On March 31, 2019 F1 Oncology, Inc., a biotechnology company discovering and developing adoptive cellular therapies (ACTs) for solid tumors, reported that it will present four abstracts at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting in Atlanta from March 29-April 3, 2019 that support novel technologies to treat solid tumor malignancies (Press release, F1 Oncology, MAR 31, 2019, View Source [SID1234534788]).

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F1 Oncology is developing these novel CAB-CAR-T therapies to target solid tumors while minimizing the potential of on-target, off-tumor activity. The four abstracts provide insight into the use of the company’s proprietary CAB-CAR-T technology to increase the potential safety of CAR-T therapeutics by turning the negative effects of the tumor microenvironment (TME) into activating signals. They will highlight proof of concept studies of same-day, point of care CAR-T and use bioinformatics data driven methods to discover protein domain combinations capable of selectively expanding CAR-T cells.

"The data to be presented highlight scientific progress that may greatly simplify CAR-T therapy for solid tumor malignancies in the future," said Gregory Frost, Ph.D., Chairman and CEO of F1 Oncology. "The teams have also made significant progress in our understanding of CAB-CAR-T’s role in adoptive cellular therapy for solid tumors, and we look forward to seeing the progress from ongoing clinical studies with these programs through collaborators in Shanghai."

The abstracts are available in the program section of the annual AACR (Free AACR Whitepaper) meeting website, and details for the poster presentations are as follows:

Same day transduction and in vivo expansion of chimeric antigen receptors and synthetic driver constructs for adoptive cellular therapy

Examining the relationship between limiting the ex vivo expansion time and less differentiated CAR-T products with enhanced effector function, as well as the development of a point of care approach to ACT and its potential to reduce the complexity of CAR-T cell immunotherapy.

Poster Board Number: Session PO.IM02.03 2327/26

Session Date and Time: April 1, 2019, 1:00 p.m. – 5:00 p.m.

Location: Georgia World Conference Center, Poster Section 22

A high-throughput screening strategy for the identification of novel lymphoproliferative elements

Examining a high throughput screening method using a barcoded high-diversity combinatorial library of various rationally-designed protein subdomains to identify novel combinations capable of selectively driving CAR-T cells in vivo.

Poster Board Number: Session PO.MCB09.05 3523/9

Session Date and Time: April 2, 2019, 8:00 a.m. – 12:00 p.m.

Location: Georgia World Conference Center, Poster Section 22

CAB-CAR-T: A novel conditionally active biologics approach to minimize on-target off-tumor effects in adoptive immunotherapy
Describing a novel Conditionally Active Biologics (CAB) approach in adoptive immunotherapy

Poster Board Number: session PO.IM02.04 3189/12

Session Date and Time: April 2, 2019, 8:00 a.m. – 12:00 p.m.

Location: Georgia World Conference Center, Poster Section 22

CAB-CAR-T: The Prioritization of Cell Surface Protein Targets for Conditionally Active Biologics to Treat All Solid Tumors

Identifying optimal targets across all TCGA cancer cohorts that when used in CAB-CAR-T therapies will provide the greatest number of treatment options for patients across all cancer malignancies.

Poster Board Number: Session PO.BSB01.05 5101/9

Session Date and Time: April 3, 2019, 8:00 a.m. – 12:00 p.m.

Location: Georgia World Conference Center, Poster Section 30

On March 31, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that the Company’s collaborators at Memorial Sloan Kettering Cancer Center (MSK), Prasad S. Adusumilli, M.D., and Michel Sadelain, M.D., Ph.D., presented encouraging results from an ongoing MSK investigator-sponsored Phase 1 clinical study (NCT02414269) of a mesothelin-targeted CAR T immunotherapy for patients with mesothelin-associated malignant pleural solid tumors, primarily mesothelioma, who progressed following prior standard platinum-containing chemotherapy (Press release, Atara Biotherapeutics, MAR 31, 2019, View Source [SID1234534786]). Mesothelin-targeted, autologous CAR T cells delivered regionally were well-tolerated and showed encouraging anti-tumor activity in combination with pembrolizumab, a PD-1 checkpoint inhibitor. The findings will be presented today in the Advances in Novel Immunotherapeutics oral session at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia.

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"Clinical results presented by our MSK collaborators reaffirm mesothelin as a promising target for patients with advanced mesothelioma and establish an important proof-of-concept advance for CAR T immunotherapy in solid tumors," said Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "These encouraging safety results and anti-tumor responses observed by lead investigator Dr. Adusumilli in combination with a PD-1 checkpoint inhibitor, support our plans to progress development of a next-generation, mesothelin-targeted CAR T immunotherapy using MSK’s novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies for patients with mesothelin-associated solid tumors."

