On June 1, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies, will present at the Jefferies Healthcare Conference on June 8, in New York, NY (Press release, SQZ Biotech, JUN 1, 2022, View Source [SID1234615368]). Presentation time and webcast information is available below.

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PRESENTATION DETAILS

Wednesday, June 8
Jefferies Healthcare Conference
2:30-2:55 p.m. ET
Webcast

Conference webcast details and the company’s most recent corporate overview presentation will be available on the Investors section of the SQZ website. Replay will be available for 90 days.

Based on guidance from the SEC, investors should note that the company may announce future healthcare conference presentations on the Events & Presentations page of the Investor Relations section of its corporate website, investors.sqzbiotech.com. It is possible that the information posted there could be deemed to be material information.

On June 1, 2022 Harbour BioMed (the "Company", HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported the progress of its dual MOA of CTLA-4 inhibition and Treg depletion, next-generation fully human heavy-chain antibody (HBM4003) with studies of monotherapy and combination therapy with anti-PD-1 antibody (Press release, Harbour BioMed, JUN 1, 2022, View Source [SID1234615385]). The two abstracts have been published on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website and will be presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting.

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Abstract One:

Study title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HBM4003 in Subjects with Advanced Solid Tumors

Abstract number: 2641

Poster number: 296

This is an open-label, multi-center study on subjects with solid tumors to receive HBM4003 at dose levels (DLs) of 0.3mg/kg QW (28-day cycle), 0.45mg/kg Q3W (21-day cycle), and 0.6mg/kg Q3W (21-day cycle). In the dose-expansion part, patients with advanced hepatocellular carcinoma (HCC), melanoma, and renal cell carcinoma (RCC) received 0.45 mg/kg Q3W (21-day cycle).
24 patients with advanced solid tumors in the dose-escalation part and 36 patients in the dose-expansion part, from 12 sites in mainland China, 5 sites in Australia, and 1 site in Hong Kong, China; including 19 HCC patients and 19 RCC patients. 46 patients (77%) received ≥ 2 lines of previous systemic therapies and 37 patients (62%) received previous PD-1/PD-L1 treatment.
In the HCC cohort, all 19 patients received previous PD-1/PD-L1 therapy, and 12 patients were evaluable for efficacy. 2 patients had stable disease (SD) and 2 patients had partial response (PR) as the best response. The objective response rate (ORR) was 16.7% and the disease control rate (DCR) was 33.3%.
Among the 19 RCC patients, 18 patients were evaluable for efficacy. 8 patients had SD as the best response; the DCR was 44.4%.
Overall, the most common treatment-related adverse event (TRAE) of all grades was rash (16 [26.7%] patients). At the 0.45 mg/kg Q3W DL, Grade≥3 TRAEs occurred in 4 (9.3%) patients, 1 patient reported Grade 4 TRAE, and no Grade 5 TRAE was reported.
The recommended phase II dose was selected as 0.45mg/kg Q3W.
Sustained Treg depletion was observed in tumor tissue on day 21 post dosing.
Abstract Two

Study title: A Phase I Open-label Study to Evaluate the Safety, Tolerability, PK/PD and Anti-tumor Activity of HBM4003 in Subjects with Advanced Melanoma and Other Solid Tumors

Abstract number: e14586

This is a phase I study to evaluate the safety, anti-tumor activity, PK/PD, and recommended phase II dose of HBM4003 in combination with toripalimab. In dose-escalation part, patients were enrolled to receive HBM4003 at 3 dose levels (DLs) (0.03 mg/kg Q3W, 0.1 mg/kg Q3W, and 0.3 mg/kg Q3W) combined with toripalimab 240 mg. In dose-expansion part, patients with advanced melanoma will be treated at recommended phase II dose.
As of 30 November 2021, in total 11 patients have been treated at one site in China, including 9 with melanoma, 1 with renal cell carcinoma, and 1 with urothelial carcinoma. 4 patients received ≥ 2 lines of previous systemic therapies and 8 received previous PD-1/PD-L1 treatment.
The most common TRAE of all grades was leukopenia (4 [36.4%] patients), followed by lymphopenia (3 [27.3%] patients). No > Grade 3 TRAE reported.
At the 0.3mg/kg Q3W DL, 6 patients were evaluable for efficacy: 2 patients had SD as the best response, whereas 1 patient had PR as the best response (mucosal melanoma, 2 lines of previous treatment including toripalimab), with tumor shrinkage of 32.6% (Week 12).
HBM4003 0.3mg/kg Q3W in combination with toripalimab showed promising antitumor activity and a tolerable safety profile in advanced melanoma and other solid tumors. Hence, 0.3mg/kg Q3W was selected as the recommended dose for dose-expansion in advanced melanoma.
Particularly in the study of HBM4003 in combination with toripalimab, another PR from a urothelial carcinoma patient (3 lines of previous treatments including toripalimab) was observed at the end of 2021. As of the date of issue, the patient recruitment of the dose-expansion part in this study has been completed.

