On October 13, 2020 BrodenBio Co., Ltd. reported the company has completed the pre-A round of financing of tens of millions (CNY), led by Tao Capital, followed by Lapam Capital and Tibet Ruihai Enterprise Management Center (L.P.) (Press release, BroadenBio, OCT 13, 2020, View Source [SID1234640197]).

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On October 13, 2020 Immuneel Therapeutics Private Limited (Immuneel) reported that it has entered into a multi-asset collaboration and licensing agreement with Hospital Clínic de Barcelona (HCB) and Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) (Press release, Imuneel, OCT 13, 2020, View Source [SID1234618847]). Under the collaboration which opens up opportunities for co-development of advanced assets to be deployed in Spain and India, Immuneel acquired the exclusive rights to develop and commercialise autologous ARI-0001, a CD19 Chimeric antigen receptor (CAR) T cell therapy, in India.

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This agreement puts Immuneel as a front-runner in the pursuit of offering accessible and affordable CAR Ts to patients in India through registration clinical trials and its investments in further process optimization.

Speaking about this milestone collaboration:

Ms. Kiran Mazumdar Shaw (Co-founder, Immuneel) said, "This partnership with HCB & IDIBAPS is pathbreaking and heralds the advent of life saving CAR T therapy for patients in India. Immuneel is committed to providing affordable access to this cutting-edge therapy at state-of-the-art facilities housed at the Mazumdar Shaw Cancer Centre. I would particularly like to call out Dr. Campistol and Dr. Juan Uriach for their willingness to partner with us in our mission to give hope to cancer patients who can benefit from cell therapies."

HCB/IDIBAPS are public institutions that collaborated with a vision to create ARI-0001 as a product that can be an affordable option to treat patients with B cell malignancies in Spain. Dr. JM. Campistol (CEO, HCB) said, "We are extremely proud about this collaboration with Immuneel. We are convinced about the benefits of our CAR T therapy on patients with ALL. This is the beginning of a fruitful and promising collaboration between our academic research efforts (HCB & IDIBAPS) and Immuneel to improve the treatment of hematological disorders."

Dr. Elias Campo (Research Director, HCB-IDIBAPS) added, "CAR T based therapies have shown efficacy in the treatment of certain leukemias and lymphomas. With this partnership we will improve our knowledge on this kind of therapies and more patients will benefit from them".

Dr. Juan Uriach Torello (Scientific Business Advisor, Immuneel-HCB-IDIBAPS Collaboration) who has played a key advisory role in the partnership added, "This a remarkable display of alignment on affordable cell therapy between an academic hospital and a start-up; and also, a demonstration of hope for Spain and India."

ARI-0001 is a novel 2nd generation autologous CD19 CAR T, that has been extensively studied in-vitro and in-vivo. Clinical data from a recently concluded Phase 1-2 trial showed ARI-0001 to be a safe and efficacious product, with persistence of CAR T cells and response in patients who had failed previous therapies. ARI-0001 is currently under review for approval as a hospital exemption product by Spanish Drug Agency (AEMPS). "This collaboration and ARI-0001 licensing marks a strong foundation event on which Immuneel will bring its purpose to fruition – to enable really high quality and affordable cell therapy for patients in India. The collaboration seeks to align efforts to globalise affordable high-quality cell therapy strategies developed in India and Spain. We are really excited to be able to accelerate access to transformative therapies with ARI-0001 and build on the excellent data already generated in Spain" said Dr. Arun Anand, COO, Immuneel.

Dr. Siddhartha Mukherjee (Co-founder, Immuneel) further added, "Immuneel is extremely proud to bring this cutting-edge cell therapy to India. These "living drugs", created from genetically modified cells, have saved the lives of hundreds of cancer patients around the world but have been unavailable in India. Unlike standard medicines, these cell therapies have to be produced and delivered with immense care and technical finesse. A clinically tested target like CD 19 will enable Immuneel validate its clinical delivery for CAR T cells in India."

According to Dr. Kush M Parmar (Co-founder, Immuneel) "As Immuneel sets out on its mission to enable access to cellular therapies in India, CD19 CAR T as a first product reflects the thoughtful and stepwise approach being taken. The manufacturing, regulatory, clinical and delivery experience in bringing this validated approach to patients in India will lay the foundation for Immuneel’s leadership role in cellular therapies in the region and positions us well to build a pipeline of next-generation products for many patients in need."

"The agreement represents a first-rate opportunity to open the use of a product, that has been used only in our Hospital Clínic, for the patients of a continental-sized country like India, with a very different regulatory environment that can facilitate the validation of improvements that also could help our patients", says Dr. Manel Juan, head of the Immunology Department of Hospital Clínic and head of the Immunogenetics of the autoinflammatory response group at IDIBAPS. Dr. Álvaro Urbano, director of the Clínic Institute of Hemato-oncological Diseases and head of the IDIBAPS group on Hematopoietic progenitor cell transplantation, points out that, "we are very proud because the effort of a large team of the Hospital Clinic/IDIBAPS has made it possible that thanks to the ARI001 many patients in India will have access to a CART, which they could not otherwise afford. At the same time, it is a great responsibility to maintain the demands of quality and efficacy, as it is highly complex gene therapy. This will be the focus of the agreement that we have signed with Immuneel".

Additional terms were not disclosed.

