On October 8, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported the filing by 2seventy bio of an updated Form 10 Registration Statement with the U.S. Securities and Exchange Commission (SEC) (Press release, 2seventy bio, OCT 8, 2021, View Source [SID1234594668]). This Form 10 reflects bluebird bio’s plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company. The spin-off is on track to be completed by early November 2021. bluebird bio also announced the appointment of Najoh Tita-Reid and Sarah Glickman to the bluebird bio board of directors. Upon effectiveness of the Form 10, Ms. Glickman will also be a member of the board of directors of 2seventy bio and will step down from the bluebird bio board of directors upon completion of the spin-off.

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"As we approach separation, we have been strategic and diligent in setting up each business for success," said Nick Leschly, chief bluebird and expected chief kairos officer, 2seventy bio. "The first part of this year was largely directed toward focusing and shaping our internal operations and continuing to advance the transformative gene and cell therapy products that sit on both sides of the current business. Rounding out those necessary pillars for success is financial strength and leadership, and we’re extremely pleased to share today further detail on the balance sheet that each company is expected to launch with, as well as key members of each board of directors. This is another step forward and we remain on track to launch bluebird bio and 2seventy bio by early November with the right pieces in place to drive both entities toward delivering for patients with meaningful, value-creating milestones."

Upon separation, bluebird bio plans to distribute 100% of the outstanding shares of 2seventy bio common stock to bluebird’s shareholders in a 3:1 ratio. For every three shares of bluebird bio stock, current shareholders will receive one share of 2seventy bio stock.

The company anticipates that its cash, cash equivalents and marketable securities balance at separation will be approximately $1.0B, inclusive of proceeds from the recent sale of the company’s manufacturing facility in North Carolina and its private placement equity financing. bluebird bio expects to fund 2seventy bio with approximately $480M in cash upon separation, with the balance to be retained by bluebird bio. Together with existing and emerging sources of revenue and other anticipated cash inflows, which includes the potential sale of priority review vouchers that would be issued with anticipated U.S. regulatory approvals of BLAs for bluebird’s therapies in beta-thalassemia and cerebral adrenoleukodystrophy, the Company expects its cash, cash equivalents and marketable securities balance will be sufficient to fund operations for bluebird bio and 2seventy bio into 2023 under current business plans.

The company also announced the appointment of two new board members.

Najoh Tita-Reid was appointed to the bluebird bio board of directors. Najoh Tita-Reid is Chief Marketing Officer for Logitech, a global manufacturer of computer peripherals, software and services with headquarters in Switzerland and California. In her role, Ms. Tita-Reid is leading the transformation of the global marketing function and spearheading a strategic, digital-first and data-driven consumer and customer omnichannel experience. A multi-faceted executive with global marketing expertise, she has a record of strategic and operational ingenuity and transformation across complex organizations. Prior to her role at Logitech, Ms. Tita-Reid was Global Chief Marketing Officer and Executive Board Member for Hero-AG, a family-run healthy food company, and held leadership positions at Bayer PLC and Merck & Co, Inc. Ms. Tita-Reid spent 19 years at Procter & Gamble where she managed several multi-billion-dollar brands. She also led African American Marketing for P&G, the world’s largest advertiser, and created breakthrough marketing strategies, including "My Black is Beautiful," which stands as a template for multi-cultural campaigns across industry today. Ms. Tita-Reid graduated with a Bachelor of Arts from Spelman College and holds an MBA from Fuqua School of Business at Duke University.

"As we approach separation, we are in a strong financial and operational position and poised to unlock value both for our patients and our shareholders," said Andrew Obenshain, president, severe genetic diseases and expected chief executive officer, bluebird bio, post separation. "We are pleased to welcome Najoh to bluebird bio’s board of directors and look forward to benefiting from her expertise in multi-brand strategy and execution as we enter the next chapter for bluebird bio, focused on the commercialization of three transformational gene therapies for severe genetic diseases."

Sarah Glickman was also appointed to the bluebird bio board of directors and is expected to join the 2seventy bio board of directors as Audit Committee Chair upon separation. Ms. Glickman is the Chief Financial Officer for Criteo, a global technology company headquartered in Paris, France and listed on Nasdaq. She jointly leads Criteo’s strategy to drive profitable long-term growth and shareholder value through transformational change, including M&A. Key responsibilities include leading all aspects of financial planning and reporting, investor relations, treasury, tax, controllership and internal controls. She is also responsible for global IT, procurement and real estate. Prior to Criteo, she was the acting Chief Financial Officer and Chief Transformation Officer of XPO Logistics in Greenwich, CT. Prior to XPO, she was the Chief Financial Officer for the Novartis Business Services division of Novartis AG, a global pharmaceutical company. Ms. Glickman spent ten years at Honeywell, Inc. and before held finance roles at Bristol-Myers Squibb and PricewaterhouseCoopers. She is a Certified Public Accountant (US) and Fellow Chartered Accountant (UK) and graduated with a Bachelor of Arts in Economics and History, with honors, from the University of York in England.

