On June 11, 2020 Simcere Pharma of Nanjing reported that it has filed with the Hong Kong Exchange for an IPO that is rumored to seek $500 million (Press release, Jiangsu Simcere Pharmaceutical Company, JUN 11, 2020, View Source [SID1234561028]). Previously, Simcere was listed in the US, but it was taken private in 2013 for $500 million by management and Hony Capital. The company is an active dealmaker, using partnerships and in-house R&D to build a portfolio of nearly 50 novel candidates in development. In 2019, the company’s ten generic products produced a profit of $140 million on $708 million in revenue.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On June 11, 2020 The Board of Directors of Bristol Myers Squibb (NYSE:BMY) reported a quarterly dividend of forty-five cents ($0.45) per share on the $.10 par value Common Stock of the corporation (Press release, Bristol-Myers Squibb, JUN 11, 2020, View Source [SID1234560997]). The next quarterly dividend will be payable on August 3, 2020, to stockholders of record at the close of business on July 6, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The directors also declared a quarterly dividend of fifty cents ($0.50) per share on the $2.00 Convertible Preferred Stock of the corporation, payable September 1, 2020 to stockholders of record at the close of business on August 4, 2020.

On June 11, 2020 Cullinan Oncology LLC and PDI Therapeutics, a portfolio company of Avalon Ventures, reported a collaboration to bring CLN-619, a first-in-class monoclonal antibody reinvigorating the MICA/NKG2D axis into human clinical testing (Press release, Cullinan Oncology, JUN 11, 2020, View Source [SID1234561013]). As a result of the transaction, Cullinan MICA, Inc., a Cullinan Oncology portfolio company, will assume operational control of the asset.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have been very impressed with the work of Neil Gibson and his team at PDI Therapeutics," stated Owen Hughes, CEO of Cullinan Oncology. "The agonistic anti-MICA antibody CLN-619 represents a novel approach to broadly engage NK cells and certain T cell populations for tumor cell lysis and may have very broad therapeutic potential across multiple cancer indications as seen for certain check point inhibitors. We look forward to initiating clinical development in the coming months."

"We are pleased to partner with the Cullinan team and are excited to advance this highly innovative immuno-oncology mechanism into Phase 1 development," stated Dr. Neil Gibson, President and CEO of PDI Therapeutics Inc. "An agent capable of boosting both the innate and adaptive arms of the immune system could represent a new breakthrough in our fight against cancer."

PDI Therapeutics was incubated by COI Pharmaceuticals, which provides Avalon Ventures’ portfolio companies operational support and intellectual knowhow through a fully equipped R&D infrastructure. It is within this environment that PDI Therapeutics was able to take CLN-619 from bench to bedside in a little over 3 years. The program is supported by a robust in vitro and in vivo data package, with strong single agent activity and a clean safety profile in non-human primates. There is also a strong rationale for combination of CLN-619 with checkpoint inhibitors.

"We were attracted to CLN-619 given its potential broad utility across a large number of cancers and untapped biology," stated Patrick Baeuerle, Chief Scientific Officer, Biologics and co-founder of Cullinan Oncology. "Natural killer cells and killer T cells share NKG2D receptors that recognize cancer cells by their stress-inducible MICA ligand. To escape this deadly connection with killer cells, cancer cells have a way to shave off MICA from their surface. Cullinan MICA’s antibody effectively prevents the shedding of MICA from cancer cells and restores recognition by the patient’s killer cells. In addition, we expect the MICA antibody to exert potent antibody-dependent cellular cytotoxicity, or ADCC, against MICA-expressing cancer cells, which we believe will further potentiate the anti-tumor effect of CLN-619."

Cullinan MICA is financed by a recently completed $26M Series A, with participation from Cullinan Oncology LLC, Avalon Ventures, Bregua Corporation and the Myeloma Investment Fund, a venture philanthropy fund for the Multiple Myeloma Research Foundation (MMRF). "As we contemplate future development paths, we are excited to explore the utility of CLN-619 across a number of cancers, including both solid tumors, as well as hematologic malignancies like myeloma," added Dr. Jon Wigginton, Chief Medical Officer of Cullinan Oncology. "We look forward to building on the efforts of our colleagues at PDI to advance this novel, first-in-class immunotherapeutic agent into the clinic, and to leverage the many strengths of the MMRF to make an immediate and meaningful impacts on patients’ lives."

On June 11, 2020 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported its financial results and provided an operational update for the three months ended March 31, 2020 (Press release, BeyondSpring Pharmaceuticals, JUN 11, 2020, View Source [SID1234560998]).

