On March 2, 2021 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported a partnership with leading health system Providence to advance the science and delivery of cancer care (Press release, Grail, MAR 2, 2021, View Source [SID1234575968]). Providence, based in Renton, Washington, will be the first health system to offer Galleri, GRAIL’s multi-cancer early detection blood test, as a complement to recommended single cancer screening tests.

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The Galleri test initially will be used by Providence at its California, Washington, and Oregon points of care, and could eventually be available across Providence’s entire seven-state footprint that includes more than 50 hospitals and nearly 1,100 health clinics serving 5 million patients. Providence aims to pursue effective ways to identify cancer earlier in patient lives, and will integrate the Galleri test into clinical care to help drive earlier detection of multiple cancers and to try to improve and save lives.

"Today, the majority of cancers are found too late when outcomes are often fatal, and as a result, cancer is projected to become the leading cause of death worldwide," said Hans Bishop, chief executive officer at GRAIL. "Providence is a leading health system that shares our commitment to improving and saving lives, and our partnership moves us that much closer to making a tremendous and potentially life-altering difference for patients and providers. We are encouraged by interest in Galleri from health systems, medical practices, and self-insured employers, and excited by the progress in our mission to detect cancer early."

"At Providence, we continuously strive to deliver the most innovative medical advances to our patients, and we are thrilled to partner with GRAIL on implementation research that may bring Galleri to all the communities we serve," said Amy Compton-Phillips, MD, chief clinical officer at Providence. "When combined with the power of our genomics research, having a single blood test that can detect more than 50 cancers advances our goal of finding cancer early, enabling our providers to administer treatment when it’s most likely to be successful and giving our patients the opportunity to achieve the best possible outcomes."

GRAIL previously announced it expects to introduce Galleri in the second quarter of 2021. The blood test, which will be prescription only, will be available initially through partner health systems, medical practices, and self-insured employers.

An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers — over 45 of which lack recommended screening tests today — with a low false positive rate of less than 1%. When a cancer signal is detected, Galleri can determine where in the body the cancer is located with high accuracy, all from a single blood draw.

On March 2, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported that clinical trial results from its Phase II study investigating Herantis’ patented gene therapy Lymfactin, for the treatment of Breast Cancer Related Lymphedema (BCRL), were inconclusive (Press release, Herantis Pharma, MAR 2, 2021, View Source,c3298919 [SID1234577482]). Lymfactin is a unique gene therapy that induces expression of VEGF-C, an endogenous protein that is responsible for driving the growth and regeneration of lymphatic vessels. The primary purpose of the trial was to determine whether there was an additional benefit of Lymfactin treatment in combination with lymph node transfer surgery, compared to surgery alone. While both treatment groups experienced clear clinical benefits, the trial did not establish additional treatment benefit for Lymfactin in combination with surgery, compared to surgery alone.

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The results unexpectedly showed differences between the treatment groups at the start of the study (baseline), in terms of arm volume and quality of life, making it unfeasible to draw conclusions on the treatment effect of Lymfactin in combination with surgery, compared to surgery alone. In addition, the outcome measures used for the study were inconsistent which was surprising and made it difficult to accurately assess treatment response. These factors reflect the pioneering nature of the study in a novel indication where there will be inevitable learnings with regard to study design and suitable outcome measures to assess treatment effect.

Dr Anne Saarikko, Coordinating Principal Investigator of the study, commented "Herantis is at the forefront of finding a treatment for BCRL. This has been a ground-breaking study for the treatment of BCRL, and I commend the Herantis team for pushing the boundaries of science in an effort to help patients suffering from this debilitating condition. The overall results of the treatment appear promising for the majority of patients; however, we need to ascertain and assess the effect of Lymfactin specifically, which has not been possible in this challenging study."

The key findings of the analysis at 12 months post treatment indicate that approximately half of the patients obtained a clinically meaningful response, over 25% reduction in the affected arm volume compared with the normal arm in both Lymfactin and placebo treatment groups. Improvement in quality of life of most patients in the study was also seen across both treatment groups. However, for a meaningful statistical analysis to be conducted, it is essential that the two groups – placebo and active treatment groups – are comparable at baseline in terms of the primary outcome measures and other disease characteristics, which was not the case in this trial at the study start. The imprecision of the outcome measures further complicated demonstration of a therapeutic effect of Lymfactin. The company will continue to analyse and review the data to gain additional insight from the study including the baseline differences, adequacy of dosing, outcome measures, measurement tools, other signals in the data, and other potentially applicable target indications. The company expects to be able to announce any further findings and decisions on the program in Q2 2021.

From a safety perspective, Lymfactin was generally safe and well tolerated. Adverse events were mild and transient. The incidence of adverse events reported in patients treated with Lymfactin was comparable to the incidence for patients in the placebo group.

Craig Cook CEO commented "We are very grateful to the patients who participated in this pioneering study of our innovative gene therapy Lymfactin for the treatment of BCRL. While the efficacy of the overall treatment regime i.e. lymph node transfer surgery plus Lymfactin – is encouraging, we are disappointed that the study design did not allow for meaningful conclusions to be drawn about Lymfactin specifically. The novel nature of the Lymfactin program generally, and this study specifically, means there have been a number of clear and important learnings, and we will now continue our analysis of the data and review of the strategic options for the program moving forward. In parallel, the company’s CDNF and xCDNF programs continue at pace, with the dedicated funds raised in recent fundraise December 2020 enabling planned development activities for these programs."

