On November 6, 2018 Vedanta Biosciences, a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, reported preclinical data for VE800, the Company’s orally-administered, live biotherapeutic product candidate in immuno-oncology (Press release, Vedanta Biosciences, NOV 6, 2018, View Source [SID1234530930]). The study showed that VE800 elicited an anti-tumor immune response as a monotherapy and also enhanced effects of immune checkpoint inhibitors. Additionally, the results describe a mechanism of action for VE800 as the robust interferon-gamma producing CD8+ (cytotoxic) T cell response was elicited via activation of dendritic cells. The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting by Dr. Bruce Roberts, Chief Scientific Officer of Vedanta Biosciences, on November 8. Vedanta Biosciences expects to initiate a clinical study of VE800 in mid-2019.

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"Our work shows that VE800 induces robust tumor infiltration by cytotoxic T cells – one of the strongest predictors of response to checkpoint inhibitors – and promotes suppression of tumor growth and enhanced survival in a range of cancer models," said Bruce Roberts, Ph.D., Chief Scientific Officer of Vedanta Biosciences. "To our knowledge, VE800 is the most advanced immuno-oncology product candidate based on a defined consortium of human microbiome-derived bacteria, a therapeutic modality that Vedanta is pioneering. With our cGMP manufacturing processes in place, we’re well-positioned to take VE800 into the clinic in the coming months."

In the preclinical study, VE800 was assessed alone and in combination with various checkpoint inhibitors in colon carcinoma and melanoma tumor models. VE800 was assessed for its ability to induce CD8+ T cells, an important marker of anti-tumor response, as well for its ability to influence accumulation of tumor infiltrating lymphocytes. The study was conducted in collaboration with Dr. Kenya Honda of Keio University, a leader in the microbiome field and a scientific co-founder of Vedanta Biosciences.

Data highlights include:

1. VE800 robustly promoted induction of interferon-gamma producing CD8+ T cells via activation of intestinal dendritic cells and stimulation of interferon-gamma producing CD8+ T cells in a manner dependent on the transcription factor BATF3
2. VE800 enhanced the anti-tumor activity of both anti-PD-1 and anti-CTLA4 antibodies by increasing the level of tumor infiltrating CD8+ T cells
3. VE800 also promoted systemic immune cell activation as evidenced by accumulation of CD8+ T cells in the spleen.

Unlike fecal transplants or single strain approaches to microbiome modulation, Vedanta Biosciences uses pure, clonal cell banks to produce defined collections, or consortia, of bacterial strains designed to effect durable therapeutic changes in a patient’s microbiota. This bypasses the need to rely on direct sourcing of fecal donor material of inconsistent composition.

About VE800
VE800 is Vedanta Biosciences’ oral immuno-oncology product candidate. It consists of a rationally-defined bacterial consortium that activates cytotoxic CD8+ T cells, a type of white blood cell that is the predominant effector in cancer immunotherapy. In preclinical studies, VE800 has been shown to enhance the ability of these T cells to infiltrate tumors, thereby promoting suppression of tumor growth and improving survival. Data also suggest that VE800 may enhance the effects of checkpoint inhibitors. Vedanta Biosciences is evaluating VE800 alone and in combination with checkpoint inhibitors as a potential treatment for patients with advanced or metastatic cancers.

On November 6, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the third quarter ended September 30, 2018 (Press release, Zymeworks, NOV 6, 2018, View Source [SID1234530768]).

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"We continue to expand our business with our seventh pharmaceutical partner, LEO Pharma, recently entering into a strategic collaboration with Zymeworks," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Importantly, this deal represents the evolving structure of our partnerships to include collaborations that provide potential assets for pipeline expansion in new disease areas, as well as significant royalty participation."

Dr. Tehrani continued, "In addition, results from the Phase 1 study for ZW25 will be presented in a plenary session at an upcoming European oncology conference later this month, highlighting new and updated data in gastric and other HER2-expressing cancers, which support our fast-to-market single agent registrational strategy. We are also on track to file an IND for ZW49, our second product candidate, by year end and plan to initiate a Phase 1 study in early 2019."

Recent Business Highlights

Zymeworks and LEO entered into a licensing and research collaboration to generate bispecific antibodies targeting cytokine-receptor pathways with Zymeworks’ Azymetric, EFECT, and antibody generation platforms. The deal expands Zymeworks’ therapeutic reach into new disease areas beyond oncology with potential applications in dermatology, inflammation, and autoimmunity and includes up to US$480 million in upfront and potential milestone payments, in addition to royalties. LEO obtains rights to two bispecifics for dermatology and Zymeworks maintains rights in all other therapeutic areas.

