On June 24, 2020 Generon BioMed Inc, an innovative biotech company developing novel biological therapeutics, announced on 24 June 2020 that it has rebranded to Evive Biotech – effective immediately Generon BioMed Inc, an innovative biotech company developing novel biological therapeutics, announced on 24 June 2020 that it has rebranded to Evive Biotech – effective immediately. The name change reinforces the company’s commitment to addressing unmet medical needs for patients worldwide.

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"We are very excited and proud to announce our new corporate identity," said Dr. Jacky Liu, CEO of Evive Biotech. "Evive Biotech is a contemporary, international brand that we feel better reflects and articulates who we are as a business and the ambitions that we hold as an Asian-rooted firm with a global outlook. As we transition to the next phase of our development, we believe that the new brand will unite us all still further as we strive to bring breakthrough therapies to patients."

Since its inception in 2004, the company has been focused on addressing unmet medical needs in oncology and inflammatory disorders that are difficult to treat and present a challenging prognosis. In that time, the company has established state-of-the-art cGMP facilities and global operations in the United States, Singapore, and China and today employ over 200 people worldwide. The company combines strong research and clinical development capabilities with exceptional regulatory expertise to bring innovative therapies to market faster.

The rebrand also marks an exciting time for Evive Biotech as it seeks to advance a portfolio of novel drug candidates through its proprietary technology platforms, and ensure broad access to treatment options for patients. These candidates include F-627 for the treatment of chemotherapy-induced neutropenia (CIN), and F-652 that is under development to treat alcoholic hepatitis (AH) and acute graft-versus-host disease (GVHD). F-652 was granted orphan drug status by the U.S. FDA in 2019.

. The name change reinforces the company’s commitment to addressing unmet medical needs for patients worldwide.

"We are very excited and proud to announce our new corporate identity," said Dr. Jacky Liu, CEO of Evive Biotech. "Evive Biotech is a contemporary, international brand that we feel better reflects and articulates who we are as a business and the ambitions that we hold as an Asian-rooted firm with a global outlook. As we transition to the next phase of our development, we believe that the new brand will unite us all still further as we strive to bring breakthrough therapies to patients."

Since its inception in 2004, the company has been focused on addressing unmet medical needs in oncology and inflammatory disorders that are difficult to treat and present a challenging prognosis. In that time, the company has established state-of-the-art cGMP facilities and global operations in the United States, Singapore, and China and today employ over 200 people worldwide. The company combines strong research and clinical development capabilities with exceptional regulatory expertise to bring innovative therapies to market faster.

The rebrand also marks an exciting time for Evive Biotech as it seeks to advance a portfolio of novel drug candidates through its proprietary technology platforms, and ensure broad access to treatment options for patients. These candidates include F-627 for the treatment of chemotherapy-induced neutropenia (CIN), and F-652 that is under development to treat alcoholic hepatitis (AH) and acute graft-versus-host disease (GVHD). F-652 was granted orphan drug status by the U.S. FDA in 2019.

On June 24, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that data from a pre-clinical study with next-generation ONCOS-200 series viruses with novel anti-cancer double-transgenes was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting (Press release, Targovax, JUN 24, 2020, View Source [SID1234564005]).

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The pre-clinical in vitro and in vivo findings demonstrated that both ONCOS-210 & ONCOS-212 have anti-cancer properties and that the double transgenes act synergistically. The encouraging preclinical findings will be further investigated to elucidate transgene functionality and mode of action.

See poster here: Next generation ONCOS oncolytic adenovirus with novel anti-cancer double-transgenes shows synergistic anti-cancer effect in a melanoma mouse model.

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 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologic therapies, reported that it intends to offer and sell, subject to market and other conditions, $40 million of its common stock in an underwritten public offering (Press release, Evelo Biosciences, JUN 24, 2020, View Source [SID1234561616]). Evelo expects to grant the underwriters a 30-day option, solely to cover over-allotments, if any, to purchase up to an additional $6 million of its common stock. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by Evelo.

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Morgan Stanley, Cowen and BMO Capital Markets are acting as joint book-running managers for the offering.

Evelo intends to use the net proceeds from the offering, in addition to its existing cash resources, for the following purposes: (i) advance EDP1815 into two Phase 2 clinical trials and a Phase 2/3 clinical trial for the treatment of inflammatory diseases and hyperinflammation caused by viral infections including SARs-CoV-2; (ii) advance EDP1815 in a Phase 1b trial in atopic dermatitis with an enteric capsule formulation; (iii) continue the clinical development of EDP1503, a monoclonal microbial candidate for oncology; (iv) other research and development activities for additional product candidates, including EDP1867 and EDP2939, for the treatment of inflammatory diseases, and advancing additional oral biologics through preclinical development in other disease areas; and (v) the remainder, if any, for working capital and other general corporate purposes.

A registration statement relating to the securities being sold in the offering has been declared effective by the Securities and Exchange Commission. The securities will be offered only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, from: Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 274-2806.

On June 24, 2020 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases including solid tumors, hematologic cancers and autoimmune disease, reported that the underwriters of its recently closed underwritten offering of 12,633,039 shares of its common stock and pre-funded warrants to purchase 2,866,961 shares of its common stock have exercised in full their option to purchase an additional 2,325,000 shares of common stock at the public offering price less the underwriting discount (Press release, Atara Biotherapeutics, JUN 24, 2020, View Source [SID1234561483]). The aggregate net proceeds to Atara from the offering, including the shares sold pursuant to the underwriters’ option, after deducting underwriting discounts and commission and estimated offering expenses, were approximately $189.4 million. Pro forma cash, which is comprised of cash, cash equivalents and short-term investments as of March 31, 2020 of $214.6 million along with the aggregate net proceeds of $189.4 million from the offering, totals $404.0 million, and is expected to enable Atara to fund its planned operations into 2022.

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Citigroup, Cowen and Evercore ISI acted as joint book-running managers for the proposed offering. Mizuho Securities acted as lead manager and Canaccord Genuity acted as co-manager for the proposed offering.

The securities described above were offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A final prospectus supplement and accompanying prospectus relating to the proposed offering have been filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the proposed offering may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; 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]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.