"During the first quarter, we continued to make progress in the two lead indications for Plinabulin for both the prevention of chemotherapy-induced neutropenia (CIN) and treatment of non-small cell lung cancer (NSCLC)," said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer. "Our recent data from PROTECTIVE-2 Phase 2 showed Plinabulin combined with G-CSF improves chemotherapy compliance compared to G-CSF alone, which potentially leads to better clinical outcomes. The Plinabulin-G-CSF combination’s potential to prevent infection and hospitalization becomes even more important to the physicians, patients and the healthcare system in the COVID-19 pandemic. We expect to reach the pre-specified interim analysis for PROTECTIVE-2 Phase 3 this month to evaluate superiority in CIN, which has the potential to mark the first significant enhancement in preventing neutropenia in 30 years."

"With over 1,200 patients enrolled to date for Plinabulin clinical programs, we believe we are well-positioned to capitalize on our upcoming regulatory milestones with multiple New Drug Application (NDA) filings followed by near term commercial opportunities. Looking ahead, we continue to advance our clinical studies to support our view of Plinabulin as a ‘pipeline in a drug’ and believe its potential in improving standard of care in CIN prevention and cancer treatments will help many patients in need globally."

Select First-Quarter 2020 and Recent Operational Highlights

Chemotherapy-Induced Neutropenia (CIN)

PROTECTIVE-2 Phase 2 for Chemotherapy-Induced Neutropenia Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes

In June 2020, BeyondSpring announced that PROTECTIVE-2 Phase 2 superiority trial for CIN shows that Plinabulin in combination with Neulasta (pegfilgrastim), a long-lasting G-CSF, which is a predominant therapy to treat CIN, enables more cancer patients to receive the optimal chemotherapy dose and regimen, which potentially leads to better clinical outcomes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In breast cancer patients treated with docetaxel, doxorubicin and cyclophosphamide (TAC, a high-risk chemotherapy) with 20mg/m2 of Plinabulin combined with 6mg of Neulasta (n=16) compared with 6mg of Neulasta alone (n=22), Plinabulin + G-CSF improved compliance with targeted chemotherapy

Dose reduction (over 15 percent): only 6.3 percent of patients in the Plinabulin-Neulasta combination arm versus 22.7 percent in Neulasta arm – a 72 percent improvement

Downgraded regimen (from TAC, to docetaxel and cyclophosphamide, or TC): No (0 percent) patients in the Plinabulin + G-CSF arm downgraded chemotherapy from the TAC regimen to the TC regimen versus 18.2 percent in the Neulasta arm – p < 0.05

Plinabulin’s Mechanism of Action Complements Neulasta in Cancer Treatment

In May 2020, two Company abstracts were presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, evaluating Plinabulin alongside Neulasta.

BeyondSpring’s e-publication, titled, "Comparison of CD34+ mobilization effects of standard dose pegfilgrastim (Peg) versus low-dose peg combined with plinabulin (Plin)," demonstrates the efficacy of Plinabulin-Neulasta combination in increasing CD34+ counts for patients, with fewer adverse events

Additionally, BeyondSpring’s poster presentation, titled, "Head-to-head comparison of the non-G-CSF small molecule single agent (SA) plinabulin with SA pegfilgrastim for the prevention of docetaxel chemotherapy (chemo)-induced neutropenia (CIN) in the protective-1 trial," compares Plinabulin versus Neulasta as an effective monotherapy for CIN prevention

Non-Small Cell Lung Cancer (NSCLC)

DSMB Recommends DUBLIN-3 Phase 3 NSCLC to Continue Without Modification

In June 2020, BeyondSpring reported it had reached the pre-specified second interim analysis for DUBLIN-3 for NSCLC treatment with Plinabulin.

Upon reviewing the efficacy and safety data of over 500 patients at an approximately 300-patient death event, DSMB advised BeyondSpring to continue the study without any modifications

DUBLIN-3 is a global Phase 3 trial for Plinabulin, in combination with docetaxel versus docetaxel alone, for the treatment of second- / third-line EGFR wild-type NSCLC

Thus far, over 600 cancer patients have been dosed with Plinabulin, which has demonstrated good tolerability and satisfies the safety database standard of both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA)

Intellectual Properties

BeyondSpring Granted U.S. Patent for Plinabulin to Treat Severe CIN from Taxane in Cancer Patients

In May 2020, the U.S. Patent and Trademark Office (USPTO) granted BeyondSpring a new patent for methods of treating severe CIN in cancer patients treated with taxane with protection through 2033. This patent establishes Plinabulin’s beneficial effects in reducing CIN associated with taxane, one of the most commonly used chemotherapies

The Company currently owns 76 patents, including 17 issued U.S. patents, for Plinabulin and its analogs with protection through 2036

Financial Results for the Three Months Ended March 31, 2020

Research and development ("R&D") expenses were $13.7 million for the quarter ended March 31, 2020, compared to $6.3 million for the quarter ended March 31, 2019. The $7.4 million increase was largely attributable to an increase of $4.4 million in clinical trial expenses and an increase of $3.0 million in non-cash share-based compensation.

