On November 6, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that the company will present new preclinical data showing that their drug candidate ATOR-1017 can induce a long-lasting immunological memory which is of great importance in a potential future patient setting (Press release, Alligator Bioscience, NOV 6, 2019, View Source [SID1234550435]). The results will be presented at the ongoing Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting. The ATOR-1017 drug candidate is in development for the treatment of metastasized cancer.

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Furthermore, the results show that treatment with ATOR-1017 activates the immune system in the tumor area but not systemically. These preclinical data support a tumor-directed activity of ATOR-1017. The aim is to focus the immune attack towards the tumor in order to increase efficacy and minimize side effects for the patient. ATOR-1017 is currently about to initiate Phase I clinical study and dosing of the first patient is expected shortly.

"These preclinical data support the potential of ATOR-1017 to generate a strong and long-lasting immune response or even to induce immunity to cancer. This is our fourth asset to enter the clinic and with its unique tumor-directed profile, we continue to build a clinical pipeline of the next generation cancer immunotherapies", said Per Norlén, CEO of Alligator Bioscience.

The upcoming Phase I study will be a first-in-human, dose escalation study in patients with advanced cancer. It will be conducted at three sites in Sweden and will enroll up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies.

Karin Enell Smith, Senior Scientist at Alligator Bioscience will present a poster with the title "ATOR-1017, a 4-1BB antibody developed for tumor-directed immunotherapy of cancer" on Saturday November 9 at the SITC (Free SITC Whitepaper) 34th Annual Meeting held in National Harbor, Maryland, US. The poster presentation will be available on the Alligator web site View Source on the day of the presentation.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on November 6, 2019.

About ATOR-1017
ATOR-1017 is an immunostimulatory IgG4 antibody that activates tumor-specific T cells and NK cells through the costimulatory receptor 4-1BB. T cells and NK cells have the capacity to detect and kill tumor cells, making 4-1BB a particularly attractive target for cancer immunotherapy. ATOR-1017 has a unique profile related to the fact that its immunostimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation, while minimizing side effects for the patient.

On November 6, 2019 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS),reported financial results for the quarter ended September 30, 2019 (Press release, Coherus Biosciences, NOV 6, 2019, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third-0" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third-0" rel="nofollow">View Source [SID1234550452]).

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Third Quarter 2019 Company Highlights

UDENYCA (pegfilgrastim-cbqv) continues as the U.S. market-leading pegfilgrastim biosimilar, achieving approximately 19% of unit market share at the end of September 2019, delivering on the promise of biosimilars for patients, providers and payers.
Net product revenue for the third quarter of 2019 was $111.7 million, and net income was $47.0 million, or $0.63 per share on a fully diluted basis for the third quarter. Net income was $50.6 million or $0.69 per share on a fully diluted basis for the nine months ending September 30, 2019. Cash flow from operations was $55.0 million for the quarter. Cash, cash equivalents and investments in marketable securities was $170.5 million at September 30, 2019.
The company completed two business development transactions:
The Company acquired exclusive rights from Bioeq IP AG, ("Bioeq") a Swiss biopharmaceutical joint venture, to commercialize Bioeq’s Lucentis (ranibizumab) biosimilar candidate in the United States. Bioeq plans to file a Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") in the fourth quarter of 2019 and Coherus plans to launch the product in the United States in 2021, applying its proficiencies and infrastructure developed for the oncology therapeutic commercial environment to the ophthalmology therapeutic commercial environment.
Coherus and Pfizer entered into a license and settlement agreement relating to Coherus’ patents and applications for patents directed to Humira (adalimumab) formulations.
The Company further advanced its internal ophthalmology product candidate, CHS-2020, a biosimilar candidate to Eylea (aflibercept).
Third Quarter 2019 Financial Results

