. The proposed immune therapy will provide new treatment options for these patients who currently face a very grim prognosis."

"These combination therapies are designed to convert ‘cold’ tumors that don’t respond well to existing immune therapies into ‘hot’ tumors that are more susceptible to targeting by immune therapies," said Equels. "We are honored to have Ampligen evaluated as part of a combination therapy in brain-metastatic breast cancer in this DoD-funded comprehensive clinical trial at Central Florida-based Moffitt Cancer Center, one of the world’s premier breast cancer research centers. Brain-metastatic breast cancer is a devastating illness with very poor prognosis, and we are hopeful that Ampligen will play a major role in providing hope to these patients."