On March 31, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech," "Nascent," or the "Company"), a clinical-stage biotechnology company pioneering the development of monoclonal antibodies targeting treatment of various cancers and viral infections, reported that patients have been enrolled and initial dosing has begun in the Company’s landmark Phase I trial to evaluate Pritumumab ("PTB") as a treatment option for Brain Cancer, including Malignant Primary Brain Tumors and adult Brain Metastases (Press release, Nascent Biotech, MAR 31, 2021, View Source [SID1234577413]).

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Patient enrollment remains open, and the trial continues to recruit new patients for participation. Those interested may review trial requirements HERE.

"Dosing human cancer patients in our Phase 1 clinical trial is a key milestone on the path toward determining the safety profile of Pritumumab under clinical conditions," noted Nascent CEO Sean Carrick. "This study will also provide fresh insight into PTB’s efficacy on primary brain tumors."

PTB is a natural human antibody that works by binding to cell surface Vimentin (also referred to as ectodomain vimentin, or EDV), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy that, unlike chemotherapy, targets only cancer cells without damaging healthy ones. Because of this dynamic, the current clinical study may have implications for future research on PTB as a treatment option for a broad range of more common cancers, including breast, colon, and lung.

On March 31, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group reported a global collaboration and licensing agreement (the "Agreement") to further develop and commercialize QED Therapeutics’ FGFR1-3 inhibitor, infigratinib, in oncology and all other indications except for skeletal dysplasias (including achondroplasia) (Press release, BridgeBio, MAR 31, 2021, View Source [SID1234577440]). Completion of the Agreement is subject to regulatory review and customary closing conditions, which are expected to occur in the second quarter of 2021.

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Infigratinib is an orally administered, ATP-competitive, tyrosine kinase inhibitor that is designed to inhibit FGFR, and being investigated for treatment of individuals with FGFR-driven conditions, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (urinary tract and bladder cancer), and other FGFR-driven cancers.

Under the terms of the Agreement, BridgeBio will retain all rights to infigratinib in skeletal dysplasia, including achondroplasia. Subject to U.S. Food and Drug Administration ("FDA") approval, QED and Helsinn will co-commercialize infigratinib in oncology indications in the U.S. and will share profits and losses on a 50:50 basis. Helsinn will have exclusive commercialization rights and lead commercialization for infigratinib in non-skeletal dysplasia indications outside of the U.S., excluding China, Hong Kong and Macau, which are covered by BridgeBio’s strategic development and commercialization collaboration with LianBio. Under the Agreement, BridgeBio will be eligible to receive more than $2 billion in upfront, regulatory and commercial milestones, as well as tiered royalties on adjusted net sales from Helsinn Group.

"We are privileged to partner with Helsinn as we strive to unlock the full potential of infigratinib for patients with FGFR-driven cancers," said BridgeBio CEO and founder Neil Kumar, Ph.D. "Helsinn has an impressive track record of advancing and commercializing oncology therapies around the globe. Our hope is that partnering with Helsinn will significantly strengthen our anticipated upcoming launch of infigratinib and our ongoing research into infigratinib’s potential across other cancer indications."

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented, "As a leader in oncology therapeutics and supportive care, Helsinn is always looking to partner with high quality companies. The combination of BridgeBio and its lead oncology product candidate, infigratinib, fall into the strategic sweet spot of a quality company and product with which we look to work. We are highly excited by the potential positive impact this collaboration can deliver for patients around the world."

BridgeBio and Helsinn Group intend to pursue an ambitious co-development plan in oncology indications, including clinical investigation underway in first-line cholangiocarcinoma and adjuvant urothelial cancer. This plan will be underpinned by close collaboration among the parties, with the aim of developing new treatments for patients with FGFR-driven cancers. As infigratinib heads toward potential approval and commercialization in a range of oncology indications, Helsinn’s unique integrated licensing business model will enable its distribution to reach patients globally.

The FDA has accepted the New Drug Application ("NDA") for infigratinib for patients with previously-treated advanced cholangiocarcinoma ("CCA") harboring an FGFR2 gene fusion or rearrangement. The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review ("RTOR") pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Additionally, infigratinib is currently under review in Australia and Canada under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

On March 31, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) ("CTI"), a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers, reported the pricing of its previously announced underwritten public offering of 14,260,800 shares of its common stock and 600 shares of its series X1 preferred stock (the "Series X1 Preferred") (Press release, CTI BioPharma, MAR 31, 2021, View Source [SID1234577458]). In addition, CTI has granted the underwriters a 30-day option to purchase up to an additional 2,139,120 shares of its common stock on the same terms and conditions. The offering price to the public of a share of common stock is $2.50 and the offering price to the public of a share of Series X1 Preferred Stock is $25,000. Each share of Series X1 Preferred will be convertible into 10,000 shares of common stock at the election of the holder, subject to beneficial ownership conversion limits applicable to the Series X1 Preferred.

