On May 4, 2022, Turning Point Therapeutics, Inc. (the "Company") reported that entered into a license agreement (the "LaNova License Agreement") with LaNova Medicines Limited ("LaNova") for an exclusive, royalty-bearing license to intellectual property related to LM-302, a clinical stage anti-Claudin18.2 antibody drug conjugate (the "Product"), on a worldwide basis excluding Greater China and South Korea (the "Company Territory") (Filing, 8-K, Turning Point Therapeutics, MAY 4, 2022, View Source [SID1234613640]). Under the LaNova License Agreement, the Company has the exclusive right to research, develop, use, register, offer for sale, import and otherwise commercialize the Product in the Company Territory and non-exclusive rights to manufacture the Product worldwide in support of activities in the Company Territory.

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Pursuant to the LaNova License Agreement, the Company will pay LaNova an upfront cash payment of $25.0 million and may be obligated to pay milestone payments, which include up to $195.0 million in development and regulatory milestones and up to $880.0 million in sales milestones, and tiered royalty payments based on percentages (ranging from the mid-single digits to the mid-teens) of net sales (subject to customary deductions).

Subject to specified exceptions, for a period of time, the Company has agreed that neither it nor its controlled affiliates or sublicensees will engage in any clinical development, use or commercialization of specified products that would compete with the Products in the Company Territory, and LaNova has agreed that neither it nor its affiliates, licensees and its sublicensees will conduct any clinical development, use or commercialization of specified products that would compete with the Products in the Company Territory, other than expressly permitted activities.

The LaNova License Agreement will continue in effect until expiration of the last royalty term for the Product in any country in the Company Territory, where the royalty term for a Product in a given country in the Company Territory continues until the later of (i) the date of the last-to-expire valid claim within the Company’s patent rights that covers the Product in such country; (ii) the expiry of the regulatory exclusivity for such Product in such country; or (iii) 10 years after the date of the first commercial sale of the Product in such country. Subject to the terms of the LaNova License Agreement, the Company may terminate the LaNova License Agreement for convenience by providing written notice to the Company, which termination will be effective following a prescribed notice period. In addition, either party may terminate the LaNova License Agreement for the other party’s uncured material breach of the LaNova License Agreement, with a customary notice and cure period, or for the other party’s insolvency. LaNova may also terminate the agreement if the Company is acquired by a third party and the acquired party is engaged in activities with competing products that are not divested or discontinued, upon notice of termination to the Company within a specific period following closing of such acquisition. In addition, LaNova may terminate the LaNova License Agreement under specified circumstances if the Company or certain other parties challenge LaNova’s patent rights. If the Company terminates the agreement for convenience, the Company will grant to LaNova a non-exclusive, worldwide license, which may be royalty-bearing in certain circumstances, to intellectual property owned by the Company that is necessary for and was used by the Company to commercialize the Product.

The Company is responsible for conducting the development and commercialization activities in the Company Territory related to the Products at its own expense. The Company and LaNova will collaborate on a global development plan under which both parties will conduct global clinical studies in their respective territories. The Company and LaNova will each be responsible for the costs allocated to them in accordance with the agreed budget under the global development plan. Both the Company and LaNova have the ability to conduct local studies outside of the global development plan at their own expense.

Both the Company and LaNova have the obligation to use commercially reasonable efforts to conduct development activities under the agreed-upon global development plan. The Company has the obligation to use commercially reasonable efforts to perform local studies independent of the global development plan and to obtain regulatory approvals for the Product in the Company Territory.

LaNova has an initial obligation to supply the Company with the Product. After a specified period, the Company will assume responsibility for supply of the Product.

As part of the LaNova License Agreement, the Company also obtained the right of first negotiation for an exclusive license to develop, use, manufacture and commercialize other products containing components of the Product. In addition, the Company has the option to collaborate with LaNova on up to three additional antibody drug conjugate programs, initiated or proposed by either the Company or LaNova.

The foregoing description of the material terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Agreement, a copy of which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022.

On May 4, 2022 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, reported first quarter 2022 financial results and provided business updates (Press release, Seres Therapeutics, MAY 4, 2022, View Source [SID1234613474]).

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"Seres continued to make important progress toward bringing SER-109 to patients suffering with recurrent C. difficile infection (rCDI). Given the robust profile of SER-109 observed in our Phase 3 study, we expect the product to have a significant impact on rCDI, a serious disease with approximately 170,000 cases annually in the US. We look forward to meaningful additional clinical data, including in first recurrence CDI patients, from our SER-109 open label study later this quarter, supporting a mid-2022 completion of our BLA submission with the U.S. Food and Drug Administration (FDA)," said Eric Shaff, President and Chief Executive Officer at Seres. "We are also advancing our commercialization efforts alongside our collaborator, Aimmune Therapeutics, Inc., a Nestlé Health Science company, in anticipation of a potential SER-109 product launch in the first half of 2023."

