On November 16, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported it has entered into a Memorandum of Understanding (MoU) with The National Nuclear Laboratory (NNL) to explore avenues to supply Pb-212 to researchers, and possibly clinicians, in the United Kingdom and Europe, using Viewpoint’s proprietary isotope generator, VMT- -GEN (Press release, Viewpoint Molecular Targeting, NOV 16, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-enters-agreement-with-uk-based-national-nuclear-laboratory-ltd-to-advance-development-of-targeted-alpha-therapy-for-cancer/ [SID1234595698]).

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VMT- -GEN is an elegantly-designed isotope generator that provides therapeutic doses of Pb-212 for the Company’s therapeutics – part of its ("Theranostic") programs for the treatment of cancers (including metastatic melanoma, neuroendocrine tumors, and other oncology indications in the company pipeline).

"This agreement is great news for the UK nuclear medicine research community and ultimately, cancer patients. Targeted radionuclide therapy with alpha-emitting radionuclides such as actinium-225 has shown some astonishing success in early small-scale trials for treating cancer patients recently, but availability of these radionuclides is a major roadblock to implementing it more widely, particularly in the UK. The availability of lead-212 made possible by this collaboration will go a long way to removing this roadblock, allowing the UK’s world-leading radiochemistry, radiobiology and clinical researchers to develop new treatments for cancer," added Phil Blower, DPhil, FRSC, Professor of Imaging Chemistry, KCL, Head of Dept of Imaging Chemistry and Biology.

The National Nuclear Laboratory is a UK government owned and operated nuclear services technology provider covering the whole of the nuclear fuel cycle. As part of the agreement, Viewpoint and NNL will explore opportunities for the provision of feedstock radionuclides at the appropriate specification for production of VMT-α-GEN generators; and the use of laboratory facilities required for the production of generators in the UK.

"This agreement with NNL is a momentous step forward as we work to deploy our proprietary VMT- -GEN generator and thereby expand the global availability of lead-212. We believe our VMT- -GEN holds a tremendous amount of potential and this collaboration enables us to supply lead-212 to support preclinical work and clinical trials utilizing VMT-α-GEN in the United Kingdom," commented Michael K. Schultz, PhD, Chief Science Officer of Viewpoint. "We are committed to bolstering our networks with researchers as well as distribution in the UK and Europe to optimize that potential. We are honored to be working with the NNL team and look forward to leveraging their knowledge and expertise."

Radionuclide generators such as VMT- -GEN are used commonly in radiopharmaceutical manufacturing operations and nuclear medicine facilities across the world. The devices share a common characteristic of enabling the production of a purified chemical form of the radionuclide needed that can be easily combined with ligands that seek out cancerous tumors. Because the shelf life of VMT- -GEN is based on longer-lived radionuclides, a single shipment of VMT- -GEN can be used to produce radiopharmaceutical doses daily, for up to a week or more. Given their small footprint, multiple generators can easily be operated within a single facility simultaneously. The device also simplifies radioactive waste management as the spent generator can be easily returned to the manufacturer in approved packaging to eliminate radioactive waste from the medical center or radiopharmacy.

On November 16, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported its 2021 third quarter unaudited financial results (Press release, Legend Biotech, NOV 16, 2021, View Source [SID1234595714]).

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"It continues to be a banner year for us, as we launch our clinical trial in the US for the T cell lymphoma program and see promising developments in our pipeline," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We intend to close the year on a strong note by presenting new and updated results from our CARTITUDE Clinical Development Program at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting next month and work to bring cilta-cel to more patients."