Commenting on the studies’ results, Dr. Humphrey Gardner, CMO of Harbour BioMed, said, "we are excited to observe the promising efficacy and excellent safety profile of HBM4003 and its potential to lead the development of next-generation therapy of immuno-oncology for multiple solid tumors. The Treg depleting activity of HBM4003 offers a potential for clinical efficacy in indications hitherto unaddressed by first generation CTLA4 inhibitors. The clinical results obtained so far have given us the confidence for further global development of HBM4003, and further relevant study results will be published in the upcoming academic conferences."

As the Company further implements its global innovation and development strategy, it will continue to fully commit to advancing the global clinical development project of HBM4003, as part of its broad and innovative immuno-oncology pipeline to address the significant unmet medical needs in multiple solid tumor indications.

About HBM4003

HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. It is the first fully human heavy-chain-only monoclonal antibody entered into clinical stage globally. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 has demonstrated significantly improved depletion specific to high CTLA-4 expressing Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combination therapy.

On June 1, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT) reported entry into agreements that include a $25 million investment by G42 Investments AI Holding RSC Ltd ("G42 Investments") (Press release, vTv Therapeutics, JUN 1, 2022, View Source [SID1234615402]). Under the terms of the agreements, G42 Investments acquired 10,386,274 shares of Class A Common Stock of vTv at an issue price of $2.407 per share, with $12.5 million paid in cash at closing, and the remaining amount of $12.5 million payable on May 31, 2023. The agreements also provide for the potential issuance of $30 million in additional shares of Class A Common Stock to G42 Investments (or cash in lieu of such issuance at the option of G42 Investments) if the United States Food and Drug Administration (the "FDA") approves the marketing and sale of a pharmaceutical product containing TTP399, a liver selective glucokinase activator, as the active ingredient for treatment of type 1 diabetes in the United States. The agreements set forth the terms under which vTv and an affiliate of G42 plan to collaborate on clinical trials for pharmaceutical products that contain TTP399, including G42’s affiliate funding a portion of the Phase 3 clinical trials for TTP399, and vTv granting G42’s affiliate an exclusive license to develop and commercialize pharmaceutical products containing TTP399 in certain territories outside of the United States and the European Union.

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"We have focused substantial energy and resources on TTP399 since obtaining Breakthrough Therapy designation from the FDA in April 2021 and are thrilled to welcome a partner to work with us to accelerate the development and potential approval and commercialization of this treatment. G42 Healthcare brings a unique combination of strong commitment to the development of new impactful drugs and treatments, as demonstrated by their success and their leadership on COVID-19 testing and other product and service offerings in the healthcare spectrum, and substantial resources, making them an ideal partner for this program. This investment into vTv will fund a substantial portion of our Phase 3 clinical trials for TTP399 in the United States and the collaboration with G42 will fund certain of the Phase 3 clinical trials that will be conducted in other territories. We are excited to partner with the G42 Healthcare team as we launch our Phase 3 clinical trials and work together towards approval and commercialization of this treatment for type 1 diabetes," said Rich Nelson, Interim Chief Executive Officer of vTv.

Dr. Fahed Al Marzooqi, the Chief Operating Officer of G42 Healthcare, noted that "We have a deep commitment to collaborating with international organizations to share our knowledge and expertise in the consumer and clinical health spectrum and we look forward to working together with vTv to further develop and commercialize this important treatment. As we move ahead, we will continue to join forces with the world’s best to innovate and invest in science and create the next wave of medicines to future-proof the health of nations."

A more detailed description of the agreements is set forth in vTv’s Current Report on Form 8-K filed with the SEC. The Stock Purchase Agreement is attached to the Current Report on Form 8-K and the Collaboration and License Agreement will be filed with vTv’s Quarterly Report on Form 10-Q for the second quarter.

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

About TTP399

TTP399 is a novel, oral, small molecule, liver selective glucokinase activator being developed as an adjunct therapy to insulin in patients with type 1 diabetes. In a recent phase 2 clinical trial, TTP399 showed a 40% reduction in hypoglycemic episodes compared to placebo. In April 2021, the FDA granted Breakthrough Therapy designation to TTP399 for the treatment of type 1 diabetes. This past October, vTv announced results of a mechanistic study of TTP399 in patients with type 1 diabetes demonstrating no increased risk of ketoacidosis. TTP399 has now been tested in almost 600 subjects. TTP399 is still in the development phase; the FDA has not reviewed or approved TTP399 for use in the United States.