"We’re excited that Sarah will join the board of 2seventy bio in this crucial launch phase," said Nick Leschly. "Her financial leadership experience at several successful companies will be a tremendous asset as we focus on shoring up our balance sheet and setting up 2seventy bio with a healthy foundation to enable the continued advancement of our cell therapy platform."

On October 8, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that its collaboration with Bristol Myers Squibb (NYSE: BMY) has been expanded to include a new cell type, triggering a payment of $ 9.0 m to Evotec (Press release, Evotec, OCT 8, 2021, View Source;announcements/press-releases/p/evotec-expands-neuroscience-collaboration-with-bristol-myers-squibb-to-include-novel-cell-type-6100 [SID1234591011]).

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The collaboration was initiated in December 2016 with the goal of identifying disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of the patients’ symptoms and there is tremendous unmet medical need for therapeutic options that slow down or reverse disease progression. The collaboration pursues an innovative approach to the discovery and development of novel medicines by leveraging Evotec’s iPSC platform using patient-derived disease models, which is one of the largest and most sophisticated platforms in the industry.

Since 2016, the companies have expanded the collaboration several times. The latest expansion will enable the companies to investigate the root causes of many neurodegenerative diseases in a cell type specific fashion using cells directly derived from patients. In addition, molecular disease signatures will be used to define detailed molecular disease phenotypes using Evotec’s leading panomics platform, EVOpanOmics & EVOpanHunter.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are delighted that our important collaboration with Bristol Myers Squibb will now investigate and target mechanisms driving neurodegeneration more comprehensively through the addition of a new cell type. Through our human iPSC-based approach we believe we have the potential to improve clinical outcomes of neurodegeneration programmes. iPSC technology enables us to directly work on human neurons to explore new drug candidates in the pre-clinical setting."

On October 8, 2021, Adhera Therapeutics, Inc. (the "Company") reported that entered into a Securities Purchase Agreement ("SPA") with an institutional investor (the "Buyer"), pursuant to which the Company issued the Buyer a 10% Convertible Redeemable Note in the principal amount of $131,250 (the "Note") and a three-year warrant to purchase 476,190 shares of common stock of the Company (the "Warrant") for which the Company received consideration of $110,000 (Filing, 8-K, Adhera Therapeutics, OCT 8, 2021, View Source [SID1234591173]).

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The Note is due October 5, 2022. The Note provides for guaranteed interest at the rate of 10% per annum, payable at maturity. The Note is convertible into shares of common stock at any time following the date of cash payment at the Buyer’s option at a conversion price of $0.075 per share, subject to certain adjustments. Furthermore, the Buyer will not be allowed to effect a conversion if such conversion, along with all other shares of the Company’s common stock beneficially owned by the Buyer and its affiliates would exceed 4.99% of the outstanding shares of common stock of the Company, which may be increased up to 9.9% upon 60 days’ prior written notice by the Buyer.

The Warrants are exercisable for three-years from October 5, 2021 at an exercise price of $0.095 per share, subject to certain adjustments, which exercise price may be paid on a cashless basis. The aggregate exercise price is $45,238.05.

Pursuant to the SPA, the Company shall have filed a registration statement within 90 days providing for the registration of all shares issuable upon conversion of the Note and exercise of the Warrant.

For services rendered in connection with the SPA, the Company paid Carter, Terry & Company a fee of $10,000. In addition, the Company reimbursed the Buyer $5,000 for legal expenses incurred in connection with the transaction.

The foregoing description of the terms of the SPA, the Note, the Warrant and the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to the form of SPA, the form of Note, and the form of Warrant, a copy which is filed as Exhibits 10.1, 10.2, and 10.3, respectively, to this Current Report on Form 8-K and is incorporated herein by reference.

On October 8, 2021 OncoNano Medicine, Inc. reported positive results from its preclinical study of ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications (Press release, OncoNano Medicine, OCT 8, 2021, View Source [SID1234591013]). The data, presented at The American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Conference on Tumor Immunology and Immunotherapy, demonstrate strong efficacy in multiple tumor models.

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"We are excited by the positive preclinical results for ONM-501 recently presented at AACR (Free AACR Whitepaper). STING plays a crucial role in mediating our innate immune systems but has consistently been a challenging pathway to target," said Martin Driscoll, Chief Executive Officer of OncoNano Medicine, Inc. "We are encouraged by the constellation of preclinical data that demonstrates ONM-501 could have a clinical profile differentiated from earlier generation cyclic dinucleotide STING agonist compounds. The novel ONM-501 formulation consisting of our STING activating pH-sensitive micelle loaded with an endogenous agonist has demonstrated a capability to produce a dual and prolonged activation of STING while recruiting a robust adaptive immune response to the tumor microenvironment. We look forward to continuing our IND-enabling activities as we advance ONM-501 to first in human trials."

Presentation Overview
TITLE: ONM-501 ― A synthetic polyvalent STING agonist for cancer immunotherapy

PRESENTER: Qingtai Su, Ph.D., Senior Scientist, OncoNano Medicine, Inc.