The Phase 1 clinical study recruited 21 patients, 19 with malignant pleural mesothelioma (MPM), one with metastatic lung cancer and one with metastatic breast cancer, who received a median of 3 prior treatment regimens, to evaluate the safety and potential anti-tumor activity of a CD28-costimulated, mesothelin-targeted autologous CAR T immunotherapy. The study included six dose cohorts with administration directly to the tumor site using regional delivery techniques, initially at a low CAR T dose without lymphodepleting chemotherapy, followed by increasing CAR T dose cohorts with lymphodepletion. A subset of these patients was subsequently treated with pembrolizumab, a PD-1 checkpoint inhibitor.

Mesothelin-targeted, autologous CAR T administration was found to be generally well-tolerated with no CAR T-related toxicities higher than grade 2 observed based on monitoring multiple clinical, radiological, and laboratory parameters. CAR T cells were found to be persistent in the peripheral blood for 13 of the 21 patients during the 38-week evaluation, and their presence was associated with evidence of tumor regression on imaging studies.

Best overall response rate (ORR) for a subset of 11 MPM patients with minimum follow-up time of 3 months who also received pembrolizumab and lymphodepleting chemotherapy was 72% including 2 durable complete metabolic responses (CMR) on PET imaging and 6 partial responses (PR). Six of the 11 patients in this subset were programmed cell death ligand 1 (PD-L1) negative, defined as undetectable expression of PD-L1 in tumor cells by immunohistochemistry, with 4 of the 8 total responses observed in PD-L1 negative patients (1 CMR and 3 PR).

Following progression on standard platinum-containing chemotherapy, the expected ORR for patients with MPM treated with a checkpoint inhibitor is estimated between 5%-29% with one patient achieving a CR across multiple studies.1-5

MSK is also investigating mesothelin-targeted CAR T cells for patients with mesothelin-associated advanced breast cancer (NCT02792114). Additional results from these ongoing studies are expected to be presented at upcoming scientific congresses.

Presentation CT036: A Phase I clinical trial of malignant pleural disease treated with regionally delivered autologous mesothelin-targeted CAR T cells: Safety and efficacy
Session CTMS01: Advances in Novel Immunotherapeutics
Presentation Date and Time:Sunday, March 31, 2019 from 3:20 pm – 3:35 pm EDT
Location:Room A411 – Georgia World Congress Center
Authors:Prasad S. Adusumilli, Marjorie Zauderer, Valerie Rusch, Roisin O’Cearbhaill, Amy Zhu, Daniel Ngai, Erin McGee, Navin Chintala, John Messinger, Alain Vincent, Elizabeth Halton, Claudia Diamonte, John Pineda, Shanu Modi, Steve Solomon, David R Jones, Renier Brentjens, Isabelle Riviere, Michel Sadelain
Affiliations:Memorial Sloan Kettering Cancer Center

On March 30, 2019 Maverick Therapeutics Inc., a private biopharmaceutical company pioneering next-generation redirected T-cell targeted immunotherapies, reported that it will unveil pre-clinical data characterizing its novel COBRATM therapeutic platform at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 being held from March 29 to April 3 in Atlanta, Georgia (Press release, Maverick Therapeutics, MAR 30, 2019, View Source [SID1234534787]). COBRA is the most advanced bispecific T-cell engaging platform in its class, designed to safely target solid tumors with highly specific and potent activity. These pre-clinical data characterize the conditional and potent activity of the COBRATM platform in vitro as well as demonstrate the regression of established solid tumors in in vivo models.

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COBRATM is a proprietary approach to cancer immunotherapy. The COBRATM molecules are designed to bind to a specific target but are engineered to activate only after they enter the tumor microenvironment, allowing for specific T-cell engagement and activation at the site of the cancer. Focusing T-cell activation and killing at the tumor site is ideal for the treatment of solid tumors, which account for 90% of all cancers1. COBRATM molecules include a component that extends their half-life in the circulation prior to activation within the tumor site; once activated, this component is lost, allowing the active molecules to then be cleared from the body more rapidly after targeting and killing the cancer cells. This further increases their safety window by reducing the potential for active COBRATM molecules to travel outside the tumor to healthy tissues and cause damage.

"We are encouraged by the inaugural data on our proprietary COBRATM platform, as they provide proof-of-concept for our approach to overcome the challenges current T-cell engagers face when addressing solid tumors," said Maverick Therapeutics Chief Executive Officer Jim Scibetta. "With its scientifically elegant design, COBRATM has the potential to deliver increased specificity, higher potency and reduced toxicity, all of which may help extend both the duration and quality of life of people living with solid tumor cancers."

Full abstracts are available online at View Source Details of the poster presentation are listed below.

