On August 12, 2021 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-108, a novel antagonist antibody targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) for the treatment of solid tumors (Press release, Immune-Onc Therapeutics, AUG 12, 2021, View Source [SID1234586477]). Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor. IO-108 reprograms immune-suppressive myeloid cells toward a pro-inflammatory phenotype, leading to enhanced innate and adaptive anti-tumor immunity.

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"The clearance of the IO-108 IND represents another major milestone for Immune-Onc as we progress our pipeline of novel myeloid checkpoint inhibitors targeting the LILRB family of immune inhibitory receptors," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "We are highly encouraged by the strength of the preclinical data of IO-108 and are pleased that our expertise in LILRB biology and translational sciences enables us to advance this asset into the clinic. We look forward to initiating the trial to further understand the role of LILRBs in cancer, and to test the potential of IO-108 in treating patients with advanced solid tumors."

The Phase 1, multicenter, dose-escalation study will consist of a monotherapy cohort and a combination therapy cohort to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-108 alone and in combination with pembrolizumab, an anti-PD-1 antibody. Biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals. After determination of the recommended Phase 2 dose, Immune-Onc plans to evaluate the efficacy, safety, and tolerability of IO-108 in combination with pembrolizumab and as monotherapy in indication-specific expansion cohorts.

IO-108 binds to LILRB2 with high affinity and specificity and blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression including HLA-G, ANGPTLs, SEMA4A, and CD1d. In preclinical studies, treatment of various primary human immune cell systems containing myeloid cells with IO-108 results in enhanced pro-inflammatory responses to multiple stimuli that are relevant to anti-tumor immunity. As a single agent, IO-108 reverses the anti-inflammatory myeloid cell phenotype that results from "tumor conditioning" and promotes the differentiation of monocytes into pro-inflammatory dendritic cells. Moreover, IO-108 potentiates the effect of PD-1 blocking antibodies on CD4+ T cell activation in co-cultures with allogeneic macrophages. In mouse models IO-108 inhibits the growth of solid tumors, which is associated with enhanced T cell responses. Together these data demonstrate that IO-108 has the potential to provide additive or synergistic benefit in combination with standard-of-care immunotherapies and/or immunogenic therapies for solid tumors that are both resistant and sensitive to T-cell checkpoint inhibitors.

ABOUT LILRB2 (ILT4)

LILRB2, also known as ILT4, is expressed mostly on myeloid cells, including monocytes, dendritic cells, macrophages, and neutrophils. In solid tumors, interaction of LILRB2 with tumor microenvironment (TME) relevant ligands, including HLA-G, ANGPTLs, SEMA4A, and CD1d, makes myeloid cells pro-tumorigenic (tolerating or promoting tumor growth) and promotes tumor immune evasion.

On August 12, 2021 Australian clinical-stage drug development company Noxopharm Limited (ASX:NOX) has reported pre-clinical data confirming a survival benefit of adding Veyonda to 177lutetium-PSMA-617 (LuPSMA) treatment in prostate cancer (Press release, Noxopharm, AUG 12, 2021, View Source [SID1234586476]). This result validates the survival benefit of the same combination seen in a recently completed Phase I/II trial of Veyonda in men with end-stage metastatic castrate-resistant prostate cancer (mCRPC).

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Pre-Clinical Data Confirm Survival Benefit of Combination Treatment

A study in mice bearing human prostate cancer xenografts, and led by Professor Kristofer Thurecht, Ph.D., at The University of Queensland, confirmed a potent ability of Veyonda to enhance the cancer-killing effect of LuPSMA treatment.

"The combination of Veyonda with LuPSMA exhibited an impressive synergistic therapeutic response, with sustained and almost complete regression of the tumor and minimally observed systemic toxicity," said Dr. Thurecht. "This combined response was not observed in any of the animals treated with monotherapy."

