On May 16, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported that it is presenting preclinical proof-of-concept data from its second next-generation SPEAR T-cell (ADP-A2M4N7X19) targeting MAGE-A4, and novel tumor-infiltrating lymphocytes (TILs) expressing IL-7 (ADP-TILIL7) at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting (Press release, Adaptimmune, MAY 16, 2022, View Source [SID1234614752]). The Company is presenting the two posters today at 5:30 p.m. EDT during the Cell Therapies I and Targeted Gene and Cell Therapy I sessions.

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"We have seen impressive clinical results with our first-generation product, afami-cel, in sarcoma, and we set a goal to increase potency to achieve responses in additional indications," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "To that end, we delivered our first next-gen product into the clinic incorporating CD8 and have shown responses across a broad range of solid tumor types in our SURPASS program. We have now presented preclinical data at ASGCT (Free ASGCT Whitepaper) from our second next-gen therapy designed to improve durability and persistence of SPEAR T-cells that supports clinical investigation."

New next-generation SPEAR T-cells show potential for enhanced clinical activity with improved proliferation, survival, and infiltration of immune cells into tumors in preclinical studies

The Company aimed to enhance durability and persistence by engineering a new next-gen SPEAR T-cell targeting MAGE-A4 to secrete IL-7 and CCL19 (ADP-A2M4N7X19) using "Proliferation-Inducing and Migration- Enhancing" (PRIME)1 technology
IL-7 stimulates T-cell proliferation and survival, and CCL19 induces infiltration of immune cells
Naturally occurring T-cells do not express IL-7 or CCL19
Next-generation ADP-A2M4N7X19 SPEAR T-cells were shown to produce IL-7 and CCL19 only in the presence of the MAGE-A4 cancer target
IL-7 production by ADP-A2M4N7X19 SPEAR T-cells enhanced T-cell survival, and CCL19 production induced infiltration of immune cells

Based on these data, Adaptimmune will initiate a Phase 1 clinical trial with ADP-A2M4N7X19 in multiple solid tumor indications
TILs engineered to produce IL-7 may result in a more effective therapy for people with metastatic melanoma with preclinical data demonstrating enhanced TIL survival

TIL therapy has shown some of the most favorable responses in refractory metastatic melanoma2
Adaptimmune applied their lentiviral technology to TILs engineering them to express IL-7 (ADP-TILIL7) with the aim to improve clinical responses

Data indicate that these engineered TILs produce biologically relevant amounts of IL-7; a factor that the TILs cannot produce on their own

IL-7 is known to support T-cell proliferation and survival, which may increase clinical activity and durability of T-cells

Based on these data, a single-center, Phase 1 clinical trial will be initiated at CCIT in Denmark with ADP-TILIL7 to treat patients with metastatic melanoma
The Company will also present a poster entitled "A Novel Flow Cytometry Method for Rapid Assessment of Lentiviral Detection" on May 19th.

On May 16, 2022 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that it has entered into a clinical supply agreement with Regeneron to evaluate the safety and efficacy of Elicio’s lead asset, ELI-002, an investigational KRAS-targeted cancer vaccine, in combination with Regeneron’s Libtayo (cemiplimab), a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, in patients with KRAS-driven tumors (Press release, Elicio Therapeutics, MAY 16, 2022, View Source [SID1234614734]). The combination therapy will be studied in KRAS-driven tumors including Stage III and IV non-small cell lung cancer (NSCLC), Stage IV colorectal cancer (CRC) and unresectable, locally advanced or oligometastatic pancreatic ductal adenocarcinoma (PDAC). The study, which is expected to begin in 2023, will be conducted by Elicio Therapeutics. Each party will provide their respective agent for the trial. Libtayo is being jointly developed by Regeneron and Sanofi.

