On October 20, 2022 MonTa Biosciences, a clinical-stage biotechnology company focused on stimulating the immune system of cancer patients to induce immune cell-based tumor cell killing and to generate an immune memory response, reported that it has raised investment capital to complete two clinical studies (Press release, MonTa Biosciences, OCT 20, 2022, View Source [SID1234622170]).

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MonTa Biosciences is currently evaluating the drug candidate MBS8, which is a TLR7 agonist micelle formulation, in a phase I clinical trial. The monotherapy trial is divided into a dose-escalation and a dose-expansion part. So far 17 patients have been treated with MBS8 and have shown good tolerability and several interesting biomarker findings. The study is expected to be completed in Q4, 2023, with an established, Recommended Phase 2 Dose (RP2D). The investment will secure MonTa Biosciences to complete this phase I trial with enrollment of up to 24 patients for the expansion part.

The investment will in addition, secure the completion of a planned phase IB/IIA trial with MBS8 in combination with an oncology drug currently approved in several indications, and where MonTa Biosciences has demonstrated a strong synergistic effect in preclinical models with MBS8. Data from the ongoing phase 1 study support support these findings.The combination study is expected to be initiated during 2023, with the first patient treated by Q4 2023.

Simon S Jensen, CEO of MonTa Biosciences, said: "We are extremely happy to secure investment to further develop MBS8 in clinical trials aiming towards better treatment for cancer patients. We expectthe current studies will enable MonTa Biosciences to continue the clinical development towards an Accelerated Approval strategy". The investment of 11 mEUR is raised from existing investors in MonTa Biosciences and will allow continued development to the end of 2025.

Simon S Jensen further stated, "We have met our deadlines and reached our milestones timely during the last years, and through this process built strong and trusted relations with our investors. The investment provides us the time and resources to pursue a focused clinical development of MBS8 and demonstrate its true value as a potential novel oncology drug".

On October 19, 2022 Ginkgo Bioworks, the leading horizontal platform for cell programming, and Zymergen (Nasdaq: ZY) reported that Ginkgo has completed its previously announced acquisition of Zymergen (Press release, Ginkgo Bioworks, OCT 19, 2022, View Source [SID1234635829]). The acquisition is expected to significantly enhance Ginkgo’s platform by integrating strong automation and software capabilities as well as a wealth of experience across diverse biological engineering approaches.

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"Today marks an important step in our long-term growth as we complete the Zymergen acquisition and welcome their world-class team to Ginkgo," said Jason Kelly, CEO and co-founder of Ginkgo Bioworks. "We are excited to integrate Zymergen’s capabilities into our platform and explore new and expanded partnerships and opportunities for their diverse array of product concepts currently under development."

Under the terms of the merger agreement entered into on July 24, 2022, Zymergen stockholders received, for each share of Zymergen common stock, 0.9179 shares of Ginkgo Class A common stock. Zymergen shares will no longer be traded on Nasdaq. Ginkgo Class A common stock will continue to trade on NYSE under the ticker symbol DNA.

On October 19, 2022 Domain Therapeutics ("Domain" or "the Company"), a drug discovery and development company focused on G Protein-Coupled Receptors (GPCRs) in immuno-oncology (IO), reported that its proprietary IO candidate, DT-9081, has cleared its clinical trial applications (CTA) by the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) in France and the AFMPS (Agence Fédérale des Médicaments et des Produits de Santé) in Belgium, enabling Domain to start its Phase I clinical trial (Press release, Domain Therapeutics, OCT 19, 2022, View Source [SID1234622445]). The first-in-human clinical trial is on track to initiate by the end of the year .

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DT-9081 is an oral small molecule drug candidate, which is able to reverse the prostaglandin E2 (PGE2)-mediated immunosuppression triggered by some tumors to bypass the immune system, by blocking the EP4 receptor present on immune cells. Given the high concentrations of PGE2 exhibited by a range of different solid tumors, Domain Therapeutics develops an extensive biomarker strategy, enabling optimal selection of tumor types and patient subpopulations and monitoring the target engagement in future clinical trials. Furthermore, this approach will help in finalizing the design of future clinical trials, in combination with standard of care including immune checkpoint inhibitors (such as anti-PD1).

Dr. Pascal Neuville, CEO of Domain Therapeutics, commented: "Today’s news marks a pivotal moment for Domain as we progress our first fully-owned immuno-oncology drug candidate towards the clinic. Our proprietary assets in immuno-oncology are selected through a rigorous approach that utilizes our unrivalled expertise of GPCRs. We believe that DT-9081 has the potential to be a best-in-class therapeutic with multi-tumor applications. We look forward to dosing our first patient by the end of this year."

Dr. Asmaa Boudribila, Medical Director at Domain Therapeutics, commented: "DT-9081 is a promising new candidate with the potential to treat a wide range of cancers. The signals and strong synergies with immune checkpoint inhibitors observed in preclinical studies strengthen our belief that DT-9081 could potentially be a game-changer in immuno-oncology therapies for cancer patients and we now look forward to progressing our first clinical milestone."

On October 19, 2022 Shanghai Hrain Biotechnology reported that it will stage an IPO on Shanghai’s STAR board that is expected to raise $352 million for its cell therapy programs (Press release, ChinaBio, OCT 19, 2022, View Source [SID1234622252]). The company used CAR-T, CAR-NK and TCR-T technology to develop a portfolio of 11 candidates. Three of Hrain’s self-developed CAR-T candidates have started clinical trials, while its BCMA T-cell injection HR003 was granted China breakthrough therapy. The company expects to file an NDA for its lead product, a CD19-targeted CAR-T HR001, in 2023, which will be reviewed under priority rules.

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On October 19, 2022 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, reported the pricing of its upsized initial public offering of 10,294,118 shares of its common stock at a price to the public of $17.00 per share (Press release, Prime Medicine, OCT 19, 2022, View Source [SID1234622217]). All of the shares are being offered by Prime Medicine. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Prime Medicine, are expected to be $175.0 million. In addition, the underwriters have a 30-day option to purchase up to 1,544,117 additional shares of common stock at the initial public offering price less underwriting discounts and commissions.

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The shares are expected to begin trading on the Nasdaq Global Market on October 20, 2022 under the ticker symbol "PRME." The offering is expected to close on October 24, 2022, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Goldman Sachs & Co. LLC, Morgan Stanley and Jefferies are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on October 19, 2022. The offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 866-803-9204 or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, via telephone: (866) 471-2526, or via email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at (866) 718-1649 or by e-mail to [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected].

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