On November 5, 2020 Seagen Inc. (Nasdaq:SGEN) reported multiple ADCETRIS (brentuximab vedotin) data presentations at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually December 5-8, 2020 (Press release, Seagen, NOV 5, 2020, View Source [SID1234570001]). Data presentations will include five-year updates from the phase 3 ECHELON-1 and ECHELON-2 clinical trials evaluating ADCETRIS plus a chemotherapy combination regimen in frontline advanced stage Hodgkin lymphoma (HL) or frontline peripheral T-cell lymphoma (PTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL. ADCETRIS is being evaluated globally in more than 70 corporate- and investigator-sponsored clinical trials across multiple settings in lymphoma and other indications.

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"At this year’s ASH (Free ASH Whitepaper) meeting, ADCETRIS will be featured in 18 data presentations, including five-year analyses from the ECHELON-1 and ECHELON-2 phase 3 frontline trials," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Reaching five-years without disease recurrence represents a significant clinical milestone for patients, as they may be considered disease-free at this time point. The five-year data presentations from our phase 3 ECHELON-1 and ECHELON-2 trials demonstrate ADCETRIS plus chemotherapy resulted in superior clinical activity and durable benefit when compared to outcomes with a standard chemotherapy regimen. We will also present additional analyses from trials evaluating ADCETRIS in combination with other therapies, with the goal of identifying potential new treatment strategies that improve outcomes for patients."

Details of Seagen Presentations at ASH (Free ASH Whitepaper):

Abstract Title

Abstract #

Presentation

Type / Date

Presenter

Company-Sponsored Trials

Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients

#471

Oral presentation / Sunday, Dec. 6 at 2:15 p.m. PT

C. Yasenchak

Brentuximab Vedotin with Chemotherapy for Patients with Previously Untreated, Stage III/IV Classical Hodgkin lymphoma: 5-year Update of the ECHELON-1 Study

#2973

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

D. Straus

The ECHELON-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in Frontline Treatment of Patients with CD30-positive Peripheral T-cell Lymphoma

#1150

Poster presentation / Saturday, Dec. 5, 7:00 a.m. – 3:30 p.m. PT

S. Horwitz

Economic Assessment of Diagnostic Revision in Peripheral T-cell Lymphoma

#1606

Poster presentation / Saturday, Dec. 5, 7:00 a.m. – 3:30 p.m. PT

N. Liu

Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory Mediastinal Gray Zone Lymphoma: Primary Efficacy and Safety Analysis of the Phase 2 CheckMate 436 Study

#2045

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

A. Santoro

Real-World Characteristics of Patients with Classical Hodgkin Lymphoma Receiving Frontline Brentuximab Vedotin with Chemotherapy: A Retrospective Analysis with Propensity Score Matching

#2499

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

T. Phillips

Real-World Adherence to National Comprehensive Cancer Network (NCCN) Guidelines Regarding the Usage of PET/CT and Reported Deauville Scores in Advanced Stage Classical Hodgkin Lymphoma: A Community Oncology Practice Perspective

#2033

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

C. Yasenchak

SGN-CD30C, an Investigational CD30-Directed Camptothecin Antibody-Drug Conjugate (ADC), Shows Strong Anti Tumor Activity and Superior Tolerability in Preclinical Studies

#2089

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

M. Ryan

Real-World Characteristics of Patients with Peripheral T-Cell Lymphoma Receiving Frontline Brentuximab Vedotin with Chemotherapy: A Retrospective Analysis with Propensity Score Matching

#3418

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

J. Burke

Nodal Peripheral T-Cell Lymphoma with T Follicular-Helper Phenotype: A Different Entity? Results of the Spanish Retrospective Real-T Study

#2972

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

AM. Garcia-Sancho

Results from the International, Multi-Center, Retrospective B-Holistic Study: Describing Treatment Pathways and Outcomes for Classical Hodgkin Lymphoma

#2979

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

B. Ferhanoglu

Investigator-Sponsored Trials

Increased Tumor Specific Cytotoxic T Cell Responses and Reversion to a Favorable Cytokine Profile after Treatment in Patients with Newly Diagnosed High Risk Hodgkin Lymphoma Treated on Children’s Oncology Group Trial- AHOD1331

