On June 29, 2020 OmniSeq, an innovator in next generation sequencing (NGS) in oncology, reported the benefits of its OmniSeq Advance comprehensive genomic and immune profiling assay to detect the presence of rare alterations in the RET gene in the tumors of some patients with non-small cell lung cancer (NSCLC) and thyroid cancer (Press release, OmniSeq, JUN 29, 2020, View Source [SID1234561571]). Those patients eligible for treatment with Eli Lilly and Company’s recently FDA-approved selective RET kinase inhibitor Retevmo* (selpercatinib).

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Retevmo is the first FDA-approved therapy specifically for cancer patients with fusions or mutations in the RET (rearranged during transfection) gene. OmniSeq Advance delivers the distinct advantage of using two technologies; RNA-sequencing for RET fusions and DNA-sequencing for RET mutations to provide optimal, comprehensive testing for Retevmo. OmniSeq Advance was one of the tests that could qualify a patient for enrollment to the LIBRETTO-001 Retevmo (selpercatinib) clinical trial.

The National Comprehensive Cancer Network (NCCN) recommends for NSCLC that when feasible, testing be performed via a broad, panel-based approach, most typically performed by next generation sequencing. For patients who, in broad panel testing don’t have identifiable driver oncogenes (especially in never smokers), consider RNA-based NGS if not already performed, to maximize detection of fusion events.

"OmniSeq Advance offers significant advantages for detecting RET fusions by RNA-sequencing as opposed to DNA-only sequencing," stated OmniSeq’s Chief Medical Officer, Roger Klein, MD, JD, FACP. "OmniSeq’s proprietary sample preparation methodologies also allow for minimal tumor tissue input, a critical factor for ensuring NSCLC patient testing can be completed with frequently limited biopsy material available."

OmniSeq’s NGS-based assays provide comprehensive genomic and immune profiling from RNA and DNA to enable oncologists to select the most appropriate therapies or clinical trials for each patient. OmniSeq’s suite of clinical diagnostic tests are offered exclusively by LabCorp to U.S.-based physicians through its Integrated Oncology specialty laboratory and to global biopharmaceutical customers through Covance, LabCorp’s drug development business. OmniSeq Advance is approved by New York State’s Clinical Laboratory Evaluation Program.

Retevmo is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer, of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trial(s). There is currently no FDA-approved companion diagnostic for Retevmo.

On June 29, 2020 ALX Oncology Holdings, a next-gen cancer biotech reported that that launched in 2015 seeking a $100 million IPO to add to its recent $105 million funding round (Press release, FierceBiotech, JUN 29, 2020, View Source [SID1234561570]).

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The Dublin- and California-based biotech has so far had a good year and, back in February, just after its series C round, grabbed an FDA speedy tag for its leading candidate ALX148 for the first-line treatment of patients with head and neck squamous cell carcinoma and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction carcinoma.

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CD47 myeloid checkpoint inhibitor ALX148 is now in line for phase 2 trials in combination with other anti-cancer therapies.

Multiple drug developers have gone after CD47 since evidence of its role in the interactions between cancer cells and the immune system became clear. The evidence suggested tumors evade immune attacks by upregulating CD47, leading researchers to posit that blocking the signal will expose cancer cells to a full-force offensive.

However, efforts to realize the therapeutic potential of anti-CD47 antibodies have been undermined by hematological adverse events stemming from the fact the target is found on host cells such as red blood cells.

ALX, formerly known as Alexo Therapeutics, thinks fusion protein ALX148 has a better risk-benefit profile than its rivals and has persuaded investors to buy into that idea.

Some of its more recent data were from patients with relapsed or refractory non-Hodgkin lymphoma (NHL) who received ALX148 in combination with rituximab. Among the 21 evaluable patients, ALX saw an objective response rate of 43% and a median progression-free survival of 7.3 months. As importantly, the drug appeared to be relatively safe and well tolerated.

The phase 1 trial that generated the lymphoma data is continuing, with other arms of the study testing the CD47 prospect in combination with Herceptin and Keytruda in solid tumor patients. But, with ALX148 coming through its first test in NHL, ALX also has plans to take the candidate deeper into the clinic.

The biotech said in a Securities and Exchange Commission (SEC) filing that it now also plans to advance ALX148 into a phase 1b/2 trial in combination with Vidaza (azacitidine) for myelodysplastic syndromes by the end of 2020 and a phase 1b/2 trial in combination with standard-of-care agents for acute myeloid leukemia in 2021.

It plans to list on the Nasdaq under the symbol "ALXO."

The second IPO attempt is a $75 million effort from autoimmune biotech Pandion Therapeutics. Since it uncloaked two years ago, Pandion has teamed up with Astellas on bispecific drugs for Type 1 diabetes and has pushed its lead program into the clinic.

Back in April, it raised $80 million to test that treatment in patients with ulcerative colitis and move a second program into phase 1.