"In tandem, we are excited about our earlier stage pipeline and continue to enroll our Phase 1b clinical study of SER-155 designed to evaluate safety, microbiome alterations, and the impact on infections and/or graft versus host disease (GvHD) in adult subjects who are undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Preclinical activities are also underway for additional Infection Protection development candidates, leveraging our prior compelling clinical data in this therapeutic category, for indications such as cancer neutropenia, solid organ transplant, and antimicrobial resistant infections more broadly," continued Mr. Shaff.

Program and Corporate Updates

SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved its primary endpoint of superiority to placebo in reducing CDI recurrence in patients with rCDI.

Seres has achieved target enrollment in an open-label study of SER-109 in patients with rCDI (ClinicalTrials.gov identifier: NCT03183141), which also enrolled over 25% of patients with a single recurrence of rCDI, to expand the SER-109 database in support of the planned BLA filing. Study results are anticipated in Q2 2022. The FDA recently endorsed Seres’ plans regarding a rolling BLA submission for SER-109. Seres intends to begin the BLA rolling submission in the coming weeks, and to complete the BLA submission, including data from the open-label study, in mid-2022.

Seres has an active SER-109 expanded access program at various sites across the U.S. The program is designed to enable eligible adults with rCDI to obtain access to SER-109 prior to a potential FDA product approval.

The Company continues to prepare for a successful product launch with Aimmune Therapeutics, Inc., a Nestlé Health Science company, who will be leading commercialization efforts. The Company believes that a substantial commercial opportunity exists for SER-109. The cost of a patient with recurrence of CDI has been estimated to result in approximately $34,000 in annual direct healthcare expenses; this does not include the substantial indirect costs associated with this disease. There are approximately 170,000 cases of rCDI annually in the U.S. and CDI results in over 20,000 deaths.

Seres continues to execute pre-commercialization activities in collaboration with Aimmune Therapeutics, including market education and data dissemination to the medical community. Medical Affairs led engagement of key opinion leaders has increased following the publication of the SER-109 Phase 3 data in the New England Journal of Medicine. In addition, activities have been initiated to engage payers in accordance with FDA guidance on pre-approval information exchange.

In January 2022, the New England Journal of Medicine (NEJM) published data from the SER-109 Phase 3 ECOSPOR III study evaluating SER-109 for the treatment of rCDI. The publication highlights key results including that SER-109 was superior to placebo in reducing CDI recurrence, with 88% of SER-109 patients achieving a sustained clinical response compared to 60% on placebo. SER-109 was well tolerated, with a side effect profile comparable to placebo and no serious drug-related adverse events observed.

SER-155 Phase 1b clinical study activities: In December 2021, Seres announced the enrollment of the first patient in the Company’s Phase 1b clinical study of SER-155 designed to evaluate safety, microbiome alterations, and the impact on infections and/or GvHD associated with SER-155 in adult subjects who are undergoing allo-HSCT. In April 2022, the SER-155 Data and Safety Monitoring Committee met as part of a planned data review, and approved a recommendation to continue with enrollment in Cohort 1 based on an evaluation of available safety data. The study is being conducted with Memorial Sloan Kettering Cancer Center and the University of Chicago with additional sites expected to be added soon.

SER-155 is an investigational oral, rationally designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal infections, bloodstream infections, and GvHD in patients receiving allo-HSCT. SER-155 is a consortium of bacterial species selected using Seres’ reverse translation discovery and development platforms. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays and in vivo disease models. The SER-155 composition aims to decrease the colonization and translocation of antibiotic-resistant bacteria in the gastrointestinal tract to decrease the incidence of bloodstream infections and additionally to modulate host immune responses to decrease GvHD. In addition to SER-109, SER-155 represents Seres’ second active development program in its Infection Protection franchise.

Infection Protection investor event: In January 2022, Seres held a webcast event that highlighted development of microbiome therapeutics as a novel approach for Infection Protection in medically compromised individuals. Building upon SER-109, and in addition to SER-155, Seres is also evaluating additional preclinical stage programs in indications such as cancer neutropenia, solid organ transplant, and antimicrobial resistant infections more broadly.

Ulcerative colitis (UC) research: The Company previously reported clinical, microbiome and metabolomic data from the SER-287 Phase 2b study and the first cohort of its SER-301 Phase 1b study. Available data suggest that there may be an opportunity to utilize biomarker-based patient selection and stratification for future studies. Research activities remain ongoing to inform potential further development activities.

Financial Results

Seres reported a net loss of $56.6 million for the first quarter of 2022, as compared with a net loss of $35.5 million for the same period in 2021.

