On August 5, 2020 Versant Ventures reported the debut of Matterhorn Biosciences AG, a biotechnology company developing T cell receptor therapies based on the recent discovery of MR1T cells that recognize and kill a wide range of tumors of various tissue origins (Press release, Versant Ventures, AUG 5, 2020, View Source [SID1234562864]). Versant has made a $30 million commitment to the new company, which was founded by pioneers in the MR1 field at the University of Basel. It is the most recent company to be launched out of Versant’s Ridgeline Discovery Engine based in Basel, Switzerland.

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While existing T cell receptor (TCR) therapies only recognize peptides in certain cancer patients, MR1T cells universally recognize and target cancer-specific metabolites presented by the MR1 molecule expressed on malignant cells. This is due to broad expression of MR1 over a range of tumor types and its conservation across all patients. The foundational know-how in Matterhorn includes a 2017 patent that describes the role of these MR1-restricted T cells in cancer immunotherapy.

"Targeting MR1 is a fundamentally new approach to cancer cell therapy. By recognizing the distorted metabolism within cancer cells, these T cell therapies can attack a wide range of liquid and solid tumors without affecting healthy tissue," said Alex Mayweg, Ph.D., managing director at Versant and Matterhorn board member.

Pan-cancer-targeting universal T cell therapies

T cell therapies have transformed the cancer landscape due to their effective killing of cancer cells and their continued persistence within the patient’s body. Current cell therapies such as CAR-Ts have shown dramatic survival improvements in liquid cancers but have been limited in solid tumors due to the lack of cancer-specific targets against which to direct the T cells.

TCR therapies overcome some of these limitations by targeting cancer-specific peptides presented on the cell surface by human leukocyte antigen (HLA) molecules. However, HLAs are highly polymorphic and current TCR therapies need to be matched to the patient’s HLA, significantly limiting the eligible patient population.

MR1 (MHC class I-related molecule 1) is monomorphic and is therefore the same in all patients. Since MR1 binds small metabolite antigens that are highly specific to cancer cells and are shared across liquid and solid tumors, it creates the opportunity for pan-cancer-targeting, off-the-shelf T cell therapies.

Matterhorn leadership and operating plans

The company’s scientific founders include:

Gennaro De Libero, M.D., Professor of Immunology at the Department of Biomedicine at the University of Basel, Switzerland. His group focuses on adaptive and innate T cells specific for non-peptidic antigens. He is a worldwide leader in the field of MR1T cells. During his career he held appointments at the Basel Institute for Immunology and at the Singapore Agency for Science, Technology and Research (A*STAR).
Lucia Mori, Ph.D., Chief Scientific Officer of Matterhorn and a faculty member in the Department of Biomedicine and University Hospital of Basel since 1994. Over the past 34 years her work has focused on antigen recognition of TCRs and non-classical T cell immunity, with appointments at A*STAR in Singapore and F. Hoffmann-La Roche in Basel, Switzerland.
The Matterhorn founders pioneered work in the MR1 field over the past decade. They first proposed the role of MR1 in cancer immunosurveillance in 2016 and subsequently described the utility of MR1T cells as cancer therapies. The mechanism and specific metabolite antigens that give MR1T cells their broad anti-tumor activity spectrum have now been elucidated. These insights provided a practical starting point for drug discovery in the field.

"It is gratifying to see the work that started 15 years ago now being translated into new therapies," said Dr. De Libero. "I look forward to working closely with the Matterhorn team to bring these treatments to patients."

During Matterhorn’s formative phase, the team at the University of Basel will continue to work alongside scientists at Versant’s Ridgeline Discovery Engine to build a platform of MR1-binding metabolites and develop a broad portfolio of TCR therapies. Based on progress to date, Matterhorn expects to start IND-enabling work on its first development candidates during 2020. Phase 1 studies should commence by late 2021.

On August 5, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first half-year of 2020 on Wednesday, 12 August 2020 (Press release, Evotec, AUG 5, 2020, View Source;announcements/press-releases/p/evotec-se-to-report-first-half-year-2020-results-on-12-august-2020-5961 [SID1234562862]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for the fiscal year 2020. The conference call will be held in English.

