On July 26, 2022 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on developing lenzilumab, a first-in class antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), reported a strategic realignment of its pipeline and resources to achieve key clinical milestones (Press release, Humanigen, JUL 26, 2022, View Source [SID1234616941]). The Company plans to accelerate the development of lenzilumab in chronic myelomonocytic leukemia ("CMML"), a rare blood cancer, for which the PREACH-M study is already underway. Humanigen will also advance its plan to study lenzilumab in acute graft versus host disease ("aGvHD") that occurs in patients undergoing bone marrow transplant, which will be the focus of the RATinG study that is expected to enroll its first patient in 3Q22. These studies are majority funded by our clinical partners.

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As part of this realignment, Humanigen expects to significantly reduce its go-forward, cash-based operating expenses including elimination of ongoing lenzilumab manufacturing, significant reduction in other R&D costs, and some reduction in general and administrative expenses through headcount reduction as well as other initiatives.

Key elements of the strategic realignment plan include:

·Advancing and expanding the ongoing PREACH-M study of lenzilumab for the treatment of high-risk chronic myelomonocytic leukemia ("CMML") in patients with NRAS, KRAS, and CBL genetic mutations to more rapidly reach the initial clinical assessment of this open-label study once sufficient patients have received three cycles of treatment with lenzilumab in addition to azacitidine. Three patients have been enrolled in the study and followed for multiple cycles, all with encouraging results.

oThe current standard of care for CMML are hypomethylating agents such azacitidine and decitabine, which historically have a complete response rate of 11%-22% according to the International Working Group Criteria.1,2,3

oAustralian clinical partners plan to open additional sites in Australia and may also expand the study to centers in New Zealand.

oHumanigen plans to support expansion of the study to U.S. sites and has received approval from the Principal Investigator to share the protocol and provide monitoring to those additional sites.

The incidence of CMML in the US, UK, and Australia is about 1,700 patients annually.4 As a rare disease, lenzilumab may qualify for certain regulatory and commercial advantages that may accelerate development and approval. Humanigen and the Principal Investigator are assessing regulatory pathways that may enable early results to support a regulatory submission and potential approval by the Therapeutic Goods Administration in Australia, which could be expanded through Project Orbis to the United States and the United Kingdom.

There have been no new therapeutic agents for patients with high-risk CMML in 30 years5 and independent publications have demonstrated the key role of GM-CSF and RAS pathway mutations in this and other cancers, including juvenile myelomonocytic leukemia ("JMML"), myelodysplastic syndromes, myeloproliferative neoplasms, and acute myeloid leukemia.6,7,8

oA clinical protocol is also being developed for JMML with NRAS, KRAS, PTPN11 and/or NF1 genetic mutations

·Continuing to execute the RATinG study for lenzilumab for the early treatment of aGvHD with the goal of reporting a planned interim assessment of the first 20 patients in 2Q23

oThe study is being run and funded primarily by the IMPACT partnership; a group of transplant centers located in the UK.

oLenzilumab will be administered to patients that are identified as having markers for high-risk steroid refractory aGvHD, a population known to have four-fold higher mortality than those identified as low-risk using the same biomarkers.9

·Identifying and supporting further clinical assessment of lenzilumab for prevention of CAR-T therapy related toxicities through an investigator-initiated trial

oPhase 1 ZUMA-19 study completed and target dose defined for further study.

oHumanigen to provide lenzilumab to investigators free of charge to support investigator-initiated trials.

·Seeking potential inclusion of lenzilumab in international, large-scale COVID-19 platform studies through partnerships

·Planning to continue the development of ifabotuzumab, an EphA-3 targeted monoclonal antibody currently in phase 1 development, as part of an antibody drug conjugate, for certain solid tumors.

·Eliminating long-term debt on the balance sheet by fully retiring the Company’s senior secured term loan, reducing interest expense, and enhancing our ability to generate additional liquidity from our intellectual property by freeing it from the loan’s collateral requirements

"We remain committed to advancing the scientific effort to prove the clinical benefits of neutralizing GM-CSF in life-threatening conditions for patients and have had to take difficult though necessary measures to do so," said Cameron Durrant, Chairman and CEO, Humanigen. "Sharpening our in-house pipeline focus and partnering other resource-intensive programs may enable Humanigen and its clinical partners to rapidly derive important data in these indications. Our CMML, aGvHD programs are already primarily funded by partners and we hope to utilize a similar approach with our other programs, reducing our cash-based R&D expenses. We believe this strategic plan offers an opportunity to return value to our stockholders while providing hope to patients with serious and life-threatening conditions for improved outcomes."