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"We’re investigating ELI-002’s immune education in combination with the ability of Libtayo to block PD-1 and potentially activate the ELI-002-induced T cells to target cancers. This combination may provide a new treatment option for patients living with these difficult to treat cancers," said Dr. Christopher Haqq, Executive Vice President, Head of Research and Development, and Chief Medical Officer at Elicio. "ELI-002 includes mutated KRAS peptides that are delivered directly to the lymph nodes, ‘the schoolhouse of the immune system.’ The AMP technology allows for ELI-002 to be delivered in high quantities to the lymph nodes and remain there, where it will ‘educate’ the immune cells to target tumor cells for killing."

Dr. Annette Matthies, Chief Business Officer at Elicio, added, "Regeneron is a leading biotech company, and this clinical supply agreement supports the development of our ELI-002 therapeutic cancer vaccine program as well as our AMP platform. With the ongoing Phase 1 trial studying ELI-002 as a monotherapy and this upcoming combination study, we believe that ELI-002 has the potential to make a difference in the often-challenging KRAS space."

About ELI-002

ELI-002 is a structurally novel investigational AMP therapeutic vaccine targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. KRAS drives 32% of lung cancers, 40% of colorectal cancers and 85% to 90% of pancreatic cancer cases. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide CpG adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they can potentially enhance the action of key immune cells.

ELI-002 is currently being studied in a Phase 1 trial (AMPLIFY-201) in patients with early-stage KRAS-driven solid tumors, following surgery and chemotherapy. Enrollment in the Phase 1 study continues, following the dosing of the first patient at MD Anderson in October 2021, with the expectation to move from Cohort 2 to Cohort 3 in the next quarter, and the Phase 1b/2 trial planned for early 2023. This trial will study the broad spectrum 7-peptide formulation of ELI-002. This formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms.

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases, and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.

On May 16, 2022 Caring Cross, a 501c(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, reported that Rimas Orentas, Ph.D., Scientific Director of Caring Cross, and Kim Anthony-Gonda, Ph.D., Director of Cell & Gene Therapy at Caring Cross, will be presenting two posters at the American Society of Gene & Cell Therapy Annual Meeting (ASGCT) (Free ASGCT Whitepaper) 2022 (Press release, Caring Cross, MAY 16, 2022, View Source [SID1234614733]). The meeting will be a hybrid event with participants online and in-person in Washington, D.C., on May 16-22, 2022.

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Details of the posters are as follows:

Poster 1 CAR T-Cell Antigen-Non-Specific Killing (CTAK), CAR-T NK-Like
Killing, and CD22 CAR-T Mediated Killing Are All Optimized by
Bryostatin Treatment of Pre-B Acute Lymphocytic Leukemia Cell
Lines
Session: Cancer – Immunotherapy, Cancer Vaccines I
Board No.: M-213
Date: May 16th, 2022
Time: 1730-1830 EDT
Speaker: Dr. Rimas Orentas

Poster 2 IND-enabling Studies Towards an Open Phase I/IIa Trial to
Evaluate the Safety and Efficacy of Anti-HIV DuoCAR-T Cell
Therapy
Session: Gene & Cell Therapy Trials in Progress
Board No.: Tu-299
Date: May 17th, 2022
Time: 1730-1830 EDT
Speaker: Dr. Kim Anthony-Gonda
Register View Source
The first poster details the results of a study conducted in partnership with the University of Washington Department of Pediatrics and the Ben Towne Center for Childhood Cancer Research, Seattle Children’s Research Institute, which defined a new property of chimeric antigen receptor therapy (CAR-T). When the CAR-T cells are activated by the signals used to produce therapeutic cell populations, they were found to mediate non-CAR-directed cytolysis, which the investigators termed CAR T-cell antigen-non-specific killing (CTAK). Importantly, the mediated killing from the CAR-T manufacturing process is distinguishable from that exhibited by natural killer (NK) cells – white blood cells that target tumors and cells infected by viruses – or lymphokine-activated killer (LAK) cells, those stimulated by cytokines alone to kill tumor cells.