#595

Oral presentation / Monday, Dec. 7 at 9:15 a.m. PT

H. Dave

Addition of Brentuximab Vedotin to Gemcitabine in Relapsed or Refractory T-Cell Lymphoma: Results of a LYSA Multicenter, Phase II Study. "The TOTAL Trial"

#1161

Poster presentation / Saturday, Dec. 5, 7:00 a.m. – 3:30 p.m. PT

O. Tournilhac

A Pilot Study of Brentuximab Vedotin, Rituximab and Dose Attenuated CHP in Patients 75 Years and Older with Diffuse Large B-Cell Lymphoma

#2102

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

P. Reagan

Dose-Dense Brentuximab Vedotin Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Is Highly Active for Second Line Treatment in Relapsed/Refractory Classical Hodgkin Lymphoma: Final Results of a Phase I/II Study

#2964

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

R. Lynch

A Phase I Trial Assessing the Feasibility of Romidepsin Combined with Brentuximab Vedotin for Patients Requiring Systemic Therapy for Cutaneous T-Cell Lymphoma

#2970

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

S. Barta

Trials-in-Progress

Trial-in-Progress: Brentuximab Vedotin in Combination with Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

#2112

Poster presentation / Sunday, Dec. 6, 7:00 a.m. – 3:30 p.m. PT

N. Bartlett

A Phase 1 Study of Sea-CD70 in Myeloid Malignancies

#2874

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

A. Aribi

Trial-in-Progress: Frontline Brentuximab Vedotin and CHP (A+CHP) in Patients with Peripheral T-Cell Lymphoma with Less Than 10% CD30 Expression

#2976

Poster presentation / Monday, Dec. 7, 7:00 a.m. – 3:30 p.m. PT

D. Jagadeesh

On November 5, 2020 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for the fiscal second quarter ended September 30, 2020 and provided a business update (Press release, Replimune, NOV 5, 2020, View Source [SID1234570000]).

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"In October, we released clinical data with our second product candidate, RP2, demonstrating durable single agent responses in heavily pre-treated patients with immune insensitive tumor types that provides validation of our platform," said Philip Astley-Sparke, CEO of Replimune. "We also presented updated data for RP1 in combination with Opdivo in melanoma and non-melanoma skin cancers that continues to improve upon our recent June update in terms of depth and durability of response, and supports our two registration-directed clinical programs in both cutaneous squamous cell carcinoma and anti-PD1 failed melanoma. Following a successful follow-on offering in October, we are well-financed to advance and expand our pipeline of product candidates and to fund the initial build of our commercial infrastructure with many exciting milestones ahead. In particular, we look forward to initiating clinical development with RP3 as we seek to establish our products more broadly beyond immune-responsive tumor types, as a cornerstone of immune-based cancer treatments."

Recent Events and Corporate Updates

Presented updated clinical data with RP1 combined with Opdivo in melanoma and non-melanoma skin cancer (NMSC). The updated data from the Phase 1 expansion of RP1 in combination with Opdivo and the Phase 2 cohorts in melanoma and NMSC showed eight of eleven patients with CSCC have achieved response (5 CR) with one patient currently assessed as stable disease at their first scan who remains on treatment. Five of 16 patients (87.5% with advanced visceral disease) with anti-PD-1 failed melanoma have achieved response, four of whom had also previously failed ipilimumab. A further patient is a surgical CR remaining tumor free currently more than 5 months from surgery and a further stable disease patient remains on treatment. Further responses have been observed in angiosarcoma and in anti-PD1 failed mucosal melanoma. All responses have been durable with only one patient with CSCC and one patient with any type of melanoma having progressed after response. Treatment has continued to be well tolerated and remains ongoing in many of the patients. RP1 is an enhanced potency oncolytic immunotherapy that expresses a GALV-GP R- fusogenic protein and GM-CSF.