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All of the securities in the offering are being sold by CTI. The gross proceeds to CTI from this underwritten public offering are expected to be approximately $50.7 million, before deducting the underwriting discount and other estimated offering expenses payable by CTI. The offering is expected to close on or about April 6, 2021, subject to the satisfaction of customary closing conditions.

CTI intends to use the proceeds from the proposed sale of its shares of common stock and Series X1 Preferred Stock for commercialization activities for pacritinib, general working capital and corporate purposes.

Stifel and JMP Securities are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering.

The offering is being made pursuant to a registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and subsequently was declared effective by the SEC. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus relating to these securities may be obtained by sending a request to Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery St, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected], or JMP Securities LLC, 600 Montgomery St, Suite 1100, San Francisco, CA 94111, Attn: Prospectus Department, telephone: 415-835-8900.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities 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 March 31, 2021 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) for use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN) (Press release, BeyondSpring Pharmaceuticals, MAR 31, 2021, View Source [SID1234577501]). Plinabulin in combination with a G-CSF therapy, which received breakthrough therapy designation from the U.S. FDA and the China NMPA for "concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of CIN," has the potential to raise the standard of care in CIN for the first time in 30 years.

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CIN remains a severely unmet medical need. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen was approved in 1991. The main benefit of G-CSF treatment, however, is in Week 2 after chemotherapy. Week 1 after chemotherapy is considered the "neutropenia vulnerability gap" where over 75% of CIN-related clinical complications occur, including febrile neutropenia, infection, hospitalization and death. Plinabulin is the first agent seeking FDA approval that has the potential to fill this gap by working in Week 1 to prevent the onset and progression of CIN. Therefore, combining plinabulin and G-CSF may maximize the protection of patients for the full cycle of chemotherapy, as demonstrated in the PROTECTIVE-2 Phase 3 registration study.

"CIN is a major concern for physicians and their patients undergoing cancer treatment. Plinabulin provides benefits above and beyond what is currently available on the market and has the potential to be a game-changer for patients undergoing chemotherapy treatment," said Dr. Douglas Blayney, Professor of Medicine at Stanford University Medical School and global PI for CIN studies. "CIN, which can lead to life-threatening infections, is the number one reason for the 4D’s in chemotherapy (Decrease, Delay and Discontinue dose and Downgrade regimen). We hope plinabulin will allow patients to better tolerate chemotherapy, thus enabling patients to stick to their optimal treatment plan and avoid serious CIN complications."

The NDA submission is based on positive data from BeyondSpring’s PROTECTIVE-2 Phase 3 registration study which showed that plinabulin in combination with pegfilgrastim demonstrated superior CIN prevention benefit, compared to pegfilgrastim alone. The study met the primary endpoint, with a statistically significant improvement in the rate of prevention of grade 4 neutropenia (improved from 13.6% to 31.5%, p=0.0015) and met all key secondary endpoints, including duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir. In addition, the combination reduced clinical complications such as incidence and severity of febrile neutropenia (FN) and incidence and duration of hospitalization for FN patients. The combination is well tolerated, with an over 20% reduction of grade 4 Treatment-Emergent Adverse Events (TEAE) in the combination compared to that of pegfilgrastim alone. The NDA submissions will include five supportive trials that show consistent CIN prevention in various chemotherapy regimens and cancers in over 1,200 patients.

"This NDA submission is the culmination of years of research to prove that plinabulin can improve the long-established standard of care and address an unmet medical need to further alleviate the risk burden of CIN for patients receiving chemotherapy," said Dr. Lan Huang, co-founder, CEO, and chairman of BeyondSpring. "With CIN responsible for potentially delaying treatment and causing life-threatening infections, we hope that receiving the improved care represented by the plinabulin and G-CSF combination will allow patients to better tolerate chemotherapy and potentially see increased treatment success rates. We are grateful for the patients’ participation in plinabulin’s clinical trials and the participation and contributions of our investigators and our many other clinical partners."

Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever (also called febrile neutropenia, or "FN"), which necessitates ER/hospital visits. Due to the COVID-19 pandemic, the updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, including pegfilgrastim, from high-risk patients only (chemo FN rate >20%), to include intermediate-risk patients (FN rate between 10-20%), to reduce the number of hospital/ER visits related to CIN. The revision of the NCCN guidelines effectively increases the addressable market of patients who may benefit from treatment with plinabulin, if approved, to approximately 440,000 cancer patients in the U.S. annually.