Recent Highlights

In October 2021, Legend Biotech and its collaboration partner Janssen Biotech, Inc. (Janssen) completed the enrollment of the Phase 3 CARTITUDE-4 study, evaluating cilta-cel in patients with multiple myeloma who have received 1-3 prior lines of therapy including a proteasome inhibitor and immunomodulatory agent and are refractory to lenalidomide. The purpose of this study is to compare the efficacy of cilta-cel with standard therapy – either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
The U.S. FDA has extended the PDUFA target date for cilta-cel by three months to February 28, 2022. The extension allows the FDA sufficient time to review information recently submitted pertaining to an updated analytical method following an FDA information request.
On October 18, 2021, Legend Biotech hosted its first Research & Development (R&D) Day in New York, sharing updates on Legend Biotech’s pipeline advancements, including expanded capabilities in cell therapy, and milestones in the cilta-cel clinical development program. The Legend Biotech pipeline has been updated to reflect the disclosures made at this event, including the targets for two of the company’s investigational autologous CAR-T therapies, LB2101 and LB2102. Additionally, the investigator-initiated clinical trial in China evaluating an investigational autologous CAR-T targeting CD33 and CLL-1 for the treatment of acute myeloid leukemia has been removed. The Phase I dose escalation study showed a lack of CAR-T expansion and efficacy.
In September 2021, the Phase 1, open-label, multicenter clinical trial began in the United States for LB1901, an investigational autologous CD4-targeted CAR-T therapy for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). The primary objectives of the trial are to characterize the safety and tolerability of LB1901 and determine the optimal dose.
Key Upcoming Milestones

New and updated data from the CARTITUDE Clinical Development Program will be presented at the 63rd ASH (Free ASH Whitepaper) Annual Meeting and Exposition taking place from December 11-14, 2021. Highlights include:
CARTITUDE-1 updated results from the Phase 1b/2 study of cilta-cel in patients with relapsed or refractory multiple myeloma (RRMM)
Adjusted indirect comparisons of patient outcomes in CARTITUDE-1 versus therapies from real-world clinical practice from the prospective LocoMMotion study
CARTITUDE-1 subgroup analysis data
CARTITUDE-2 first data in patients with multiple myeloma and early relapse after initial therapy (Cohort B) and updated data in lenalidomide-refractory patients with progressive multiple myeloma after 1-3 prior lines of therapy (Cohort A)
First preclinical in vivo data for novel tri-specific single-domain antibody (VHH) CAR-T cells (LCAR-AIO)
Legend Biotech’s collaboration partner, Janssen, anticipates submitting a New Drug Application (NDA) to the Japan Pharmaceuticals and Medical Devices Agency in Q4 2021, seeking approval of cilta-cel for the treatment of adults with RRMM.
Financial Results for the Three-month and Nine-month Periods Ended September 30, 2021

Cash and Cash Equivalents and Time Deposits

As of September 30, 2021, Legend Biotech had approximately $636.0 million of cash and cash equivalents, interest yielding securities and time deposits.

Revenue

Revenue for the three months ended September 30, 2021 was $16.9 million compared to $11.7 million for the three months ended September 30, 2020. $2.2 million out of the increase of $5.2 million was due to two additional milestones achieved pursuant to Legend Biotech’s agreement with Janssen in the fourth quarter of 2020 and in the second quarter of 2021, respectively. The remaining $3.0 million increase in revenue was consideration for the exclusive licensing of patents to Nanjing Probio Biotech Co., Ltd (Probio), a related party controlled by Legend Biotech’s majority shareholder, Genscript Corporation, and affiliates of Probio in September 2021.

Revenue for the nine months ended September 30, 2021 was $50.8 million compared to $34.9 million for the nine months ended September 30, 2020.

Milestone payments are constrained and only included as customer consideration for revenue recognition when it is highly probable that the associated milestone will be achieved, typically when the triggering event occurs. This resulted in an increase in revenue recognized in 2021.

Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2021 were $72.3 million compared to $63.7 million for the three months ended September 30, 2020. This increase of $8.6 million was primarily due to continuous research and development activities in cilta-cel and toward other pipeline advancements. Consistently, research and development expenses for the nine months ended September 30, 2021 was $226.8 million compared to $165.2 million for the nine months ended September 30, 2020, an increase of $61.6 million.

Administrative Expenses

Administrative expenses for the three months ended September 30, 2021 were $11.8 million compared to $6.0 million for the three months ended September 30, 2020. The increase of $5.8 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to facilitate continuous research and development activities as well as activities to establish elements of a commercialization infrastructure. Due to the consistent business expansion, administrative expenses for the nine months ended September 30, 2021 increased by $15.8 million, which was $29.8 million for the nine months ended September 30, 2021 compared to $14.0 million for the nine months ended September 30, 2020.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended September 30, 2021 were $19.5 million compared to $9.3 million for the three months ended September 30, 2020. This increase of $10.2 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel. Driven by the same cause, selling and distribution expenses for the nine months ended September 30, 2021 was $49.7 million compared to $25.4 million for the nine months ended September 30, 2020, an increase of $24.3 million.

