On June 24, 2020 Bolt Biotherapeutics reported that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,675,358 entitled "Antibody Adjuvant Conjugates (Press release, Bolt Biotherapeutics, JUN 24, 2020, View Source [SID1234562557])." Bolt Biotherapeutics a private clinical-stage biotechnology company developing a new category of immunotherapies called Immune-Stimulating Antibody Conjugate (ISAC).

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The platform technology is designed to harness the power of the innate immune system to treat cancer.

The patent provides protection for immunoconjugates of a piperazinyl imidazoquinoline adjuvant bound to an antibody, including Bolt’s BDC-1001 ISAC.

HER2-expressing solid tumors
BDC-1001 is being developed as a monotherapy for patients with HER2-expressing solid tumors. BDC-1001 is an ISAC comprised of trastuzumab conjugated to a Bolt proprietary TLR7/8 agonist payload.

In preclinical models, systemic administration of HER2-ISACs demonstrated localized immune activation that results in robust single-agent activity, generation of host immunological memory against cancer, and epitope spreading.

Furthermore, preclinical data, presented at SITC (Free SITC Whitepaper) 2019, showed complete, durable regression of established tumors resistant to trastuzumab (Herceptin; Genentech/Roche) and immunological memory providing protection against tumor cells that no longer express the HER2 antigen in syngeneic mouse cancer models. This offers the potential for durable and meaningful responses for HER2-expressing cancers. The promise of Immunological memory. Bolt Biotherapeutics’ ImmuneStimulating Antibody Conjugate (ISAC) selectively target tumors for U.S. Patent for Bolt Biotherapeutics’ Boltbody ISAC Platform Technology is a Major Milestone in the Development of BDC-1001 By ADC Review | Editorial Team-July 9, 2020  destruction by the immune system. Tumor-associated myeloid cells engulf ISAC-bound tumors, become armed with tumor neoantigens, and migrate to the lymph nodes where they mediate the activation and expansion of tumor-reactive T-cells. In preclinical tumor models, ISAC therapy leads to the regression of established tumors and generation of immunological memory, which guards against the recurrence of tumors that express tumor neoantigens even if they no longer express the ISAC target antigen. Image courtesy: © 2020 Bolt Biotherapeutics.

Translating scientific discovers in therapeutic agents
"The development of Boltbody ISACs is motivated by the insatiable need to translate scientific discoveries into products that will help cancer patients become survivors," noted Michael N. Alonso, Ph.D., scientific co-founder and vice president of immunology and pharmacology of Bolt Biotherapeutics.

"This patent issuance is an important milestone that provides protection for our BDC-1001 clinical asset and our Boltbody ISAC technology platform. Our dedicated and talented teams will continue to aggressively build a robust patent portfolio to protect our pipeline, our platform, and our commitment to patients," Alonso added.

In March Bolt Biotherapeutics confirmed that it had started a clinical trial for BDC-1001 involving patients with HER2-expressed solid tumors. This phase I, open-label, dose-escalation, and doseexpansion study will evaluate the safety, pharmacokinetics, pharmacodynamics, and proof of mechanism of BDC-1001.

"Bolt is eager to explore the potential of BDC-1001 for treating HER2-expressing cancers, which includes patients with breast and gastric cancers that are refractory to trastuzumab and adotrastuzumab emtansine (Kadcyla; Genentech/Roche), as well as cancers for which no HER2-targeting therapies have yet been approved," Schatzman said at the time of the announcement.

"We’re looking forward to working with the medical community to bring the promise of this exciting new approach to patients and anticipate initial data will drive our future development plans."

Technology platform

The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of innate immune agonists to convert cold tumors into immunologically hot tumors thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells.

Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

Funding Earlier this month Bolt Biotherapeutics completed a U.S. $ 93.5 million Series C round of financing. the funding round was led by Sofinnova Investments and included additional investors RA Capital Management, Rock Springs Capital, and Samsara BioCapital.

In conjunction with the financing, Jason Pitts Ph.D., principal at Sofinnova Investments, will join Bolt Biotherapeutics’ board of directors.

"We believe Bolt is well-positioned to execute on its vision of developing immuno-oncology therapies with the potential to generate systemic immunological memory and provide durable clinical benefit. I look forward to helping the company realize its goal of developing the ISAC platform across a range of solid tumor targets," Pitts said. Since its founding in 2015, the company has raised more than U.S. $ 170 million. This latest funding round will be used to support the clinical development of its lead Immune-Stimulating Antibody Conjugate (ISAC), BDC-1001.