Conference call details

Date: Wednesday, 12 August 2020
Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for seven days after the conference and can be accessed in Europe by dialling +49 69 20 17 44 222 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 844 307 9362. The access code is 315597273#. The on-demand version of the webcast will be available on our website: View Source

On August 4, 2020 T-Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the Company has extended its ongoing research collaboration with the National Heart Lung and Blood Institute (NHLBI), through a formal Collaborative Research and Development Agreement (CRADA) to advance the Company’s HERV-E targeting TCR therapy for renal cell cancer (Press release, T-Cure Bioscience, AUG 4, 2020, View Source [SID1234572979]). Additionally, T-Cure has amended an existing license to expand to worldwide rights for the intellectual property it licensed from NHBI related to the anti-HERV-E TCR product. This TCR therapy is currently in a Phase 1 trial at NHLBI for the treatment of metastatic clear cell Renal Cell Carcinoma (ccRCC) that failed an angiogenic inhibitor and a checkpoint inhibitor. T-Cure has been actively collaborating for the past 18 months with NHLBI on the research and development of the HERV-E-specific TCR.

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Under the CRADA, T-Cure and NHLBI will collaborate to develop a companion test to identify HERV-E transcripts in patients’ tumors as well as to identify additional therapy candidates targeting HERV-E using the Company’s proprietary TCR discovery platform, iSORTTM. Additionally, NHLBI and T-Cure plan to conduct preclinical experiments characterizing novel TCR and will evaluate various drug and TCR combination anti-tumor therapeutic strategies.

"We are extremely excited to work with the NIH to advance this novel HERV-E TCR therapy candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "Of note, the TCR was isolated from a dominant killer T cell clone of a late stage metastatic ccRCC patient who responded to an immunotherapy and survived 4 years. The HERV-E-specific TCR represents a rare opportunity for us to specifically target ccRCC, a potential T cell responsive solid tumor."

The HERV-E target is one of the quiescent Human Endogenous Retrovirus (HERV) sequences that are activated during tumor development. A growing number of HERV genes and proteins are expressed in different cancers raising the possibility that HERV derived antigens might represent excellent targets for tumor immunotherapy. Its expression in renal cell carcinoma (RCC) is highly selective, with no transcripts detected in any normal tissues. In contrast to well-studied antigens such as NY-ESO-1 and MAGE, HERV-E represents a new frontier of TCR targets with significant clinical potential for immunotherapy.

On August 4, 2020 Astellas reported that Financial Results for 1Q/FY2020 (Press release, Astellas, AUG 4, 2020, View Source [SID1234564041])

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FY2020
Business Results for 1Q (August 4, 2020)
Financial Results (Q1/FY2020) （795KB）
Supplementary Documents (Q1/FY2020) （770KB）
Presentation Material for Information Meeting (Q1/FY2020) （759KB）
On-demand Replay of Information Meeting

FY2019
Business Results (May 14, 2020)
Financial Results (FY2019) （1,291KB）
Supplementary Documents (FY2019) （1,156KB）
Presentation Material for Information Meeting (FY2019) （756KB）
On-demand Replay of Information Meeting
Business Results for 3Q (January 31, 2020)
Financial Results (Q3/FY2019) （334KB）
Supplementary Documents (Q3/FY2019) （791KB）
Presentation Material for Information Meeting (Q3/FY2019) （941KB）
On-demand Replay of Information Meeting
Business Results for 2Q (October 31, 2019)
Financial Results (Q2/FY2019) （328KB）
Supplementary Documents (Q2/FY2019) （423KB）
Presentation Material for Information Meeting (Q2/FY2019) （964KB）
On-demand Replay of Information Meeting
Business Results for 1Q (July 30, 2019)
Financial Results (Q1/FY2019) （253KB）
Supplementary Documents (Q1/FY2019) （1,292KB）
Presentation Material for Information Meeting (Q1/FY2019) （862KB）