Other Income and Gains

Other income and gains for the three months ended September 30, 2021 was $0.6 million compared to $1.5 million for the three months ended September 30, 2020. Other income and gains for the nine months ended September 30, 2021 was $2.3 million compared to $5.3 million for the nine months ended September 30, 2020. The decrease of $0.9 million and $3.0 million, respectively, primarily resulted from lower government grant and interest income earned during the three- and nine-month periods ended September 30, 2021, as compared to the corresponding prior year periods.

Other Expenses

Other expenses for the three months ended September 30, 2021 was $2.5 million compared to $1.2 million for the three months ended September 30, 2020. The increase of $1.3 million was primarily due to higher foreign currency exchange loss. Other expenses for the nine months ended September 30, 2021 was $6.9 million compared to $1.3 million for the nine months ended September 30, 2020. The increase of $5.6 million was primarily due to higher foreign currency exchange loss, loss from disposal of assets and other expenses during the nine months ended September 30, 2021.

Finance Costs

Finance costs for the nine months ended September 30, 2021 was $0.3 million compared to $4.2 million for the nine months ended September 30, 2020. The decrease was primarily due to finance costs related to the issuance of convertible redeemable preferred shares in 2020, which were fully converted into ordinary shares upon the completion of Legend Biotech’s initial public offering in June 2020.

Fair Value Loss of Warrant Liability

Fair value loss of warrant liability for the nine months ended September 30, 2021 was $37.4 million caused by changes in fair value of a warrant, which was issued to an institutional investor through a private placement transaction in May 2021. Concurrently, ordinary shares were sold to the same institutional investor in a private placement transaction. The warrant was assessed as a financial liability with a fair value of $119.1 million as of September 30, 2021 and a fair value loss of $35.8 million was recorded for the three months ended of September 30, 2021.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the nine months ended September 30, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of fair value of Series A convertible redeemable preferred shares (Series A Preferred Shares). Upon consummation of Legend Biotech’s U.S. initial public offering, all outstanding Series Preferred Shares were converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech.

Loss for the Period

Net loss for the three months ended September 30, 2021 was $124.8 million, or $0.43 per share, compared to $66.5 million, or $0.25 per share, for the three months ended September 30, 2020. Net loss for the nine months ended September 30, 2021 was $297.9 million, or $1.07 per share, compared to $245.7 million, or $1.08 per share, for the nine months ended September 30, 2020.

On November 16, 2021 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, reported that it successfully closed a $40 million Series A3 financing round led by Perceptive Xontogeny Ventures Fund II (PXV Fund) (Press release, Sermonix Pharmaceuticals, NOV 16, 2021, View Source [SID1234595680]). Existing investors also participated in the financing.

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As part of the agreement, Fred Callori and Ben Askew, Ph.D., partners in the PXV Fund, were appointed to the Sermonix Board of Directors.

"We are excited to welcome investors who share our passion as we work to leverage a precision medicine approach to address a significant unmet need in the metastatic breast cancer setting," said David Portman, M.D., Sermonix founder and chief executive officer. "This is a pivotal moment for Sermonix. With a strengthened balance sheet and both our ELAINE Phase 2 studies fully enrolled and progressing, we have set the stage for a catalyst-rich 2022, with initial data from each trial expected in the first half."

The PXV Fund team brings significant scientific, business, operational and investment expertise to the Sermonix team, with a singular goal of shepherding lasofoxifene through compelling and rigorously designed clinical proof-of-concept studies.

"We are pleased to announce our support for Sermonix Pharmaceuticals in their endeavors to develop an effective treatment for the approximately 40% of breast cancer patients who develop ESR1 mutations and progress following endocrine therapy," said Mr. Callori. "We believe lasofoxifene, if approved, may become a treatment of choice for oncologists and many of their patients with this challenging disease. The accomplished team at Sermonix recognizes the acute medical need and will be executing effectively on these strategies."

