On September 8, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that management will host an investor conference call to discuss AUTO3 data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 and to participate in Banking conferences through September (Press release, Autolus, SEP 8, 2020, View Source [SID1234564755]):

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9 September 2020 – The company will participate in an analyst moderated group meeting at the Wells Fargo Virtual Healthcare Conference at 9.20 am EDT, 2.20 pm BST and will also host virtual one-on-one meetings. A live audio webcast of the fireside chat will be available on the investor relations section of the Company’s website at Autolus. An archived replay will be available for a period of 30 days after the conference.

15 September 2020 – The company will present at the H.C. Wainwright & Co 22nd Annual Global Investment Conference at 10.30 am EDT, 3.30 pm BST and will also host virtual one-on-one meetings. A live audio webcast of the presentation will be available on the investor relations section of the Company’s website at Autolus. An archived replay will be available for a period of 30 days after the conference.

17 September 2020 – The company will present at the Cantor Fitzgerald Virtual Global Healthcare Conference at 4.00 pm EDT, 9.00 pm BST and will also host virtual one-on-one meetings.

18 September 2020 – Dr. Christian Itin, chairman and chief executive officer, along with the AUTO3 clinical team, will host an investor call and webcast at 8.00 am EDT, 1.00 pm BST to discuss a presentation related to its AUTO3 program, the company’s CAR T cell therapy being investigated in the Alexander study, a Phase 1/2 study in relapsed/ refractory diffuse large B cell lymphoma (DLBCL), during the ESMO (Free ESMO Whitepaper) conference. To listen to the webcast and view the accompanying slide presentation, please go to Autolus.

The call may also be accessed by dialing (866) 652-5200 for U.S. and Canada callers or (412) 317-6060 for International callers. Please ask to be joined into the Autolus Therapeutics call. An archived replay will be available for a period of 12 months after the call.
22 September 2020 – The company will participate in a Q&A at the virtual JP Morgan CEO Series Investor Call at 11.00 am EDT, 4.00 pm BST.

On September 8, 2020 Alkermes plc (Nasdaq: ALKS) reported that it will present new clinical data related to ALKS 4230, its investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress, taking place Sept. 18-21, 2020 (Press release, Alkermes, SEP 8, 2020, View Source [SID1234564754]). Safety and anti-tumor efficacy data from the ongoing phase 1/2 ARTISTRY-1 study, evaluating ALKS 4230 as monotherapy and in combination with pembrolizumab in patients with refractory solid tumors, will be shared in a mini oral presentation. The company will host an accompanying webcast and conference call at 8:30 a.m. ET on Friday, Sept. 18, 2020.

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"The ESMO (Free ESMO Whitepaper) Virtual Congress serves as an important forum to share the latest data on our immunotherapy candidate, ALKS 4230, with the global oncology community," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We look forward to sharing new safety and efficacy data from our ARTISTRY-1 clinical trial, where we are evaluating ALKS 4230 as a monotherapy and combination therapy to treat a variety of tumor types in patients with tumors that are refractory to currently established treatments."

A mini oral presentation (#1027) titled, "ALKS 4230 Monotherapy and in Combination With Pembrolizumab in Patients With Refractory Solid Tumors (ARTISTRY-1)," to be presented by Ulka N. Vaishampayan, M.D., Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan, will be available on the ESMO (Free ESMO Whitepaper) website at View Source

Conference Call and Webcast
Alkermes will host a webcast presentation and conference call with accompanying slides for analysts and investors on Friday, Sept. 18, 2020, at 8:30 a.m. ET (1:30 p.m. BST) to discuss the latest data from the ARTISTRY-1 clinical trial. The webcast will feature the lead study investigator, Dr. Ulka N. Vaishampayan, Professor of Internal Medicine, Division of Hematology/Oncology, at the University of Michigan, and members of Alkermes’ management team. The webcast player may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. To participate in the question and answer session, please also dial in to the conference call, which may be accessed by dialing +1 877-407-2988 for U.S. callers and +1 201-389-0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website or by dialing +1 877-660-6853 for U.S. callers and +1 201-612-7415 for international callers, using replay access code 13708824. The conference call replay will be available from 11:30 a.m. ET (4:30 p.m. BST) on Friday, Sept. 18, 2020 through Friday, Sept. 25, 2020.

About ALKS 4230
ALKS 4230 is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

On September 8, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop treatments for patients with severe diseases including solid tumors, hematologic cancers and autoimmune disease, reported that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application providing clearance to initiate an open-label, single-arm Phase 1 clinical study of ATA2271, the Company’s next-generation autologous CAR T therapy targeting mesothelin under development in collaboration with Memorial Sloan Kettering Cancer Center (MSK), for the treatment of advanced mesothelioma (Press release, Atara Biotherapeutics, SEP 8, 2020, View Source [SID1234564753]).

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"We are pleased the FDA has cleared the IND for ATA2271 for the treatment of advanced mesothelioma," said Jakob Dupont, Global Head of Research and Development, Atara Biotherapeutics. "This milestone marks an important moment in the advancement of cell and gene immunotherapy for patients, for the field and for Atara. As the first-ever CAR T therapy leveraging the combination of PD1DNR checkpoint inhibition and 1XX CAR signaling technologies to enter the clinic, we are advancing such a unique CAR T program with the goal of developing transformative therapies for patients with solid tumors."

