On August 29, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical trial of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy (Press release, Tracon Pharmaceuticals, AUG 29, 2022, View Source [SID1234618723]).

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The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma. Additionally, the safety and efficacy of the combination of YH001, envafolimab and doxorubicin will be assessed in the more prevalent sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.

"We are pleased to receive approval from the FDA to initiate our triplet combination therapy trial in sarcoma, which includes our potentially best-in-class CTLA-4 antibody YH001 and the only subcutaneous checkpoint inhibitor approved anywhere in the world, envafolimab," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We look forward to enrolling patients in this trial and giving patients additional options for their sarcoma treatment."

About YH001

YH001, an IgG1 antibody against CTLA-4 invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON, has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About the Phase 1/2 Clinical Trial of YH001, envafolimab and doxorubicin (NCT05448820)

The Phase 1/2 clinical trial is a multicenter, open label study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma, including treatment naive patients. The primary objective of the Phase 1 portion of the trial is to determine the recommended phase 2 dose of YH001 in combination with envafolimab and in combination with envafolimab with doxorubicin. The primary objective of the Phase 2 portion is to determine the objective response rate (ORR) of the combination of YH001 and envafolimab in patients with alveolar soft part sarcoma and chondrosarcoma and the ORR of the combination of YH001, envafolimab and doxorubicin in patients with leiomyosarcoma and dedifferentiated liposarcoma.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

On August 29, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported financial results for the first half of 2022 (Press release, Ambrx, AUG 29, 2022, View Source [SID1234618741]).

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"I am very grateful for all that Tian accomplished during his tenure leading Ambrx, from spearheading the development of the company’s research and development programs to the transition to a public company last year," said Kate Hermans, Interim Chief Executive Officer of Ambrx. "While the Board conducts a search for a permanent CEO, we will review the company’s pipeline to focus on Ambrx’s strongest commercial opportunities and further extend our cash runway. Additionally, I would like to congratulate NovoCodex for their recent successful Series B financing and am thankful for the relationship we have built. Our strong partnerships will remain a priority for us. We remain confident in our platform to deliver on the promise of precision medicine and I look forward to having the opportunity to lead Ambrx during this transition."

1H 2022 and Subsequent Highlights

Appointed Kate Hermans as Interim Chief Executive Officer. In August, Ambrx announced the appointment of Kate Hermans as Interim Chief Executive Officer (CEO), replacing Feng Tian, Ph.D. Ms. Hermans has more than two decades of commercial and operational experience in the healthcare industry, previously serving in executive leadership roles at companies including Radius Health, Bristol Myers Squibb and Pfizer. Ambrx’s Board has commenced a search for a permanent CEO. Dr. Tian has agreed to continue with Ambrx in an advisory capacity.
Received a "Study May Proceed" letter from the FDA related to an IND application for ARX305. In February, Ambrx announced that the FDA accepted the company’s IND and provided a "Study May Proceed" letter for ARX305 for the treatment of solid and hematological tumors. ARX305 is the third antibody drug conjugate (ADC) developed by Ambrx on its proprietary EPB platform to receive IND clearance. In July, Ambrx’s partner in China, NovoCodex, announced that it had received drug clinical trial approval notice for ARX305 and intends to initiate a Phase 1 trial in China in the second half of 2022.
Announced Inclusion of ARX788 in a Quantum Leap’s I-SPY 2.2 Phase 2 Clinical Trial. In April, the company announced the inclusion of ARX788 in Quantum Leap Healthcare Collaborative’s investigational treatment arm in the I-SPY 2.2 TRIAL for the treatment of HER2-positive breast cancer in the neoadjuvant setting. Sponsored by Quantum Leap, I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates emerging targeted agents, allowing those agents to either be combined with less toxic chemotherapeutic regimens or to replace cytotoxic chemotherapy entirely. The first patient was dosed with ARX788 in August 2022.
Appointed Janice Lu, M.D., Ph.D., as Chief Medical Officer. In May, Janice Lu, M.D., Ph.D., joined Ambrx as its Chief Medical Officer. Dr. Lu is a distinguished clinical professor of medicine who has more than 18 years of experience in leading clinical trials and breast cancer drug development. Dr. Lu, a board-certified medical oncologist, was on the faculty in Hematology and Oncology at UCLA, and most recently served as Clinical Professor of Medicine and Medical Director of the Breast Oncology Program at the USC Keck School of Medicine.
Strengthened Board of Directors. In August, Ambrx announced the appointment of Katrin Rupalla, Ph.D. to Chair of the Board of Directors. Since the start of 2022, Ambrx has appointed Paul V. Maier, Janet Loesberg, Pharm. D., Edward Hu and Kate Hermans to its Board.
Financial Highlights

Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $129.7 million as of June 30, 2022, of which $64.1 million are marketable securities, compared to $170.1 million in cash and cash equivalents as of December 31, 2021.
Revenue: Revenue was $2.9 million for the six months ended June 30, 2022, as compared to $5.1 million for the six months ended June 30, 2021. The decrease was primarily driven by less revenue recognized in connection with our R&D and license agreements, partially offset by increased third party reimbursable charges.
Research and development (R&D) expenses: R&D expenses were $32.8 million for the six months ended June 30, 2022, as compared to $22.1 million for the six months ended June 30, 2021. The increase was mainly due to increased costs related to our clinical trial programs, primarily driven by our lead product candidate ARX788, and related manufacturing costs, partially offset by lower stock-based compensation expense.
Impairment loss on intangible assets: The loss of $9.7 million for the six months ended June 30, 2022 was driven by the impairment of intangible assets related to assets that were in development with a collaboration partner.
General and administrative (G&A) expenses: G&A expenses were $9.4 million for the six months ended June 30, 2022, as compared to $8.4 million for the six months ended June 30, 2021. The increase was mainly attributable to professional services and fees in connection with operating as a public company including directors & officer insurance.
Other expenses, net: Other expense, net, for the six months ended June 30, 2022 were $0.9 million, as compared to $3.9 million for the six month ended June 20, 2021. The current period expense is mainly related to fees and interest incurred related to a promissory note settlement and capital reduction related to Ambrx Shanghai.
Net loss: Net loss for the six months ended June 30, 2022 was $51.5 million, as compared to $29.0 million for the six months ended June 30, 2021.

On August 29, 2022 Yumanity Therapeutics, Inc. ("Yumanity") (Nasdaq: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative diseases, reported the filing of a registration statement on Form S-4 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") (Press release, Kineta, AUG 29, 2022, View Source;utm_medium=rss&utm_campaign=kineta-announces-the-filing-of-a-registration-statement-on-form-s-4-with-the-u-s-sec-related-to-the-reverse-merger-with-yumanity-therapeutics-ymtx [SID1234618724]).

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The Registration Statement contains a preliminary proxy statement and prospectus in connection with Yumanity’s previously announced proposed asset sale to Janssen Pharmaceutica NV ("Janssen") and merger with Kineta, Inc. ("Kineta"). Although the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Yumanity and the proposed transactions.

Both definitive transaction agreements were announced on June 6, 2022.

The two transactions are expected to close during the fourth fiscal quarter of 2022, subject to customary closing conditions, including approval of both transactions by the stockholders of Yumanity.

On August 29, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, AUG 29, 2022, View Source [SID1234618742]):

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Wells Fargo Healthcare Conference on Thursday, September 8 at 10:25am Eastern Time

Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 13 at 10:35am Eastern Time

Baird Global Healthcare Conference on Wednesday, September 14 at 9:40am Eastern Time

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.

On August 29 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, AUG 29, 2022, View Source [SID1234618725]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 August 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 August 2022 to 31 October 2022.

Since the announcement 22 August 2022, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 19,133,211 B shares of DKK 0.20 as treasury shares, corresponding to 0.8% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12-month period beginning 2 February 2022. As of 26 August 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 17,422,432 B shares at an average share price of DKK 768.20 per B share equal to a transaction value of DKK 13,383,917,995