On December 2, 2021 MingMed Biotechnology, a clinical stage company dedicated to developing first-in-class pharmaceutical products, reported the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for PRJ1-3024, a HPK1 small-molecule inhibitor for cancer immunotherapy (Press release, MingMed Biotechnology Co, DEC 2, 2021, View Source [SID1234596425]).

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Dr. Xuebin Liao, a professor of Pharmaceutical Science at Tsinghua University and a member of the board of directors at MingMed Biotechnology, said, "HPK1 plays a key role in controlling immune responses against various cancers. Targeting HPK1 effectively regulates several important immune cells, activating their synergistic anti-tumor effects."

"MingMed’s scientists have built a solid foundation around the molecular mechanism underlying how HPK1 functions in promoting the exhaustion of local anti-tumor immunity," Liao introduces. "Additionally, our HPK1 inhibitor PRJ1-3024 has showed very good selectivity as a drug candidate and FDA approval is a crucial milestone announcing MingMed as a potential key player in the competition to find novel cancer immunotherapeutics. We will continue to push our clinical studies for the benefits of cancer patients around the world."

Meanwhile, MingMed also announced completion of Phase I clinical trials for their dry age-related macular degeneration (dry AMD) drug QA102 in the US.

Mr. Yan Zhang, CEO of MingMed Biotechnology, commented, "QA102 is a new drug to treat dry AMD, a blinding eye disease with currently no cure that attracts enormous clinical demand with broad market prospects. Successful completion of Phase 1 clinical trials for QA102 in the US represents the first endeavor from a Chinese R&D team to develop a first-in-class ophthalmic drug," Zhang continues. "The progress achieved by our scientists in the development of PRJ1-3024 and QA102 demonstrates that MingMed Biotechnology has built a solid foundation to make breakthrough scientific innovations, and is also capable of designing and managing the development of multiple product pipelines in an effective and efficient manner. It is our hope to develop more innovative medicines for human health."

On December 2, 2021 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported that is has secured €280m of funding to significantly expand and advance its clinical pipeline, including its lead asset SOT101, an IL-15 superagonist, and three new clinical programs until end of 2023 (Press release, SOTIO, DEC 2, 2021, View Source [SID1234596442]).

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The funding will be used to advance SOT101 through two multi-indication phase 2 clinical trials: The phase 2 AURELIO-03 study tests SOT101 as monotherapy in patients with melanoma, squamous skin carcinoma and kidney cancer, and a planned phase 2 AURELIO-04 study will evaluate the combination of SOT101 with a checkpoint inhibitor.

This funding will also be used to advance three novel programs through phase 1: BOXR1030 is the company’s lead CAR-T program for the treatment of various solid tumors expressing GPC3. It’s based on the proprietary BOXR platform that aims to enhance the fitness of T cells in the hostile tumor microenvironment. The study is scheduled to start early 2022. SOT102 is a novel ADC with a best-in-class potential for Claudin 18.2 targeting therapies. A phase 1 dose escalation in patients with gastric and pancreatic cancer shall start in March 2022. Finally, SOTIO plans to initiate a phase 1 study with our first IL-15 based immunocytokine using a PD-1 inhibitor as the targeting arm by the end of 2022.

"We are very excited and grateful for the continued strong support we’ve received from PPF Group today and since our inception," said Radek Spisek, Ph.D., CEO of SOTIO. "This very significant funding will allow us to advance a broad pipeline of unique clinical stage programs to key value inflection points."

"Over the last several years SOTIO has created an attractive pipeline of programs based on multiple differentiated modalities," said Ladislav Bartonicek, CEO and shareholder of PPF Group. "We appreciate the successful track record of execution by the Company to this point and are confident that this funding will further enable SOTIO to continue building a unique, privately financed oncology company with a mature and diversified pipeline. It will be an important step to achieve our long-term goal of building a fully integrated oncology business."

The funding is contingent on the achievement of certain development and regulatory milestones.

On December 2, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the pricing of an underwritten public offering of 11,636,364 shares of its common stock at a price of $6.60 per share, before underwriting discounts and commissions, and to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 27,363,636 shares of its common stock at a price of $6.59, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant (Press release, ImmunoGen, DEC 2, 2021, View Source [SID1234596389]). The offering is expected to close on or about December 6, 2021, subject to satisfaction of customary closing conditions. ImmunoGen also granted the underwriters a 30-day option to purchase up to an additional 5,850,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering are to be sold by ImmunoGen.

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ImmunoGen anticipates the total gross proceeds from the offering (before deducting the underwriting discounts and estimated offering expenses) will be $257.1 million, excluding any exercise of the underwriters’ option to purchase additional shares.