The study is a randomized, double-blinded, placebo-controlled, Phase II clinical trial conducted in 39 patients across 5 sites in Finland and Sweden. Patients selected according to strict inclusion criteria were enrolled into the study and randomized to receive either one dose of placebo or Lymfactin, together with lymph node transfer surgery. The study was unblinded after all patients were monitored for 12 months post-surgery. Primary endpoints were volume reduction in the affected arm, changes in quality of life (QoL) and changes in lymphatic flow assessed by quantitative lymphoscintigraphy. The patients will continue to be monitored for efficacy and safety endpoints for 36 months and 60 months post-operation, respectively.

About Lymfactin

Lymfactin is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication.

Lymfactin, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki.

About Breast Cancer Associated Lymphedema

Approximately 20% of breast cancer patients who undergo axillary lymph node dissection develop secondary lymphedema: a progressive, disabling, and disfiguring disease that severely affects the quality of life. Symptoms include a chronic swelling of an upper limb, thickening and hardening of skin, loss of mobility and flexibility, pain, and susceptibility to secondary infections. Secondary lymphedema is currently treated with compression garments, special massage, and exercises. While these therapies may relief the symptoms in some patients, they do not address the underlying cause of lymphedema, which results from damage to the lymphatic system. There are currently no approved medicines for the treatment of secondary lymphedema.

On March 2, 2021 Oscotec Inc. (039200: KOSDAQ), the Korean drug development company, and Beactica Therapeutics AB, the Swedish drug discovery company, reported a new research development and licensing agreement (Press release, Oscotec, MAR 2, 2021, View Source [SID1234575874]). Oscotec and Beactica will initially jointly collaborate concerning research and early preclinical development of novel anti-cancer drug candidates arising out of Beactica’s LSD1 programme. Oscotec may thereafter opt to take full responsibility for clinical development and commercialization.

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Under the terms of the agreement, Oscotec is entitled to gain exclusive global rights for further development and commercialization of Beactica’s programme. Beactica is eligible to receive up to EUR 149 million in potential preclinical, clinical and regulatory milestones, including an upfront and equity payment from Oscotec upon signing of the agreement. Furthermore, Beactica is eligible to receive double-digit royalties on commercial sales of the products resulting from the partnership. Beactica is also entitled to revenue shares from any related future licensing activities by Oscotec. Full financial details remain undisclosed.

"We are thrilled about the opportunity to work with Beactica on the LSD1 allosteric inhibitor programme that we hope opens up very unique and exciting possibilities," said Dr Taeyoung Yoon, CEO/CSO of Oscotec. "Not only could this opportunity fill our need of balancing the preclinical pipeline in the short term, we are convinced that the partnership will also bring to us added value of collaborative science where the two companies complement each other extremely well.""This is a landmark agreement for Beactica, and we are delighted to be working with Oscotec." said Dr Per Källblad, CEO of Beactica Therapeutics. "Their commitment to building a strong clinical pipeline of targeted therapeutics in immunology and oncology makes Oscotec an ideal partner for our programme."

On March 2, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported the addition of three new executives to the company’s management team (Press release, Vincerx Pharma, MAR 2, 2021, View Source [SID1234575899]). Hermes Garbán, M.D., Ph.D. has been appointed as Chief Medical Officer, Hans-Georg Lerchen, Ph.D. has been appointed as Chief Scientific Officer, and Tom Thomas, has been appointed as General Counsel and Chief Legal Officer of Vincerx.

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"The addition of Hermes, Hans-Georg, and Tom to the Vincerx team provides important expertise and experience to our accomplished management team as we enter the next stage of our development," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "The past months have been transformative at Vincerx, marked by our launch as a public company, and this groups’ combined decades of medical, scientific and legal acumen across biotech will be key as we work towards advancing our pipeline of targeted oncology therapeutics. We look forward to leveraging this strengthened team as we work towards important milestones through 2021 including the initiation of our Phase 1b studies evaluating VIP52, our highly selective and potent CDK9 inihitor, in Myc-driven hematologic malignancies and solid tumors, as well as relapsed/refractory chronic lymphocytic leukemia."

