On November 3, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the quarter ended September 30, 2020 (Press release, Zymeworks, NOV 3, 2020, View Source [SID1234569784]).

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"Zanidatamab’s clinical development continued to expand this quarter, having opened new sites across the globe for the pivotal trial in HER2-amplified biliary tract cancers toward our first potential BLA submission," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We are well-resourced to achieve this milestone for zanidatamab, along with advancing the development of ZW49 into expansion cohorts and beyond."

Third Quarter 2020 Business Highlights and Recent Developments

Zanidatamab Pivotal Trial Expands to Europe and Asia-Pacific Region
Sites are active and recruiting in North America, Europe, and Asia in the global pivotal trial of single agent zanidatamab in previously-treated HER2 gene-amplified biliary tract cancers. This study aims to support accelerated approval and may enable filing of a Biologics License Application (BLA) as early as 2022.
ZW49 Continues Dose Escalation
Zymeworks’ second clinical candidate, ZW49, a bispecific antibody-drug conjugate targeting HER2, continues to be evaluated across multiple dosing regimens in the dose-escalation portion of a Phase 1 clinical trial.
Zymeworks Implements Expanded Access Program (EAP) for Patients not Eligible for Existing Trials
Zymeworks’ EAP or Compassionate Use program will enable critically ill patients who are not eligible for the Company’s clinical trials and who may not have options for alternative therapies to be considered for access to Zymeworks’ pipeline of investigational medicines. More on Zymeworks’ EAP: View Source
First Patients Dosed in Investigator-Initiated Trial of Zanidatamab in Endometrial Cancers
Dr. Vicky Makker at Memorial Sloan Kettering Cancer Center is conducting a Phase 2 trial to evaluate single agent zanidatamab in HER2-overexpressed advanced endometrial cancers and carcinosarcomas. This study is expected to enroll up to 25 patients with the primary endpoint of assessing the overall response rate.
Financial Results for the Quarter Ended September 30, 2020

Revenue of $2.6 million for the three months ended September 30, 2020 related to research support and other payments from our partners. For the same period in 2019, revenue of $7.9 million included $7.5 million for a commercial license option milestone from BMS and $0.4 million in research support payments from our partners.

Research and development expenses were $53.5 million for the three months ended September 30, 2020 compared to $29.3 million for the same period of 2019. The increase related primarily to additional clinical trial activities and associated drug manufacturing for zanidatamab as well as an increase in internal headcount. Expenses also increased during this period due to higher development activity for ZW49, licensing and milestone payments and stock-based compensation expense. Research and development expenses included non-cash stock-based compensation expense of $6.0 million comprised of $3.6 million from equity-classified awards and $2.4 million related to the non-cash mark-to-market revaluation of certain historical liability-classified awards.

General and administrative expenses were $22.8 million for the three months ended September 30, 2020 compared to $12.2 million for the same period in 2019. The change was primarily due to an $8.1 million increase in non-cash stock-based compensation expense. Expenses also increased during this period due to higher headcount and insurance expenses. General and administrative expenses included non-cash stock-based compensation expense of $12.6 million comprised of $4.4 million from equity-classified awards and a $8.2 million expense related to the non-cash mark-to-market revaluation of certain historical liability-classified awards.

Net loss for the three months ended September 30, 2020 was $72.6 million as compared to $30.5 million for the same period of 2019. This was primarily due to the increases in research and development expenses and general and administrative expenses referred to above as well as lower revenue recognized during current period.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of September 30, 2020, Zymeworks had $497.0 million in cash resources consisting of cash, cash equivalents, short-term investments and certain long-term investments.

On November 3, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 1:15 p.m. EST on Tuesday, November 10, at the Credit Suisse 29th Annual Healthcare Conference (Press release, Puma Biotechnology, NOV 3, 2020, View Source [SID1234569783]). The conference will be held virtually.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

On November 3, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported results for the third quarter of 2020 in addition to providing an update on the company’s recent activities (Press release, Five Prime Therapeutics, NOV 3, 2020, View Source [SID1234569782]).

