On July 30, 2024 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported a poster (display) presentation of clinical data from the TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo) at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 taking place in Barcelona, Spain on September 13-17, 2024 (Press release, MacroGenics, JUL 30, 2024, View Source [SID1234645162]).

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The abstract submitted to ESMO (Free ESMO Whitepaper) was based on an April 12 data cut off, and the poster will report additional data from a July 9 data cut-off, including safety, efficacy and landmark 6-month radiographic progression-free survival (rPFS) data. The poster is titled:

1654P; TAMARACK: Randomized Phase 2 trial of the B7-H3 targeting antibody drug conjugate (ADC) vobramitamab duocarmazine (vobra duo) in metastatic castration-resistant prostate cancer (mCRPC)

"We are pleased to have the opportunity to present updated safety and efficacy data from our TAMARACK trial at the upcoming ESMO (Free ESMO Whitepaper) Congress in September," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We believe that these data will give us valuable insights to inform potential next steps for the vobra duo program in mCRPC, and we look forward to providing additional perspective to the investment community following our ESMO (Free ESMO Whitepaper) presentation."

In accordance with ESMO (Free ESMO Whitepaper)’s embargo policy, the poster will be published under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source on or around September 15, 2024. Given the embargoed TAMARACK data, the Company’s management has entered a quiet period and will not be hosting a conference call to discuss its financial results or corporate progress for the quarter ended June 30, 2024. The Company expects to issue a release detailing its financial results and corporate progress on or around August 6, 2024, and plans to host an investor conference call following the ESMO (Free ESMO Whitepaper) presentation to discuss the TAMARACK data and potential next steps for the vobra duo program.

TAMARACK Study Update

MacroGenics completed enrollment of the TAMARACK study in the fourth quarter of 2023, and plans to present at ESMO (Free ESMO Whitepaper) the study’s landmark primary endpoint of 6-month rPFS rate, which represents the proportion of study participants who remain alive and progression-free at 6 months.

In late July 2024, after a review of accumulated study data, MacroGenics agreed with the study’s Independent Data Monitoring Committee’s (IDMC) recommendation that study treatment should be discontinued for the remaining mCRPC study participants who potentially could have received additional doses. Most of these remaining study participants had already received 8-12 cycles of vobra duo. Participants continue to be monitored for adverse events, disease progression and survival.

"Patient safety is our top priority, and having reached the study’s primary endpoint, we decided to discontinue additional dosing for the remaining TAMARACK participants who had not yet completed treatment. We expect to have the data necessary to determine next steps for the vobra duo program later this year and will provide further updates on an investor call following our ESMO (Free ESMO Whitepaper) presentation," continued Dr. Koenig. "We are committed to fully assessing the potential of vobra duo in mCRPC through rigorous evaluation of the data, including the mature median rPFS and OS. We look forward to completing follow-up for the TAMARACK trial before year-end and presenting final data at a future conference."

The Company expects to have the mature efficacy findings, including median rPFS, later in the second half of 2024 and plans to present the data at a subsequent medical conference. The data to be presented at ESMO (Free ESMO Whitepaper) will be used to inform how future potential studies could be designed.

About Vobra Duo and the TAMARACK Study

Vobra duo is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. The TAMARACK Phase 2 study of vobra duo is being conducted in participants with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W).

On July 30, 2024 Pinetree Therapeutics, Inc. ("Pinetree" or the "Company"), an emerging biotechnology company pioneering next-generation targeted protein degraders (TPD) to combat drug resistance in oncology and beyond, reported the successful completion of a Series A funding round, raising $17 million from new and existing investors (Press release, PineTree Therapeutics, JUL 30, 2024, View Source [SID1234645180]).

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The investment was co-led by STIC Investments and DSC Investment. New investors include Atinum Investment, Quantum FA, and S&S Investment, joining existing investors DSC Investment, Schmidt, and SGI Partners. The proceeds will be used to leverage the Company’s AbReptor antibody degrader platform to advance its novel multispecific TPD development programs across multiple tumor types and targets in several oncology indications, with potential application in other therapeutic areas.