FY2018
Business Results (April 25, 2019)
Financial Results (FY2018) （347KB）
Supplementary Documents (FY2018) （294KB）
Presentation Material for Information Meeting (FY2018) （1,492KB）
Business Results for 3Q (January 31, 2019)
Financial Results (Q3/FY2018) （347KB）
Supplementary Documents (Q3/FY2018) （508KB）
Presentation Material for Information Meeting (Q3/FY2018) （871KB）
Business Results for 2Q (October 31, 2018)
Financial Results （312KB）
Supplementary Documents （500KB）
Overview of R&D Pipeline （97KB）
Presentation Material for Information Meeting （634KB）
Business Results for 1Q (July 27, 2018)
Financial Results （305KB）
Supplementary Documents （326KB）
Overview of R&D Pipeline （95KB）
Presentation Material for Information Meeting （507KB）

FY2017
Business Results (April 26, 2018)
Financial Results （429KB）
Supplementary Documents （417KB）
Overview of R&D Pipeline （94KB）
Presentation Material for Information Meeting (April 26, 2018) （695KB）
Business Results for 3Q (January 31, 2018)
Financial Results （263KB）
Supplementary Documents （507KB）
Overview of R&D Pipeline （93KB）
Presentation Material for Information Meeting (January 31, 2018) （585KB）
Business Results for 2Q (October 31, 2017)
Financial Results （259KB）
Supplementary Documents （512KB）
Overview of R&D Pipeline （94KB）
Presentation Material for Information Meeting (October 31, 2017) （557KB）
Business Results for 1Q (July 28, 2017)
Financial Results （366KB）
Supplementary Documents （315KB）
Overview of R&D Pipeline （95KB）
Presentation Material for Information Meeting (July 28, 2017) （793KB）

On August 4, 2020 (the "Effective Date"), Generex Biotechnology Corporation (the "Company") and three (two of whom are affiliates) institutional accredited investors (each a "Buyer" and, collectively, the "Buyers") reported entered into a securities purchase agreement (the "Securities Purchase Agreement") pursuant to which the Company sold and issued to the Buyers an aggregate of 5,102,040 shares (the "Common Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at an aggregate price of $2,000,000 (the "Private Placement") (Filing, 8-K, Generex, AUG 4, 2020, View Source [SID1234563163]).

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Pursuant to the Securities Purchase Agreement, the Company issued to the Buyers (i) Series A Warrants to purchase 5,102,040 shares of Common Stock in the aggregate (the "Series A Warrants") with an initial exercise price equal to $0.392 per share (the "Series A/B Exercise Price"), (ii) Series B Warrants to purchase 15,306,122 shares of Common Stock in the aggregate (the "Series B Warrants") with an initial exercise price equal to the Series A/B Exercise Price; (iii) Series C Warrants to purchase the number of shares of Common Stock equal to Maximum Eligibility Number (as defined therein) (the "Series C Warrants") at an initial exercise price equal to $0.539 per share; and (iv) Series D Warrants to purchase the number of shares Common Stock equal to the Maximum Eligibility Number (as defined therein) (the "Series D Warrants" and together with the Series A Warrants, the Series B Warrants and the Series C Warrants, the "Warrants" and the Warrants together with the Common Shares and the shares of Common Stock underlying the Warrants, the "Securities") at an exercise price equal to $0.001 per share, in each case, subject to adjustment and beneficial ownership limitations set forth therein. Subject to the satisfaction or waiver of certain conditions set forth in the Series A Warrants, the Company may force the Buyers to exercise the Series A Warrants in full on the twenty second (22nd) trading day (the "Forced Exercise Date") after the effectiveness of the Company’s registration statement that registers all of the Common Shares and shares underlying the Warrants. The exercise price set forth in each of the Series A Warrants, the Series B Warrants and Series C Warrants is subject to adjustment on certain trigger dates as provided in each such Warrant. The holders of the Series A Warrants, Series B Warrants and Series C Warrants shall be allowed a cashless exercise if a registration statement registering the Securities is not effective within 180 days following the issuance of such Warrants. On certain trigger dates as set forth in the Series D Warrants, the Series D Warrants will become exercisable into a number of shares of Common Stock that would have been issued on the issuance date and upon exercise of the Series A Warrants and Series B Warrants had the purchase price per share and exercise price of the Series A Warrants and Series B Warrants been equal to the applicable reset price as set forth in the Series D Warrant.