ImmunoGen intends to use the net proceeds of the offering to fund its operations, including, but not limited to, commercialization activities, clinical trial activities, supply of drug product, business development activities, capital expenditures, and working capital.

Jefferies, Cowen, and Guggenheim Securities are acting as joint book-running managers for the proposed offering. Canaccord Genuity is acting as lead manager for the proposed offering.

The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any 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. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY,11717, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.

On December 2, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of the abstract highlighting interim data, as of a July 14, 2021 cutoff, from the phase 1/2 trial of bispecific antibody MCLA-145 in patients with solid tumors (Press release, Merus, DEC 2, 2021, View Source [SID1234596408]). The e-poster will be presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (ESMO IO) Congress 2021 being held December 8-11, 2021 in Geneva, Switzerland.

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Presentation Details:

Title: Phase I Dose Escalation Study of MCLA-145, a Bispecific Antibody Targeting CD137 and PD-L1 in Solid Tumors
Poster #: 136P

The e-poster will be available on the virtual platform, in the e-poster section as of Monday, December 6 at 6:00 am ET and on-site at the e-Poster stations starting on Wednesday, December 8. The poster will also be available on the Merus website.

The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Merus Biclonics platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States; and Incyte holds full rights to develop and commercialize MCLA-145 outside the United States.

About MCLA-145
Discovered through an unbiased functional screening of multiple immunomodulatory target combinations, MCLA-145 is a Biclonics T-cell agonist that binds with high affinity and specificity to human PD-L1 and CD137 in preclinical models. The unique immunostimulatory profile of MCLA-145 derives from the potential to potently activate immune effector cells in the context of the tumor microenvironment while simultaneously blocking inhibitory signals in the same immune cell population.

On December 2, 2021 Integra Therapeutics, a biotechnology company that is creating next-generation gene writing tools to boost the efficiency and safety of advanced therapies, reported the company has completed its first round of funding for €4.5 million with Advent France Biotechnology (France), Invivo Capital (Spain) and Takeda Ventures (USA) (Press release, Integra Therapeutics, DEC 2, 2021, View Source [SID1234654526]).

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Integra Tx was founded in late 2020 as a spin-off of Pompeu Fabra University (UPF) based on technology developed in the Translational Synthetic Biology Lab led by Dr Marc Güell (EMBO Young Investigator, National Research Award for Young Talent and co-founder of two biotech firms).

The great potential of this novel gene writing technology lies in the fact that it resolves some of the main technical limitations of gene therapy: it can be used to paste DNA sequences of any size gene with high precision. Advanced therapies are one of the pillars of the medicine of the future and are aimed at both preventing and treating genetic and oncological diseases that, for now, are incurable.

The funds raised in this round will allow Integra Tx to complete the prototype of the new gene writing technology platform, carry out preclinical validation using in vivo and ex vivo models, and manage its patent portfolio in 2022 and 2023. After that, the company plans to open a Series A round to seek regulatory approval and carry out clinical trials with patients.

"We’re very proud to be transferring our scientific knowledge and technological skills in gene editing from the lab to society. We thank all our investors for their commitment to Integra Tx and to making advanced therapies safer and more effective, and getting them to patients that urgently need them," says Dr Avencia Sánchez-Mejías, co-founder and CEO of Integra Tx. Sánchez-Mejías joined the UPF Translational Synthetic Biology Lab in 2018 after doing research at the Institute of Biomedicine of Seville, the National University of Singapore and the University of Miami Miller School of Medicine.

Dr Marc Güell, co-founder and CSO of Integra Tx, explains, "the Integra Tx technology platform is very promising because it is an evolution of the CRISPR-Cas techniques. We’ve found a way to merge them with transposase and integrase proteins that have a great capacity for gene transfer and to not depend on viral vectors for transporting the components into the cell, which is a step forward in making these therapies safer." Plus, it has applications both in vivo (directly in patients) and ex vivo (outside of patients).

Matthieu Coutet, Managing Partner at Advent France Biotechnology, adds: "We decided to invest in Integra Tx because we believe in its seasoned scientific and management team. Its founders have shown a strong passion and ambition to move Integra Tx’s technology forward, combined with a proven expertise in gene editing and advanced therapies."

Dr Luis Pareras, Managing Partner at Invivo Capital, says: "We’re thrilled with the possibilities Integra Tx’s plataform can develop to solve the problem of cargo size in gene therapy. We’re also very pleased with the international syndicate supporting this seed round, in yet another example of technology transfer opportunity and the competitiveness of the biotech ecosystem in Spain."

Miles Gerson, Takeda Ventures Partner and Senior Investment Director, says: "Takeda Ventures is very excited to support Integra Tx and their next generation gene writing platform with many potential applications to benefit patients."