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 the achievement of $100 million in milestones from Incyte Corporation related to development progress of ZYNYZ (retifanlimab-dlwr), following an agreement on July 24, 2024, pursuant to which certain milestones were deemed to have been met (Press release, MacroGenics, JUL 30, 2024, View Source [SID1234645160]). ZYNYZ is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma. ZYNYZ is a monoclonal antibody initially developed by MacroGenics and licensed to Incyte under a 2017 exclusive global collaboration and license agreement. Incyte and its collaborators continue to pursue development of retifanlimab in other indications, which include both monotherapy and combination regimens.

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Under the 2017 collaboration agreement with Incyte, MacroGenics received an upfront payment of $150 million and has achieved a total of $215 million in milestones, including the recent $100 million described above. MacroGenics remains eligible to receive up to a total of $210 million in potential development and regulatory milestones and up to $330 million in potential commercial milestones. MacroGenics receives tiered royalties, which range from 15 to 24 percent, on worldwide net sales of ZYNYZ.

MacroGenics expects to provide its June 30, 2024 cash, cash equivalents and marketable securities balance in its second quarter earnings announcement on or around August 6, 2024. The Company currently anticipates that its June 30, 2024 cash balance plus the $100 million in milestones achieved from Incyte, in addition to projected and anticipated future payments from partners and product revenues should support its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to its ongoing clinical and preclinical studies.

On July 30, 2024 Pillar Biosciences, Inc., the leader in Decision Medicine, reported that Molecular Pathology Laboratory Network, Inc., (MPLN) is now the first national molecular reference laboratory to verify and launch oncoReveal CDx (Press release, Pillar Biosciences, JUL 30, 2024, View Source [SID1234645179]).

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The oncoReveal CDx pan-cancer solid tumor IVD kit has been FDA PMA approved for general tumor profiling for 22 clinically relevant genes across all solid tumors, including CDx claims for KRAS (Erbitux & Vectibix) in colorectal cancer (CRC) and EGFR (TKI Class Approval) in non-small cell lung cancer (NSCLC). oncoReveal CDx has a rapid single-day workflow that can be performed by any clinical laboratory enabled with an Illumina MiSeq Dx platform with an integrated sample-to-report time of as little as 48 hours. Up to 46 clinical samples can be performed on a single MiSeq Dx run.

"We are proud to partner with Pillar Biosciences on the global launch this important IVD assay kit," said Dr. Roger Hubbard, Ph.D., Chief Executive Officer, Molecular Pathology Laboratory Network. "MPLN’s goal is to bring innovative technologies to diagnostic care and clinical trial studies. We see this diagnostic assay as an important clinical tool to help quickly select certain cancer patients for 1st line targeted therapy or clinical trials. Given this assay was an FDA approved kit, our laboratory team was quickly able to perform full IVD assay verification within 2 weeks of training. We look forward to working with our physician network and biopharma partners to implement this new solid tumor IVD product."

"The potential of increased FDA regulation on LDTs is putting immense pressure on CLIA-certified molecular reference laboratories," said Dan Harma, Chief Commercial Officer, Pillar Biosciences. "The launch of our oncoReveal CDx now enables these laboratories with an FDA approved solid tumor assay which can be quickly and easily verified and performed in any laboratory with an Illumina MiSeq Dx NGS platform to rapidly profile patients with solid tumors. We see this as a great opportunity to improve care and reduce the delay in patients receiving targeted therapy."

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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