Net product revenue for third quarter of 2019 was $111.7 million. Cost of goods sold for the third quarter of 2019 was $6.4 million, resulting in a gross profit margin of 94% for the third quarter of 2019.
Research and development (R&D) expense for the third quarter of 2019 was $21.6 million compared to $31.6 million for the same period in 2018. R&D expenses for the nine months ended September 30, 2019 were $59.2 million, as compared to $83.6 million for the same period in 2018. The decrease in R&D expense in both periods was primarily due to the capitalization of UDENYCA manufacturing costs since the approval of UDENYCA on November 2, 2019 and a decrease in costs related to impairment loss, facilities, supplies and materials.
Selling, general and administrative (SG&A) expense for the third quarter of 2019 was $31.8 million, as compared to $25.4 million for the same period in 2018. SG&A expense for the nine months ended September 30, 2019 was $101.0 million, as compared to $60.3 million for the same period in 2018. The increase in SG&A expense in 2019 was primarily attributable to the costs related to commercializing UDENYCA in the United States, which included personnel and third-party services costs for commercial and marketing initiatives.
Cash, cash equivalents and investments in marketable securities for the third quarter totaled $170.5 million at September 30, 2019, as compared to $111.9 million at June 30, 2019 and $72.4 million at December 31, 2018.
Net income attributable to the Company for the third quarter of 2019 was $47.0 million, or $0.63 per share on a fully diluted basis, compared to a net loss of ($58.8) million, or ($0.87) per share on a basic and fully diluted basis for the same period in 2018.
Guidance for the Next Twelve Months from September 30, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
Maintain market position as the leading pegfilgrastim biosimilar of choice, continuing the validated biosimilar-specific strategy of offering a robust value proposition across all key customer segments including ample product supply.
Achieve 2019 exit unit market share of 20% or greater and gain additional market share beyond 20% through 2020.
Continue to increase penetration against all Neulasta dosage forms.
CHS-1420, biosimilar candidate to Humira (adalimumab)
Complete certain development and regulatory objectives to support a BLA filing in 2020.
Ophthalmology pipeline
Facilitate the Bioeq filing of a BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in the United States in the fourth quarter of 2019.
Advance the development of CHS-2020, a biosimilar candidate to Eylea (aflibercept).
Conference Call Information

Date: Wednesday, November 6, 2019 starting at 4:30 p.m. ET
Connect: Dial 844.452.6826 (toll free) or 765.507.2587 (international)
Enter: Conference ID: 8589299
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA IS A LEUKOCYTE GROWTH FACTOR INDICATED TO DECREASE THE INCIDENCE OF INFECTION, AS MANIFESTED BY FEBRILE NEUTROPENIA, IN PATIENTS WITH NON-MYELOID MALIGNANCIES RECEIVING MYELOSUPPRESSIVE ANTI-CANCER DRUGS ASSOCIATED WITH A CLINICALLY SIGNIFICANT INCIDENCE OF FEBRILE NEUTROPENIA.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Adverse Reactions

MOST COMMON ADVERSE REACTIONS (≥ 5% DIFFERENCE IN INCIDENCE COMPARED TO PLACEBO) ARE BONE PAIN AND PAIN IN EXTREMITY.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On November 6, 2019 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the third quarter and nine months ended September 30, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, NOV 6, 2019, View Source [SID1234550469]).

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"During the third quarter we made significant strides in the advancement of our novel T cell engagers, as we continue to advance our two clinical stage programs," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We are also excited by the progress of our two preclinical TriTAC programs, highlighted by the encouraging HPN328 data we recently presented at a medical meeting which further exemplifies the platform. We expect to present clinical data from both our HPN424 and HPN536 programs next year."

Third Quarter 2019 Business Highlights and Other Recent Developments

In October, Harpoon presented data on HPN328 for the treatment of small cell lung cancer at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston. The presentation demonstrated that HPN328 has the potential to be an efficacious, safe, and convenient therapeutic for patients with DLL3-expressing malignancies. HPN328 was well-tolerated in cynomolgus monkeys at 1 and 10 mg/kg and pharmacokinetic data support the potential for once weekly dosing.