Results Support Survival Benefit Found in Phase I/II Clinical Trial

The results of Noxopharm’s LuPIN Phase I/II clinical trial were published recently in The Journal of Nuclear Medicine and showed a median overall survival of 19.7 months with combination therapy in men with mCRPC with no remaining treatment options.

"The LuPIN study was a non-randomized study, so the question remained of how much the remarkable outcome of 19.7 months was due to the combination effect versus LuPSMA monotherapy alone," said Noxopharm CEO, Graham Kelly. "The pre-clinical study results confirmed that LuPSMA monotherapy had an impressive anti-cancer effect on tumor growth — but when Veyonda was added, the tumors mostly disappeared."

On August 12, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the quarter ended June 30, 2021, and provided an update on the company (Press release, Schrodinger, AUG 12, 2021, View Source [SID1234586475]).

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"The second quarter was highly productive for Schrödinger. We continued to make progress on our key strategic priorities, including our investments to advance our internal drug discovery pipeline and drive adoption of our software," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "We announced a collaboration on a new program with Zai Lab, which expands our pipeline and provides the option to co-develop and co-commercialize in collaboration with an established commercial leader in oncology. We look forward to sharing additional updates on our progress throughout the year, and remain committed to making strategic investments in our business to drive long-term growth of the company."

Recent Business Highlights

Continued pipeline progress

During the second quarter, Schrödinger continued to advance its MALT1, CDC7 and Wee1 preclinical development programs. The company has initiated IND-enabling studies for its MALT1 program, and CDC7 and Wee1 continue to advance toward IND-enabling studies. Subject to completion of the preclinical data packages, the company expects to submit up to three IND applications in 2022, with the first submission to the FDA expected in the first half of next year. Schrödinger expects to present preclinical data from at least one of its internal programs in the second half of 2021.
The company continued to advance discovery efforts to allow the addition of new programs to the company’s internal pipeline in 2021.
Collaborations highlight continued strategic execution

In August, Schrödinger and Zai Lab Limited announced a global discovery, development and commercialization collaboration focused on a novel DNA damage response program in oncology. The research program will be conducted jointly by the Schrödinger and Zai Lab scientific teams. Following the selection of a development candidate, Zai Lab will assume primary responsibility for global development, manufacturing and commercialization. Schrödinger has the option to equally fund clinical development in the U.S. with Zai Lab, as well as the option to co-commercialize in the U.S. The companies will share research expenses for the program, and Zai Lab will make an upfront payment to Schrödinger to help fund Schrödinger’s share of research costs. If Schrödinger elects to co-fund clinical development of a product candidate under the collaboration, it will be entitled to 50 percent of any profits from the commercialization of such product candidate in the U.S. Schrödinger will also be eligible to receive up to approximately $338 million in preclinical, development, regulatory and sales-based milestone payments. Additionally, Schrödinger is entitled to receive royalties on net sales outside the U.S.
In June, Schrödinger’s partner, Ajax Therapeutics, completed a $40 million financing to support the advancement of Ajax’s lead drug development programs targeting hematologic malignancies. Through the companies’ collaboration, Schrödinger and Ajax scientists are working together to design and optimize molecules targeting cytokine signaling pathways.
Continued commitment to education and publication

In August, Schrödinger hosted its first annual Educator’s Day, which brought together K-12 and university educators from across the globe to discuss the growing role of computational tools in the classroom. The company also announced "Teaching with Schrödinger," a new initiative to develop curricula for academic institutions to teach students about chemical interactions, drug design and materials research using Schrödinger software.
During the second quarter, Schrödinger scientists authored multiple publications in peer-reviewed journals, independently and with customers, supporting application of the company’s platform to advance both drug discovery and materials science. Materials science advancements included research with the Edwards Air Force Base to develop molecular dynamics simulations to aid in the development of next-generation aerospace materials, as well as research with Panasonic Corp. to identify new molecules that can improve the efficiency of printed electronics.
Second Quarter 2021 Financial Results

