On May 9, 2022 Singapore-based SCG Cell Therapy Pte Ltd ("SCG"), a leading biotechnology company, reported that Singapore’s Health Sciences Authority (HSA) has cleared the company’s Investigational New Drug (IND) application for clinical trials for SCG101 – an autologous T-cell receptor (TCR) T-cell therapy (Press release, SCG Cell Therapy, MAY 9, 2022, View Source [SID1234614172]). SCG101 is being developed to treat hepatitis B virus (HBV) related hepatocellular carcinoma (HCC) – the most common form of liver cancer.

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The treatment has recently secured IND approval from China’s National Medical Products Administration (NMPA), making it the first TCR-T cell therapy product approved by the NMPA for the treatment of HCC and the first multi-regional IND approval in the field of cell therapy across Singapore and China.

"The multi-country IND approval for SCG101 is a key milestone for SCG’s cell therapy pipeline, proving our capability to fulfil regulatory requirements in the target markets", said Frank Wang, Chief Executive Officer of SCG Cell Therapy. "Globally, liver cancer has the second-highest cancer-mortality rate accounting for over 700,000 deaths each year. Four in five new HCC cases are diagnosed in the Asia Pacific. Singapore is known as a medical centre of excellence in Southeast Asia and is one of the world’s top medical tourism destinations. This milestone pushes forward our mission to advance cell therapy to patients in need and strengthens our position as a key global player", Frank added.

"In Singapore, liver cancer is the third most common cause of cancer-related death. There are significant challenges with the available treatment options in meeting patient needs. SCG101 offers a novel treatment option for patients," said Dr Yong Wei Peng, Principal Investigator of the study and Senior Consultant at the Department of Haematology-Oncology at the National University Cancer Institute, Singapore.

"Cell therapy is one of the most promising and rapidly advancing treatments for chronic and life-threatening diseases such as cancer. SCG101, an individualised cancer treatment which is manufactured locally at Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF), offers potential new hope to such cancer patients in Singapore," said Dr Toh Han Chong, Principal Investigator at National Cancer Centre Singapore.

According to Grand View Research, the global T-cell therapy market is expected to reach USD 20.3 billion by 2028, expanding at a CAGR of 20.2% from 2021 to 2028.

With SCG101, the function of T-cells is activated by recognising peptide fragments – short chains of amino acids – of pathogen-derived proteins in the form of complexes of peptides and MHC molecules (major histocompatibility complex) on the cell surface via the TCR. SCG101 specifically recognises the epitope of the hepatitis B virus surface antigen (HBsAg), which redirects T-cells specificity against the HBV antigens. With the specific HLA typing, SCG101 can recognise both HBsAg membrane antigen and HBsAg intracellular antigen. Therefore, SCG101 eliminates HBsAg-positive HCC cells and also eradicates HBV cccDNA (covalently closed circular DNA).

T-cells are important white blood cells of the immune system and play a central role in the adaptive immune response. TCRs are molecules on the surface of T-cells that allow the immune system to distinguish the body’s own healthy cells from diseased pathogen-infected or tumour cells.

In November 2021, SCG Cell Therapy announced a collaboration with the Cell Therapy Facility of Singapore’s Health Sciences Authority (HSA-CTF) for the evaluation and validation of SCG’s proprietary cell therapy manufacturing process for the development of new treatment options for patients with HBV related HCC.

The validation process of SCG101 was performed in the Good Manufacturing Practice (GMP)-certified facility at HSA-CTF and is fully compliant with current GMP (cGMP) requirements.

On May 9, 2022 (the "Closing Date"), OPKO Health, Inc., a Delaware corporation (the "Company"), reported that entered into an Agreement and Plan of Merger (the "Merger Agreement") with Orca Acquisition Sub, Inc., a Delaware corporation and wholly owned subsidiary of the Company ("Merger Sub"), ModeX Therapeutics, Inc., a Delaware corporation ("ModeX"), and Gary J. Nabel, solely in his capacity as sellers’ representative (Filing, 8-K, Opko Health, MAY 9, 2022, View Source [SID1234614516]).