The Company has been selected to participate in the SITC (Free SITC Whitepaper) 2020 Virtual Press Conference being held on Monday, November 9, 2020 at 7:45 AM ET where the principal investigator will discuss the Company’s poster titled "An Open-label, multicenter, Phase 1/2 clinical trial of RP1, an enhanced potency oncolytic HSV, combined with nivolumab: Updated results from the skin cancer cohorts".
Presented single agent data from Phase 1 trial evaluating RP2 in heavily pre-treated patients. The data presented demonstrated compelling monotherapy clinical activity in patients with immune insensitive tumor types. Nine patients were treated with single agent RP2. One patient (with mucoepidermoid carcinoma) has an ongoing complete response and two other patients (with uveal melanoma and esophageal cancer) have ongoing partial responses. All three of these responses are durable; ongoing at between eight and 11 months from the first dose. RP2 was observed to be well-tolerated with side effects consistent with RP1. Following from this single agent data, enrollment of patients being treated with RP2 combined with Opdivo is currently underway. RP2 is an enhanced potency oncolytic immunotherapy which expresses an anti-CTLA-4 molecule, intended to improve on the safety and efficacy profile of systemic antibody approaches to targeting CTLA-4.

Clinical trials authorization (CTA) accepted by the MHRA for RP3. The CTA for RP3, Replimune’s third product candidate, which in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4 also expresses CD40L and 4-1BBL, has been accepted by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom allowing initiation of the Phase 1 clinical trial with RP3 alone and combined with anti-PD1 therapy, which is expected to initiate by the end of 2020. RP3, in addition to maximizing so-called Signal 1 (antigen presentation), is intended to also maximize Signal 2 (immune co-stimulation) and Signal 3 (the production of inflammatory cytokines, stimulated by CD40L and 4-1BBL).
Extended cash runway into the second half of 2024. In October 2020, the Company raised gross proceeds of approximately $287 million through a public offering of common stock and pre-funded warrants. The Company believes that the existing cash, cash equivalents and short-term investments at September 30, 2020, together with the proceeds raised in October, will enable the Company to conduct additional clinical trials including potentially registration-directed clinical development of RP2 and/or RP3, build initial commercial infrastructure, and to fund overall operations into the second half of 2024.
Announced new appointment to the Board of Directors. In October, the Company announced the appointment of Tanya Lewis to the Board of Directors. The appointment adds deep strategic expertise in developing and executing regulatory strategies.
Completed manufacturing facility to support late-stage development and commercialization. The 63,000-square-foot state-of-the-art facility in Framingham, MA provides multi-product manufacturing capabilities for the Company’s product candidates with sufficient capacity to support full commercialization. The facility is now fully operational and technology transfer activities for RP1 complete. GMP batch production is underway with product expected to be released for use in 2021.
COVID-19 potential impact on milestones: Enrollment into our clinical trials, such as the Company’s clinical trial of RP1 in solid organ transplant patients with CSCC, representing a highly immunocompromised patient population, has been slower than expected, which the Company attributes to the global pandemic. As the clinical sites continue to evaluate their capacity to treat patients, the Company could see additional impact on the pace of enrollment in the final quarter of 2020 and the first half of 2021 across its clinical trial programs.

Program Highlights

RP1 in combination with Libtayo in cutaneous squamous cell carcinoma (CSCC): The Company is actively enrolling patients into its 240-patient, registration-directed Phase 2, randomized, controlled, global clinical trial.

RP1 in combination with Opdivo in melanoma, non-melanoma skin cancers, and MSI-H/dMMR tumors: Enrollment and accrual of the initial melanoma cohort (including anti-PD1 naïve and failed patients) was completed in the first half of 2020. The Company continues to enroll into a cohort of patients with non-melanoma skin cancers which has been expanded from 30 patients to 45 to include anti-PD1 failed patients. The Company is accumulating data from the MSI-H/dMMR (anti-PD1 naïve) cohort to inform a decision as to whether to pursue MSI-H/dMMR tumors into registration-directed development in 2021.

RP1 in combination with Opdivo in anti-PD-1 failed melanoma: The Company initiated recruitment into a new registration-directed 125-patient cohort in the Phase 2 clinical trial of RP1 in combination with Opdivo in the first half of 2020 and continues to enroll patients.

RP1 in anti-PD1 failed patients with non-small cell lung cancer (NSCLC): The Company plans to initiate the 30 patient cohort of anti-PD1 refractory patients with NSCLC to the RP1 combined with Opdivo clinical trial later this year with the first patient expected to be dosed by the end of 2020 or in early 2021.

RP1 as monotherapy in solid organ transplant recipients with CSCC: A 30 patient Phase 1b clinical trial assessing the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC is open for enrollment.

