On November 5, 2020 Omeros Corporation (NASDAQ: OMER) reported that the company will issue its third quarter financial results for the period ended September 30, 2020, on Monday, November 9, 2020, after the market closes (Press release, Omeros, NOV 5, 2020, View Source [SID1234570172]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

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Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 1738549. Please dial in approximately 10 minutes prior to the start of the call. A webcast replay will be available following the call.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and select "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On November 5, 2020 BiomX Inc. (NYSE American: PHGE), a clinical stage company developing natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and live audio webcast on Thursday, Nov. 12, 2020, at 8:00 a.m. EST, to report third quarter 2020 financial results and provide a corporate update (Press release, BiomX, NOV 5, 2020, View Source [SID1234570171]). The conference call dial-in numbers are 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (international). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

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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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On November 5, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported CLR 131 has demonstrated preliminary activity in inoperable brain tumors in a Phase 1 study (Press release, Cellectar Biosciences, NOV 5, 2020, View Source [SID1234570166]). The study is an international, open-label, dose escalation, safety study of CLR 131 in children and adolescents with relapsed or refractory cancers, specifically high grade gliomas (HGGs), high risk neuroblastomas and select soft tissue sarcomas.

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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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Highlights from the study:

-Four dose levels (15, 30, 45 and 60mCi/m2 ) have been evaluated to date with all deemed safe and tolerated by the independent Data Monitoring Committee; patients are currently being evaluated at the 75mCi/m2 dose level

-Initial activity was expected to occur at doses of 60mCi/m2 and higher; activity has been noted at lower dose levels

-CLR 131 has been measured in tumors, confirming that systemic administration of CLR 131 crosses the blood brain barrier and is delivered into tumors

-Disease control has been exhibited in heavily pretreated patients with ependymomas

"CLR 131’s ability to cross the blood brain barrier along with the initial responses in pediatric brain tumors are most encouraging. CLR 131 may provide an attractive new treatment option for these patients beyond the current paradigms of external beam radiation and/or systemic targeted radiation as standards of care," said Dr. John Friend, CMO of Cellectar. "These ultra-orphan pediatric indications align with the development and regulatory strategy that we have successfully employed with our lead program in heme-oncology. We look forward to providing feedback from our recent FDA Guidance meeting, outlining the registrational pathway for our priority adult hematology indications and planned initiation of our pivotal trial later in the fourth quarter."

Similar to previous CLR 131 studies in adults, this study demonstrated that 20-40% of the infused CLR 131 is delivered to the tumors. Additionally, the study demonstrated that systemic administration of CLR 131 results in a sufficient proportion of infused drug crossing the blood brain barrier and is delivered to different types of malignant brain tumors. CLR 131 has achieved disease control at multiple dose levels in rapidly progressing, heavily pretreated patients, including two patients at distinct dose levels with rapidly growing ependymomas. Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes (i.e. diffuse intrinsic pontine gliomas, glioblastomas, astrocytomas, ependymomas, etc.) with about 400 new pediatric cases diagnosed annually in the United States. Children with these tumors have a poor prognosis and limited 5 year survival.

It is noteworthy that CLR 131 is currently being dosed at 75mCi/m2 and when compared to another targeted radiotherapeutic, MIBG-Iodine-131 (second line standard of care in neuroblastoma), CLR 131 achieves a nearly 16 fold increase in the amount of radiation delivered to the tumor. This enhanced delivery suggests that doses of CLR 131 between 60 and 75mCi/m2 would be predicted to achieve similar responses in patients as an MIBG-Iodine-131 dose of up to 1,300mCi. Neuroblastoma is a cancer type that occurs in immature nerve cells of the adrenal gland, neck, chest or spinal cord with approximately 800 new cases diagnosed per year in the United States. Over 60% of the newly diagnosed cases of neuroblastoma are advanced with at least one site of metastasis resulting in a poor patient prognosis.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in relapsed/refractory (r/r) multiple myeloma. The U.S. Food and Drug Administration (FDA) granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large B-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma (LPL)/Waldenstrom’s macroglobulinemia (WM), neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Earlier this year, the European Commission granted an ODD for r/r multiple myeloma and most recently, the FDA granted Fast Track Designation for CLR 131 in LPL/WM in patients having received two prior treatment regimens or more.