Selling, general and administrative ("SG&A") expenses were $2.9 million for the quarter ended March 31, 2020, compared to $1.6 million for the quarter ended March 31, 2019. The $1.3 million increase was mainly due to a $0.6 million increase in commercial and marketing expense, a $0.3 million increase in salary, wages and benefits expense, and a $0.4 million increase in other expenses.

Net loss attributable to the Company was $16.1 million for the quarter ended March 31, 2020, compared to $7.3 million for the quarter ended March 31, 2019.

As of March 31, 2020, the Company had a cash balance of $24.9 million. The Company believes currently available financial resources will be sufficient to support its clinical trials and submit NDAs in the U.S. and China for Plinabulin for the CIN and NSCLC indications, as well as to advance its immuno-oncology pipeline and ubiquitination protein degradation research platform.

Anticipated Milestones

The following outlines the Company’s anticipated upcoming milestones and projected timelines:

Interim topline data readout for PROTECTIVE-2 Phase 3 for CIN – June 2020

Final data readout for PROTECTIVE-2 Phase 3 for CIN – H2 2020

Final data readout for PROTECTIVE-1 Phase 3 for CIN – H2 2020

NDA submission for Plinabulin for CIN in the U.S. – H2 2020

Final data readout for DUBLIN-3 for NSCLC – H2 2020

NDA submission for Plinabulin for NSCLC in China – H2 2020

NDA submission for Plinabulin for NSCLC in the U.S. – H1 2021

On June 11, 2020 Egle Therapeutics SAS, an emerging biotechnology company focused on developing first-in-class immunotherapies targeting immune suppressor regulatory T-cells for oncology and autoimmune diseases, reported a corporate strategic research alliance with Takeda Pharmaceutical Company Limited ("Takeda") with the goal of validating novel tumor-infiltrating regulatory T-cell (Treg) targets against which Takeda will develop potential therapies (Press release, Egle Therapeutics, JUN 11, 2020, View Source [SID1234561014]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As a newly established bioscience company spun out of Institut Curie in the field of Treg immune modulation, Egle Therapeutics has assembled a proprietary translational based target discovery engine leveraging patient samples to map out – at the single cell level – unique transcriptomic signatures and targets specific for tumor-infiltrating Treg sub-populations. Capitalizing on these newly identified tumor-infiltrating Treg targets, the company is building a proprietary Treg modulating drug pipeline which also includes computationally designed resurfaced IL-2 proprietary variants, featuring unique mechanism of action to engage or dis-engage Tregs.

Under the terms of the agreement, Egle Therapeutics will lead target validation efforts on a subset targets Egle has identified and Takeda will be responsible for the development, manufacturing, and commercialization of resulting therapies. Egle Therapeutics will receive an upfront payment and research funding, and will be eligible to receive additional development and sales milestone payments based on the exclusivity of targets selected by Takeda.

Luc Boblet, co-founder and CEO of Egle Tx, commented "We are thrilled to engage with Takeda to fully exploit the great therapeutic potential of inhibiting the most immunosuppressive arm of immunity to restore antitumor immune response. We believe that joining forces would be the most efficient path to successfully develop novel generation of anti-Treg immunotherapies for the benefit of patients."

"Working with Egle to leverage the unique translational derived patient data bringing tumor-specific Treg targets is an exciting prospect to further advance our immuno-oncology drug discovery efforts," said Loïc Vincent, Head, Oncology Drug Discovery Unit at Takeda. "Targeting tumor-infiltrating regulatory T-cells to overcome the immune suppression in tumor microenvironments will complement our current immuno-oncology approaches and help advance an exciting portfolio."

In addition to the funding of the multi-target research collaboration, Takeda will invest €4.6 million in convertible debt through its venture arm, Takeda Ventures, Inc. ("TVI"), to support Egle’s corporate growth and internal programs on IL-2-based Treg modulation. Egle’s flagship program pioneers the dis-engagement of tumor-infiltrating Treg through unique proprietary series of IL-2 variants that act as IL-2 antagonists.

"While the whole competition converges solely on a similar approach to enhance effector T cells by disrupting binding of IL-2 to Tregs, our IL-2 variants conserve intact IL-2 binding to CD25, conferring a unique mechanism of action for starving Treg from endogenous IL-2, while leaving active the CD8+ effector T cell arm of the immune response," Luc Boblet added. "Takeda’s equity commitment will help Egle’s launch strikingly hit the road building on our excellent scientific foundation."