RP2 alone and in combination with Opdivo: RP2 is being evaluated in a Phase 1 clinical trial evaluating the safety and efficacy of RP2 alone and combined with Opdivo. Following the monotherapy phase, enrollment is currently underway in a 30-patient expansion cohort in combination with Opdivo.

RP3 alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial remains on track to be initiated in 2020.

Financial Highlights

Cash Position: As of September 30, 2020, cash, cash equivalents and short-term investments were $244.6 million, as compared to $168.6 million as of March 31, 2020. This increase was primarily related to $109.5 million in net proceeds from financing activities offset by cash utilized in operating activities largely associated with advancing our expanded clinical development plan.

In October the company closed on an offering of common stock and pre-funded warrants raising approximately $287 million in gross proceeds and received aggregate net proceeds of approximately $270 million after deducting underwriting discounts, commissions, and other offering expenses. This includes the exercise in full by the underwriters of their option to purchase additional shares of common stock.
R&D Expenses: Research and development expenses were $14.0 million for the second quarter ended September 30, 2020, as compared to $8.2 million for the second quarter ended September 30, 2019. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $1.3 million in stock-based compensation expenses for the second quarter ended September 30, 2020.

G&A Expenses: General and administrative expenses were $5.6 million for the second quarter ended September 30, 2020, as compared to $4.1 million for the second quarter ended September 30, 2019. The increase was primarily driven by personnel-related costs, professional fees, and facility expansion. General and administrative expenses included $1.5 million in stock-based compensation expenses for the second quarter ended September 30, 2020.

Net Loss: Net loss was $20.1 million for the second quarter ended September 30, 2020, as compared to a net loss of $11.1 million for the second quarter ended September 30, 2019.

About RP1

RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response through the expression of a GALV-GP R- fusogenic protein and GM-CSF.

About RP2 & RP3

RP2 and RP3 are derivatives of RP1 that express additional proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

On November 5, 2020 Asieris Pharmaceuticals (Asieris), a China-based biotech company specializing in the development and commercialization of new drugs for the treatment of genitourinary tumors and related diseases, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved the clinical trial application (CTA) for its Phase III trial of APL-1202 as single oral agent for the first-line treatment of NMIBC (Press release, Asieris Pharmaceuticals, NOV 5, 2020, View Source [SID1234569887]).

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"This Phase III clinical trial for the first-line treatment of NMIBC, a key step to verify the advantages and characteristics of APL-1202, is another milestone of Asieris," commented Dr. Kevin Pan, founder and CEO of Asieris. "The single oral drug therapy of APL-1202 has the potential to replace intravesical chemotherapy and thereby avoiding the pain and adverse reactions associated with catheterization. If proven, it should become a new choice to prevent cancer recurrence. Asieris will continue to adhere to the vision of ‘we strive for healthy and dignified lives’ and focus on genitourinary tumors and related diseases. We hope to bring better treatment choices to more patients soon."

Currently, another pivotal registration trial of APL-1202 is ongoing in China. The treatment regimen is a combination of oral APL-1202 and intravesical chemotherapy as second-line treatment of patients with intermediate and high-risk recurrences of intravesical chemotherapy. This finished enrollment in 2019.

The approved trial is a randomized, open-labeled, parallel controlled, multicenter study to compare the safety and efficacy of oral APL-1202 as single drug versus intravesical epirubicin hydrochloride for the treatment of naive NMIBC with recurrence-free survival as the primary endpoint. This study will expand the clinical utility of APL-1202 and if successful will demonstrate the characteristics and advantages of APL-1202.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

According to Globocan (2018), bladder cancer is the tenth most common type of cancer worldwide, with an estimated 549,000 new cases and 200,000 deaths every year. Among them, 75% – 85% is non-muscle invasive bladder cancer (NMIBC). Currently, the common treatment of NMIBC is Trans-Urethral Resection of Bladder Tumors (TURBT). Because of high tumor recurrence rate after TURBT, intravesical chemo- or immuno-therapies are required after the procedure. Intravesical catheterization requires a hospital visit and is often associated with pain and other adverse reactions. No oral drugs have been approved for NMIBC to date.