On November 5, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that an abstract detailing results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients, has been selected for oral presentation at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held virtually December 5-8 (Press release, ERYtech Pharma, NOV 5, 2020, View Source [SID1234570160]). A second abstract detailing population pharmacokinetics of eryaspase in ALL or pancreatic adenocarcinoma patients has been accepted for a poster presentation at the meeting.

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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

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Abstract #467: NOR-GRASPALL 2016 (NCT03267030): Asparaginase encapsulated in Erythrocytes (eryaspase) – a promising alternative to PEG-asparaginase in case of hypersensitivity

The NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase. The trial was conducted at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. The study findings will be featured as an oral presentation at ASH (Free ASH Whitepaper) by Dr. Line Stensig Lynggaard, representing NOPHO, on 6th December 2020 2.45pm PST/ 5.45pm EST / 11.45pm CET. Final results from this trial will be presented at the meeting.

The abstract can be found on-line at: View Source

Abstract #2799: Population Pharmacokinetics of Eryaspase in Patients with Acute Lymphoblastic Leukemia or Pancreatic Adenocarcinoma

An analysis of the population pharmacokinetics (Pop PK) of eryaspase in patients with ALL or pancreatic adenocarcinoma (PAC) will be presented as a poster by Dr. Frank Hoke (ERYTECH’s Head of Clinical Pharmacology) on Monday 7th December 2020 from 8am PST / 11am EST / 5pm CET. The analysis shows the extended circulation time of eryaspase, provides information on patient factors that influence the exposure of eryaspase, and evaluates patient population (PAC vs ALL) and formulation (native vs recombinant).

The abstract can be found on-line at: View Source

"We are proud to be working with the NOPHO group and look forward to their presentation of new clinical data for the treatment of ALL at ASH (Free ASH Whitepaper) this year. Alongside the POP PK analysis, the reporting of the NOPHO study represents significant progress towards our goal of finding a potential path forward with the FDA for eryaspase in ALL," said Dr. Iman El-Hariry, ERYTECH’s Chief Medical Officer. "We believe that our science-driven approach to the development of eryaspase will provide a new option for people with ALL and, potentially, other haematological malignancies and solid tumours."

Data included in the abstracts is based on data cut-offs in second quarter 2020. The final oral presentation and poster will include additional data collected between the abstract submission cut-off and the ASH (Free ASH Whitepaper) congress.

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options.

On November 5, 2020 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer,reported financial results and provided a business update for the third quarter ended September 30, 2020 (Press release, Adaptimmune, NOV 5, 2020, View Source [SID1234570156]).

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"Later this month, we will present data at SITC (Free SITC Whitepaper) and CTOS. Data to be presented at SITC (Free SITC Whitepaper) from the dose escalation cohorts of our SURPASS trial confirm that ADP-A2M4CD8 is a highly active agent across a range of tumors. At CTOS, we will present data regarding the durability of responses in synovial sarcoma, which support our ambition to market ADP‑A2M4 in 2022. And finally, at our Investor Day, I will lay out our broader strategy including the opportunity we see for our late-stage pipeline," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "Recruitment into our clinical trials has been steadily recovering following the first wave of COVID-19 and projected patient numbers currently look good for the remainder of this year and into 2021."