Sermonix recently announced significant progress in the advancement of its ELAINE (Evaluation of Lasofoxifene in ESR1 Mutations) Phase 2 clinical program for lasofoxifene:

In August, Sermonix announced completion of enrollment in its Phase 2 ELAINE 1 trial (NCT03781063), which is evaluating lasofoxifene versus the current standard of care, fulvestrant, for the treatment of ER+/HER2- breast cancer in patients with an ESR1 mutation. Sermonix expects topline data from the trial, which enrolled a total of 100 patients, in the first half of 2022.
In June, Sermonix announced completion of enrollment in its Phase 2 Elaine 2 trial (NCT04432454), which is evaluating lasofoxifene in combination with Eli Lilly and Company’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib. Initial data from the trial is expected in the first half of 2022.
LifeSci Capital acted as placement agent for Sermonix on this transaction.

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On November 16, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenues and cash position for the first nine months of 2021 (Press release, Innate Pharma, NOV 16, 2021, View Source [SID1234595699]).

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"In the period, we continued to execute against our strategic priorities as we reported readouts from two of our partnered portfolio programs. This included randomized Phase 2 data for monalizumab in combination with durvalumab in unresectable, Stage III NSCLC as well as pre-clinical data from our lead ANKET molecule targeting CD123 in acute myeloid leukemia. These readouts continue to set the stage for delivering both near and long-term value, while also highlighting the strength and depth of our core R&D efforts," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Looking ahead, we will continue to advance our lacutamab development program and move our early-stage R&D activities towards the clinic with our next generation ANKET platform. We also look forward to seeing AstraZeneca’s upcoming plans for monalizumab’s registrational study in unresectable, Stage III NSCLC, which further reinforces our strategy of building a sustainable business with a robust R&D engine."

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website following the event.

Pipeline highlights:

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

In September, AstraZeneca presented a late-breaker abstract on the randomized COAST Phase 2 trial in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The presentation highlighted progression-free survival (PFS) and overall response rate (ORR) results for durvalumab in combination with monalizumab, Innate’s lead partnered asset, and oleclumab, AstraZeneca’s anti-CD73 monoclonal antibody. After a median follow-up of 11.5 months, the results of an interim analysis showed a 10-month PFS rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone in unresectable, Stage III NSCLC patients following chemoradiation therapy. The results also showed an increase in the primary endpoint of confirmed ORR for durvalumab plus monalizumab over durvalumab alone (36% vs. 18%).
Based on the data, AstraZeneca announced plans to initiate a Phase 3 trial for both combinations of monalizumab or oleclumab plus durvalumab in the unresectable, Stage III NSCLC setting for patients who had not progressed after concurrent chemoradiation therapy.
Separately, AstraZeneca also announced that it is starting a Phase 2 clinical trial, NeoCOAST-2, that includes a treatment arm with durvalumab in combination with chemotherapy and monalizumab in resectable, early-stage NSCLC.
Innate will present data from the Phase 2 expansion cohort (‘cohort 3’), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with recurrent/metastatic squamous cell carcinoma of the head and neck, which was accepted as a mini oral presentation at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (ESMO-IO) conference in December 2021.
Lacutamab (anti-KIR3DL2 antibody):

Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are initiating:
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) plans to initiate an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
ANKET (Antibody-based NK cell Engager Therapeutics):

IPH6101/SAR443579

In November Innate and Sanofi shared new data on IPH6101/SAR443579 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference. IPH6101/SAR443579 is the first NKp46/CD16-based NK cell engager using Innate’s proprietary ANKET multispecific antibody format that targets CD123 on acute myeloid leukemia (AML) cells and co-engages NKp46 and CD16a on NK cells.

IPH6101/SAR443579 demonstrated potent antitumor activity against AML cell lines and primary AML blasts, including those resistant to ADCC by a comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted strong and specific NK-cell activation and induced cytokine secretion only in the presence of AML target cells. In addition, IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor cytokine release and a favorable safety profile in comparison to T-cell engagers.
Tetra-specific ANKET

In September and November 2021, Innate also presented at the ESMO (Free ESMO Whitepaper) 2021 and SITC (Free SITC Whitepaper) conferences respectively. Innate shared data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a cytokine receptor (IL-2Rb) and a tumor antigen via a single molecule. In preclinical studies, the tetra-specific ANKET demonstrated in vitro the ability to induce human NK cell proliferation, cytokine production and cytolytic activity against cancer cells expressing the targeted antigen.