On July 26, 2022 Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd), a clinical-stage biotech company focused on biologic and small molecule discovery and development, reported that it has entered into a collaboration and exclusive license agreement with MSD (the tradename of Merck & Co., Inc Rahway NJ USA), to develop an investigational antibody drug conjugate (ADC) for the treatment of solid tumors (Press release, Merck & Co, JUL 26, 2022, View Source [SID1234616940]).

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Under the terms of the agreement, Kelun-Biotech has granted MSD global, exclusive rights to develop, manufacture and commercialize an investigational ADC. Kelun-Biotech and MSD will also collaborate on the early clinical development of the investigational ADC. In return, Kelun-Biotech will receive an upfront payment of $35mm and is eligible to receive future development, approval and commercial milestone payments totaling up to $901mm, plus tiered royalties on net sales.

This latest transaction follows MSD’s decision earlier this year to exercise an option for worldwide rights, except for the Greater China region (including Mainland China, Hong Kong, Macau, and Taiwan), to SKB-264, an investigational TROP2 targeting ADC. SKB-264 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic triple-negative breast cancer and in Phase 2 trials for non-small cell lung cancer and advanced solid tumors. Kelun-Biotech and MSD will collaborate on certain early clinical development plans, including evaluating the potential of SKB-264 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) for advanced solid tumors.

"These collaborations with MSD underscore the sophistication and capabilities of Kelun-Biotech’s ADC platform and the potential of our ADC therapeutics," said Dr. Junyou Ge, Chief Executive Officer of Kelun-Biotech. "Incorporating MSD’s deep and broad global expertise with Kelun-Biotech’s innovation power has the potential to generate great development synergy, significantly accelerating the development and commercialization of the collaboration programs. These collaborations will also strengthen our strategic position in building a global, innovative, fully-integrated biopharmaceutical company."

"The collaboration with Kelun-Biotech strengthens and diversifies MSD’s oncology pipeline as we seek to further the potential of ADCs to provide more treatment options and improve outcomes for people with cancer," commented Dr. Eric H. Rubin, senior vice president, oncology early development, MSD Research Laboratories. "We look forward to advancing this collaboration with the Kelun-Biotech team."

On July 26, 2022 Brooklyn ImmunoTherapeutics, Inc. (Nasdaq:BTX) ("Brooklyn" or the "Company") reported that results from the INSPIRE phase 2 trial of IRX-2, a multi-cytokine biologic immunotherapy, in patients with newly diagnosed stage II, III, or IVA squamous cell carcinoma of the oral cavity (Press release, Brooklyn ImmunoTherapeutics, JUL 26, 2022, View Source [SID1234616939]).

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The primary endpoint of the study was to estimate 2-year Event-Free Survival (EFS) with key secondary endpoints of Overall Survival (OS) and safety of IRX-2. One hundred and fifty patients were enrolled in the study. At two years of follow-up in the intention-to-treat (ITT, n=105) population the median EFS was 48.3 months and was not reached in the control arm (Hazard Ratio 1.10 (95% Confidence Interval, 0.6-2.1; p value=0.62)).

In key pre-specified subgroups defined by stage and type of adjuvant treatment, outcomes favored IRX-2. Patients in these subgroups were less likely to experience an EFS event in the IRX-2 arm compared to control. Trends in EFS rates as defined by the Kaplan-Meier estimate at two years of follow-up in patients with later stage (III and IV) disease were 57.2 (40.3, 70.9) vs 49.4 (28.3, 67.4) in favor of IRX-2. In patients that did not receive chemotherapy (radiation only) as part of adjuvant treatment, the EFS Kaplan-Meier estimate at two years of follow-up was 76.4 (52.2, 89.4) vs 60.6 (29.4, 81.4) in favor of IRX-2. There were no new safety signals observed with IRX-2. Adverse events related to study treatment were higher in the IRX-2 arm than the control arm (55.9% vs 40%) and were driven primarily by injection site reactions and fatigue.

"We thank the patients and their families for their participation in this trial," said Roger Sidhu, M.D., Brooklyn’s Chief Medical Officer. "IRX-2 immunotherapy treatment was administered as a local subcutaneous injection and was well tolerated in this patient population with squamous cell head and neck cancer of the oral cavity in the neoadjuvant setting. We observed compelling trends in favor of IRX-2 in patients with higher stage disease and those that did not receive chemotherapy as part of adjuvant treatment, representing patient populations with high unmet need and who comprise a significant proportion of patients with head and neck cancer. The mechanism of action of IRX-2 and prior preclinical and translational studies of IRX-2 suggest potential synergy with checkpoint inhibitors and represents a novel combination immunotherapy strategy to explore in patients that may not be eligible for or require intensive adjuvant treatment."

