On November 12, 2021 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2021 and provided a business update (Press release, Savara, NOV 12, 2021, View Source [SID1234595457]).

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"The team is focused and driving hard on advancing the pivotal Phase 3 IMPALA 2 trial," said Matt Pauls, Chair and Chief Executive Officer, Savara. "Given that an increasing number of sites are actively screening and enrolling patients, and we completed an important regulatory milestone with EMA’s acceptance of our proposed revised PIP, we are pleased with our progress over the last quarter. While the potential impact of COVID-19 and the flu over the winter is unknown, we remain confident in our guidance of a 20-month enrollment timeframe and top-line data by the end of Q2 2024. Finally, we significantly bolstered our inhalation delivery and biological product expertise in the manufacturing, regulatory, and quality functions with the addition of Peter Clarke and Charles LaPree."

Third Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the three months ended September 30, 2021, was $10.5 million, or $(0.07) per share, compared with a net loss attributable to common stockholders of $11.1 million, or $(0.18) per share, for the three months ended September 30, 2020.

Research and development expenses increased by $0.9 million, or 16.6%, to $6.5 million for the three months ended September 30, 2021 from $5.6 million for the three months ended September 30, 2020. The increase was primarily attributable to an approximately $3.2 million increase in costs associated with the screening of patients and progression of the IMPALA-2 trial for the molgramostim development program. This was partially offset by a $2.1 million decrease in chemistry, manufacturing, and control ("CMC") and clinical operations activities associated with the wind down of the vancomycin study in methicillin-resistant Staphylococcus aureus (MRSA) lung infection.

General and administrative expenses decreased by $2.0 million, or 36.7%, to $3.4 million for the three months ended September 30, 2021 from $5.4 million for the three months ended September 30, 2020. The decrease was primarily due to the recognition of a one-time non-recurring charge of $0.8 million for non-cash stock-based compensation and approximately $1.5 million of paid and accrued severance payments to former members of executive management during the three months ended September 30, 2020.

As of September 30, 2021, Savara had cash, cash equivalents, and short-term investments of approximately $171 million and debt of approximately $25 million.

On November 12, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that Grant Bogle, President and Chief Executive Officer of Epizyme, will present at the Jefferies London Healthcare Conference (Press release, Epizyme, NOV 12, 2021, View Source [SID1234595473]). A pre-recorded fireside chat will be available to play on demand starting at 3:00am EST (8:00am GMT) on November 18, 2021.

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A live webcast of the fireside chat will be available in the investor section of the Company’s website at www.epizyme.com and will be archived for 60 days following the presentation.

On November 12, 2021 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, reported the presentation of data on multiple immuno-oncology programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, OncoResponse, NOV 12, 2021, View Source [SID1234595489]).

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Data presented included preclinical findings on three monoclonal antibodies developed utilizing OncoResponse’s proprietary B-cell platform that leverages data from elite responders to cancer immunotherapy in order to rapidly identify fully human therapeutic antibodies.

"OncoResponse is focused on the development of human antibodies that modulate immune cell activity and enhance immunotherapy responses. Our data presented at SITC (Free SITC Whitepaper) highlight three investigational targets that provide initial and compelling data demonstrating immune activity and the ability to modulate the tumor microenvironment," said Kamal Puri, PhD, Chief Scientific Officer of OncoResponse.

Clifford Stocks, OncoResponse Chief Executive Officer, added, "We look forward to the continued evaluation of our lead candidate, OR2805, in an ongoing clinical trial as well as further advancing additional targets toward IND-enabling studies."

Presentation highlights include:

Poster: 271

Development of OR2805, an anti-CD163 antibody derived from an elite responder to checkpoint inhibitor therapy that relieves immunosuppression caused by M2c macrophages

The evaluation of OR2805 alone and in combination with an anti-PD1 or -PD-L1 antibody in various preclinical in vitro and in vivo assays modeling an immunosuppressive tumor microenvironment, demonstrated:

OR2805 binds with high specificity to M2 macrophages and tumor-associated macrophages (TAMs) in human primary non-small cell lung cancer tumors
OR2805 reduces expression of cell-surface markers associated with tumor-promoting M2c macrophages and relieves the immunosuppressive effect on T-cell activation and proliferation in coculture assays
Robust anti-tumor activity was demonstrated in lung cancer xenograft models in humanized NSG-SGM3 mice. Additionally,
OR2805 reduces TAM mediated immunosuppression and enhances anti-tumor immune responses.
Combination with OR2805 restores and amplifies anti-PD-1 and anti-PD-L1 activity in coculture assays
OR2805 toxicology predicts a tolerable safety profile
OR2805 is currently being evaluated in a Phase 1/2 study in patients with advanced cancer
Poster: 262

Preclinical characterization of humanized anti-Siglec-15 antibodies that rescue T cells from macrophage-mediated immune suppression

The identification of novel humanized anti-Siglec-15 antibodies identified using functional screens modeling Siglec-15-mediated immune suppression by M2c macrophages demonstrated:

Ability of antibodies to block the interaction of Siglec-15 with an immune suppressive checkpoint on T cells and restore T-cell effector function.
Rescue of T cell activation and proliferation from M2c macrophage-mediated immunosuppression in M2c/CD8 coculture assays.
Restoration of effector function of activated and exhausted T cells from M2c-mediated immune suppression, with favorable half-life and anti-tumor activity in humanized mouse models.
Data provide a rationale for further development of these antibodies as anti-cancer immunotherapy.
Poster: 276

Discovery and preclinical characterization of anti-LILRB2 antibodies that rescue T cells from macrophage-mediated immune suppression

Identification of anti-LILRB2 antibodies that demonstrate:

Enhanced IFN-γ production by peripheral blood mononuclear cells and TNF-α secretion by macrophages
Relief of CD8+ T cells from M2c macrophage-mediated immunosuppression
Anti-tumor activity in an SK-MEL-5 tumor model in humanized NSG-SGM3 mice with up to 79% tumor growth inhibition and 44% tumor regression
Results support further development of lead anti-LILRB2 antibodies for cancer immunotherapy
Accessing Posters
The OncoResponse posters presented at SITC (Free SITC Whitepaper) are accessible from the Publications & Presentations page of OncoResponse website at View Source

About OR2805
OR2805 is a fully human antibody discovered using B cells derived from an elite responder to checkpoint inhibitor (CPI) therapy. This antibody binds to CD163 which is highly expressed on tumor associated macrophages (TAMs) that create an immunosuppressive tumor microenvironment and inhibit anti-tumor T-cell responses. High frequency of CD163-expressing TAMs generally predicts an unfavorable prognosis in solid tumors. OR2805 is designed to improve anti-tumor T-cell responses, by reversing the immunosuppression of TAMs, as a therapeutic strategy for monotherapy and in combination with CPI.

On November 12, 2021 Upsher-Smith Laboratories reported that (Press release, Upsher-Smith Laboratories, NOV 12, 2021, View Source [SID1234595512])

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1. Financial Highlights for the First Quarter of FY2021 (for the six-month period ended September 30, 2021)

(1） Consolidated Operating Results
(2) Consolidated Financial Position

2. Cash Dividends

On November 12, 2021, Shattuck Labs, Inc. presented at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Presentation, Shattuck Labs, NOV 12, 2021, View Source [SID1234595579]).

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