"This discovery is a significant milestone in our mission to increase the efficacy of CAR-T therapies," commented Dr. Orentas. "Increasing our knowledge of how bryostatin effects are disease-type specific, even within hematologic malignancies, will contribute to our development of curative therapies. Moreover, many of the side-effects attributed to CAR-T may be due to CTAK activity. We are excited to share our findings at ASGCT (Free ASGCT Whitepaper) and use this opportunity to collaborate with others and strengthen the efforts of the Caring Cross network to provide place of care infrastructure for effective gene therapies to areas where it is most needed."

The second poster highlights results from an IND-enabling study examining whether Caring Cross’ Anti-HIV DuoCAR-T cell technology can travel to the spleen of humanized mice with active HIV infection and inhibit replication of the virus. Data from the study concluded that intravenously administered Anti-HIV DuoCAR-T cells travelled from the peripheral blood to the spleen and demonstrated potent and durable suppression of HIV replication after a single injection of Anti-HIV DuoCAR-T cells.

"It is the Caring Cross mission to create accessible, curative therapies. There is currently no such cure for HIV, only long-term drug therapies," stated Dr. Anthony-Gonda. "Our Anti-HIV DuoCAR-T cell therapeutic candidate is designed to be a curative treatment option that eliminates HIV-infected cells and safely suppresses HIV infection long-term in the body after a single infusion of Anti-HIV DuoCAR-T cells. We are grateful to ASGCT (Free ASGCT Whitepaper) for hosting our presentation, we are determined to investigate our technology further in a Phase 1/2a clinical trial."

On May 16, 2022, Inhibikase Therapeutics, Inc. (the "Company") reported that entered into an Equity Distribution Agreement (the "Agreement") with Piper Sandler & Co., as sales agent (the "Agent"), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, par value $0.001 per share, in an aggregate offering price of up to $9,801,287 (the "Shares") through the Agent (Filing, 8-K, Inhibikase Therapeutics, MAY 16, 2022, View Source [SID1234614730]).

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The offer and sales of the Shares made pursuant to the Agreement, if any, will be made under the Company’s effective "shelf" registration statement on Form S-3 (File No. 333-262551) dated February 11, 2022, the base prospectus contained therein, and a prospectus supplement related to the offering of the Shares dated May 16, 2022.

Under the terms of the Agreement, the Agent may sell the Shares at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act, as amended.

Subject to the terms and conditions of the Agreement, the Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the Agreement or terminate the Agreement in accordance with its terms. The Company has provided the Agent with customary indemnification rights, and the Agent will be entitled to a fixed commission of 3.0% of the aggregate gross proceeds from the Shares sold. The Agreement contains customary representations and warranties, and the Company is required to deliver customary closing documents and certificates in connection with sales of the Shares. The Company has agreed to reimburse the Agent for the fees and disbursements of its counsel, payable upon execution of the Equity Distribution Agreement, in an amount not to exceed $75,000 in connection with the establishment of this at-the-market offering program plus an additional amount of up to $15,000 for each quarterly period thereafter.

The legal opinion of McDermott Will and Emery LLP, counsel to the Company, relating to the Shares is filed as Exhibit 5.1 hereto.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which was filed as Exhibit 10.1 hereto and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the Shares, nor shall there be an offer, solicitation or sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

On May 16, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it will host a virtual R&D Day for investors and analysts on Friday, June 10, 2022 at 10:00 am ET (Press release, SpringWorks Therapeutics, MAY 16, 2022, View Source [SID1234614711]). The program will include presentations by members of the SpringWorks executive leadership team as well as external thought leaders in the Company’s core development areas. A Q&A session will follow the presentations.

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To register for SpringWorks’ virtual R&D Day, please sign up here. The webcast will also be available under "Events and Presentations" in the Investors & Media section of the SpringWorks website at View Source A replay of the webcast will be available on the Company’s website for a limited period of time following the event.