The Company expects to receive gross proceeds from the Private Placement of $2.0 million initially, before deducting transaction costs, fees and expenses payable by the Company. The Company intends to use the net proceeds of the Private Placement to first pay certain accrued expenses and the remaining proceeds for working capital purposes and acquisitions.

As required by the Securities Purchase Agreement, each director and officer of the Company has previously entered into a lock-up agreement with the Company whereby each director and officer has agreed that during the period commencing from the date of such agreement until 90 days after the earliest to occur of (x) such time as all of the Securities may be sold without restriction or limitation pursuant to Rule 144 ("Rule 144") under the Securities Act of 1933, as amended (the "1933 Act") and without the requirement to be in compliance with Rule 144(c)(1), (y) the one (1) year anniversary of the Issuance of the Warrants, and (z) the date that the initial registration registering the Securities has been declared effective by the Securities and Exchange Commission (the "SEC"); provided, that, this clause (z) shall only apply if there are no limitations as to the number of Securities registrable pursuant to Rule 415 under the 1933 Act, such director or officer will not sell, hypothecate, pledge, grant any option to purchase, make any short sale or otherwise dispose of or agree to dispose of, directly or indirectly, any shares of Common Stock or Common Stock Equivalents, or establish or increase a put equivalent position or liquidate or decrease a call equivalent position with respect to any shares of Common Stock or Common Stock equivalents owned by such director or officer.

The foregoing descriptions of the Securities Purchase Agreement and the Warrants do not purport to be complete and are qualified in their entirety by reference to the complete text of the Securities Purchase Agreement and the forms of Warrants, which are attached hereto as Exhibits 10.1 and 4.1, 4.2, 4.3 and 4.4, respectively, to this Current Report on Form 8-K and are hereby incorporated by reference into this Item 1.01.

Registration Rights

In connection with the Private Placement, the Company and the investors entered into a Registration Rights Agreement dated August 4, 2020 (the "Registration Rights Agreement") providing for the registration for resale of the Securities (the "Registration Statement") to be filed with the SEC on or prior to twelve (12) business days after the Effective Date. The Company has agreed to use its commercially reasonable best efforts to cause the Registration Statement to be declared effective as soon as possible, but in no event later than the earlier of the (x) seventy fifth (75th) day after the Effective Date and (y) fifth (5th) business day after the Company is notified by the SEC that the Registration Statement will not be reviewed. The Company shall also be required to register Securities not covered by the Registration Statement in accordance with the provisions of the Registration Rights Agreement. If the Company does not meet its filing or effectiveness deadlines or does not maintain its listing on the OTC QB, then, the Company must pay a cash amount to the Buyers equal to two percent (2.0%) of the aggregate Purchase Price for each missed deadline or maintenance failure and then again on successive dates until such filing or effectiveness is achieved or such failure is cured. In the event these payments are not timely made interest at a rate of to 1.5% per month on late payments shall accrue until such amounts are paid.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Registration Rights Agreement, which is attached hereto as Exhibit 4.5 to this Current Report on Form 8-K and is hereby incorporated by reference into this Item 1.01.

Item 3.02 Unregistered Sales of Equity Securities.

The information disclosed in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02. The sale and issuance of the Common Stock and Warrants in the Private Placement have been determined to be exempt from registration under the 1933 Act in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D promulgated thereunder as a transaction by an issuer not involving a public offering, in which the investors are accredited and have acquired the securities for investment purposes only and not with a view to or for sale in connection with any distribution thereof. Such securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Item 3.03 Material Modification to Rights of Security Holders.