Research and development expenses for the first quarter of 2022 were $39.6 million, compared with $29.3 million for the same period in 2021. The research and development expenses were primarily related to Seres’ late-stage SER-109 clinical development program and manufacturing costs, as well as personnel expenses.

General and administrative expenses for the first quarter of 2022 were $18.6 million, compared with $11.7 million for the same period in 2021. General and administrative expenses were primarily related to personnel expenses, professional fees, including SER-109 commercial readiness and pre-launch expenses, and facility costs.

Seres ended the first quarter of 2022 with approximately $248.0 million in cash, cash equivalents and investments as compared with $291.2 million at the end of 2021.

Conference Call Information

Seres’ management will host a conference call today, May 4, 2022, at 8:30 a.m. ET. To access the conference call, please dial 877-270-2148 (domestic) or 412-902-6510 (international) and reference the Seres Therapeutics conference call. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

On May 4, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo for patients with solid and hematologic malignancies, reported that it will have an oral presentation at the International Society for Cell and Gene Therapy (ISCT) Annual Meeting 2022, to be held May 4-7, 2022 in San Francisco, California (Press release, Umoja Biopharma, MAY 4, 2022, View Source [SID1234613506]).

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On Friday, May 6th, Dave Vereide, Ph.D., Senior Scientist at Umoja Biopharma, will give an oral presentation titled "A synthetic cytokine receptor platform for producing cytotoxic innate lymphocytes as ‘off-the-shelf’ cancer therapeutics." The presentation will highlight Umoja’s rapamycin-activated cytokine receptor (RACR) platform which seeks to address current challenges in the cellular therapy space. Current approaches for differentiating induced pluripotent stem cells (iPSCs) into therapeutic immune cell types often requires expensive exogenous gamma-chain cytokines for expansion and survival, and often, the presence of feeder cells. The RACR platform permits the production of immune effector cells, termed RACR-induced cytotoxic innate lymphocytes (iCILs), in the absence of exogenous cytokines and feeder cells by genetically modifying iPSC-derived progenitor cells to express the RACR synthetic cytokine receptor. A synthetic small molecule ligand then binds RACR to drive the differentiation and expansion of the iCILs. RACR technology can be employed in both a manufacturing setting to generate iCILs and in vivo to enable the selective expansion and survival of iCILs.

"iPSCs are an excellent source of renewable, modifiable, and scalable material for cell therapy manufacturing, yet several limitations exist with the current manufacturing processes for differentiating iPSCs into therapeutic cell types, including the need for exogenous growth factors and feeder cells." said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja. "At Umoja we are excited about our RACR-iCIL iPSC platform and its capacity to generate immune effector cells in the absence of these limitations. Due to the selective growth advantage provided by our RACR platform, a highly pure iCIL population can be produced during manufacturing. We are evaluating iCILs in pre-clinical studies to assess their in vivo anti-tumor activity, and are optimistic about their potential for development as "off-the-shelf" cell therapies for diverse hematologic malignancies and solid tumors."

Presentation details:

Presentation Title: A synthetic cytokine receptor platform for producing cytotoxic innate lymphocytes as ‘off-the-shelf’ cancer therapeutics
Presenting Author: Dave Vereide, Ph.D., Senior Scientist at Umoja Biopharma
Abstract Number: 44
Oral Presentation Session: Gene Editing/Gene Therapies
Oral Presentation Date, Time: Friday May 6, 2022; 4:45-5:45 p.m. PT
Poster Presentation Session: Poster Networking Reception 2
Poster Presentation Date, Time: Thursday May 5, 2022; 5:45-7:15 p.m. PT

On May 4, 2022 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended March 31, 2022 (Press release, Adaptive Biotechnologies, MAY 4, 2022, View Source [SID1234613522]).

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"We started the year strong and completed a strategic reorganization of our company around two key business areas: MRD and Immune Medicine," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "I am encouraged by the solid momentum across both business areas as we optimize our resource allocation to capitalize on the multiple opportunities ahead."

Recent Highlights

Revenue of $38.6 million for the first quarter 2022, representing a 0.5% increase from the first quarter 2021.

clonoSEQ test volume in the first quarter 2022 grew 45% versus the first quarter of prior year and 12% over the fourth quarter of 2021.

Signed expanded MRD pan-portfolio agreement with major partner in MM and CLL for the use of MRD status as a clinical endpoint.

Recognized $3.0 million in MRD regulatory milestone revenue resulting from a biopharmaceutical partner who used data from our MRD assay to support its drug approval.

Completed analysis from immuneSense Lyme blinded data from 990 participants, confirming T-Detect Lyme is nearly twice as sensitive as the current standard of care (54% T-Detect Lyme vs 30% STTT sensitivity, both at 99% specificity). T-Detect Lyme offering to be made available during 2022 Lyme season.

