On October 1, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported the acceptance of a presentation on TPST-1495, a selective antagonist of both EP2 and EP4 prostaglandin receptors, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place November 10-14, 2021 at the Walter E. Washington Convention Center in Washington, D.C (Press release, Tempest Therapeutics, OCT 1, 2021, View Source [SID1234590635]).

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Details of the poster presentation are as follows:

Title: Dual blockade of the EP2 and EP4 PGE2 receptors with TPST-1495 is an optimal approach for drugging the prostaglandin pathway
Abstract #: 850
Category: Novel Single Agent Immunotherapies
Date/time: 11/12/2021 – 11/13/2021, 7:00 am – 8:30 pm ET
Location: Poster Hall
To view the abstract details, please visit the SITC (Free SITC Whitepaper) 2021 website located at View Source

About TPST-1495

TPST-1495 is an orally-available small molecule designed to block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway, while sparing the homologous but differentially active EP1 and EP3 receptors. PGE2 signaling through EP2 and EP4 has been observed both to enhance tumor progression and promote immune suppression. Tempest has conducted head-to-head preclinical studies comparing TPST-1495 to single antagonists of EP2 and EP4 and observed significantly enhanced activity of TPST-1495 in both overcoming PGE2-mediated suppression of human immune cells in vitro, as well as significantly increased anti-tumor activity in mouse models of human colorectal cancer. Tempest is currently evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and possible anti-tumor activity of TPST-1495 in a multicenter Phase 1a/1b dose and schedule optimization study in subjects with advanced solid tumors, with the potential to expand in indications known to be prostaglandin-driven, including colorectal cancer, or CRC, and in a tumor indication-agnostic, biomarker-selected cohort.

On October 1, 2021 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating several investigational therapies and technologies in the company’s solid tumor product pipeline will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36thAnnual Meeting (SITC 2021), being held in Washington, DC, and virtually, November 10-14 (Press release, Genmab, OCT 1, 2021, View Source [SID1234590634]). The presentations will include a mini-oral session featuring the results of the first-in-human (FIH) phase 1/2 trial evaluating the safety and initial clinical activity of the investigational bispecific antibody, DuoBody-CD40×4-1BB (GEN1042), in patients with advanced solid tumors. Data from another FIH phase 1/2a trial, evaluating the investigational bispecific antibody, DuoBody-PD-L1×4-1BB (GEN1046) in patients with advanced solid tumors, will be presented as a poster. In addition, four posters will be presented, including one evaluating DuoBody-CD3xB7H4 (GEN1047), an investigational therapy in Genmab’s early-stage solid tumor product pipeline.

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All the abstract titles have been published on the SITC (Free SITC Whitepaper) website and may be accessed online via the SITC (Free SITC Whitepaper) Annual Meeting website. Full abstracts will be posted on November 9, 2021, at 8:00 a.m. ET.

GEN1046 and GEN1042 are being co-developed by Genmab and BioNTech (NASDAQ: BNTX) under an agreement in which the companies share all costs and future profits on a 50:50 basis.

"We are excited to present the results of these important clinical and pre-clinical studies to show the progression of the innovative technologies and investigational medicines in our antibody product pipeline and to demonstrate our commitment to delivering new therapeutic options to patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "While most of these studies have been conducted in the beginning stages of the clinical evaluation process, we are encouraged by the early results and look forward to seeing further results from ongoing clinical trials."

Abstracts accepted for presentation at SITC (Free SITC Whitepaper) 2021:

DuoBody-CD40×4-1BB (GEN1042):

First-in-human phase 1/2 trial to evaluate the safety and initial clinical activity of DuoBody-CD40×4-1BB (GEN1042) in patients with advanced solid tumors

DuoBody-PD-L1×4-1BB (GEN1046):

Peripheral and tumoral immune activity in the expansion part of the first-in human DuoBody-PD-L1×4-1BB (GEN1046) trial
Dose selection for DuoBody-PD-L1×4-1BB (GEN1046) using a semi-mechanistic pharmacokinetics/pharmacodynamics model that leverages preclinical and clinical data
DuoBody-CD3xB7H4 (GEN1047):

In vitro and in vivo studies establish DuoBody-CD3xB7H4 as a novel drug candidate for the treatment of solid cancers

New Research and Technologies:

A scalable deep learning framework for rapid automated annotation of histologic and morphologic features from large unlabeled pan-cancer H&E datasets
A translational approach to catalog pancreatic cancer heterogeneity using spatial genomics in large patient cohorts to empower target validation and rational combination selection
Molecular characterization of AXL in solid tumor malignancies using real-world data

About DuoBody-PD-L1×4-1BB (GEN1046)
DuoBody-PD-L1x4-1BB (GEN1046) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. It targets PD-L1 and 4-1BB, selected to block the inhibitory PD1/PD-L1 axis and simultaneously conditionally activate essential co-stimulatory activity via 4-1BB using an inert DuoBody antibody format. Two clinical studies (NCT03917381, NCT04937153) in solid tumors are ongoing. DuoBody-PD-L1x4-1BB is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

