On June 28, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for its fourth fiscal quarter and year ended March 31, 2019, and provided an update on its business (Press release, Replimune, JUN 28, 2019, View Source [SID1234537335]).

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"This past fiscal year has been incredibly productive for Replimune, with the advancement of several important clinical programs and a successful IPO that provides us with a solid financial foundation to continue to develop our portfolio of therapies," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "We are continuing to make significant strides as we work towards delivering on the promise of our oncolytic immuno-gene therapies. Importantly, we expect to initiate our randomized controlled registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC) in the near term, and to advance our second product candidate into the clinic with the initiation of a Phase 1 trial of RP2 later this year. The Phase 2 part of our clinical trial of RP1 in combination with nivolumab in four solid tumor types has also initiated, and we expect to be sharing the first set of clinical data from the Phase 1 part of the clinical trial in the fourth quarter of 2019."

Recent Business Highlights and Upcoming Events

RP1 – Initiated the Phase 2 part of the Phase 1/2 clinical trial of RP1 in combination with nivolumab. In the Phase 2 part of the clinical trial, RP1 in combination with nivolumab is being tested in four 30-patient cohorts of patients with melanoma, non-melanoma skin cancers (NMSC), metastatic bladder cancer and microsatellite instability-high (MSI-H) tumors. Enrollment in the United States and the United Kingdom is now open in the melanoma, NMSC and bladder cancer cohorts, and enrollment in the MSI-H cohort will open as soon as a protocol-required MSI-H patient is evaluable from Phase 1. The patients enrolled into the melanoma cohort will either be treatment naïve or have received one prior systemic therapy, including anti-PD1 and/or anti-CTLA-4 therapy, and the patients enrolled into the other three cohorts will all be naïve to anti-PD1 therapy. Efficacy and biomarker data will be evaluated within each tumor-type cohort.
RP1 – Data from the Phase 1 part of the Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab is expected to be reported at a medical conference in the fourth quarter of 2019. The Phase 1 part of this ongoing clinical trial tested single-agent RP1 by direct injection into a single superficial or nodal tumor and by imaging-guided injection into a single visceral tumor in patients with advanced heavily pre-treated cancers who have failed available therapy, with the goal of defining the recommended Phase 2 dose. Following determination of the recommended Phase 2 dose, an expansion group of advanced cancer patients, who have failed available therapy, then received RP1 at the recommended Phase 2 dose in combination with nivolumab at standard clinical doses. This clinical trial is being conducted under a clinical trial supply agreement with Bristol Myers Squibb (BMS) for the supply of nivolumab.
RP1 – Opening of the Phase 2 clinical trial of RP1 in combination with cemiplimab is expected in the near term. The registration directed randomized controlled Phase 2 clinical trial will enroll approximately 240 patients with CSCC, comparing treatment with cemiplimab alone to treatment with cemiplimab in combination with RP1, under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 therapy that was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally recurrent and metastatic CSCC.
RP 2 – Phase 1 clinical trial of RP2 as a single agent and in combination with nivolumab anti-PD1 therapy anticipated to initiate in the third quarter of 2019.RP2 is a further armed oncolytic immuno-gene therapy that, in addition to expressing GALV-GP-R- and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP2 is intended to be used primarily in combination with anti-PD1 or anti-PD-L1 therapy. Because of the need to address questions from regulatory authorities regarding certain Chemistry, Manufacturing, and Controls aspects of RP2, this clinical trial is expected to initiate one quarter later than originally anticipated. As with the clinical trial with RP1 in combination with nivolumab, this clinical trial will be conducted under a clinical trial supply agreement with BMS for the supply of nivolumab.
RP3 – Phase 1 clinical trial of RP3 as a single agent and in combination with anti-PD1 therapy to initiate in 2020.RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4. Following the assessment of a number of co-stimulatory pathways, which, like anti-CTLA-4, are expected to be primarily active at the site and time of anti-tumor immune response initiation, the selected immune co-stimulatory pathway activating proteins are CD40L and 4-1BBL. CD40L activates CD40, resulting in the broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137) to promote the expansion of cellular and memory immune responses.
Presented posters at ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper). At the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Replimune presented a "trials in progress" poster on the Company’s Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab. A poster describing preclinical data relating to Replimune’s Immulytic platform and entitled "Development & characterization of a new oncolytic immunotherapy platform based on herpes simplex virus type 1" was presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in March 2019. Both posters are available on the Company’s website.
Build out of Replimune’s manufacturing facility to support late-stage development and commercialization is on track and expected to be operational in the first half of 2020. In July 2018, Replimune signed a lease for a 63,000-square-foot facility in Framingham, MA where the Company intends to establish world-class multi-product manufacturing capabilities for its Immulytic product candidates. The capacity of this facility is expected to be sufficient to support full commercialization of the Company’s product candidates. The facility is expected to be operational in the first half of 2020.
Financial Highlights

