On April 27, 2022 ShiftBio reported its partnership with RoosterBio Inc. (Frederick, MD) for its first pipeline, SBI-102 (Press release, ShiftBio, APR 27, 2022, View Source;bmode=view&idx=11285502&t=board [SID1234629019]). This partnership cooperates to start clinical sample production of ShiftBio’s first driving pipeline for rare diseases and cancer.

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RoosterBio is a leading supplier of human mesenchymal stem cells (h-MSCs) not only with broad knowledge and expertise in bioprocess development services but also with their success in producing cell and media products with FDA-approved type II master files. Through this partnership, RoosterBio and ShiftBio will comprehensively carry out all the process optimization required to produce exosomes expressing a therapeutic ligand at a scalable GMP level by minimizing the risk with bilateral confirmation tests and utilizing their ability to fulfill the current regulation criteria at a very high level.

This strategic collaboration of the knowledge, expertise, and experience aimed to overcome existing know-how limitations of such a recently emerged drug modality in commercial production. ShiftBio applies the regulatory-supported latest innovations to its process and minimizes the years-long new drug development with its perfectly coordinated production strategy that brings the latest technologies of Asia, Europe, and the U.S together. Working with the aim and motto of giving patients a second chance from the very beginning, ShiftBio plans to reach this goal with the right strategic decisions as soon as possible to not lose another incurable patient.

On April 27, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will report first quarter 2022 financial results on Wednesday, May 4, 2022 after the close of the market (Press release, Allogene, APR 27, 2022, View Source [SID1234616274]). The announcement will be followed by a live audio webcast and conference call at 2:00 PM Pacific Time/5:00 PM Eastern Time.

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Audio Webcast
The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On April 27, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-605, the Company’s next-generation AlloCAR T product candidate targeting BCMA for the treatment of multiple myeloma (Press release, Allogene, APR 27, 2022, View Source [SID1234616273]).

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ALLO-605 is the Company’s first TurboCAR product candidate. TurboCAR is a proprietary, next generation platform technology based on a programmable cytokine signaling, designed to control T cell exhaustion and to improve T cell function and potency. These properties may enable CAR T products to succeed in more difficult to treat hematologic malignancies and solid tumors. The FDA granted Fast Track designation to ALLO-605 in Q2 2021 based on the potential for the product candidate to address an unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 study evaluating ALLO-605 is ongoing.

"Orphan-drug designation marks an important step towards developing our anti-BCMA portfolio for patients with multiple myeloma and making allogeneic CAR T products readily available for patients," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We look forward to providing an update on our BCMA clinical assets by the end of the year with an eye toward prioritizing a strategy for the next stage of development."

Orphan-drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S. ODD granted therapies entitle companies to development incentives including tax credits for clinical testing and prescription drug user fee exemptions. If a product that has ODD subsequently receives the first FDA approval for the designated disease, the FDA may not approve any other applications to market the same biologic for the same indication for seven years, except in limited circumstances. ODD does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

About ALLO-605
ALLO-605, a next-generation AlloCAR T known as a TurboCAR, is an investigational product that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. This study uses ALLO-647, Allogene’s proprietary monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. ALLO-605 incorporates Allogene’s proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells. Preclinical results with ALLO-605 were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020. In June 2021, ALLO-605 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory multiple myeloma. The Phase 1 study evaluating ALLO-605 is underway.

On April 27, 2022 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported that it has agreed to sell 953,834 of its common shares at a price of $26.21 per share to Pfizer for gross proceeds of $25.0 million (the "Transaction") (Press release, Pfizer, APR 27, 2022, View Source [SID1234613277]). The common shares were offered and sold to Pfizer in a registered direct offering conducted without an underwriter or placement agent. The offering is expected to close on or about April 29, 2022, subject to customary closing conditions. Zentalis intends to use the net proceeds of the offering to help fund ongoing and planned clinical trials, including studies of ZN-c3, its Wee1 inhibitor, and ZN-d5, its BCL-2 inhibitor, and for working capital and general corporate purposes. With prioritization of the clinical development of ZN-c3 and ZN-d5, budget reallocation and Pfizer’s investment, the Company extends current cash runway into Q1 2024.

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Pfizer also expects to leverage its global development capabilities and expertise to enhance Zentalis’ clinical development program. The parties have entered into an agreement to collaborate to advance the clinical development of ZN-c3, a selective Wee1 inhibitor designed to induce synthetic lethality in cancer cells.

Zentalis will maintain full economic ownership and control of ZN-c3 and the rest of its pipeline.

Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis, commented, "Given Pfizer’s deep expertise in developing treatments for genitourinary cancers, we are proud not only to receive capital support but to partner with them to develop a potential treatment option for patients living with cancer. We look forward to advancing our promising therapeutics to hopefully realize the full potential of our internally discovered oncology pipeline."

"We are proud to support Zentalis and to assist in the clinical advancement of its pipeline," said Chris Boshoff, M.D., Ph.D., FMedSci, Chief Development Officer, Pfizer Oncology. "We believe Zentalis’ commitment to developing innovative treatments holds promise, and we are looking forward to continuing our relationship to potentially help better the lives of people with cancer."

In addition, Adam Schayowitz, Ph.D., MBA, Vice President & Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and Melanoma, Pfizer, will join Zentalis’ Scientific Advisory Board. Dr. Schayowitz will work closely with Zentalis’ senior management team to provide input on the Company’s clinical strategy.

The securities described above were offered by means of a prospectus supplement dated April 26, 2022, and accompanying prospectus dated May 4, 2021, forming a part of the Company’s effective shelf registration statement (File No. 333-255769). The prospectus supplement and accompanying prospectus relating to this offering will be filed with the U.S. Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the common shares, nor shall there be any sale of the common shares in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On April 27, 2022 Global pharma major Lupin Limited (Lupin) reported that it has entered into a strategic partnership with Yabao Pharmaceutical Co. Inc. (Yabao), to meet the growing demand for quality drugs with pediatric formulations in the Chinese markets (Press release, Lupin, APR 27, 2022, View Source [SID1234613252]).

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The demand for high quality pediatric medicines has been growing rapidly in China as a result of the government’s support and policy measures. The latest Chinese pediatric pharmaceutical market report indicates that the market for pediatric drugs in China is expected to reach 210 billion CNY (33 billion USD) in 2021, growing at a rate of 9.23%.

Dr. Fabrice Egros, President – Corporate Development and Growth Markets, Lupin said, "We are excited about this partnership as it paves the way for us to bring quality pediatric formulations to the growing needs of patients in China. In addition to marketing our pediatric products in the Chinese market, we intend to expand our collaboration in other strategic therapeutics areas such as cardio-metabolic, central nervous system and gastro-enterology."

Mr. Wei Ren, President of Yabao said, "We are very pleased to be partnering with Lupin to further strengthen Yabao’s leadership position in the pediatric market. Yabao strives to develop its pediatric pipeline to address the urgent unmet needs in the market and to serve the pediatric patients. Moreover, Yabao also looks forward to expanding the collaboration with Lupin in other areas."