Title: COBRATM: A Novel Conditionally Active Bispecific Antibody that Regresses Established Solid Tumors in Mice
Session Title: Immunology – Therapeutic Antibodies 1
Abstract Number: 557
Poster Board Number: 21
Presentation Time: Sunday, March 31, 1pm – 5pm ET
Location: Georgia World Congress Center – Exhibit Hall B, Poster Section 23

About COBRA Therapeutic Platform

The company’s proprietary COBRA, or COnditional Bispecific Redirected Activation, therapeutic platform is the most advanced bispecific T-cell engagement platform, designed to target solid tumors with highly potent and specific activity, while avoiding damage to normal healthy tissues. COBRATM molecules are designed to bind to a specific target, but are engineered to activate only after they enter the tumor microenvironment, allowing for specific T-cell engagement and activation at the site of the cancer. COBRATM molecules include a component that extends their presence in the circulation prior to activation within the tumor site; once activated this component is lost, allowing the active molecule to then be cleared from the body more rapidly after targeting and killing the cancer cells. This increases their safety window by reducing the potential for active COBRA molecules to escape the tumor and travel to healthy tissues.

On March 29, 2019 Immunomic Therapeutics, Inc. reported its late-breaking preclinical data which shows that its investigational nucleic acid platform, UNITE, may enhance antitumor immunity when used in connection with its investigational DNA vaccine, ITI-7000 (Press release, Immunomic Therapeutics, MAR 29, 2019, View Source [SID1234534890]). In preclinical studies, ITI-7000, an investigational DNA vaccine targeting ErbB2/HER2, demonstrated robust activation of known anti-tumor CD4 and CD8 cells in vivo and promoted tumor infiltration with activated CD8 T cells. These data are presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 meeting in Atlanta, Georgia.

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In addition to observing activation of known anti-tumor CD4 and CD8 cells in vivo, Immunomic scientists observed the overexpression of PDL1 in the tumor microenvironment. This pathway has shown clinical relevance as a cancer immunotherapy target of the tumor microenvironment. PDL1 overexpression upregulated by ITI-7000 suggests that a combination of ITI-7000 with an anti-PD1/PDL1 therapy may increase the therapeutic potential of either agent on its own. This data also supports the prevailing belief in the immunotherapy community that cancer vaccination could synergize with anti PD1 and PDL1 and other immunotherapies, as well as support the viability of the UNITE platform as a means to do so. In summary, these findings support the potential of ITI-7000 as a cancer vaccine and highlight that UNITE, Immunomic’s nucleic acid platform, may have the potential to enhance immunity of investigational cancer therapies.

View the poster.

Poster Title: DNA vaccine co-expressing Her2/ErbB2 antigen, fused with LAMP, elicits strong antitumor effects in vivo by increasing tumor infiltration with CD8+ T cells
Session Category: Immunology
Session Title: Late-Breaking Research: Immunology 2
Session Date and Time: Tuesday, April 2, 2019 8:00 AM- 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 42

On March 29, 2019 Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stabilized cell-permeating peptides to treat cancer and other diseases, reported that it has entered into a securities purchase agreement with a group of institutional accredited investors for the private placement of $26 million of Aileron common stock and warrants (Press release, Aileron Therapeutics, MAR 29, 2019, View Source [SID1234534815]). The private placement is expected to close on or about April 2, 2019 subject to the satisfaction of customary closing conditions.

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The private placement was led by Satter Medical Technology Partners, L.P. with significant additional participation from Jennison Associates (on behalf of certain clients) and an undisclosed institutional investor, in addition to other new and existing investors.

The Company is selling in the private placement 11,838,582 units, consisting of 11,838,582 shares of common stock and associated warrants to purchase 11,838,582 shares of common stock, for a combined price of $2.01 per unit. In addition, the Company is also selling in the private placement 1,096,741 units, consisting of pre-funded warrants to purchase 1,096,741 shares of common stock and associated warrants to purchase 1,096,741 shares of common stock, for a combined price of $2.01 per unit.

William Blair & Company, L.L.C. will act as sole placement agent in connection with the financing.

Aileron expects to receive aggregate gross proceeds of approximately $26 million, before deducting placement agent fees and offering expenses, and excluding the exercise of any warrants. Aileron expects to use the net proceeds from the financing to fund the further advancement of its ALRN-6924 clinical trials and research programs, including its ongoing clinical trial collaboration with Pfizer testing ALRN-6924 in combination with palbociclib in MDM2-amplified cancers and its planned Phase 1b/2 clinical trial to evaluate ALRN-6924 as a myelopreservative agent, to protect against chemotherapy-induced toxicity. This use of proceeds reflects Aileron’s determination to cease enrollment and clinical development in AML/MDS in light of the Company’s resources and its assessment of the commercial opportunities, as well as the changed competitive landscape where seven drugs were approved for AML in the United States in the last two years.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Aileron has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of

common stock issued in the private placement and the shares of common stock issuable upon the exercise of the warrants issued in the private placement.

This release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.