Replimune reported a net loss of $6.6 million for the fiscal fourth quarter, ended March 31, 2019, and a net loss of $30.8 million for the fiscal year ended March 31, 2019, as compared to a net loss of $7.1 million and net loss of $19.7 million for the comparable periods in the prior fiscal year, respectively. The increase in net losses for both periods were primarily due to an increase in research and development expenses and administrative costs associated with our operations.

Research and development expenses were $5.4 million for the fiscal fourth quarter of 2019, and $22.2 million for the year ended March 31, 2019, as compared to $4.5 million and $13.5 million for the comparable periods in the prior fiscal year, respectively. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as increased salary and related benefits costs due to the increase in employee headcount from 44 on March 31, 2018 to 67 on March 31, 2019.

General and administrative expenses were $2.4 million for the fiscal fourth quarter of 2019, and $8.8 million for the year ended March 31, 2019, as compared to $2.5 million and $5.7 million for the comparable periods in the prior fiscal year, respectively. The increase in general and administrative expenses was primarily due to the increase in employee headcount and the impact of stock-based compensation in 2019.

Replimune ended the fiscal year with $134.8 million in cash and cash equivalents and short-term investments, compared with $141.8 million as of December 31, 2018 and $61.6 million as of March 31, 2018. The year-on-year increase reflects net proceeds received of $103.3 million (net of deferred offering costs of $9.9 million) in connection with the Company’s IPO in July 2018.

Based on its current operating plan, Replimune expects that its current cash and cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of calendar 2021.

On June 28, 2019 BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported the appointment of Eric L. Sievers, M.D., as chief medical officer (Press release, BioAtla, JUN 28, 2019, View Source [SID1234537333]). Dr. Sievers, an experienced biotechnology drug developer in oncology, joins the Company bringing clinical development and management experience directly relevant to BioAtla’s oncology focus and pipeline of Conditionally Active Biologic (CAB) candidates including in immuno-oncology and antibody drug conjugates (ADCs). His clinical development leadership, design and execution resulted in several successful oncology registration trials and approvals including, for Seattle Genetics, approvals of ADCETRIS in Hodgkin lymphoma, in peripheral T-cell lymphoma, and in cutaneous T-cell lymphoma.

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"Dr. Sievers’ experience and proven capabilities in leading the clinical development of innovative oncology products greatly enhances BioAtla’s ability to design, implement, and execute clinical programs evolving from our CAB platform that uniquely yields tumor-targeting antibodies with high safety," said Jay M. Short, Ph.D., chairman and chief executive officer of BioAtla.

"Dr. Sievers’ knowledge of and background in developing advanced biologics including ADC’s, and his experience in leading partnership interactions with pharmaceutical company partners is directly applicable to our current and future product and strategic plans," stated Scott Smith, president of BioAtla.

About Dr. Sievers
Dr. Sievers joins BioAtla with over 25 years of clinical and translational biomedical research experience in multiple settings, including biotechnology industry, hospital- and clinic-based clinical practice and academics. During his nine years at Seattle Genetics, he was closely involved with the development and regulatory approval of ADCETRIS (brentuximab vedotin), an ADC. Serving in multiple roles of increasing leadership responsibility, he led the Seattle Genetics clinical team and Takeda (Millennium) development partner to design, initiate and enroll four randomized Phase 3 registration trials for ADCETRIS that each ultimately resulted in new indications approved by the FDA. Dr. Sievers has managed clinical development efforts from Phase 1 to Phase 3 clinical trials, from strategy planning to study execution and BLA/NDA submissions. Prior to his career at Seattle Genetics, Dr. Sievers was Medical Director at ZymoGenetics where he designed and supervised clinical trials of recombinant human interleukin 21 and TACI-Fc5 for patients with cancer and evaluated new oncology opportunities. Before then, he was with the Fred Hutchinson Cancer Research Center for 12 years where he attained the position of Assistant Member and was Assistant Professor of Pediatrics at the University of Washington. During this time, he served as the lead investigator of Phase 1 and pivotal trials that resulted in the approval of an antibody drug conjugate MYLOTARG indicated for patients with acute myeloid leukemia. Dr. Sievers’ most recent position was Chief Medical Officer at Trillium Therapeutics where he developed clinical trial strategies and oversaw all clinical development employing a decoy receptor to block the CD47 "do not eat" signal overexpressed by cancer cells. Dr. Sievers received both his medical degree and his B.A. degree from Brown University.