The tetra-specific ANKET also demonstrated in vivo anti-tumor efficacy in several tumor models, allowing regression of established tumors as well as control of metastasis, associated with increased NK cell infiltration, cytokine and chemokine production at the tumor site. ANKET also showed a pharmacodynamic effect, low systemic cytokine release and a manageable safety profile in non-human primates.
IPH5201 (anti-CD39):

AstraZeneca is conducting a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab. The data is expected to be presented in 2022.
IPH5301 (anti-CD73):

The Company is initiating an investigator-sponsored Phase 1 trial of IPH5301 in collaboration with the Institut Paoli-Calmettes.
Financial Results:

Cash, cash equivalents and financial assets of the Company amounted to €141.8 million as of September 30, 2021. At the same date, financial liabilities amounted to €16.1 million.

Revenues for the first nine months of 2021 amounted to €10.3 million (€33.6 million for the same period in 2020). For the nine-month period, ended September 30, 2021, revenue from collaboration and licensing agreements mainly results from the spreading of the payments received under our agreements with AstraZeneca and Sanofi.

On November 16, 2021 Individualized cancer diagnosis and treatment regimens are the future of oncology care and require harnessing the advances of scientific research (Press release, Indivumed, NOV 16, 2021, View Source [SID1234595715]). In a milestone moment, Northwell Health and its partner Indivumed GmbH, a Hamburg, Germany-based oncology research company, reported that they have successfully consented 1,000 patients, enabling the standardized collection and analysis of cancer biospecimens to be made available for researchers worldwide and to provide a unique basis for the multi-omics database of Indivumed to define novel targets and subsequently therapies.

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Northwell Health’s Cancer Institute diagnoses and cares for more than 19,000 new cancer patients annually. During the consented patient’s normal treatment, the Northwell Health Biospecimen Repository (NHBR) research team applies the Indivumed Standard Operating Procedure for collecting excess cancer tissue from various organ sites, including lung, breast, colorectal, and uterine. They send the carefully procured cancer tissue – frozen within 10 minutes to assure biological tissue composition – to Indivumed GmbH’s U.S. headquarters in Frederick, MD. These de-identified patient samples are then made available to scientists to further study at The Feinstein Institutes for Medical Research, Northwell Health’s science arm, and others across the globe in an effort to advance cancer research, develop anti-tumor drugs and enhance personalized medicine approaches.

"We strive to provide outstanding patient care, cutting-edge clinical trials and new scientific discoveries to treat cancer," said Jeff Boyd, PhD, vice president, chief scientific officer and director of the Center for Genomic Medicine at Northwell Health Cancer Institute. "We will continue to expand our ability to collect these critical biospecimens and gain a better understanding between cell biology and the development of targeted, effective cancer therapies," added Dr. Boyd, who is also the director of the Institute of Cancer Research at the Feinstein Institutes.

"Individualized cancer diagnosis and treatment that is based on specialized, comparable, high-quality clinical data and biospecimens are essential," said Hartmut Juhl, MD, PhD, Founder and CEO of Indivumed. "This milestone achievement and continued partnership with Northwell Health revives our hope that we make a dramatic difference in precision medicine by deciphering multi-omics data for the benefit of cancer patients."

Samples have been collected since 2017 at the start of a three-year agreement, and in 2020 Northwell Health and Indivumed GmbH initiated a new five-year partnership to expand the cancer biobanking activities. Northwell Health, the largest health care provider in New York State, serves a diverse regional patient population. This is critical for cancer research, as the collected samples represent a broad spectrum of patient demographics and genetics. The close relationship between Indivumed GmbH and Northwell Health also strengthens Northwell Health’s ability to support its affiliation with Cold Spring Harbor Laboratory, further bolstering basic and translational cancer research to develop new oncology therapies.

Indivumed is a world leader in tissue collection, preservation, and data analytics based on the largest comprehensive multi-omics database available. With Northwell Health’s help, it will add thousands of biological samples to be used in research and clinical trials for communities worldwide. Indivumed is on track to collect and store an additional 100 samples by year’s end with Northwell Health.