This novel next-generation autologous, mesothelin-targeted CAR T therapy was developed in collaboration with researchers at MSK, Dr. Prasad Adusumilli, who led two trials with first-generation mesothelin CAR T therapy and engineered T-cell intrinsic checkpoint blockade by PD1DNR to overcome the immune suppression of PDL1, and Dr. Michel Sadelain, a leader in the CAR T-cell field who developed the 1XX co-stimulatory domain technology to extend T-cell effector function while limiting cell exhaustion.

At the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, preclinical data were presented from ATA2271 IND-enabling studies conducted collaboratively in Dr. Adusumilli’s laboratory, showing the effects of combining multiple novel technologies in this next-gen CAR T therapy, which includes both 1XX co-stimulatory domain signaling and an engineered PD1DNR. ATA2271 was associated with less cell exhaustion, improvements in functional persistence, serial cell killing, and enhanced in vivo efficacy when compared with first-generation mesothelin CAR T therapy. These effects were maintained through multiple redosings with ATA2271 and are consistent with emerging views in the field regarding preferred characteristics of CAR Ts when targeting solid tumors, including mesothelioma. This improved profile of ATA2271 will now be assessed in a Ph1 clinical trial led by principal investigator, Dr. Roisin O’Cearbhaill.

Although CAR T cell therapies have been approved for certain hematologic malignancies, they have not yet proven effective in solid tumor settings. Mesothelin is a tumor-specific antigen that is commonly expressed at high levels on the cell surface in many aggressive solid tumors including mesothelioma, ovarian cancer, pancreatic cancer, and non-small cell lung cancer. Atara has selected mesothelin as the target for both the ATA2271 autologous and the ATA3271 allogeneic programs along with novel CAR T-cell technologies that have the potential to further enhance activity and resulting clinical benefits. ATA3271, the allogeneic version of this CAR T, leverages Atara’s EBV T-cell platform and is currently in IND-enabling studies.

About ATA2271

In collaboration with MSK, Atara is developing ATA2271, a next-generation autologous mesothelin-targeted CAR T using novel 1XX CAR signaling and programmed death-1 (PD-1) dominant negative receptor (PD1DNR) checkpoint inhibition technologies (M28z1XX PD1DNR CAR T cells). This technology is supported by the safety and anti-tumor efficacy that was exhibited in prior studies evaluating a mesothelin-directed CAR utilizing a CD28 co-stimulatory signaling domain. This autologous mesothelin-targeted construct (using M28z CAR T cells) combined with PD-1 antibody is being studied in two ongoing MSK Phase 1 studies in patients with malignant pleural disease and mesothelioma, non-small cell lung cancer, and breast cancer (NCT02414269 and NCT02792114).

Michel Sadelain, MD, Ph.D., Director, Center for Cell Engineering, and Head, Gene Expression and Gene Transfer Laboratory at MSK and Prasad Adusumilli, MD, Deputy Chief of Thoracic Service, Vice Chair of Department of Surgery, and Head Solid Tumors, Cell Therapy, Cellular Therapeutics Center at MSK have intellectual property interests in technology licensed by Memorial Sloan Kettering (MSK) to Atara, related to this program. Dr. Adusumilli also has compensated consulting relationships with Atara. MSK has institutional financial interests related to Atara in the form of intellectual property rights and associated interests by virtue of licensing agreements between MSK and Atara.

On September 8, 2020 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported that Ayala management will present at two upcoming investor conferences (Press release, Ayala Pharmaceuticals, SEP 8, 2020, View Source [SID1234564750]):

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H.C. Wainwright & Co. 22nd Annual Global Healthcare Conference: Tuesday, September 15, 2020 at 12:30 pm ET.
Oppenheimer & Co. Fall Healthcare Life Sciences & MedTech Summit: Monday, September 21, 2020 at 1:40 pm ET.
A live webcast of each presentation may be accessed by visiting the Events & Presentations section of Ayala’s website at ir.ayalapharma.com. An archived replay of each webcast will be available on the website for 90 days following the presentations.

On September 8, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported the completion of the sale of Lexicon’s rights, title and interest in XERMELO (telotristat ethyl) to TerSera Therapeutics LLC (Press release, Lexicon Pharmaceuticals, SEP 8, 2020, View Source [SID1234564749]).

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Lexicon received $160.4 million in cash at closing, comprised of a $155 million upfront payment and additional payments for inventory and other closing considerations. Lexicon may receive additional milestone payments of up to an aggregate of $65 million for the development and commercialization of telotristat ethyl in patients with biliary tract cancer. Additionally, Lexicon will be eligible to receive mid-teens royalties on net sales of XERMELO in biliary tract cancer. In connection with the transaction, TerSera offered employment to 28 Lexicon employees. Lexicon plans to realign its business around its research and development assets, with a focus on its LX9211 neuropathic pain program, now in Phase 2 clinical development, while substantially reducing its debt by fully repaying its $150 million secured term loan.

About LX9211
LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.