There is a large unmet medical need and a growing market for CIN prevention and treatment in China as well. According to Lancet Oncology, 60% of East Asia cancer patients are treated with chemotherapy1. In 2020, there were 4.6 million new cancer patients in China which could correspond to 2.8 million patients using chemotherapy and needing CIN prevention agents. According to IQVIA data, the G-CSF drug market (for CIN treatment) in China is growing at over 30% a year.

About PROTECTIVE-2 (Study 106) Phase 3 Registration Study
The Phase 3 portion of PROTECTIVE-2 was a double-blind and active-controlled global registration study. It was designed as a superiority study to compare the safety and efficacy of plinabulin (40 mg, Day 1 dose) + pegfilgrastim (6 mg, Day 2 dose) versus a single dose of pegfilgrastim (6 mg, Day 2 dose) in patients with breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle. TAC is an example of high FN risk chemotherapy and is the regimen used in all G-CSF biosimilar registration studies.

The primary endpoint was the rate of prevention of Grade 4 neutropenia and secondary endpoints included DSN and mean ANC nadir in Cycle 1. Literature shows that despite the use of pegfilgrastim, 83 to 93 percent of patients treated with TAC still suffer Grade 4 neutropenia (or rate of Grade 4 neutropenia prevention at 7-17%), which demonstrates the severe unmet medical need for improved treatment2,3.

The ANC data, which are used to calculate these endpoints, were obtained through central laboratory assessments by Covance Bioanalytical Methods using standardized and validated analytical tests. Covance was the clinical contract research organization (CRO) for patient recruitment and monitoring of global sites for this study.

About CIN
Chemotherapy-induced neutropenia (CIN) is the primary dose-limiting toxicity in cancer patients who receive chemotherapy and is the primary cause for the 4D’s (Decrease, Delay, Discontinue dose and Downgrade regimen). The 4D’s lead to a decrease of the anti-cancer benefit of chemotherapy, e.g., >15% of dose reduction correlated to >50% survival reduction4. The National Comprehensive Cancer Network (NCCN) recently updated its treatment guidelines for CIN prophylaxis using G-CSFs to include both high- and intermediate-FN risk patients treated with chemotherapies, to preserve hospital and ER resources for COVID-19 patients, and to maximize protection from CIN. The NCCN’s action effectively doubled the number of patients recommended to receive CIN prophylaxis.

About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immune-modulating microtubule-binding agent (SIMBA). A global Phase 3 clinical trial in CIN (PROTECTIVE-2) with plinabulin in combination with pegfilgrastim versus pegfilgrastim alone has been completed and is the basis for an NDA filing in the U.S. and China for the prevention of CIN. In this trial, plinabulin reduced the "neutropenia vulnerability gap" associated with G-CSF therapy alone. Additionally, a global Phase 3 study for the treatment of later-stage NSCLC in EGFR wild-type patients (DUBLIN-3) is now fully enrolled and will evaluate the combination of plinabulin and docetaxel versus docetaxel alone for overall survival in NSCLC patients. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells5,6 and the second is early-onset action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs)7. Effects on HSPCs could explain the potential for plinabulin not only to prevent CIN but also to increase circulating CD34+ cells in patients. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1 / PD-L1 antibodies.

On March 31, 2021 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins,reported financial results and provided a business update for the year ended December 31, 2020 (Press release, Galectin Therapeutics, MAR 31, 2021, View Source [SID1234577441]). These results are included in the Company’s Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, "I am very encouraged by the progress achieved in fiscal 2020, and remain extremely optimistic for 2021. Given the current challenging environment, I am proud of our success, highlighted by site activations and ongoing enrollment of our innovative NAVIGATE study. This global program continues to be the only active late-stage trial of patients with compensated NASH cirrhosis, where the medical need is greatest and with a clinically meaningful endpoint. Our concurrent hepatic impairment study will also provide important information on belapectin tolerance, safety and exposure in advanced cirrhotic patients.

Over the course of the last year at the Board’s direction we have taken aggressive steps to strengthen our organization, adding Pol Boudes as Chief Medical Officer, as well as Mr. Richard Zordani and Dr. Elissa Schwartz to our Board of Directors. These changes informed my decision to accept the role of Chief Executive Officer, and they afforded me the confidence to receive 80% of my compensation in the

form of Galectin stock. Additionally, I believe this breadth of talent reinvigorated Galectin and placed the Company in a position to monetize our assets. This has served to strengthen my commitment to my compensation strategy, which aligns my interests with all shareholders.

More recently, the peer-reviewed publication of a well-recognized mouse model has shown that the combination of belapectin, a galectin-3 inhibitor, with immunotherapy reprograms the tumor microenvironment. This favors anti-tumor immunity, results in better anti-tumor activity, and most importantly, brings further rationale for our ongoing cancer trial combining belapectin with Keytruda, a potent PD-1 inhibitor. Providence Cancer Institute is currently conducting the study and preliminary results suggest improved activity and, potentially, improved tolerance of this regimen.