"The INSPIRE study achieved its primary objective of identifying patient populations that may benefit from IRX-2 in the neoadjuvant setting," said Matt Angel, Ph.D., Brooklyn’s CEO. "These encouraging results are a testament to the design of the INSPIRE study and provide a clear path forward for testing in patient populations that may benefit from treatment with IRX-2 in combination with checkpoint inhibitors. The potential to offer an effective, well tolerated treatment to patients with advanced head and neck cancer who are ineligible for chemotherapy is particularly exciting."

The Company plans to present the results of the INSPIRE study at a scientific conference later this year.

About IRX-2
IRX-2 is a primary cell-derived multi-cytokine biologic immunotherapy in development for multiple solid tumor indications. IRX-2 is administered locally by subcutaneous injection and is designed to activate T cells to generate an anti-tumor response.

About the INSPIRE Study
The INSPIRE study is a Company-sponsored, randomized (2:1 IRX-2 vs control), open label, phase 2 estimation trial of neoadjuvant therapy with IRX-2 compared to standard of care in patients with newly diagnosed stage II, III, or IVA squamous cell carcinoma of the oral cavity.

On July 26, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that its second quarter 2022 financial results will be released on Tuesday, August 9, 2022 after the markets close (Press release, Exelixis, JUL 26, 2022, View Source [SID1234616938]). At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 888-338-9509 (domestic) or 412-902-4281 (international) and ask to be joined into the Exelixis conference call to participate by phone.

A telephone replay will be available until 8:00 p.m. ET on August 11, 2022. Access numbers for the telephone replay are: 877-344-7529 (domestic) and 412-317-0088 (international); the passcode is 8698613. A webcast replay will also be archived on www.exelixis.com for one year.

On July 26, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that it has closed its previously announced registered direct offering for the purchase and sale of 375,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof), priced at a premium to market under Nasdaq rules (Press release, Enveric Biosciences, JUL 26, 2022, View Source [SID1234616937]). In addition, the Company has issued to the investors in the registered direct offering unregistered preferred investment options (the "preferred investment options") to purchase up to 375,000 additional shares of the Company’s common stock. The purchase price for one share of common stock (or pre-funded warrant) and one preferred investment option to purchase one share of common stock is $8.00. The preferred investment options have an exercise price of $7.78 per share, are immediately exercisable, and will expire five and one-half years from the date of issuance.

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The Company also closed its previously announced private placement offering for the purchase and sale of 625,000 shares of common stock (or pre-funded warrants in lieu thereof) and preferred investment options to purchase up to 625,000 shares of the Company’s common stock priced at a premium to market under Nasdaq rules. The purchase price for one share of common stock (or pre-funded warrant) and one preferred investment option to purchase one share of common stock is $8.00. The preferred investment options have an exercise price of $7.78 per share, are immediately exercisable, and will expire five and one-half years from the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offerings.

The gross proceeds to the Company from the offerings were approximately $8 million, before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offerings for working capital and general corporate purposes.

The Company also amended certain existing warrants to purchase up to an aggregate of 122,000 shares of common stock of the Company that were previously issued to the investors, with an exercise price of $27.50 per share and expiration date of February 15, 2027, effective upon the closings of the offerings so that the amended warrants have a reduced exercise price of $7.78 per share and expire five and one-half years following the closing of the offerings.

The shares of common stock, pre-funded warrants and shares of common stock underlying the pre-funded warrants (but excluding the shares of common stock and pre-funded warrants issued in the private placement and the preferred investment options and the shares of common stock underlying the preferred investment options) offered by the Company in the registered direct offering were offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-257690) previously filed with the Securities and Exchange Commission (the "SEC") on July 2, 2021, and declared effective by the SEC on July 9, 2021. The offering of the common stock and pre-funded warrants in the registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered was filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The preferred investment options to purchase common stock, pre-funded warrants and the shares of common stock offered under the private placement, as well as the preferred investment options issued to investors in the registered directed offering, were offered in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, those securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Under a registration rights agreement with the investors, the Company agreed to file a registration statement with the SEC covering the resale of the shares of the common stock and shares of common stock underlying the pre-funded warrants issued in the private placement and the shares of common stock underlying the preferred investment options issued in both offerings, within 15 days and to use best efforts to have the registration statement declared effective as promptly as practical and in any event within 45 days or within 75 days in the event of a full review by the SEC.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.