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Pursuant to the Merger Agreement, on the Closing Date, Merger Sub merged with and into ModeX (the "Merger"), with ModeX surviving the Merger as a wholly owned subsidiary of the Company. On the Closing Date, the Company paid consideration for ModeX of $300.0 million, subject to a customary purchase price adjustment mechanism, including that ModeX be free of debt, as well as deduction for certain equity awards issued on the Closing Date, as described below. The Company paid the entirety of the purchase price pursuant to the issuance of an aggregate of 89,907,310 shares (the "Consideration Shares") of the Company’s common stock, par value $0.01 per share ("Common Stock"), to the former stockholders of ModeX (the "Selling Stockholders"), of which 10% of such shares were deposited in a twelve-month escrow for purposes of satisfying the potential indemnity obligations of the Selling Stockholders under the Merger Agreement. Additionally, the Company issued equity awards to ModeX employees in an aggregate amount equal to $12.4 million, which was deducted from the consideration payable on the Closing Date. If any of such awards are forfeited or otherwise remain unvested on the four-year anniversary of the Closing Date, up to $2.6 million of shares of Common Stock (valued at the same price used for determining the number of Consideration Shares issuable upon consummation of the Merger) may be distributed pro rata to ModeX’s former stockholders in respect of such forfeited or unvested awards. Shares of Common Stock with respect to such potential distribution have been escrowed and will remain escrowed for such four-year period.

In accordance with the Merger Agreement, Dr. Phillip Frost, the Company’s Chief Executive Officer and Chairman of the Board of Directors (the "Board"), Dr. Jane Hsiao, the Company’s Chief Technical Officer and a Director, and Frost Gamma Investments Trust ("FGIT"), a trust controlled by Dr. Frost, entered into a lockup and voting agreement, together with the Company (the "Lockup and Voting Agreement"), pursuant to which: (i) FGIT has agreed that, for a period of four years immediately following the Closing Date, it will not sell or otherwise transfer its shares of Common Stock, subject to certain customary exceptions; and (ii) Drs. Frost and Hsiao agreed that, for as long either Dr. Elias A. Zerhouni or Dr. Gary J. Nabel remains an employee of the Company or ModeX, Drs. Frost and Hsiao will vote, or cause to be voted, all of their respective shares of Common Stock in favor of such person’s election to the Board.
Additionally, in accordance with the Merger Agreement, certain recipients of the Consideration Shares, holding in aggregate approximately 88.0% of the Consideration Shares, agreed not to sell or otherwise transfer their respective Consideration Shares for a period of four years immediately following the Closing Date on the same terms as contained in the Lockup and Voting Agreement.
The foregoing description of each of the Merger Agreement and the Lockup and Voting Agreement is only a summary and is qualified in its entirety by reference to the full text of the Merger Agreement and the Lockup and Voting Agreement, which are filed as Exhibit 2.1 and Exhibit 10.1, respectively, to this Current Report on Form 8-K and incorporated by reference herein.
The Merger Agreement is filed with this Current Report on Form 8-K to provide securityholders with information regarding its terms. It is not intended to provide any other factual information about the Company, ModeX or any other party thereto. The representations, warranties and covenants contained in the Merger Agreement were made solely for purposes of such agreement and as of specific dates, are solely for the benefit of the parties to the Merger Agreement, may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures made for the purpose of allocating contractual risk between the parties to the Merger Agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to securityholders. Securityholders should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company, ModeX or any other party thereto. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Merger Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures, except to the extent required by law.

On May 09, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that its board of directors has authorized a share repurchase program to acquire up to $1 million of the Company’s common stock (Press release, Immix Biopharma, MAY 9, 2022, View Source [SID1234613883]). The Company may purchase common stock on the open market, through privately negotiated transactions, or otherwise, in compliance with the rules of the United States Securities and Exchange Commission and other applicable legal requirements. As of December 31, 2021, the Company had approximately $18 million of cash, cash equivalents and marketable securities. The Company had approximately 13.9 million shares of common stock outstanding as of April 15, 2022.