I am extremely confident in our science, our team, and our progress," concluded Lewis. The upcoming year will be dedicated to advancing our trial in NASH cirrhosis and supporting investigations of belapectin’s safety and efficacy in other indications, such as the ongoing cancer trial in conjunction with the Providence Cancer Institute. I also want to recognize the outstanding efforts of our entire team, who persevered through the challenges precipitated by COVID-19 in the interest of developing a therapy for NASH cirrhosis, a critical, unmet medical need. Let me once again thank the investigators and patients participating in our NAVIGATE trial, where a positive outcome would be very clinically relevant for patients with NASH cirrhosis."

Richard E. Uihlein, Chairman of the Board, added, "I want to echo Joel’s sentiment and thank Pol, Jack and our entire team for their dedication throughout

this past year, especially their commitment to initiating our exciting NAVIGATE trial under less than optimal circumstances due to the global pandemic. Joel has proven to be the leader we all expected, and I am pleased with the progress he has achieved since assuming the role and confident in his ability to unlock the value of our proprietary compound, belapectin. Peer-reviewed research, such as that recently published in OncoImmunology, clearly confirms our basic scientific premise regarding belapectin’s anti-inflammatory characteristics in a broad range of fibrosis as well as its ability to potentially enhance the efficacy of cancer therapies. As such, the NAVIGATE trial represents an opportunity to further demonstrate the anti-inflammatory activity of belapectin, which would open up vast new opportunities to investigate other indications and establish our compound as a foundation for a platform technology."

NAVIGATE Trial Update

The NAVIGATE trial uses a seamless, adaptive design to confirm dose selection and reaffirm the observed efficacy of belapectin to prevent the development of esophageal varices in the NASH-CX trial. Pre-planned adaptations will inform the larger Phase 3 trial component.

Key clinical study milestones:

First patient randomized August 2020

130+ sites, 12 countries in North America, Europe, Asia and Australia

Phase 2b part to Interim Analysis will be ~315 patients

Recruiting period for phase 2b portion now expected to conclude around the end of 2021 due to COVID-19 impact on recruitment

Key inclusion criteria – NASH cirrhosis (baseline or historical liver biopsy), clinical sign of portal hypertension, no esophageal varices (esophago-gastro endoscopy)

Interim analysis expected late 2023

Peer-reviewed publication, Scientific Presentations and Conferences

OncoImmunology published a peer-reviewed article describing how belapectin, a potent galectin-3 inhibitor, in combination with an anti-OX40 (CD134) monoclonal antibody, reduces tumor progression compared to either agent alone. The paper, titled "Galectin-3 inhibition with belapectin combined with anti-OX40 therapy reprograms the tumor microenvironment to favor anti-tumor immunity," describes results from a collaboration between Galectin Therapeutics and Providence Cancer Institute highlighting the mechanism of action of the combination which is explained by a reduction in myeloid-derived suppressor cell infiltration and function coupled to an increase in T-cell effector function. For many years, galectin-3 has been known to play a key role in the control of tumor-induced immunosuppression. Galectin-3 acts to maintain tumor growth, in part, by supporting the generation of suppressive macrophages and inhibiting T cell function. This creates an attractive rationale for the use of a galectin-3 inhibitor, such as belapectin, to improve anti-tumor activities of multiple cancer therapies.

Financial Results

For the year ended December 31, 2020, the Company reported a net loss applicable to common stockholders of $23.6 million, or ($0.41) per share, compared to a net loss applicable to common stockholders of $20.2 million, or ($0.39) per share for the full year 2019. The increase is largely due to an increase in research and development expenses related to our NAVIGATE clinical trial, partially offset by a non-cash, one-time warrant modification charge of $6.6 million in 2019.

Research and development expense for 2020 was $18.0 million compared with $7.5 million for 2019. The increase was primarily due to costs related to our NAVIGATE clinical trial, along with preparations and some preclinical activities incurred in support of the clinical program, such as development and reproductive toxicity studies, clinical supplies and other supportive activities. General and administrative expenses for 2020 were $5.5 million, down from $6.0 million for the full year 2019, primarily due to decreases in legal, investor relations and non-cash stock-based compensation expenses partially offset by an increase in insurance expenses.

As of December 31, 2020, the Company had $27.1 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least March 31, 2022.

The Company expects that it will require more cash to fund operations after March 31, 2022, and believes it will be able to obtain additional financing as needed. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. Currently, we expect to require an additional approximately $45-$50 million to cover costs of the trial to reach the planned interim analysis estimated to occur in the second half of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs and further amounts to complete the Phase 3 portion of the trial. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.