About APL-1202

APL-1202 is a selective human methionine aminopeptidases II (MetAP2) inhibitor. In preclinical studies, APL-1202 has demonstrated both anti-angiogenic and anti-tumor activities as well as a potential synergistic effect with anti-BCG or epirubicin. APL-1202 is currently under clinical investigation for multiple indications. The treatment regimen with APL-1202 is convenient and well-tolerated, without causing pain or injury to the urethra, and may help some high-risk patients avoid radical cystectomy.

On November 5, 2020 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its third quarter 2020 results (Press release, Targovax, NOV 5, 2020, View Source [SID1234569886]).

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An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 CET today (details below).

RECENT HIGHLIGHTS

Announced that the ONCOS-102 and Imfinzi (durvalumab) trial successfully completed part 1 in colorectal cancer. The pre-defined disease control efficacy threshold in the colorectal cancer cohort was met and the part 2 has opened for recruitment of 14 additional patients.
Announced that an abstract on the mesothelioma trial has been accepted and will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, 9 -14 November 2020. The abstract presents the 12-month analysis of biomarkers and clinical outcome from the phase I/II trial in malignant pleural mesothelioma where ONCOS-102 is added to standard of care chemotherapy (pemetrexed / cisplatin). This analysis supports the data previously presented in June.
Completed a private placement, raising gross proceeds of approximately NOK 75 million (USD 8 million). The Private Placement attracted strong interest from existing shareholders and new institutional investors, both in the Nordics and internationally, and the transaction was oversubscribed multiple times.
Announced grant of European Patent no 3293201 by the European Patent Office. The patent covers the use of ONCOS-102 in combination with checkpoint inhibitors until 2036.
Formed a new Scientific Advisory Board (SAB), consisting of a group of world-renowned experts in immuno-oncology research and drug development carefully selected to act as advisors to guide the Targovax R&D strategy.
Øystein Soug, CEO commented: "As the end of 2020 is approaching, we are entering a period of intensive data analysis and reporting from our ongoing ONCOS-102 clinical program. Important efficacy and immune marker readouts from our two Targovax-sponsored ONCOS-102 trials in mesothelioma and melanoma are due late in the year. In October we reported that the pre-defined threshold for clinical benefit was met in the colorectal cancer cohort of the ONCOS-102 and Imfinzi collaboration trial. The second part of this trial has now been opened for recruitment, and results are expected in about a year’s time. As we wrap up these phase I/II clinical trials, we are in parallel planning the next steps for ONCOS-102 development and expanding our pre-clinical pipeline to shape our future R&D programs."

Presentation
As a consequence of the Corona situation, there will not be a physical presentation of the results. Instead, we invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On November 5, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that its CD40 targeting antibody mitazalimab will be presented at the World Immunotherapy Congress, November 2-6, 2020 (Press release, Alligator Bioscience, NOV 5, 2020, View Source [SID1234569885]). The presentation will include new benchmark data demonstrating that mitazalimab has the potential to be best-in-class in the CD40 field.

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The new preclinical data include analyses of mitazalimab compared with analogues of the CD40 antibodies of key competitors. The comparison demonstrates the potent immune-activating properties and anti-tumor effects of mitazalimab.

Mitazalimab’s mode of action is clearly dependent on Fc-gamma-receptor engagement, resulting in a more tumor-selective immune-activation. This differentiation may translate into a superior risk-benefit profile in patients.

The presentation will also summarize previously released clinical data from the Phase I study performed by Janssen Biotech Inc. Mitazalimab shows a manageable safety profile both with and without corticosteroid premedication. A partial response was observed in one patient with renal cell cancer and 10 patients with different advanced cancers showed stable disease lasting ≥ 6 months. In addition, clinical biomarker data confirm proof of mechanism in patients.

"The solid clinical package from Phase I and the new favorable benchmark data to our key competitors further strengthen our belief in mitazalimab as a potent immunotherapy agent. Mitazalimab has demonstrated strong activity and superior tolerability, which probably reflects the fact that the antibody has been optimized for more tumor-selective effects", said Per Norlén, CEO at Alligator Bioscience. "We are now completing the clinical file for the submission of the CTA for the upcoming Phase Ib/II efficacy study in pancreatic cancer," he added.

Dr Peter Ellmark, VP Discovery, Alligator Bioscience will give an oral presentation with the title "Mitazalimab – a CD40 agonist to unleash CD40 in immuno-oncology" on November 5, 2020, at 12:50 p.m CET. For further information, please see View Source