"We are pleased to announce the closing of this investment round to fuel Pinetree’s novel targeted degradation approach," said Dr. Hojuhn Song, Founder and CEO of Pinetree. "Our best-in-class multispecific antibody platform, AbReptor, leverages a novel mechanism of action to degrade surface and extracellular proteins to improve outcomes across therapeutics areas. This technology enables the development of effective and versatile protein degrader molecules, including our lead preclinical degrader candidate for EGFR-mutated cancers, for which we recently announced an exclusive option and global license agreement with AstraZeneca. With our first global partnership secured, this additional funding, and with the encouraging preclinical data generated to date from AbReptor, we are excited to continue applying our scientific approach to advance additional candidates in oncology and other indications."

"We are proud to provide our continued support as part of an exceptional syndicate for Pinetree, whose promising AbReptor platform has yielded novel programs with the potential to address unmet medical needs in people living with a range of treatment-resistant diseases," said Yohan Kim, Executive Director of DSC Investment. "Recent data from Pinetree’s degrader programs solidifies our confidence in the Company’s approach, and we look forward to continuing our support for Pinetree and its platform technology and pipeline."

AbReptor is a versatile antibody-based TPD platform that functions through co-engaging a surface-receptor or extracellular protein of interest together with another proprietary receptor target. Pinetree is advancing multiple preclinical candidates derived from its AbReptor TPD platform with potential in oncology and other therapeutics areas, including candidate degraders indicated for TKI-resistant tumors, immune checkpoint inhibitor-resistant tumors, and other disease targets.

On July 30, 2024 NEC reported consolidated Financial Results for the Three-month Period Ended June 30, 2024 (Press release, NEC, JUL 30, 2024, View Source [SID1234647173]).

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On July 30, 2024 MEI Pharma presented its corporate presentation (Presentation, MEI Pharma, JUL 30, 2024, View Source [SID1234645163]).

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On July 30, 2024 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin (Press release, BioThera Solutions, JUL 30, 2024, View Source [SID1234645181]). Sandoz AG and its affiliates have rights to market BAT1706 in Europe under the brand name Avzivi. BAT1706 is Bio-Thera’s second EMA approved product and Bio-Thera’s second product to receive marketing authorization from NMPA, US FDA and EMA.

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"The EMA approval of BAT1706 is another significant accomplishment for Bio-Thera as it marks Bio-Thera’s second EMA approved product," said Shengfeng Li, CEO at Bio-Thera. "As our biosimilar pipeline continues to mature, we intend to seek more biosimilar approvals, expanding patient access to important therapies."

Bio-Thera and Sandoz AG entered into a license and commercialization agreement for BAT1706 (Avzivi) in September 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz is responsible for the commercialization of Avzivi in the European Union, the United States and other countries around the world.

About BAT1706 (Avzivi, bevacizumab)

BAT1706 (Avzivi, bevacizumab) is a humanized monoclonal antibody that targets VEGF. It specifically binds to VEGF and blocks the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. The brand name for BAT1706 in the EU and the United States is Avzivi. In the Europe, Avzivi is indicated for the treatment of 1) Metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine-based chemo-therapy is indicated for treatment of adult patients, 2) Metastatic breast cancer, in combination with paclitaxel is indicated for first-line treatment of adult patients, 3) Metastatic breast cancer, in combination with capecitabine is indicated for first-line treatment of adult patients in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avzivi in combination with capecitabine. 4) Unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology, in addition to platinum-based chemotherapy is indicated for first-line treatment of adult patients, 5) Unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations, in combination with erlotinib, is indicated for first-line treatment of adult patients, 6) Advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a is indicated for first line treatment of adult patients, 7) Advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients, 8) Platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel in adult patients with first recurrence who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents, 9) Platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in adult patients who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents, 10) Persistent, recurrent, or metastatic carcinoma of the cervix, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in adult patients who cannot receive platinum therapy.