New ZW25 data will be presented at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) symposium in a plenary session by Dr. Murali Beeram, START, San Antonio, TX, on November 14, 2018. Ongoing clinical activity and durability in gastric and tumor-agnostic cohorts will be highlighted, including new patients and data from patients continuing on study since the last data update.

Anthony (Tony) Polverino, Ph.D., joined Zymeworks as Executive Vice President of Early Development and Chief Scientific Officer. With an extensive background in drug discovery and development, including cancer biology and immunotherapy, Dr. Polverino, a former Kite Pharma and Amgen executive, will play a key role in driving Zymeworks’ R&D strategy and the advancement of product candidates from discovery research through translational research/early development.

Zymeworks hosted an R&D Briefing featuring the clinical development strategy of the Company’s lead clinical candidate, ZW25, as well as differentiating IND-enabling studies for its second product candidate, ZW49. Zymeworks also showcased the depth of its ADC platform and selected immuno-oncology programs from its maturing multispecific pipeline.

An IND-submission milestone was achieved in the Lilly collaboration. Eli Lilly is Zymeworks’ first pharmaceutical partner to submit an IND application to the U.S. Food

and Drug Administration (FDA) for a bispecific antibody enabled by Zymeworks’ Azymetric platform.

Financial Results for the Three Months Ended September 30, 2018

Revenue for the three months ended September 30, 2018 was $2.1 million as compared to $0.1 million in the same period in 2017. The change between the two periods was primarily due to a $2.0 million development milestone upon Lilly’s submission of an IND.

For the three months ended September 30, 2018, research and development expenditures were $14.1 million as compared to $11.5 million for the same period in the prior year. The change between the two periods was primarily due to an increase in clinical and drug manufacturing costs for ZW25, as well as an increase in other research and development activities.

General and administrative expenses were $7.5 million for the three months ended September 30, 2018, and $5.3 million for the same period in 2017, primarily due to an increase in non-cash liability classified equity adjustments and stock-based compensation, as well as other increases in compensation and professional fees associated with year-on-year growth following the Company’s initial public offering in 2017.

Non-cash charges for the three months ended September 30, 2018 included $1.8 million ($1.3 million in G&A and $0.5 million in R&D) related to the quarterly mark-to-market revaluation of liability classified equity adjustments (attributed to the accounting treatment of historical stock-based compensation in both Canadian and US dollars) and stock-based compensation.

The net loss for the three months ended September 30, 2018 was $18.8 million as compared to $16.2 million for the same period in 2017. Zymeworks expects R&D expenditures to increase over time due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities. Additionally, Zymeworks expects to continue receiving 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, 2018, Zymeworks had $150.0 million in cash and cash equivalents and short-term investments.

On November 6, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that CFO and Head of Corporate Strategy, John Leaman, M.D., will present at the Stifel Healthcare Conference in New York City at 12:45 p.m. ET on Tuesday, November 13, 2018 (Press release, Selecta Biosciences, NOV 6, 2018, View Source [SID1234530791]). A live and archived webcast of the presentation can be accessed via the Investors & Media section of the company’s website, View Source

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On November 6, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, provided a corporate update and reported financial results for the third quarter of 2018 (Press release, Agenus, NOV 6, 2018, View Source [SID1234530830]).

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"We have made substantial operational advances. These are unprecedented for a company of our size but also for the field of I-O," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We have shown that our CTLA-4 and PD-1 antibodies are active in the clinic with clinical benefit seen in the majority of the more than 130 patients treated. Recently we met with the FDA to confirm our clinical path to a BLA filing. In addition to these, our discovery engines have produced 4 INDs which have been filed this year, including our next generation CTLA-4. We plan to finish the year with two additional IND filing of first-in-class bispecifics. We also expect the closure of at least one corporate partnership transaction by year end."

Key operational and business updates

Operational Achievements:
PD-1 & CTLA-4 show clinical benefit in majority of patients across multiple solid tumors, including cervical cancer
Clinical benefit rate of 68% and 63% for AGEN2034 & AGEN18842
FDA meeting confirms path to BLA filing for lead molecules
Three trials are ongoing to leverage accelerated approval pathways
New discoveries advance to clinic
Four INDs filed in 2018, including Next-Gen CTLA-4, AGEN1181
Two First-in-class bispecific IND filings on track by year end
2018 Payment milestones triggered in partnerships with Incyte, Merck
LAG-3 (INCAGN02385) and TIM-3 (INCAGN02390) in the clinic with milestones received and to be received in Q4
Undisclosed target with Merck entered clinic also generating a milestone payment
Sales of GSK’s Shingrix, containing QS-21 Stimulon, have significantly exceeded earlier sales projections
Partnership discussions on track to be concluded by year end
Manufacturing Speed and Innovation driving advances to the clinic:
Setting industry records for clinical & pivotal grade material
3-5x faster for lead compounds
First-in-class bispecific, AGEN1223, manufactured at scale in <2 months
AgenTus Cell Therapy Business:
Lead identified for IND filing; private financing and plans for IPO underway
Third Quarter 2018 Financial Results