On June 1, 2022 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported a corporate reorganization to extend its cash runway through 2023, including a workforce reduction of more than 25% (Press release, Atreca, JUN 1, 2022, View Source [SID1234615417]). Atreca will remain focused on the development of ATRC-101, ATRC-301, and its other preclinical oncology programs, and will continue efforts to generate new lead antibodies against tumor specific targets utilizing its proprietary discovery platform.

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"While we are taking steps to significantly streamline our operations, we remain committed to the development of ATRC-101 and ATRC-301, the advancement of earlier-stage assets, and the discovery of additional novel tumor-targeting lead antibodies using our platform," said John Orwin, Chief Executive Officer of Atreca. "We look forward to sharing additional monotherapy and combination data from the ongoing Phase 1b clinical trial of ATRC-101, as well as key preclinical toxicology data from the ATRC-301 program, later this year. While it is difficult to part with so many talented and valued members of our team, we view this as a necessary step to ensure we have the capital required to execute on our mission to deliver novel therapeutics to patients in need. I’d like to thank those leaving Atreca for their important contributions to the Company."

Corporate Updates and Revised Guidance

Atreca has extended its guidance on cash runway through the end of 2023 as a result of revisions to its operating plan and a workforce reduction of more than 25%, including both current employees and open positions.
Atreca still plans to present updated monotherapy and pembrolizumab combination data from the Phase 1b clinical trial of ATRC-101 in the second half of 2022.
Initial non-human primate toxicology data in the ATRC-301 development program remains expected in the second half of 2022.
Based on the efficiency of its discovery platform, Atreca continues to target one additional investigational new drug, or IND, filing per year beginning with ATRC-301 in 2023.
The chemotherapy combination arm of the ATRC-101 Phase 1b clinical trial is no longer expected to initiate enrollment in 2022.
"In 2022 so far, we’ve not only named our next clinical candidate, ATRC-301, an antibody drug conjugate targeting EphA2, but we’ve disclosed multiple lead-stage oncology programs, all generated via our discovery platform," said Tito A. Serafini, Ph.D., Chief Strategy Officer and Founder of Atreca. "Given the productivity of our platform, and the validation provided by ATRC-101 clinical activity reported earlier this year, we remain committed to leveraging the platform for the continued growth of our pipeline, while also supporting the development of existing programs. We sincerely thank our team, including those who are leaving Atreca, for working so creatively and diligently to build a highly efficient and scalable platform in service of delivering potential medicines to patients with unmet needs."

On June 1, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that an abstract titled "A phase I/II study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in patients with advanced solid tumors (TORCH-2)" will be presented as a poster during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2022), taking place from June 3rd to 7th in Chicago, Illinois via in person or virtual attendance (Press release, Antengene, JUN 1, 2022, View Source [SID1234615296]).

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"Antengene is very pleased to share the clinical data from the TORCH-2 study with the oncology community. Based on the data outlined in the abstract, we are very enthusiastic to further explore the combination of ATG-008 and the PD-1 inhibitor, toripalimab, in the treatment of patients with advanced solid tumors, including cervical cancer. We hope to validate these encouraging early data and thereby help guide the next steps in our clinical development program with ATG-008." said Dr. Kevin Lynch, Antengene’s Chief Medical Officer.

As of the data cut-off on December 20, 2021, the overall response rate (ORR) was 28.6% (based on 6 patients with 5 confirmed responses) and the disease control rate (DCR) was 71.4%. These data are based on 21 efficacy evaluable patients of 28 patients with advanced solid tumors enrolled in the dose-escalation and dose-expansion phases of the Phase I/II TORCH-2 study (median of 2 prior lines of therapy). No dose-limiting toxicities were reported in the dose escalation phase. Most common adverse events (grade 3 or greater) included lymphocyte count decrease, rash and hyperglycemia etc.

Toripalimab was developed by Junshi Biosciences.

The abstract provided several observations regarding cohorts in the efficacy evaluable patients:

Efficacy Evaluable Cervical Cancer Cohort: Among the 5 efficacy evaluable patients in the cervical cancer cohort, 1 patient with negative PD-L1 expression experienced a complete response (CR) and 3 patients experienced a partial response (PR); all responses were confirmed.
Additional Responses in the Efficacy Evaluable Patients: the study reported two additional PRs (one nasopharyngeal carcinoma and one ovarian cancer).
Progression Free Survival (PFS) and Duration of Response: The median PFS for all 28 efficacy evaluable patients was 3.52 months and the 18-month PFS rate was 31.2% (as of December 20, 2021). Note that the patient who achieved CR in the cervical cancer cohort had remained on treatment for 580 days.
The Recommended Phase II Dose was determined.