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"We are confident that with the $24.2 million gross proceeds raised in our recent IPO, ImmixBio is sufficiently capitalized to reach what we believe will be 2 upcoming inflection points: clinical data from IMX-110 monotherapy clinical trial, as well as clinical data from the IMX-110 combined with BeiGene anti-PD-1 tislelizumab clinical trial," said Ilya Rachman, MD PhD, CEO of ImmixBio. "The current market situation allows us to capture additional value for all shareholders through this measured buyback program. Our interests have always been, and continue to be, aligned with all IMMX shareholders."

The timing, amount of shares repurchased and prices paid for the stock under this program will depend on market conditions as well as corporate and regulatory limitations, including blackout period restrictions. The repurchase program does not obligate the Company to acquire any particular amount of shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion.

On May 9, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported that it will report financial results for the first quarter ended March 31, 2022 on Monday, May 16, 2022, after the close of U.S. markets (Press release, Inhibikase Therapeutics, MAY 9, 2022, View Source [SID1234613916]). Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET on Tuesday, May 17, 2022 to provide a corporate update and review the financial results.

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The conference call can be accessed by dialing 877-407-4018 (United States) or 201-689-8471 (International) with the conference code 13729218. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On May 9, 2022 Sutro Biopharma, Inc. ("Sutro" or the "Company") (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application ofprecise protein engineering and rational design to create next-generation cancer therapeutics, reported its financial results for the quarter ended March 31, 2022, its recent business highlights, and a preview of anticipatedselect milestones (Press release, Sutro Biopharma, MAY 9, 2022, View Source [SID1234613932]).

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"Sutro remains steadfastly dedicated to advancing next generation cancer therapeutics by leveraging the advantages of our proprietary platform," said Bill Newell, Sutro’s Chief Executive Officer. "We are pleased with the progress of our lead program, STRO-002, a FolRα-targeting antibody-drug conjugate. Our top priority is charting the course for a potential registrational trial for patients with advanced ovarian cancer. We are also expanding our clinical studies into endometrial cancer and have plans for non-gynecological indications, including NSCLC, to explore the possibility of treatment with STRO-002 for people who suffer from these debilitating cancers and have limited available treatment options."

Recent Business Highlights and Anticipated Select Milestones
STRO-002, FolRα-Targeting Antibody-Drug Conjugate (ADC): STRO-002 is being studied in the clinic, in both the United States and Europe, for patients with ovarian and endometrial cancers.

The Phase 1 dose-expansion cohort for patients with advanced ovarian cancer has completed enrollment and is ongoing. Sutro expects to report additional data on efficacy, safety, and durability from the dose-expansion cohort in the second half of 2022.
Regulatory discussions on a potential registrational study for patients with advanced ovarian cancer are planned for mid-year 2022.
The STRO-002 study in combination with bevacizumab for patients with advanced ovarian cancer is ongoing and the first patient was dosed in March 2022. A dose-expansion study of STRO-002 for patients with endometrial cancer continues to enroll patients.
Nonclinical data presented at the AACR (Free AACR Whitepaper) Annual Meeting 2022 in April demonstrated STRO-002’s ability to induce immunogenic cell death. Additionally, studies showed robust STRO-002 activity in endometrial and non-small cell lung cancer (NSCLC) patient-derived xenograft models with diverse levels of folate receptor alpha (FolRα) expression.
Sutro expects to initiate clinical trials for STRO-002 in NSCLC and other non-gynecologic solid tumors in the second half of 2022.
STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B‑cell malignancies, including patients withnon-Hodgkin’s lymphoma and multiple myeloma, continues in dose escalation.

Dose escalation is ongoing to achieve a recommended phase 2 dose (RP2D), with the last reported doses of 5.0 mg/kg in the multiple myeloma (MM) cohort and 5.0 mg/kg in the non-Hodgkin’s lymphoma (NHL) cohort.

Additional Pipeline Programs: Research and preclinical development are underway for several internal candidates.

