On June 16, 2020 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol Myers Squibb") reported the commencement of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $19,000,000,000 aggregate principal amount of senior unsecured notes previously issued on May 16, 2019 ("May Notes") pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), and (ii) $18,545,623,000 aggregate principal amount of its outstanding senior unsecured notes previously issued on November 22, 2019 (the "November Notes" and, together with the May Notes, the "Original Notes") pursuant to an exemption from the registration requirements of the Securities Act, for an equal principal amount of new notes in a transaction registered under the Securities Act (the "Registered Notes") (Press release, Bristol-Myers Squibb, JUN 16, 2020, View Source [SID1234561123]).

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The May Notes were issued in a private offering to fund a portion of the aggregate cash consideration payable in connection with the Bristol Myers Squibb’s acquisition of Celgene Corporation ("Celgene") and to pay related fees and expenses. The November Notes were issued in a private offering upon the completion of Bristol Myers Squibb’s offers to exchange ("prior exchange offers") any and all outstanding notes issued by Celgene.

Bristol Myers Squibb is offering to issue the Registered Notes to satisfy its obligations under the registration rights agreement entered into with the initial purchasers of the May Notes and the registration rights agreement entered into with the dealer managers for the prior exchange offers. The Registered Exchange Offers do not represent a new financing transaction.

The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the issuance of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. Bristol Myers Squibb will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes.

The following table sets forth the outstanding aggregate principal amount of each series of Original Notes. The Registered Exchange Offers consist of offers to exchange up to the entire aggregate principal amount of each series of Original Notes for an equal principal amount of the corresponding series of Registered Notes.

Bristol Myers Squibb will accept for exchange any and all Original Notes validly tendered and not validly withdrawn prior to 5:00 p.m., New York City time, on July 15, 2020 (as the same may be extended by Bristol Myers Squibb with respect to one or more series of Original Notes, the "Expiration Date"). Prior to the Expiration Date, tenders of Original Notes may be withdrawn according to the procedures described in the Prospectus (as defined below). Promptly after the Expiration Date, Bristol Myers Squibb will settle the Registered Exchange Offers by issuing Registered Notes pursuant to the terms of the Registered Exchange Offers.

A Registration Statement on Form S-4 (File No. 333-238533) (the "Registration Statement") relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on May 20, 2020 and was declared effective on June 15, 2020. The Registered Exchange Offers are being made pursuant to the terms and subject to the conditions set forth in a prospectus dated June 16, 2020 (as the same may be amended or supplemented, the "Prospectus"), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement. The complete terms and conditions of the Registered Exchange Offers, including instructions regarding procedures for tendering Original Notes, are described in the Prospectus, the Registration Statement and related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent in connection with the Registered Exchange Offers, at (866) 924-2200 (U.S. toll-free) or (212) 430-3774.

On June 16, 2020 OBI Pharma, Inc. (TPEx: 4174), a leader in Glycosphingolipid Immuno-Oncology therapeutics targeting the Globo Series antigens (Globo H and SSEA-4), reported that data highlighting the role of Globo H antigen in cancer survival and its prevalence in different tumor types, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II from June 22–24, 2020 (Press release, OBI Pharma, JUN 16, 2020, View Source [SID1234561121]).

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"We are excited to share that we have demonstrated Globo H antigens (GH) may play an important role in cancer survival, both in vitro and in vivo. Furthermore, anti-GH antibody treatment can abolish the GH effects and overcome the erlotinib resistance in lung cancer cells in vivo. We are also pleased to share our recent findings on the presence of GH-positive immune cells in the intra- or peri-tumor region using an IHC assay approved by the FDA for investigational use, which suggest GH-ceramide may suppress normal immune functions. The heterogeneous expression of GH among different molecular subtypes of cancer cells may provide a biomarker in the selection of patients for GH-directed therapies," stated Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma.

Session PO ET04.02 Identification of molecular targets 2
Title: The role of Globo H in cancer cell survival
Presenter: Tzer-Min Kuo, PhD, et. al., OBI Pharma, Inc., Taipei, Taiwan
Virtual Meeting II: E-Posters Session: Poster 2934/8
Date/Time: June 22, 2020 from 9:00 AM – 6 PM EST
View Source!/9045/presentation/1616

Session PO ET04.02 Identification of molecular targets 2
Title: The prevalence of Globo H in different tumor types: Breast, pancreatic, lung, gastric, colorectal, liver, and esophageal cancers
Presenter: I-Ju Chen, PhD, et. al., OBI Pharma, Inc. Taipei, Taiwan
Virtual Meeting II: E-Posters Session: Poster 2946/20
Date/Time: June 22, 2020 from 9:00 AM – 6 PM EST
View Source!/9045/presentation/1631

The above poster presentations will be available online at www.obipharma.com on June 22, 2020.

On June 15, 2020 ENB Therapeutics, INC., a biotechnology company pioneering a new and differentiated class of therapeutics targeting the ETB receptor (ETBR), reported the successful completion of the first dosing cohort in a Phase I dose escalation of ENB-003 in combination with pembrolizumab (Press release, ENB Therapeutics, JUN 15, 2020, View Source [SID1234634060]). The Phase I trial includes a monotherapy run-in followed by combination therapy. Doses of ENB-003 administered to date appear well-tolerated and the safety review committee has approved the dose escalation. ENB-003 is a selective and potent inhibitor of the ETBR receptor which is overexpressed in over 40% of all tumor types and blocks T-cell trafficking, thus creating "cold" tumors which have a high unmet need.