PLANNED MILESTONES Q4 2020

Four posters to be presented at the virtual SITC (Free SITC Whitepaper) meeting (November 9-14)
Poster entitled "Initial safety, efficacy, and product attributes from the SURPASS trial with ADP‑A2M4CD8, a SPEAR T-cell therapy incorporating an affinity optimized TCR targeting MAGE-A4 and a CD8α co-receptor" with an update on the dose escalation cohorts (6 patients in total)
Poster entitled "Inhibition of AKT signaling during expansion of TCR-Engineered T-Cells from patient leukocyte material generates SPEAR T-Cells with enhanced functional potential in vitro" with data indicating that AKT inhibition during manufacture of SPEAR T-cells results in a more consistent expansion and phenotype of the final product
Two posters about the previously terminated ADP-A2M10 Phase 1 program: one for the lung cancer trial, and one for the triple tumor trial in melanoma, urothelial, and head & neck cancers
Durability of response data from patients with synovial sarcoma from the ADP-A2M4 Phase 1 trial to be presented in an oral presentation at the virtual CTOS conference ("Immunotherapy in Sarcoma" session on November 19, 2020 from 9 a.m. to 10 a.m. EST)
Investor Day to be held on November 20, 2020
CLINICAL UPDATES

As the management of COVID-19 at clinical sites continues to evolve, there has been an increase in recruitment and enrollment during the latter part of Q3 and into Q4 for all ongoing clinical trials
SPEARHEAD-1 is recruiting well and remains on target to complete enrollment in the first half of 2021
On track to start a Phase 2 trial with ADP-A2M4CD8 in gastroesophageal cancers (gastric, esophageal, and esophagogastric junction) in the first half of 2021
Data update from the Phase 1 ADP-A2AFP trial presented in an oral presentation and poster, at the International Liver Congress, confirmed safety profile and demonstrated potential benefit for patients with hepatocellular carcinoma. Four patients were treated with ~5 billion or more transduced cells with best responses of one complete response, one patient with stable disease, and two patients with progressive disease.
Presented SPEARHEAD-2 trial-in-progress poster at ESMO (Free ESMO Whitepaper) summarizing design for this first combination clinical trial with ADP-A2M4 and pembrolizumab
Financial Results for the three and nine month periods ended September 30, 2020

Cash / liquidity position: As of September 30, 2020, Adaptimmune had cash and cash equivalents of $78.5 million and Total Liquidity1 of $399.9 million.

Revenue: Revenue for the three and nine months ended September 30, 2020 was $1.2 million and $2.5 million, respectively, compared to $0.2 million and $0.4 million for the same periods in 2019. Revenue increased due to the commencement of development activity under the Astellas Collaboration Agreement and increased development activity under the GSK Collaboration and License Agreement.

Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2020 were $24.1 million and $65.8 million, respectively, compared to $29.6 million and $77.1 million for the same periods in 2019. R&D expenses were higher in the three and nine months ended September 30, 2019 due to recognition of accrued purchase commitment expenses related to the supply of the Dynabeads CD3/CD28 technology of $5.0 million and in-process research and development as a result of entering into a collaboration agreement with Noile-Immune Biotech, Inc. in August 2019. The nine-month period ended September 30, 2019 also included $2.0 million of in-process research and development as a result of entering into a collaboration agreement with Alpine Immune Sciences, Inc. in May 2019.

General and administrative (G&A) expenses: G&A expenses for the three and nine months ended September 30, 2020 were $13.0 million and $32.6 million, respectively, compared to $10.7 million and $32.7 million for the same periods in 2019. The increase in the three months ended September 30, 2020 was primarily driven by an increase in professional fees, investment in our IT systems, and costs associated with the buildout of our commercial capabilities.

Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three and nine months ended September 30, 2020 was $35.4 million and $93.5 million, respectively, and $(0.04) and $(0.11) per ordinary share, respectively, compared to $39.3 million and $107.8 million and $(0.06) and $(0.17) per ordinary share for the same periods in 2019.
Financial guidance

The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company’s current operations into 2022, as further detailed in the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020, to be filed with the Securities and Exchange Commission following this earnings release.

Conference Call and Webcast Information
The Company will host a live teleconference at 8:00 a.m. EST (1:00 p.m. GMT) today, November 5, 2020. The live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6183339).