Hermes Garbán, M.D., Ph.D.
Hermes Garbán, M.D., Ph.D. is the Chief Medical Officer of Vincerx Pharma, Inc. Before joining Vincerx, Dr. Garbán served as Head, Therapeutics Discovery and Development at ImmunityBio, Inc., a registration stage immuno-oncology and infectious disease company responsible for conducting Phase 1 through Phase 3 clinical trials focusing on solid tumors and immunotherapies development, from March 2019 to February 2021. Before that, Dr. Garbán served as Head, Therapeutics Discovery and Development at NantBioscience, Inc., a biopharmaceutical company focused on the discovery of innovative cancer and infectious diseases, therapeutics and their clinical applications, from June 2017 to March 2019, and as Head, Therapeutic Antibody Discovery from September 2014 to June 2017. During his tenure at NantBioscience, Dr. Garbán also served as Deputy Vice President, Global Cell Manufacturing supporting operations at Nantkwest, Inc, an innovative clinical-stage immunotherapy company, from June 2017 to October 2018. Dr. Garbán served as Principal Investigator at the California NanoSystems Institute (CnSI) and Professor of Medicine at the University of California, Los Angeles (UCLA) from 2009 to 2014. Prior to that, Dr. Garbán served as Assistant Professor of Surgery in the Division of Surgical Oncology at UCLA from 2005 to 2009. Dr. Garbán is a physician-scientist who earned his M.D. from the Central University of Venezuela (UCV), where his medical practice focused on underserved and indigenous communities. He earned his Ph.D. in Microbiology, Immunology and Molecular Genetics at the University of California, Los Angeles (UCLA). Dr. Garbán trained as postdoctoral fellow in Molecular and Medical Pharmacology at UCLA under the mentorship of Dr. Louis Ignarro (1998 Nobel Prize for Physiology or Medicine).

Hans-Georg Lerchen, Ph.D.
Hans-Georg Lerchen, Ph.D. is the Chief Scientific Officer of Vincerx. Before joining Vincerx, Dr. Lerchen was a Distinguished Fellow in the Bayer Science Fellow Network of the Pharmaceuticals R&D organization of Bayer AG. With 33 years background in medicinal chemistry, he is author or coauthor of 81 patents/patent applications and 27 peer reviewed publications. Dr. Lerchen contributed to 5 INDs and to the identification of numerous preclinical candidates and lead structures. With his research focus on prodrugs and drug delivery modalities, he was the medicinal chemistry lead and key driver of diverse bioconjugate programs, including the development of ADCs with the novel KSPi toxophore and legumain linker platform, which Vincerx acquired from Bayer. Dr. Lerchen received his Ph.D. in organic chemistry from the University of Mainz with Professor Horst Kunz. After a year of research as a Max Planck postdoctoral scholarship holder at the MPI for Biochemistry in Munich, he started his industrial career at Bayer AG Leverkusen in the Central Research Department. After 14 years with responsibilities for different basic research programs he moved to the Medicinal Chemistry unit of the Pharmaceuticals Division of Bayer in Wuppertal. As a renowned scientist in the ADC field, Dr. Lerchen is an invited speaker on various international conferences. He serves as a board member of the biochemistry subgroup of the German Chemical Society (GDCh).

Tom Thomas, J.D.
Tom Thomas will be joining as General Counsel and Chief Legal Officer of Vincerx on March 15. Mr. Thomas is a partner at Pillsbury Winthrop Shaw Pittman LLP, a leading international law firm with offices in major metropolitan centers around the world. He has over 30 years of experience representing life science and technology companies at all stages of development, from start-up and emerging companies, to pre-IPO companies, to large public and private companies. His practice has focused on corporate and securities matters, including corporate governance, debt and equity financings, public and private acquisitions and dispositions, venture capital financings and investments, SPAC transactions, PIPE offerings, joint ventures and strategic alliances, SEC compliance and reporting, executive compensation, and technology transactions. Mr. Thomas received his B.B.A. in Accounting from the University of Iowa, where he graduated summa cum laude, and his J.D. from the University of Minnesota Law School, where he graduated magna cum laude.

On March 2, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported it has entered into an asset purchase agreement (APA) to acquire Ipsen’s (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087 (Press release, Fusion Pharmaceuticals, MAR 2, 2021, View Source [SID1234575921]). IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1.

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"The acquisition of IPN-1087 augments and further diversifies our pipeline of potent alpha-emitting radiopharmaceuticals and leverages our expertise to create targeted alpha therapies (TATs) using different classes of targeting molecules," said Chief Executive Officer John Valliant, Ph.D. "In clinical imaging studies, IPN-1087, which targets an established tumor target, has shown uptake in multiple tumor types. Combining IPN-1087 with the power of actinium-225, an alpha-emitter, we believe FPI-2059 will precisely target and kill tumor cells, leading to a significant opportunity to advance the treatment of high unmet need diseases, such as colorectal cancer and pancreatic ductal adenocarcinoma (PDAC)."

Under the terms of the APA, Fusion will issue to Ipsen 400,000 shares of its common stock upon closing and an additional 200,000 shares upon the achievement of a patent-related milestone. Such shares will be issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended. Fusion will also be obligated to pay Ipsen up to an additional €67.5 million upon the achievement of certain development and regulatory milestones; low single-digit royalties on potential future net sales; and up to €350.0 million in net sales milestones, in each case, relating to products covered by the APA. Fusion will be responsible for paying to a third-party licensor up to €70.0 million in development milestone payments and mid-single to low-double-digit royalties on potential future net sales of products covered by the license agreement.

Covington & Burling and Goodwin Proctor represented Fusion as legal advisors in the transaction. Barclays represented Ipsen as exclusive financial advisor and Hogan Lovells acted as Ipsen’s legal advisor.

About FPI-2059

FPI-2059 will be a radioconjugate combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1.