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"We look forward to achieving three milestones before the end of the year that will inform future development of our pipeline," said Tom Civik, Chief Executive Officer of Five Prime Therapeutics. "Before year end, we expect to report top-line data from the FIGHT Phase 2 trial in front-line gastric cancer. We also expect to have enough FPT155 monotherapy data to inform next steps for the program, and we will present the first data set from our anti-CCR8 program at the upcoming SITC (Free SITC Whitepaper) annual meeting. The Five Prime team has done an excellent job advancing our clinical and research programs despite the many challenges we have all confronted this year."

Third Quarter 2020 Milestones

Clinical Pipeline:

Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) being studied in the FIGHT trial as a targeted therapy for front-line FGFR2b+/HER2- gastric and gastroesophageal junction (GEJ) cancer.

The company expects to report top-line data before year end from the double-blind Phase 2 FIGHT study where all 155 patients receive standard mFOLFOX6 chemotherapy and are randomized to receive bemarituzumab or placebo.
The primary endpoint of the Phase 2 FIGHT trial is progression-free survival (PFS), and a secondary endpoint is overall survival (OS).
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that directly engages CD28 and binds to CTLA-4, promoting CD8 T cell activation in the tumor microenvironment.

Patients with warm/hot tumor types continue to be enrolled at the 560mg dose in the ongoing Phase 1a/1b trial, with the aim of generating early clinical data at a potentially active dose to determine next steps for this program.
The first cohort has been cleared and the second cohort is open for enrollment in a dose escalation of FPT155 and pembrolizumab in patients with non-small cell lung cancer.
FPA157 (anti-CCR8) is a novel antibody directed to CCR8, a promising immuno-oncology target that is expressed by a highly immunosuppressive population of T regulatory cells within tumors. Eliminating CCR8-expressing T regulatory cells is anticipated to reduce immunosuppression in the tumor microenvironment and promote development of anti-tumor responses.

The company’s FPA157 late-breaking abstract has been accepted for a poster presentation at the 2020 Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
The company expects to submit an IND application for this program in the first half of 2022.
Summary of Third Quarter 2020 Financial Results and Cash Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $112.9 million as of September 30, 2020 compared to $157.9 million as of December 31, 2019. This decrease was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.

Revenue: Collaboration and license revenue for the third quarter of 2020 decreased by $0.9 million, or 31%, to $2.0 million from $2.9 million for the third quarter of 2019. The decrease was primarily the result of a reduction in revenue pursuant to progress achieved toward satisfying performance obligations under the company’s November 2014 cabiralizumab collaboration agreement with BMS. The decrease was partially offset by higher collaboration revenue from Zai Lab that resulted from the company’s decision to amend the FIGHT trial to a Phase 2 design.

R&D Expenses: Research and development expenses for the third quarter of 2020 decreased by $5.5 million, or 20%, to $21.4 million from $26.9 million for the third quarter of 2019. The decrease was primarily due to lower compensation costs resulting from the October 2019 restructuring, lower clinical trial expense and manufacturing costs, along with lower allocated costs, bioanalytics and central lab costs, and a decrease in costs related to preclinical programs. These reductions were partially offset by an impairment charge on right-of-use assets and other fixed assets related to the sublease of a portion of the company’s facility, as well as an increase in companion diagnostics costs related to bemarituzumab.

G&A Expenses: General and administrative expenses for the third quarter of 2020 increased by $0.5 million, or 4%, to $13.7 million from $13.2 million for the third quarter of 2019. The increase was primarily due to an impairment charge taken in the third quarter on the right-of-use asset and other fixed assets related to the sublease of a portion of the company’s facility, as well as higher allocated costs that were offset by lower compensation, depreciation, and other miscellaneous general and administrative costs.

Net Loss: Net loss for the third quarter of 2020 was $26.4 million, or $0.74 per basic and diluted share, compared to a net loss of $36.1 million, or $1.03 per basic and diluted share, for the third quarter of 2019.

Shares Outstanding: Total shares outstanding were 35,620,167 as of September 30, 2020.