About Conditionally Active Biologics (CABs)
Conditionally Active Biologics are proteins generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

On June 28, 2019 Menarini Ricerche reported the publication of the results of a non-clinical study describing the characterization of the anti-CD205 Antibody-Drug Conjugate (ADC) MEN1309/OBT076. These findings have been published by the journal Molecular Cancer Therapeutics (View Source) (Press release, Menarini, JUN 28, 2019, View Source [SID1234537332]).

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The study showed that CD205, a transmembrane glycoprotein, is robustly expressed in a variety of solid malignancies, such as pancreatic and bladder tumors, as well as triple negative breast cancer (TNBC). In these settings, MEN1309/OBT076 showed substantial in vitro antitumor activity. These results were confirmed in vivo where MEN1309/OBT076 demonstrated potent antitumor activity in TNBC, pancreatic, and bladder xenografts and patient-derived PDX models, resulting in durable responses and complete tumor regressions.

"These non-clinical data show the promising activity of MEN1309/OBT076 in solid tumors expressing CD205, thus supporting the clinical development of MEN1309, which is being evaluated in the phase I SHUTTLE study" (NCT03403725), said Monica Binaschi, PhD, Director of the Preclinical and Translational Sciences Department of Menarini Ricerche. "Moreover, these results provide a strong rationale for one of the key elements of the clinical development strategy of MEN1309/OBT076, represented by the specific targeting of patients with tumors expressing CD205 as confirmed by an appropriate assay developed in-house. The published study represents an example of fruitful scientific collaboration between academic centers of excellence in oncology research and industry, involving Joaquin Arribas and his team at the Vall D’Hebron Institute of Oncology (VHIO) in Barcelona, as well as our partner Oxford BioTherapeutics (OBT)."

About MEN1309/OBT076

MEN1309/OBT076, is an ADC comprising a fully human antibody targeting CD205, coupled to the DM4 toxin. MEN1309/OBT076 is in development for a number of CD205-driven tumors.

MEN1309/OBT076 is currently in development with a multicenter first-in-human clinical study in major European oncology centers in Italy, Spain, Belgium and UK, (NCT03403725) to evaluate the activity of the antibody in the treatment of metastatic solid cancers, including gastric cancer, triple-negative breast cancer, bladder cancer and pancreatic cancers as well as non-Hodgkin lymphoma (NHL). This clinical trial follows a precision oncology approach, key component of Menarini’s strategy, recruiting only patients positive for the expression of the therapeutic target CD205. Dose-Escalation phase I clinical trial is starting in the United States in highly experienced academic centers under the sponsorship of OBT.

On June 28, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Imbruvica (ibrutinib) in two indications (Press release, Johnson & Johnson, JUN 28, 2019, View Source [SID1234537331]). One recommendation is for the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL).1 The second is for use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).1

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Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies, said: "This is an important step forward in further enhancing our ability as haematologists to meet the treatment needs of more patients with these complex blood cancers. Ibrutinib has already offered important progress in both CLL and WM in the indications for which it is currently approved, and these new combination regimens show the potential to further extend the remission period for patients versus standard of care."