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"We are pleased that the doses of ENB-003 administered to date in combination with pembrolizumab appear to be very well tolerated and that our safety committee has approved moving on to the next higher dose," said Sumayah Jamal, MD-PhD, President, Co-Founder and CSO of ENB Therapeutics, Inc. "We are very excited to have cleared this initial safety hurdle in the first clinical trial of a selective ETBR inhibitor (ETBRI) for cancer immunotherapy. ETBRIs have demonstrated preclinical proof of concept for overcoming anti-PD1 resistance across multiple cancer types. We believe that ENB-003, when combined with pembrolizumab in the anti-PD1 resistant patient population, may result in enhanced anti-tumor activity and immunologic effects."

The Phase I/II multi-center, open-label trial of ENB-003 is currently enrolling patients with advanced solid tumors in indications associated with ETBR expression. The Phase I dose escalation of ENB-003 in combination with pembrolizumab is primarily designed to assess safety and tolerability and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, we expect to initiate a Phase II dose expansion portion with the primary objective of evaluating the clinical ability of ENB-003 to enhance responsiveness to pembrolizumab in patients who have previously failed pembrolizumab therapy or have tumors associated with pembrolizumab resistance.

On June 15, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the body, reported an update on its Phase 1 trial of CUE-101 monotherapy as second-line or later therapy for patients with HPV+ recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) (Press release, Cue Biopharma, JUN 15, 2020, View Source [SID1234608302]).

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As of June 15, 2020, the ongoing Phase 1, first-in-human, multicenter trial has enrolled 13 patients, with a majority of patients having received multiple cycles of therapy. In cohorts 1 through 4, patients received dosages of 0.06 mg/kg, 0.18 mg/kg, 0.54 mg/kg and 1.0 mg/kg, respectively. Out of the 13 patients enrolled, there are six patients presently remaining on study for ongoing data generation.

As recently presented by Daniel Passeri, chief executive officer of Cue Biopharma, at the Jefferies Healthcare Conference on June 4, preliminary observations include:

Pharmacokinetic data indicating drug exposure that is in line with preclinical projections and is dose-proportional; furthermore, comparable exposures have been observed upon repeated administration
Pharmacodynamic data indicating selective expansion of the targeted T cells in the peripheral blood of several patients across cohorts 2 and 3; evaluation of activity in patients from cohort 4 is ongoing
Preliminary radiographic evidence indicating CUE-101 is clinically active, with a patient from cohort 2 experiencing reduction of target lesion following two cycles of CUE-101 that was sustained through day 84 of treatment, at which point the patient was confirmed as having stable disease; this patient continues to be on study
To date, CUE-101 has been overall well-tolerated with treatment-related adverse events (AEs) primarily being mild-to-moderate (Grade 1 or 2) with no discontinuations due to AEs. One patient from dose cohort 4 at 1.0 mg/kg experienced a Grade 3 adverse event (anemia and fatigue) that was reported on day 19 of the 21-day safety evaluation period. Of note, this patient had an underlying condition, and following a blood transfusion the anemia resolved, allowing for the patient to receive the second planned dose of CUE-101 at the same 1.0 mg/kg dose on June 8 which to date, appears to have been well tolerated. This patient remains on study. On June 5, the Safety Review Committee designated this event as a possible drug-related dose limiting toxicity (DLT), and thus an additional three patients will be enrolled at the 1.0 mg/kg dose level within cohort 4 per protocol. This will allow for a more thorough evaluation of CUE-101 pharmacodynamics and clinical activity in order to better define the therapeutic window. The fourth patient in cohort 4 has received their cycle 1 dose and the other two patients have been identified and are scheduled to receive their first dose of CUE-101 before the end of this month. If no additional DLTs emerge within these three additional patients, the company will proceed to the cohort 5 dose.

"Based on the preliminary safety, tolerability, biomarker metrics and clinical activity observed to date, we are highly encouraged that CUE-101 appears to have an attractive therapeutic window. We are looking forward to launching our combination trial with Merck’s Keytruda (pembrolizumab) as well as a neo-adjuvant trial later this year to generate clinical data sets pertaining to tumor-infiltrating lymphocytes, or TILs, from the targeted T cell population," said Ken Pienta, M.D., acting chief medical officer. "Moreover, based on our collective data to date, we are now well-positioned to further exploit the flexibility of our trial design which allows us to expand any given dose level up to nine patients, further enhancing the supporting data evaluating the drug’s safety and therapeutic window. This will enable us to select the optimal dose to be advanced into Part B of the Phase 1 trial."

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

On June 15, 2020 AbGenomics Holding Inc., a clinical stage biotech company, announced today that the company will be operating under a new name, AltruBio Inc., effective immediately (Press release, AltruBio, JUN 15, 2020, View Source [SID1234572765]). Its headquarters will remain in Redwood City in the San Francisco Bay Area, and its Taiwanese subsidiary will also reflect the rebranding operating under AltruBio Taiwan, Inc.

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The new name reflects a refocusing of the company with recent changes to its management team, board of directors, and overall strategy. Over the past year, under the leadership of Chairman Dr. Patrick Y. Yang, who is an industry veteran, the company recruited a new slate of directors with depth and breadth of experience in the biopharmaceuticals industry. In December, the company announced the hiring of Dr. Judy Chou as President and Chief Executive Officer. Since starting in January, Dr. Chou has revamped the company, focusing on its autoimmune disease pipeline and the potential to quickly realize value for patients and stakeholders in the Steroid-refractory acute Graft versus Host Disease (SR-aGVHD) space.

President and CEO, Dr. Judy Chou, stated "I am pleased to announce the rebranding of the company to AltruBio Inc. This reflects the new beginning the company has made and the values it seeks to uphold. The name speaks for our belief that our drugs should truly benefit the patients in an altruistic way with the desirable efficacy without compromising safety. It also represents our operations for being ‘all true’ to our patients, investors, partners, and employees"