Cambridge, Massachusetts-based Pandion set up shop with its so-called TALON platform to create better treatments for autoimmune conditions, in which the immune system "forgets what the self is" and attacks its own tissues and organs. It aims to replace old-school systemic immunosuppression—which can lead to side effects like an increased risk of infection or cancer—as well as newer anti-cytokine antibodies, which have improved care for some patients but don’t work for all autoimmune diseases.

Its lead asset, PT101, is a combination of an interleukin-2 mutein effector module with a protein backbone and is designed to selectively expand regulatory T cells systemically without activating proinflammatory cells, such as conventional T cells and natural killer cells.

"We are initially developing PT101 for the treatment of patients with moderate-to-severe ulcerative colitis, or UC, and are currently conducting a Phase 1a clinical trial of PT101 in healthy volunteers, with final data expected in the first half of 2021," the biotech said in its SEC-1 filing.

Using its TALON platform, it added it would also "continue to develop and expand our library of effector and tether modules as part of our early stage research and discovery pipeline."

On June 29, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported it has enrolled and safely dosed the last patient for stage 2 of Part A (1st line NSCLC) of its TACTI-002 Phase II study, completing recruitment for Part A (Press release, Immutep, JUN 29, 2020, View Source [SID1234561557]).

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TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada) and is evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") with MSD’s KEYTRUDA (pembrolizumab).

Immutep recently reported new data from TACTI-002 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Annual Meeting 2020, including results from stage 1 of Part A which showed an improving Progression Free Survival ("PFS") estimate of more than 9 months in patients with 1st line NSCLC.

The Company expects to report more mature data from TACTI-002 in H2 CY20.

TACTI-002 Recruitment Update

In total 81 patients out of up to 109 (74%) are already enrolled in the trial at 12 clinical sites across Australia, Europe, the UK and US. Recruitment is ongoing for Part B (second line NSCLC) and for stage 2 of Part C (2nd line HNSCC). Current recruitment numbers for each Part are below.

About the TACT-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe, UK and Australia.

Patients participating in three parts:

Part A – First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

Part B – Second line NSCLC, PD-X refractory

Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score ³1% (US) and ³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.

On June 29, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported its second quarter earnings conference call will be webcast on Tuesday, August 4, 2020, at 8:30 a.m. ET (Press release, Zimmer Holdings, JUN 29, 2020, View Source [SID1234561551]). A news release detailing the quarterly results will be made available that day at 6:30 a.m. ET.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985. For a complete listing of international toll-free and local numbers, please visit https://investor.zimmerbiomet.com. A digital recording will be available after the completion of the conference call, from August 4, 2020 to October 4, 2020. To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.

On June 29, 2020 OmniSeq, an innovator in next generation sequencing (NGS) in oncology, reported the benefits of its OmniSeq Advance comprehensive genomic and immune profiling assay to detect the presence of rare alterations in the RET gene in the tumors of some patients with non-small cell lung cancer (NSCLC) and thyroid cancer (Press release, OmniSeq, JUN 29, 2020, View Source [SID1234561550]). Those patients eligible for treatment with Eli Lilly and Company’s recently FDA-approved selective RET kinase inhibitor Retevmo* (selpercatinib).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Retevmo is the first FDA-approved therapy specifically for cancer patients with fusions or mutations in the RET (rearranged during transfection) gene. OmniSeq Advance delivers the distinct advantage of using two technologies; RNA-sequencing for RET fusions and DNA-sequencing for RET mutations to provide optimal, comprehensive testing for Retevmo. OmniSeq Advance was one of the tests that could qualify a patient for enrollment to the LIBRETTO-001 Retevmo (selpercatinib) clinical trial.

The National Comprehensive Cancer Network (NCCN) recommends for NSCLC that when feasible, testing be performed via a broad, panel-based approach, most typically performed by next generation sequencing. For patients who, in broad panel testing don’t have identifiable driver oncogenes (especially in never smokers), consider RNA-based NGS if not already performed, to maximize detection of fusion events.

"OmniSeq Advance offers significant advantages for detecting RET fusions by RNA-sequencing as opposed to DNA-only sequencing," stated OmniSeq’s Chief Medical Officer, Roger Klein, MD, JD, FACP. "OmniSeq’s proprietary sample preparation methodologies also allow for minimal tumor tissue input, a critical factor for ensuring NSCLC patient testing can be completed with frequently limited biopsy material available."

OmniSeq’s NGS-based assays provide comprehensive genomic and immune profiling from RNA and DNA to enable oncologists to select the most appropriate therapies or clinical trials for each patient. OmniSeq’s suite of clinical diagnostic tests are offered exclusively by LabCorp to U.S.-based physicians through its Integrated Oncology specialty laboratory and to global biopharmaceutical customers through Covance, LabCorp’s drug development business. OmniSeq Advance is approved by New York State’s Clinical Laboratory Evaluation Program.

Retevmo is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer, of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trial(s). There is currently no FDA-approved companion diagnostic for Retevmo.