Discovery and preclinical work on multiple programs are underway to determine Sutro’s next product candidates to advance to the clinic.
Sutro presented preclinical data for a novel immunostimulatory antibody-drug conjugate (iADC) at the 12th Annual World ADC Conference in March 2022. The iADC modality provides for dual mechanisms to attack the tumor, through cytotoxic killing as well as potentially building a protective immune response.
Corporate Updates: Sutro expands the strength of its leadership team with several appointments and promotions.

Venkatesh Srinivasan joined Sutro in April 2022 as Senior Vice President, Process and Analytical Development and part of the senior management team. Dr. Srinivasan brings more than 25 years of experience in bioprocess development, biologics manufacturing and tech transfer in the biopharmaceutical industry. He was most recently Vice President, Global Manufacturing Sciences & Technology at Bayer.
Kristin Bedard, Vice President of Discovery, who joined Sutro in February 2020, recently became part of the senior management team. Recent promotions within the senior management team include Brunilda Shtylla to Senior Vice President of Business Development and Annie Chang to Vice President of Investor Relations.
Collaboration Updates: Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has received from collaborators an aggregate of approximately $456 million in payments, including equity investments, through March 31, 2022.

Sutro is manufacturing initial drug supply for the potential clinical development of the first molecule in the Merck cytokine derivative collaboration; clinical trial materials for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA‑targeting ADC, for treatment of multiple myeloma, in Phase 1 studies; and clinical trial materials for M1231, a MUC1-EGFR-targeting bispecific ADC, for Merck KGaA, Darmstadt, Germany, known as EMD Serono in the U.S. and Canada (EMD Serono), in Phase 1 studies.
Sutro supplies cell-free extract to Vaxcyte for the manufacture of clinical trial materials for VAX-24, which is designed to prevent invasive pneumococcal disease. Vaxcyte announced in April 2022 that the first participants were dosed in the Phase 2 portion of the clinical study of VAX-24.
Sutro plans to support BioNova Pharmaceuticals (BioNova) in clinical trial initiations for STRO-001 in the Greater China market and provide clinical drug supply as needed.
In April 2022, Sutro and Tasly Biopharmaceuticals (Tasly) amended Tasly’s exclusive license to develop and commercialize STRO-002 in Greater China. Pursuant to the amended agreement, the upfront payment due from Tasly was changed to $25.0 million and $15.0 million will become payable to Sutro based on certain regulatory milestones. The amended agreement provides for additional potential payments to Sutro totaling up to $350.0 million related to development, regulatory and commercialization milestones. Sutro plans to support Tasly for initiation of clinical development activities in Greater China and provide clinical drug supply as needed.
First Quarter 2022 Financial Highlights
Cash, Cash Equivalents and Marketable Securities

As of March 31, 2022, Sutro had cash, cash equivalents and marketable securities of $192.1 million, as compared to $229.5 million as of December 31, 2021, with projected cash runway into the second half of 2023, based on current business plans and assumptions. The above balances do not include the value associated with Sutro’s holdings of Vaxcyte common stock.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock

As of March 31, 2022, Sutro held approximately 1.6 million shares of Vaxcyte common stock, with a fair value of $37.7 million. The non-operating, unrealized gain of $0.6 million in the first quarter of 2022 was due to the increase since December 31, 2021 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’sstatements of operations.

Revenue

Revenue was $5.9 million for the quarter ended March 31, 2022, as compared to $14.7 million for the same period in 2021, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any additional collaboration partners, will fluctuate as a result of the amountand timing of revenue recognition of upfront, milestones, and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2022 were $45.0 million, as compared to $33.7 million for the same period in 2021. The first quarter of 2022 includes non-cash expenses for stock-based compensation of $7.0 million and depreciation and amortization of $1.3 million, as compared to $4.0 million and $1.3 million, respectively, in the comparable 2021 period. Total operating expenses for the quarter ended March 31, 2022 were comprised of research and development expenses of $30.0 million and general and administrative expenses of $15.0 million, which are expected to increase in 2022 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.