Cash and cash equivalents were $46.3 million at the end of the 3rd quarter compared to $43.2 million and $60.2 million at June 30, 2018 and December 31, 2017 respectively. Subsequent to the end of 3rd quarter, Agenus announced the completion of a private financing of $40 million with a single investor netting the company approximately $39.9 million.

For the third quarter ended September 30, 2018, we reported a net loss of $34 million or $0.29 per share compared to a net loss for same period in 2017 of $37 million, or $0.37 per share. In the third quarter, we recognized revenue of $13 million which includes a milestone achieved and non-cash royalties earned.

For the nine months ended September 30, 2018, we had a net reported loss of $113 million or $1.04 per share compared to a net reported loss for the same period in 2017 of $86 million or $0.88 per share. The increased net loss reflects reduced revenue during 2018 due to accelerated milestones received during 2017 from Incyte and the 2018 loss on early extinguishment of debt.

Conference Call, Webcast and Prepared Statement Information

Conference Call Information:

Date: Tuesday November 6, 2018

Time: 8:30 a.m. ET

Domestic Dial-in Number: (844) 492-3727

International Dial-in Number: (412) 317-5118

Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

On November 6, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that it will present results from a study that further demonstrates the ability of the Company’s proprietary Discovery Engine, featuring the Company’s Immune Repertoire Capture (IRC) technology, to identify antibodies from treatment-responsive cancer patients that bind to non-autologous tumor tissue (Press release, Atreca, NOV 6, 2018, View Source [SID1234530932]). The study will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 7-11, 2018, at the Walter E. Washington Convention Center in Washington, D.C.

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"Atreca has built a proprietary and unique discovery platform that enables us to discover, in a very efficient and industrialized manner from active immune responses, antibodies that can serve as the foundation of therapeutics," said Tito A. Serafini, Ph.D., Chief Strategy Officer and an Atreca founder. "The results to be presented at this conference provide another example of what this Discovery Engine enables in oncology; namely, our ability to identify tumor-targeting antibodies in treatment-responsive patients with the potential to be developed into therapeutics designed to treat large patient groups. Our most advanced program, ATRC-101, which we anticipate entering clinical trials in 2019, is a product of this approach."

In the study, (Abstract #O3; Title: Anti-tumor immune responses in metastatic breast cancer exceptional responder patients) to be presented both as an oral presentation and a poster by William Robinson, M.D., Ph.D., Professor of Medicine at Stanford University and an Atreca Founder, Atreca researchers collaborated with researchers led by Joyce O’Shaughnessy, M.D., at Baylor University Medical Center and Texas Oncology. Atreca researchers investigated the properties of antibodies identified in the active immune response of eleven metastatic breast cancer patients who had exceptional and durable responses to systemic therapy. Of the patient-derived antibodies assessed, over 40% displayed specific immunoreactivity to breast carcinoma tissue from unrelated patients, but not to adjacent tissue, indicating that they bind to public tumor antigens. Multiple antibody lineages, predominantly of the IgG2 subclass, showed evidence of convergent antibody evolution across patients, and a subset of responder antibodies drove killing of tumor cells in in vitro functional assays.

Abstract Title: Anti-tumor immune responses in metastatic breast cancer exceptional responder patients (Abstract #O3)

Oral Presentation

Concurrent Session 216: Role of B cells in Immunotherapy & Toxicity
Date & Time: Saturday, Nov. 10, 6:10 – 6:25 p.m. EST
Location: East Salon ABC
Atreca also has a second presentation. Details are below:

Abstract Title: The identification of potent anti-tumor antibodies applicable for ADC therapeutics from patients undergoing immunotherapy (Abstract #P1)

Poster Display (for both posters)

Date & Time: Friday, Nov. 9, from 8 a.m. – 8 p.m. EST and Saturday, Nov. 10, from 8 a.m. – 12 p.m. EST
Presentation Hours: Friday, Nov. 9, 12:45 – 2:15 p.m. EST and 6:30 – 8 p.m. EST
Location: Hall E