Patient enrollment and dose escalation continues in Phase 1 trial for HPN424 and Phase 1/2a trial for HPN536. Harpoon plans to present interim HPN424 results at a medical meeting in the first half of 2020 and plans to present proof of concept data for HPN536 in 2020.

Anticipated Milestones

HPN424 – present interim Phase 1 data in the first half of 2020 at a medical conference and initiate expansion cohort in 2020

HPN536 – present proof of concept data in 2020

HPN217 – submit IND by the end of 2019 and initiate Phase 1/2 trial in the first half of 2020

HPN328 – initiate Phase 1 trial in 2020

Third Quarter and Year-to-Date Financial Results

Harpoon Therapeutics ended the third quarter of 2019 with $121.2 million in cash, cash equivalents, and marketable securities compared to $89.5 million as of December 31, 2018. The increase was due to approximately $70.7 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations.

Net loss for the third quarter ended September 30, 2019 was $15.9 million compared to $6.8 million for the third quarter ended September 30, 2018. The net loss for the nine months ended September 30, 2019 was $41.3 million compared to $17.6 million in the first nine months of the prior year.

Revenue for the third quarter of 2019 was $1.4 million compared to $1.1 million for the third quarter of 2018. For the nine months ended September 30, 2019, revenue was $3.5 million compared to $3.7 million for the nine months ended September 30, 2018. For the three months ended September 30, 2019, the increase was due to an increase in the recognized portion of the deferred $17.0 million upfront payment received by the company in October 2017 under the collaboration agreement with AbbVie. For the nine months ended September 30, 2019, the decrease was due to an upfront payment of $0.5 million recognized in the first quarter of 2018 related to the license agreement with Werewolf Therapeutics, Inc., offset by a $0.3 million increase in the portion of the upfront payment under the collaboration agreement with AbbVie recognized for the quarter ended September 30, 2019. During both the three and nine month periods, revenue primarily consisted of the recognized portion of the deferred $17.0 million upfront payment under the collaboration agreement with AbbVie.

Research and development (R&D) expense for the third quarter of 2019 was $9.5 million compared to $5.9 million for the third quarter of 2018. For the nine months ended September 30, 2019, R&D expense was $28.9 million, compared to $17.7 million for the nine months ended September 30, 2018. The increase for both periods primarily arose from clinical development expenses and an increase in personnel-related expenses, which included conducting preclinical studies, the continuation of the clinical trials for HPN424 and HPN536, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative (G&A) expense for the third quarter of 2019 was $8.5 million compared to $1.9 million for the third quarter of 2018. G&A expense for the nine months ended September 30, 2019 was $18.1 million compared to $3.9 million for the nine months ended September 30, 2018. The increase for both periods was due to higher expenses primarily related to legal fees associated with ongoing Maverick litigation, consulting and accounting services, an increase in headcount, and other professional services to support our ongoing operations as a public company.

On November 6, 2019 Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS platform, reported that initial results from the ongoing Phase 1/2a trial of its lead investigational off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191, will be presented during the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, Florida, December 7-10, 2019 (Press release, Precision Biosciences, NOV 6, 2019, View Source [SID1234550485]).

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PBCAR0191 is Precision’s first allogeneic CAR T therapy candidate in clinical trials and targets the well characterized cancer cell surface protein CD19. It is being developed in collaboration with Servier, an international pharmaceutical company. The Phase 1/2a trial includes adult patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The abstract outlining initial data from patients treated with PBCAR0191 at Dose Level 1 is available on the ASH (Free ASH Whitepaper) conference website (View Source). This trial is ongoing and updated results, including from patients treated at Dose Level 2, will be presented at the ASH (Free ASH Whitepaper) Annual Meeting on December 9, 2019 starting at 6:00 p.m. ET.