About DuoBody-CD40×4-1BB (GEN1042)
DuoBody-CD40x4-1BB (GEN1042) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. CD40 and 4-1BB were selected as targets to enhance both dendritic cell (DC) and antigen-dependent T-cell activation, using an inert DuoBody format. A Phase 1/2 clinical study (NCT04083599) of DuoBody-CD40x4-1BB in solid tumors is ongoing. DuoBody-CD40x4-1BB is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

On October 1, 2021, Cue Biopharma, Inc., a Delaware corporation (the "Company"), reported that it entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC, as agent (the "Agent"), pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, having an aggregate offering price of up to $80,000,000 (the "Shares") from time to time through the Agent (the "Offering") (Filing, 8-K, Cue Biopharma, OCT 1, 2021, View Source [SID1234590633]). The Company is filing a prospectus supplement with the Securities and Exchange Commission (the "SEC") in connection with the Offering (the "Prospectus Supplement") under the Company’s existing shelf Registration Statement on Form S-3 (File No. 333-239357), as amended by Post-Effective Amendment No. 3, which became effective on May 21, 2021 (the "Registration Statement").

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Upon delivery of a placement notice to the Agent and subject to the terms and conditions of the Sales Agreement, the Agent may sell the Shares by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market or on any other existing trading market for the Company’s common stock.

The Company or the Agent may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. The Agent will act as sales agent on a commercially reasonable efforts basis consistent with its normal sales and trading practices.

The Company has agreed to pay the Agent commissions for its services of acting as agent of 3.0% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement. The Company has also agreed to provide the Agent with customary indemnification and contribution rights.

A copy of the Sales Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement, and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

On October 1, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, to be held both virtually and at the Walter E. Washington Convention Center in Washington, D.C., from November 10 to 14, 2021 (Press release, CRISPR Therapeutics, OCT 1, 2021, View Source [SID1234590631]). The Company also announced an oral presentation at the SITC (Free SITC Whitepaper) 2021 Pre-Conference Program, The Evolution of Immunotherapy: An Exploration of Immunity Beyond T cells, CAR T in Solid Tumors and Novel Combinations, which will be held from 2:00 p.m. – 6:00 p.m. ET on November 10, 2021.

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CRISPR Therapeutics presentation:

Title: CRISPR/Cas9 gene-edited allogeneic CAR-T cells targeting CD33 show high preclinical efficacy against AML without long-term hematopoietic toxicity
Abstract Number and Type: 133, poster
Date and Time: Friday, November 12, 2021, 7:00 a.m. – 8:30 p.m. ET
Location: Walter E. Washington Convention Center, Hall E, or View Source

Presented jointly with Nkarta:

Title: A combined strategy of CD70 CAR co-expression with membrane-bound IL-15 and CISH knockout results in enhanced NK cytotoxicity and persistence
Abstract Number and Type: 16439, oral
Date and Time: Wednesday, November 10, 2021, 2:40 p.m. ET
Location: Walter E. Washington Convention Center, or View Source

Title: CISH gene-knockout anti-CD70-CAR NK cells demonstrate potent anti-tumor activity against solid tumor cell lines and provide partial resistance to tumor microenvironment inhibition
Abstract Number and Type: 113, poster
Date and Time: Friday, November 12, 2021, 7:00 a.m. – 8:30 p.m. ET
Location: Walter E. Washington Convention Center, Hall E, or View Source

On October 1, 2021 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported it will present preclinical data for RTX-224, a broad immune costimulatory agonist for the treatment of cancer, at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting which is being held from November 10-14, 2021, in Washington, D.C., and virtually (Press release, Rubius Therapeutics, OCT 1, 2021, View Source [SID1234590630]).

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RTX-224 is an allogeneic cellular therapy that is engineered to express hundreds of thousands of copies of 4-1BB ligand (4-1BBL) and interleukin-12 (IL-12) on the cell surface. RTX-224 is designed as a broad immune agonist of both adaptive and innate responses, activating CD8+ and CD4+ T cells, promoting antigen presentation and activating and expanding NK cells. It is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and have anti-tumor activity in those tumor types with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and prior responsiveness to checkpoint inhibitors.

"At SITC (Free SITC Whitepaper), we plan to present preclinical data indicating that RTX-224 activates immune cells in the spleen and blood, leading to their trafficking into the tumor microenvironment to deliver an anti-tumor effect in our preclinical models," said Laurence Turka, M.D., chief scientific officer of Rubius Therapeutics. "The combination of IL-12 and 4-1BB ligand has the potential to broadly induce an immune response in patients with solid tumors and may serve as the bridge between the innate and adaptive immune systems. These preclinical data are encouraging, and we plan to submit an Investigational New Drug application to the FDA by year end."

Details of the poster are as follows:

Poster Title: RTX-224, An Engineered Allogeneic Red Cell Therapeutic Expressing 4-1BBL and IL-12, Activates Immune Cells in Blood and Spleen to Promote Tumor Growth Inhibition in Mice
Abstract Number: 208 (ePoster)
Date, Time and Location: Friday, November 12, 2021, at 7 a.m. EST through Sunday, November 14, 2021, at 5 p.m. EST on the SITC (Free SITC Whitepaper) website: www.sitcancer.org/2021