ONM-501 demonstrated antitumor efficacy in six different syngeneic mouse models from different tissues of origin (MC38, 4T1, TC-1, B16-F10, CT26 and A20). The animals were treated intratumorally with ONM-501 as a monotherapy or in combination with PD-1 blockade. The findings indicate that ONM-501 demonstrated:

Strong antitumor efficacy across all tumor models tested as a mono or combo therapy
Significantly improved efficacy with increased complete response in several modelswhen combined with PD-1 blockade
Successful combination of a novel, proprietary STING activating micelle with theendogenous cGAMP potentially offers a synergistic immunotherapy strategy against cancer

On October 8, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported the presentation of preclinical data for three early-stage pipeline programs in oral and poster sessions at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Black Diamond Therapeutics, OCT 8, 2021, View Source [SID1234591032]).

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"Despite clinical advances in precision medicines for patients with non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation, multiple areas of unmet need persist, which include patients whose tumors have developed resistance to current-generation therapies, express non-canonical (or uncommon) mutations, and have metastasized to the brain," said Elizabeth Buck, Ph.D., Chief Scientific Officer of Black Diamond Therapeutics. "BDTX-1535 has demonstrated a breadth of coverage of oncogenic EGFR mutations expressed in NSCLC, which coupled with a brain-penetrant pharmacokinetic (PK) profile, supports the potential of BDTX-1535 as an optimal therapeutic candidate for these NSCLC patient populations."

Dr. Buck continued: "Additionally, B-Raf (BRAF) and fibroblast growth factor receptor (FGFR) are validated therapeutic targets, yet current standards of care are associated with meaningful limitations, yielding persistent unmet needs for these cancer patients. Our BRAF program compounds are designed to selectively target a full spectrum of Class II/III BRAF oncogenic mutations without inducing paradoxical activation, which can lead to secondary malignancies. Our FGFR compounds are designed to target a full spectrum of oncogenic FGFR2 and FGFR3 mutations, including known resistance mutations, while sparing FGFR1, the inhibition of which is associated with toxicities, including hyperphosphatemia."

The presentations describe the following data:

BDTX-1535 Program:
The presentation describes preclinical data for BDTX-1535, which is designed as a potent, selective, and brain-penetrant inhibitor of a spectrum of EGFR mutations expressed in glioblastoma multiforme (GBM) and NSCLC.

In cell-based assays, BDTX-1535 achieved potent and selective inhibition of EGFR mutations expressed in NSCLC, including the EGFR- C797S mutation that can arise following treatment with osimertinib.
BDTX-1535 demonstrated a favorable brain-penetrant PK profile in mouse, rat, and dog models.
In an EGFR Exon19+C797S mouse allograft efficacy model, BDTX-1535 showed dose-dependent tumor growth inhibition and achieved complete regression without notable impact on body weight.
Black Diamond expects to file an Investigational New Drug (IND) application for BDTX-1535 in the first half of 2022.
BRAF Program:
The presentation describes preclinical data for a lead compound from Black Diamond’s BRAF program, which is designed for potency and selectivity against a spectrum of non-canonical Class II/III (non-V600) mutations, as well as to avoid induction of paradoxical activation.

In cell-based assays, the lead compound demonstrated potent inhibition of a spectrum of Class II/III BRAF mutations.
In contrast to current-generation BRAF inhibitors, such as encorafenib and vemurafenib, treatment of cells harboring wild type BRAF (WT-BRAF) with the Black Diamond compound was not observed to lead to an increase in protein kinase RNA-like endoplasmic reticulum kinase (pERK), a signal of paradoxical activation.
In a BRAF-KIAA1549 fusion allograft tumor model, the lead compound exhibited dose-dependent inhibition of pERK and anti-tumor efficacy.
Black Diamond anticipates an IND filing in 2022.
FGFR Program:
The presentation illustrates the Black Diamond approach, which centers on a four-pronged optimization strategy designed to deliver an inhibitor with broad coverage of FGFR2 and FGFR3 oncogenes, while sparing inhibition of FGFR1 and retaining activity against resistance mutations.

In cell-based assays, FGFR program compounds demonstrated potent and selective inhibition of a spectrum of FGFR2/3 oncogenic mutations, while sparing FGFR1.
Additionally, in cell-based assays, FGFR program compounds demonstrated improved potency against resistance mutations.
In an in vivo study conducted in a UM-UC-14 (FGFR3-S249C) mouse model, FGFR program compounds demonstrated anti-tumor activity. Additionally, in mouse and rat models, FGFR program compounds did not promote hyperphosphatemia.
Black Diamond anticipates an IND filing in 2022.
"Our BDTX-1535, BRAF, and FGFR programs exemplify Black Diamond’s MasterKey approach to drug discovery in which we are able to harness the power of our proprietary MAP drug discovery engine to design spectrum-selective candidates engineered to overcome the limitations of current therapies in each target area," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "These programs underscore the productivity of our MAP engine, and we look forward to providing updates across our pipeline as we advance toward our goal of delivering product candidates that can expand the reach of precision medicine and, in turn, address areas of true unmet need."

The presentations from the AACR (Free AACR Whitepaper)-NCI-EORTC meeting are available on the "Scientific Presentations and Publications" section of the Black Diamond Therapeutics website.