Cash Guidance: Five Prime expects full-year 2020 net cash used in operating activities to be between $70 and $75 million and has raised guidance to end 2020 with cash, cash equivalents and marketable securities between $100 and $105 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 7757227. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On November 3, 2020 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR platform, reported an update on its ongoing APVO436 Phase 1 clinical trial (Press release, Aptevo Therapeutics, NOV 3, 2020, https://aptevotherapeutics.gcs-web.com/news-releases/news-release-details/aptevo-therapeutics-announces-first-complete-remission-ongoing [SID1234569781]).

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APVO436 is a novel anti-CD123 x anti-CD3 targeted investigational bispecific antibody therapy being evaluated for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in a Phase 1/1b open-label, dose-escalation study evaluating the safety and pharmacokinetic profile.

Aptevo is pleased to announce that, based on preliminary data, a patient in cohort 6 of the clinical trial has shown complete remission.

In summary:

Patient bone marrow blasts decreased from 29% at screen to 6% after the first cycle of treatment, and to 0% after the second cycle of treatment; and,
The patient’s platelet count and absolute neutrophil count (ANC) met complete remission criteria (CR).
"We are greatly encouraged by the complete remission in the patient in cohort 6, which is a wonderful outcome for them," said Marvin White, President and CEO of Aptevo Therapeutics. "We are now in a critical phase of the study, as pharmacokinetic modelling suggests that dosing in cohorts 5 through 8 is in a therapeutic range, which could result in potential clinical activity of the drug. We look forward to continuing the dose escalation and monitoring potential clinical responses as we advance through the upcoming dose cohorts," concluded Mr. White.

APVO436 was built on Aptevo’s next generation proprietary ADAPTIR protein therapeutic platform. Focused on generating novel, targeted bispecific antibody-based immunotherapies for cancer the ADAPTIR platform offers key advantages over other bispecific formats, derived in part from the flexible and modular nature of the ADAPTIR structure.

Aptevo believes that its differentiated ADAPTIR bispecific technology platform has the potential to offer a more convenient and cost-effective solution compared to other immunotherapies such as CAR-T therapies. While CAR-T therapies have proven effective in generating robust and durable treatment responses, they remain challenging and expensive to manufacture and administer to patients. In contrast, bispecific technologies may represent a simpler, more competitive ‘off-the-shelf’ solution in the rapidly advancing field of cancer immunotherapy.

On November 3, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported that it will present new positive interim data from its KEYNOTE-695 registration-enabled Phase 2b clinical trial investigating TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), in combination with KEYTRUDA (pembrolizumab) in patients with anti-PD-1 checkpoint refractory metastatic melanoma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting, to be held virtually from November 9-14, 2020 (Press release, OncoSec Medical, NOV 3, 2020, View Source [SID1234569780]).

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The KEYNOTE-695 abstract was selected as one of five studies to be featured in an oral presentation and discussion during the "Virtual Poster Walks" to be held on Tuesday, November 10, time to be determined.

Dr. Paolo Ascierto will also discuss the KEYNOTE-695 data at a Company Symposium entitled, "DNA Plasmid-Based IL-12 Delivered Intratumoral Electroporation: Achieving Meaningful Tumor Response while Avoiding Systemic Toxicities," to be held on November 12 at 7:30 a.m. ET. The Symposium will include presentations from additional key opinion leaders about TAVO and DNA electro-transfer for cancer immunotherapies.

Additionally, OncoSec will be presenting two posters regarding immunological data in metastatic triple negative breast cancer (mTNBC) and preliminary pre-clinical data regarding CORVax12, OncoSec’s novel DNA-encodable vaccine for COVID-19. CORVax12 combines TAVO with the National Institute of Health’s DNA-encodable stabilized trimeric SARS-CoV-2 spike glycoprotein and is expected to enter a Phase 1 clinical trial in the immediate future given recent IND acceptance.