Entered a new T-MAP collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson to map T cell responses to RSV to support Janssen’s RSV vaccine program.

Announced the appointment of Tycho Peterson as chief financial officer, who brings several decades of financial leadership and experience within the life science and diagnostic industries.

First Quarter 2022 Financial Results

Revenue was $38.6 million for the quarter ended March 31, 2022, representing a 0.5% increase from the first quarter in the prior year. Immune Medicine revenue was $20.8 million for the quarter, representing a 4% increase from the first quarter in the prior year. MRD revenue was $17.8 million for the quarter, representing a 3% decrease from the first quarter in the prior year.

Operating expenses were $101.7 million for the first quarter of 2022, compared to $79.7 million in the first quarter of the prior year, representing an increase of 28%.

Net loss was $62.8 million for the first quarter of 2022, compared to $40.6 million for the same period in 2021.

Cash, cash equivalents and marketable securities was $500.7 million as of March 31, 2022.

2022 Financial Guidance

Adaptive Biotechnologies reiterates full year 2022 revenue to be in the range of $185 million to $195 million.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its first quarter 2022 financial results after market close on Wednesday, May 4, 2022 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On May 4, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the Company has engaged Wolfram C. M. Dempke, MD, PhD, MBA, MRCP as its EU Chief Medical Officer and part-time contractor for its European clinical trials (Press release, Moleculin, MAY 4, 2022, View Source [SID1234613539]).

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Dr. Dempke currently serves as the Vice President, Scientific Solutions: Hematology & Oncology, at Worldwide Clinical Trials. He holds oncology/hematology society memberships in the U.S. and Europe. He has published five textbooks and more than 150 peer-reviewed papers. Dr. Dempke continues to teach classes in the Munich University Medical Oncology department, Germany, and he even continues to see patients on a monthly basis.

Walter Klemp, President and Chief Executive Officer of Moleculin commented, "As we look to commence our clinical studies in Europe, we believe Dr. Dempke will be a tremendous asset. Over the course of his career, he has played a key role in clinical oncology programs and made noteworthy contributions to the industry and academia. We are honored and pleased to have his leadership and guidance for our European clinical teams and help to drive these important programs forward."

"There remains critical unmet needs across a number of oncology indications. I have dedicated my career to advancing innovative therapeutics that have the potential to provide patient benefit and make a positive impact in the treatment of cancer. After overseeing developments in the hem/onc space for more than 30 years, we are clearly committed to our patients to bring drug candidates like annamycin, which has the potential to become a game changer in anthracycline development in the future to the market. Thus, I am pleased to join the Moleculin team and help to advance their broad portfolio of drug candidates targeting highly resistant tumors and viruses. I am excited for the initiation of clinical studies in Europe and further advancing development of these important assets to meet unmet needs in the space," added Dr. Dempke.

Prior to his current role, Dr. Dempke served as the External Expert at Novartis Oncology Global Clinical Development (NSCLC) (Basel, Switzerland), where he was responsible for the development of capmatinib (c- MET inhibitor), nazartinib (EGFRmut inhibitor), and novel compounds in Phase 1. Prior to that, he served as the Executive Medical Director Global Clinical Development (Head of Global Clinical Development in EU) at Incyte Biosciences; Head, Global Medical Affairs for EUSA Pharma; and as Executive Medical Director for Kyowa Kirin Pharmaceutical Development Ltd., where he was responsible for the global clinical development (Phase 1-3) in the therapeutic area of leukaemias and lymphomas (antibodies). This included the development of Phase 1/2 trials for an anti-CD123 antibody in AML, first-in-human studies with novel immune-oncology drugs (immune checkpoint antibodies) and support for the EMA submission of mogamulizumab based on the Phase 3 trial results. Additionally he served as the Executive Medical Director and Global Clinical Lead (Global Medical Oncology) at AstraZeneca. During his tenure there, he was responsible for the global clinical development in the therapeutic area of NSCLC and ovarian cancer (antibodies, TKIs). This included the responsibility for the FDA submission and re-launch of gefitinib in the US (NSCLC), the development of durvalumab for NSCLC (Phase 1/2) and the design and execution of Phase 2/3 trials for a novel wee-1 inhibitor in ovarian carcinomas. Other career appointments include Head of the Department of Haematology, Oncology and Gastroenterology at the Elbland Clinic Holding; Head of Global Medical Affairs Oncology at MerckSerono; Lead Medical Science Manager Oncology at Bristol-Myers Squibb and thereafter promoted as TA Head Oncology; Executive Medical Director of the TTG Bochum; Head of the Medical Oncology Department of the General Hospital Goch; Deputy Head and Acting Representative of the Medical Clinic IV (Haematology and Oncology) at the University of Halle; and Deputy Head of the Haematology Departments at Elisabeth Hospital in Germany.