Clinical trial

A First-in-human Study Using BDC-1001 in Advanced and HER2-Expressing Solid Tumors – NCT04278144

Reference
Gingrich J. How the Next Generation Antibody Drug Conjugates Expands Beyond Cytotoxic Payloads for Cancer Therapy. ADC Review; April 7, 2020 [Article]

On June 24, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that Geert Kersten, Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright Virtual Fireside Chat Series on Thursday, June 25, 2020 at 12:30 p.m. ET (Press release, Cel-Sci, JUN 24, 2020, View Source [SID1234561448]).

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A live audio webcast of the chat will be available at View Source or on the Investor Relations section of CEL-SCI’s website at cel-sci.com/new-investor-information/, where it will be archived for approximately 90 days.

The focus of this Fireside Chat Series is how COVID-19 has made biodefense and pandemic preparedness important again and how preparedness gives rise to potential commercial opportunities. Aside from its almost finished Phase 3 clinical trial in cancer immunotherapy, CEL-SCI also has an ongoing program using another technology that has previously shown good results against pandemic flu and is now being developed against COVID-19.

On June 24, 2020, Abbott Laboratories ("Abbott") reported that it completed the public offering and issuance of $1,300,000,000 aggregate principal amount of senior notes, consisting of $650,000,000 aggregate principal amount of its 1.150% Notes due 2028 (the "2028 Notes") and $650,000,000 aggregate principal amount of its 1.400% Notes due 2030 (the "2030 Notes" and together with the 2028 Notes, the "Notes") (Filing, 8-K, Abbott, JUN 24, 2020, View Source [SID1234561431]).

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The Notes were sold pursuant to a pricing agreement, dated June 22, 2020 (the "Pricing Agreement"), among Abbott, Morgan Stanley & Co. LLC, Barclays Capital Inc., BofA Securities, Inc. and J.P. Morgan Securities LLC, for themselves and as representatives of the several other underwriters named therein. The Notes were issued pursuant to the Prospectus Supplement, dated June 22, 2020, and filed with the Securities and Exchange Commission (the "SEC") on June 23, 2020, and the Prospectus, dated June 22, 2020, filed as part of the shelf registration statement (File No. 333-239333) that became effective under the Securities Act of 1933, as amended, when filed with the SEC on June 22, 2020.

Abbott may redeem some or all of the Notes of each series at any time at its option, in whole or from time to time in part, at the redemption prices specified in the applicable Note. Abbott intends to use the net proceeds from the Notes offering for general corporate purposes, which may include, without limitation, the repayment of indebtedness.

On June 24, 2020 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Karyopharm to be a specialty pharmacy partner for XPOVIO (selinexor), a new oral treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy (Press release, Onco360, JUN 24, 2020, View Source [SID1234561449]).

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"Onco360 is excited to be selected as a specialty pharmacy provider for XPOVIO patients," said Paul Jardina, President and CEO, Onco360. "The recent approval of XPOVIO unlocks a new treatment option for relapsed or refractory DLBCL patients who have failed previous lines of treatment. As a provider of this key treatment, Onco360 can support the highly specialized needs of relapsed or refractory DLBCL patients and their physicians across the states."

DLBCL is the most common type of non-Hodgkin lymphoma (NHL). According to the National Comprehensive Cancer Network Guidelines for B-Cell Lymphomas, 74,200 patients are diagnosed with NHL annually with a corresponding 19,970 deaths from NHL annually. Approximately 32% of NHL cases are classified as DLBCL. The median age at initial diagnosis with DLBCL is 66 years old. The five-year overall survival for DLBCL is 63.8% when considering all stages of disease.

XPOVIO is manufactured by Karyopharm Therapeutics, a global, commercial-stage, research-based biotechnology company, and was previously approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory multiple myeloma, in combination with dexamethasone, who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. The FDA’s approval of XPOVIO for relapsed/refractory DLBCL is based on the results of the Phase IIb SADAL (NCT02227251) Clinical Trial which demonstrated a 29% overall response rate in patients who failed two to five prior lines of systemic therapy. For full prescribing information, visit XPOVIO.com.

On June 24, 2020 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that it has commenced an underwritten public offering of $60 million of its common stock (Press release, Magenta Therapeutics, JUN 24, 2020, View Source [SID1234561432]). Magenta also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering. All of the shares in the proposed offering are to be sold by Magenta.

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Goldman Sachs & Co. LLC and Cowen are acting as joint bookrunning managers for the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

Magenta intends to use the net proceeds of the offering to advance its clinical and earlier stage programs and for research and development, working capital and general corporate purposes.

The securities described may be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233127), including a base prospectus. The proposed offering will be made only by means of a prospectus. A preliminary prospectus supplement and a final prospectus supplement relating to, and describing the terms of, 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. When available, copies of the preliminary prospectus may also be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected].

Important Information

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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.