About CD19 CAR T cell therapy

CD19 CAR T therapy is an adoptive autologous antitumor immunotherapy for patients with resistant or refractory CD19 + leukemia or lymphoma. This autologous product consists of a suspension of T-cells obtained from a patient, activated & genetically modified to express a chimeric antigen receptor (CAR) on its surface, in this case CD19. CAR Ts typically consist of a binding domain, a transmembrane domain & co- stimulatory molecules. Three CD19 CAR T products have been approved so far globally.

On October 13, 2020 exigen, Inc., a clinical-stage biopharmaceutical company, reported that Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview of the company at the upcoming Solebury Trout Fall 2020 Virtual Private Company Showcase (Press release, Apexigen, OCT 13, 2020, View Source [SID1234590993]). The 25-minute presentation includes an interactive Q&A with participants prompted to submit questions electronically. Details are as follows:

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Date/time: Thursday, October 15, 2020 at 4:00pm EDT

Access to live presentation and replay: Virtual Webcast

On October 13, 2020 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female oncology products in the precision medicine metastatic breast cancer arena, reported the enrollment and dosing of the first patient into the Phase 2 clinical trial collaboration of its lead investigational drug, lasofoxifene, in combination with Eli Lilly and Company’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib (Press release, Sermonix Pharmaceuticals, OCT 13, 2020, View Source [SID1234568478]).

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The open-label, multi-center study will evaluate the safety of lasofoxifene in combination with abemaciclib for the treatment of pre- and postmenopausal women with locally advanced metastatic estrogen receptor-positive (ER+)/HER2- breast cancer and an ESR1 mutation. It is Sermonix’s second Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study and is known as ELAINE 2.

Preclinical models of invasive breast cancer at the University of Chicago identified synergy between lasofoxifene, a selective estrogen receptor modulator (SERM), and palbociclib, a CDK 4 and 6 inhibitor, in the presence of ESR1 mutations.

"Combination therapy with a CDK 4/6 inhibitor and an endocrine backbone will likely continue to be widely utilized for women with metastatic breast cancer, and our positive preclinical data encouraged us to pursue further safety data with a lasofoxifene and abemaciclib combination in collaboration with Eli Lilly," said Dr. Paul Plourde, Sermonix vice president of clinical development. "It’s an important step toward conducting a larger study, so we are pleased to be in the clinic, continuing our research and our momentum."

Recruitment Through Tempus

Sermonix is partnering with Tempus, a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, for ELAINE study recruitment. The first ELAINE 2 patient was enrolled at one of Tempus’s TIME Trial Network sites. Tempus, with the world’s largest library of clinical and molecular data, uses innovative, proprietary software to match patients to clinical trials in real-time. For Sermonix, it is helping to identify and enroll eligible patients who have an ESR1 mutation.

"We’re thrilled to have Sermonix leveraging our real-time clinical trial network, which is focused on harnessing genomic and clinical data to rapidly match patients to these kinds of biomarker-driven trials," said Dr. Kim Blackwell, MD, Tempus chief medical officer. "Both companies share a mutual vision of advancing precision medicine through targeted therapeutics."

ELAINE 1, which began enrollment in September 2019, will continue to assess the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

"Sermonix is delighted to begin ELAINE 2 enrollment, in line with our initially anticipated timeline," said Dr. David Portman, Sermonix founder and chief executive officer. "Tempus has a state-of-the-art approach in identifying eligible patients at the point of care, providing both agility and speed, and we are certain this innovative collaboration in the precision medicine arena will prove fruitful in expediting our clinical trial enrollment efforts in both of our clinical programs."

Both ELAINE 1 and ELAINE 2 are actively enrolling patients. To learn more about the trials, visit www.sermonixpharma.com.

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

About Abemaciclib
Abemaciclib (trade name Verzenio) is a CDK4 and 6 inhibitor and the first and only oral tablet of its kind that can be taken every day for the treatment of HR+, HER2– metastatic breast cancer. It is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer, in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; in combination with fulvestrant for women with disease progression following endocrine therapy; or as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

On October 13, 2020, Vaxart, Inc. ("Vaxart" or the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC, as agent ("Jefferies") and Piper Sandler & Co. ("Piper Sandler") and, together with Jefferies, the "Sales Agents"), pursuant to which Vaxart may offer and sell, from time to time through the Sales Agents, shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $250 million (the "Shares") (Filing, 8-K, Aviragen Therapeutics, OCT 13, 2020, View Source [SID1234568466]). The Shares will be sold pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-239751), as previously filed with the U.S. Securities and Exchange Commission (the "Commission"). The Company filed a prospectus supplement, dated October 13, 2020, with the Commission in connection with the offer and sale of the Shares.

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Under the Sales Agreement, the Sales Agents may sell the Shares by any method permitted by law and deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Common Stock. In addition, under the Sales Agreement, the Sales Agents may sell the Shares in privately negotiated transactions with the Company’s consent and in block transactions. Under certain circumstances, Vaxart may instruct the Sales Agents not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time

Vaxart is not obligated to make any sales of the Shares under the Sales Agreement. The offering of the Shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by the Sales Agents or the Company, as permitted therein.

The Sales Agreement contains customary representations, warranties and agreements by Vaxart, and customary indemnification and contribution rights and obligations of the parties. Vaxart will pay the Sales Agents a commission rate equal to 4.5% of the aggregate gross proceeds from each sale of the Shares. Vaxart will also reimburse the Sales Agents for certain specified expenses in connection with entering into the Sales Agreement.

The Sales Agreement is filed as Exhibit 1.1 to this Current Report on Form 8-K, and the description of the terms of the Sales Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of Thompson Hine LLP relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

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