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.

On November 16, 2021 The Centers for Medicare & Medicaid Innovation (CMMI) reported that released results for the 8th Performance Period (PP8) of the Oncology Care Model (OCM), and practices in The US Oncology Network (The Network) participating in the program achieved high marks on quality metrics and provided significant cost savings to Medicare (Press release, US Oncology, NOV 16, 2021, View Source [SID1234595681]).

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All 14 of The Network participating practices improved patient care by achieving top quality measurement scores, resulting in a 100% Performance Multiplier for all 14 practices. Together, the practices saved Medicare approximately $54 million over the six-month performance period — for a total savings of $197 million since the OCM began in 2016.

The OCM is a pilot program designed by CMMI to provide higher quality, more coordinated cancer care at the same or lower cost to Medicare. It is an integral part of Medicare’s ongoing effort to transition healthcare to a more value-based approach.

"We are extremely proud of the exceptional performance of all 14 of the practices in The US Oncology Network participating in the OCM and the cost savings they delivered to Medicare," said Stuart Staggs, senior director of Strategic Programs for The Network. "Practices in The Network are bending the cost curve for oncology while providing enhanced care to patients, as demonstrated by their outstanding quality performance scores."

Since the program’s inception, The Network practices have improved steadily in OCM metrics, culminating in these impressive results for PP8. For example, patient emergency department use was the lowest since the start of the program, as practices cared for patients needing immediate attention through a variety of heightened services, such as nurse navigation, enhanced triage, telehealth or urgent care visits within the clinic. All practices also reported substantial gains on depression screening and pain management.

The 14 OCM practices in The Network represent approximately one-fourth of all providers participating in the program, demonstrating the leadership role The US Oncology Network is playing in the development of value-based oncology care. Since the program launched, more than 110,000 patients have been enrolled in the OCM across The Network, receiving high-quality, value-based care in their local communities.

"Much of the success The Network practices have achieved in the OCM is the result of strong support from The US Oncology Network," said Lalan Wilfong, MD, vice president of Payer Solutions and Practice Transformation for The Network. "The Network is dedicated to ensuring its member practices have access to the tools and expertise they need to thrive in the evolving healthcare landscape."

Comprehensive, proven resources are available, including industry-leading technologies from Ontada that support decision-making at the point of care and advanced analytics for optimal data management and reporting. The Network, supported by McKesson, also gives practices access to thought leaders and key staff who have deep expertise in value-based care. This includes a Value-Based Care Transformation Lead, an expert assigned to each practice to guide them in not only program requirements, but also performance improvement.

"It is reassuring to see how well The Network practices are performing, as the OCM is a bridge to the future and an important first step in creating patient-centered cancer care that focuses on both quality and value," said Judi Payne, director of Value-Based Care Transformation for The Network. "Building on our successes in the OCM, The US Oncology Network will continue working to advance value-based cancer care by finding new and innovative ways to elevate and enhance patient care while controlling costs."

On November 16, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported that it will incorporate data from both the Memorial Sloan Kettering Cancer Center (MSK) OncoKB database and National Comprehensive Cancer Network (NCCN)’s Clinical Practice Guidelines in Oncology (NCCN Guidelines) into its clinical reports (Press release, Tempus, NOV 16, 2021, View Source [SID1234595716]). Tempus is collaborating with two of the world’s largest clinical decision-support resources to support the genomic foundational science and clinical applications of its xT assay.

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Tempus reports will reflect therapy choices based on molecular profile and corresponding NCCN Guidelines recommendations and information from the OncoKB database, therefore making it easier for physicians to optimize treatment plans for their patients. Tempus is also the largest genomic sequencing company to incorporate the OncoKB database, which recently received partial recognition by the Food & Drug Administration (FDA) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.

"We are combining and curating two of the most robust oncology resources in the world and delivering them to physicians through the lens of their patients’ specific molecular and clinical profiles," said Kimberly Blackwell, MD, Chief Medical Officer at Tempus. "This initiative is a step towards making our diagnostics even smarter and making personalized care achievable for every patient facing cancer."

The OncoKB database features detailed information regarding specific alterations in 682 cancer genes, curated from various sources, including FDA drug labels, medical professional group guidelines, medical and scientific literature, and clinical trial eligibility criteria. The FDA recognized a portion of the OncoKB database as a source of valid scientific evidence and mapped the selection of cancer mutations to FDA Level 2 (clinical significance) and FDA Level 3 (potential clinical significance).

"OncoKB channels the clinical and scientific expertise of MSK physician-scientists into a structured database that provides information about the biologic and therapeutic implications of cancer-specific alterations," said Debyani Chakravarty, PhD, Lead Scientist, OncoKB and Assistant Attending, Department of Pathology at MSK.

The NCCN Guidelines are a comprehensive, continuously-updated set of guidelines detailing the sequential management decisions and interventions that currently apply to 97 percent of cancers affecting patients in the United States. Specific NCCN Guidelines have also been developed for cancer screening and prevention, therapeutic management, supportive care issues, and specific populations. The NCCN Guidelines are intended to assist all individuals who impact decision-making in cancer care including physicians, nurses, pharmacists, payers, patients and their families, and many others.

"This collaboration with Tempus will help us share the frequently-updated, evidence and expert consensus-based recommendations in the NCCN Guidelines more seamlessly with healthcare providers," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "We are happy to be working with this precision medicine technology company to place important cancer decision support tools at the point-of-care, ultimately benefiting patients."