"We are excited to share initial clinical data from Precision’s PBCAR0191 program at ASH (Free ASH Whitepaper), which we believe demonstrate the potential of our differentiated approach to the development of allogeneic CAR T therapies," said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. "These data bring the reality of a true off-the-shelf CAR T therapy a step closer for patients in need of new and improved treatment options. We remain committed to the wider goal of improving access to cellular therapies for patients with advanced NHL and ALL, and we are optimistic, based on these initial findings, that we may be able to help meet this need. While preliminary and from a limited number of patients, the safety profile, in vivo cell expansion and early evidence of clinical activity we have demonstrated at our lowest dose level with PBCAR0191 in the absence of biologic lymphodepletion is very encouraging. We look forward to sharing updated results from patients treated at Dose Levels 1 and 2 at ASH (Free ASH Whitepaper)."

Investigator Update & Webcast Information
Precision will host a live webcast of an investigator update event during the ASH (Free ASH Whitepaper) Annual Meeting to discuss the presented data, beginning at 8:15 p.m. ET on Monday, December 9, 2019. To access the webcast, please visit the "Events & Presentations" page within the Investors & Media section of the Precision BioSciences website at View Source A replay of the webcast will be available on the Precision website for 30 days following the call.

First Clinical Data from Precision’s PBCAR0191 Program
Title: Initial findings of the Phase 1 trial of PBCAR0191
Presenter: Bijal Shah, MD, Moffitt Cancer Center
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Retrospective/Observational Studies
Poster/Presentation Number: Poster III
Date and Time: December 9, 2019, 6:00-8:00 p.m. ET
Location: Orange County Convention Center, Hall B

PBCAR0191 is Precision’s first allogeneic CAR T therapy candidate in clinical trials. This presentation will include initial data from the Phase 1 portion of the ongoing Phase 1/2a trial of PBCAR0191, which is designed to assess safety, identify an optimal dose of PBCAR0191 and evaluate preliminary clinical activity in patients with R/R NHL and B-ALL. The trial is a 3+3 dose escalation study (at dose levels of 3×105, 1×106, and 3×106 CAR T+ cells/kg); in each of the three dose levels up to six patients may be enrolled in each of the two cohorts (NHL and B-ALL). Lymphodepletion is achieved using fludarabine 30mg/m2/day and cyclophosphamide 500mg/m2/day.

Data in the abstract include results as of the data cutoff date of August 1, 2019 for three patients with advanced NHL treated at Dose Level 1, one with mantle cell lymphoma (MCL) and two with diffuse large B cell lymphoma (DLBCL). No significant toxicity was observed, including no serious adverse events and no dose-limiting toxicities. All patients had a minimum follow-up of 28 days (median 60 days).

Findings indicate preliminary evidence of cell-mediated anti-tumor activity, which will be evaluated more fully at subsequent dose levels. Two of the three patients experienced an objective tumor response by Lugano criteria, at day 14 and day 28, respectively. Both patients progressed due to new lesions (on day 28 and day 60, respectively). The third patient, who had previously progressed following treatment with axicabtagene ciloleucel (Yescarta), an approved anti-CD19 autologous CAR T therapy, had not met the definition of response, but had shown evidence of central necrosis, decreased tumor size, and decreased PET-avidity at day 28, in the context of post-infusion tumor site pain and mild CRS symptoms.

Peripheral blood analysis for CAR T cell expansion has identified preliminary evidence of cell expansion.

This trial is ongoing and updated results, including from patients treated at Dose Level 2, will be shared at the ASH (Free ASH Whitepaper) conference.

Precision’s Off-The-Shelf CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy by improving access to care through a well-tolerated lymphodepletion regimen. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured and is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

On November 6, 2019 4D Pharma plc (AIM: DDDD), a leading-edge pharmaceutical company in the development of live biotherapeutics, reported preliminary safety and clinical observations from an ongoing clinical phase -I / II study, in collaboration with MSD, a trade name of Merck & Co., Inc. of Kenilworth, NJUSA, in conjunction with its leading oncology candidate, Mrx0518, in combination with the MSD anti-PD-1 therapy with KEYTRUDA (pembrolizumab) in patients with advanced malignancies who previously responded and whose disease was subsequently co-administered PD-1 / PD-L1 inhibitors has progressed to evaluate (Press release, 4d Pharma, NOV 6, 2019, View Source;814041836.html [SID1234550511]). These are the first observations of an oncology study in humans with a live biotherapy product.