Details about the presentations and Symposium are as follows:

Oral Presentation – Poster Walk
Title: Durable responses and immune activation with intratumoral electroporation of pIL-12 plus pembrolizumab in actively progressing anti-PD-1 refractory advanced melanoma: KEYNOTE 695 interim data
Poster #: 799
Date/Time: Tuesday, November 10, time to be determined.
Presenter: Adil Daud, M.D., HS Clinical Professor, Department of Medicine (Hematology/Oncology), University of California, San Francisco (UCSF); Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center

Symposium
Event Name: DNA Plasmid-Based IL-12 Delivered Intratumoral Electroporation: Achieving Meaningful Tumor Response while Avoiding Systemic Toxicities
Date/Time: Thursday, November 12, 2020 from 7:30 – 8:30 a.m. ET
Presenters:

Paulo Ascierto, M.D., Director Dept. of Melanoma, Cancer Immunotherapy, Development Therapeutics, Ist. Naz. Tumori IRCCS Pascale
Deborah Charych, Ph.D., Founder and Chief Technology Officer at RayzeBio
Richard Heller, Ph.D., Professor at University of South Florida
Michael Pritchett, D.O. and M.P.H. ,Director of Thoracic Oncology; Director, Chest Center of the Carolinas; FirstHealth of the Carolinas; Pinehurst Medical Clinic Pulmonary & Critical Care Medicine
Chris Twitty, Ph.D., Chief Scientific Officer (moderator)
Additional Poster Presentations
Title: Intratumoral plasmid IL-12 expands CD8+ T cells and induces a clinically validated CXCR3 signature in triple-negative breast cancer
Poster #: 789
Date/Time: Wednesday, November 11, 2020 from 5:15–5:45 p.m. ET and Friday, November 13 from 4:40–5:10 p.m. ET
Session: Virtual Poster Hall
Presenter: Erika J. Crosby, Ph.D., Department of Surgery, Duke University Medical Center

Title: Preliminary evaluation of a novel coronavirus vaccine (CORVax) using electroporation of plasmid DNA encoding a stabilized prefusion SARS-CoV-2 spike protein alone or with transfection of plasmid IL-12
Poster #: 480
Date/Time: Thursday, November 12, 2020 from 4:50–5:20 p.m. EST and Saturday, November 14 from 1–1:30 p.m. EST
Session: Virtual Poster Hall
Presenter: Shawn M. Jensen, Ph.D., Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute, Providence Portland Medical Center

Copies of the posters will be archived and available in the Investors section of the Company’s website at www.oncosec.com on Nov. 9, 2020.

About KEYNOTE-695
KEYNOTE-695 is OncoSec’s registration-directed Phase 2b trial (NCT#03132675) evaluating TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12) + KEYTRUDA (pembrolizumab) in patients with anti-PD-1 checkpoint resistant metastatic melanoma. The trial aims to enroll up to 100 patients with refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab). TAVO has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA or OPDIVO.

About TAVO
OncoSec’s gene therapy technology combines TAVOTM (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-895 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.

About Advanced Metastatic Melanoma
Metastatic melanoma refers to stage IV melanoma, which has typically spread through the lymph nodes to distant sites in the body such as the liver, lungs, bones and brain. Every year, approximately 100,000 adults in the United States are diagnosed with metastatic melanoma. Due to this metastatic tumor burden, stage IV melanoma is often very difficult to treat. Available treatment options frequently combine surgery with immunotherapy or targeted therapy. The 5-year survival rate for metastatic melanoma is approximately 25%.

About Metastatic Triple Negative Breast Cancer (TNBC)
Metastatic triple negative breast cancer (mTNBC) is an aggressive type of breast cancer with a high recurrence rate within the first five years following diagnosis, which accounts for 10-20% of all breast cancers. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is difficult to treat and there are very few FDA approved treatment options for these patients, which mostly rely on surgery, radiation, and chemotherapy. The 5-year survival rate for these patients is approximately 11%.

About CORVax
CORVax is the only DNA vaccine that uses an immune stimulant to promote an immune response against the SARS-CoV-2 virus. The CORVax vaccine approach combines the co-administration of TAVO (plasmid IL-12) with a DNA-encodable version of the SARS-CoV-2 spike or "S" glycoprotein to enhance immunogenicity of the component developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. CORVax12 is designed to drive a coordinated vaccine response, capable of drawing upon the innate and adaptive humoral and cellular arms. This multi-pronged innate, adaptive and cellular immune response has the potential to generate a robust anti-viral response.