The Positive Opinion for CLL was based on results from the Phase 3 iLLUMINATE (PCYC1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.2 After a median follow-up of 31.3 months (interquartile range [IQR] 29.4–33.2), median progression-free survival (PFS) was significantly longer in the ibrutinib plus obinutuzumab group (median not reached [95 percent confidence interval [CI] 33.6–non-estimable]) than in the chlorambucil plus obinutuzumab group (19.0 months [15.1–22.1]; hazard ratio 0.23; 95 percent CI 0.15–0.37; p<0.0001).2

In WM, the Positive Opinion was supported by data from the Phase 3 iNNOVATE (PCYC-1127) study, presented at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2018. The study evaluated the safety and efficacy of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3 At a median follow up of 30.4 months, a significant improvement in the Independent Review Committee (IRC)-assessed primary endpoint of PFS was seen with ibrutinib plus rituximab when compared with placebo plus rituximab (estimated 30-month PFS rates were 79 percent vs. 41 percent, respectively).3

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).4,5

"We are incredibly encouraged by these CHMP recommendations, which represent our continued commitment to develop chemotherapy-free combinations for those living with CLL and WM," said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag France. "Ibrutinib has been used to treat more than 140,000 patients worldwide and we are continuing to deliver on our ambition to optimise outcomes for patients with complex B-cell malignancies, that have in the past been very difficult to treat."

Both Positive Opinions will now be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Dr Alessandra Tedeschi is co-investigator in both the iNNOVATE and iLLUMINATE studies. She was not compensated for any media work.

#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.6 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.7

Ibrutinib is currently approved in Europe for:8

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell lymphoma.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
Ibrutinib is approved in more than 95 countries, and, to date, has been used to treat more than 140,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.8

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.9 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.10 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.11

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).12 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.13 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.14 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.12,14.

On June 28, 2019 Biodesix, Inc. reported that it will extend the company’s blood-based lung cancer diagnostic portfolio with acquisition of Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the United States (Press release, Biodesix, JUN 28, 2019, View Source [SID1234537330]). The United Kingdom-based company’s U.S. operations, including a CLIA lab in De Soto, Kansas, will transition to Biodesix on November 1, 2019. The lab is the sole U.S. provider of Oncimmune’s EarlyCDT -Lung test.

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"Oncimmune’s extensive experience and patent portfolio in autoantibodies, and their relationship to cancer, attracted us to evaluate the use of Oncimmune’s EarlyCDT Lung test as a strategic addition to our diagnostic test offering in the U.S.," said David Brunel, CEO of Biodesix. "Biodesix is the leader in blood-based diagnostic solutions for lung cancer that provide actionable results and reimbursement with best-in-class turnaround time. Our Nodify XL2 test is used to help rule-out malignancy in low-to-moderate risk incidental lung nodules. EarlyCDT Lung is a rule-in test for lung cancer risk, and a natural and important extension of our commitment to care in the early disease setting."

Each year 1.6 million Americans are diagnosed with incidental lung nodules. Most of these nodules are benign, but the EarlyCDT Lung test helps identify those that could be cancerous. The blood-based lung nodule test enables earlier intervention by helping clinicians detect lung cancer at all stages of disease (I-IV). The extensively validated proteomic test measures seven autoantibodies to tumor-associated antigens created by the body’s response to cancer.

In addition to the lung nodule indication, the Early Cancer Detection Test – Lung Cancer Scotland (ECLS) study, a 12,210 patient study investigating the utility of the EarlyCDT Lung test in lung cancer screening, recently announced meeting primary end-points. ECLS is believed to be the largest randomized controlled study using biomarkers for detection of lung cancer and could lead to a future screening indication for the EarlyCDT Lung test. Full results from the study will be published in a peer-reviewed publication later this year.

"The addition of EarlyCDT Lung to the Biodesix portfolio will allow more patients to benefit from this unique diagnostic tool," said Scott Hutton, COO of Biodesix. "The Nodify XL2 and EarlyCDT Lung tests complement each other to help provide physicians with the ability to stratify patients into distinct nodule management pathways."

"This agreement is a significant milestone for Oncimmune," said Adam M. Hill, MD Ph.D, CEO of Oncimmune. "Like us, Biodesix is committed to developing and delivering lung cancer diagnostic solutions to improve patient outcomes. EarlyCDT Lung is highly complementary to Nodify XL2 to help guide treatment decisions, and Biodesix is an excellent partner for Oncimmune in the U.S. market."

Additional terms of the agreement provide that Biodesix will make milestone payments to Oncimmune upon achieving certain commercial objectives. In addition, Oncimmune will continue to collaborate with Biodesix on new strategic endeavors to improve patient outcomes in lung cancer.