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Important observations:

Initial data from the first six patients show that the combination of Mrx0518 and KEYTRUDA is well tolerated.
Induction of clinically relevant response in two out of six patients with previous progressive disease
Three patients had to retire for illness-related reasons (two after the diagnosis of a progressive illness and one due to a disease-related adverse event).
The Phase I / II trial is an open-label study evaluating the safety and preliminary efficacy of Mrx0518 and KEYTRUDA in patients with renal cell carcinoma (RCC), melanoma, non-small cell lung cancer (NSCLC) and bladder cancer who have resistance against PD-1 / PD-L1 inhibitors. In preclinical studies, Mrx0518 has previously demonstrated significant efficacy as a monotherapy and as a combination therapy with the checkpoint therapy. Mrx0518 has also been shown to be an effective immune stimulant and capable of increasing the number of tumor infiltrating lymphocytes (TILs) that have been shown to be anticancer in preclinical cancer models.

Although the checkpoint therapies have proven to be effective anti-cancer treatments, they are not effective in all patients, and those who respond may develop resistance over time, leading to a loss of efficacy and progression of the disease Disease leads. The mode of action of Mrx0518 has the potential to reactivate the efficacy of checkpoint therapies, and this study was designed to investigate this effect in patients with advanced metastatic disease.

Patients eligible for the Phase I / II trial must have a progressive disease prior to enrollment, which has been confirmed by two residual scans. Part A of the study aims to enroll 12 patients, with the primary outcome being measurement of safety and tolerability. Part A will be performed over three weeks and patients will receive one cycle of KEYTRUDA, taking Mrx0518 orally twice a day (the "offer") .After completion of the first cycle, patients will be eligible for up to 35 cycles of KEYTRUDA in the drug combination (over about two years) or until disease progression occurs Patients routinely have restaging scans every nine weeks More information on the study can be found at the end of this announcement.

The clinical observations of the first six patients in Part A include:

Two patients showed partial response (according to RECIST version 1.11 criteria) with evidence of tumor disappearance and continue to participate in the study (one patient has been in the study for more than six months).
In another patient, the disease is stable and continues to participate in the study.
Two patients were excluded from the study because of a progressive disease.
One patient was excluded prior to the restaging scan for a serious disease-related adverse event.
The only patient currently tested for tumor biomarker showed signs of increased TIL after treatment (approval for biomarker assessment is optional).
No serious adverse drug reactions were noted.
Dr. Alex Stevenson, Chief Scientific Officer of 4D, said, "We are very encouraged by these early signs of activity in the combination of Mrx0518 and KEYTRUDA in patients with advanced disease. One third of patients who had previously stopped responding to PD-1 inhibitors and had a progressive disease have now shown clinical benefit. There is also a first indication in a patient suggesting that the treatment is capable of increasing the number of tumor infiltrating lymphocytes in a clinical setting, which is in line with our preclinical results. Although more work will be required to determine the robustness of the observed responses and their frequency in a larger number of patients, we are pleased to to report these initial results – the first from an oncological study with a live biotherapeutic. The open label trial continues and we will continue to review the data to optimize our future development strategy for Mrx0518 in these indications.

"These first results further support our ongoing investment in our oncology franchise. We plan to include Mrx0518 in additional clinical trials of various tumor types and settings, either in combination or as monotherapy. The next study with Mrx0518 in combination with radiotherapy for pancreatic cancer will start at MD Anderson before the end of this year. In addition, we continue to develop live biotherapeutic candidates with different modes of action for oncology applications. The first, MRx1299, is currently in GMP manufacturing development. "

Notes:
1 Criteria for assessing response to solid tumors

This notice contains inside information as defined in Article 7 of the Market Abuse Regulation (MAR) No 596/2014. The person responsible for making this announcement on behalf of the Company is Duncan Peyton . After the publication of this notice, this inside information will be considered publicly available.