Revenue was $29.8 million for the second quarter of 2021, a 29 percent increase compared to the second quarter of 2020.
Software revenue was $24.1 million for the second quarter of 2021, a 15 percent increase compared to the second quarter of 2020.
Drug discovery revenue was $5.7 million for the second quarter of 2021, compared to $2.2 million in the second quarter of 2020. Discovery revenue in the second quarter of 2021 included $3.3 million in revenue from our collaboration with Bristol Myers Squibb. Discovery revenue in the second quarter of 2021 also included a payment from a collaborator for the acquisition of intellectual property from Schrödinger related to a drug discovery program following the achievement of a lead optimization milestone.
Gross profit was $12.0 million in the second quarter of 2021, compared to $13.6 million in the second quarter in 2020. Software gross margin was 77 percent in the second quarter of 2021, compared to 82 percent for the same period in the prior year, reflecting planned investment to drive and support large-scale adoption of Schrödinger’s platform.
Operating expenses for the second quarter of 2021 were $42.3 million, compared to $30.7 million in the second quarter of 2020, driven by expenses required to scale the company’s business and advance its internal drug discovery programs.
Other expense, which included gains and losses on equity investments, changes in fair value of equity investments and interest income, was $4.6 million in the second quarter of 2021 compared to income of $13.1 million for the second quarter of 2020 due to adjustments to the fair value of the company’s equity investments.
Net loss, after adjusting for non-controlling interest, was $34.6 million for the second quarter of 2021, compared to a net loss of $3.4 million in the second quarter of 2020, driven by adjustments to the fair value of the company’s equity investments as well as planned investments to advance the company’s growth strategy.
Cash, cash equivalents, restricted cash and marketable securities as of June 30, 2021 were $616.6 million, compared to $649.0 million as of March 31, 2021.
Full-Year 2021 Financial Outlook

As of August 12, 2021, Schrödinger continues to expect total revenue to range from $124 million to $142 million, with software revenue expected to range from $102 million to $110 million and drug discovery revenue expected to range from $22 million to $32 million for the fiscal year ending December 31, 2021. Additional details are as follows:

Schrödinger expects the majority of anticipated second half software revenue growth to occur in the fourth quarter of 2021.
Drug discovery revenue can be highly variable quarter to quarter based on the timing of potential milestones related to collaborative agreements.
Schrödinger continues to aggressively fund R&D to advance its technology and drug discovery pipeline. The company continues to expect operating expense growth to be higher than the 42 percent annual growth rate reported in 2020 and expects software gross margin to be lower than the 81 percent reported in 2020.
Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its second quarter financial results on Thursday, August 12, 2021, at 8:30 a.m. ET. The conference call can be accessed live by dialing (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and referring to conference ID 5365647 The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.

On August 12, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the closing of its previously announced underwritten public offering of approximately $15 million (Press release, PharmaCyte Biotech, AUG 12, 2021, View Source [SID1234586474]).

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The public offering includes 3,529,412 shares of the Company’s common stock (or pre-funded warrants to purchase common stock in lieu of common stock) and warrants to purchase up to an aggregate of 3,529,412 shares of common stock. In addition, PharmaCyte granted the underwriter a 30-day option to purchase up to an additional 529,411 shares of its common stock and/or accompanying warrants to purchase an aggregate of up to 529,411 shares of its common stock, which the underwriter has partially exercised for warrants to purchase an aggregate of up to 499,116 shares of common stock. At closing, PharmaCyte received net proceeds from the offering of approximately $13.6 million, after deducting underwriting discounts and commissions and estimated offering expenses. All of the securities in the offering were sold by PharmaCyte.

H.C. Wainwright acted as sole book-running manager for the offering.

The offering was made only by means of a written prospectus and related prospectus supplement forming part of PharmaCyte’s shelf registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the U.S. Securities and Exchange Commission (SEC) on April 14, 2021. The final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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.

On August 12, 2021 Aptevo Therapeutics Inc. ("Aptevo" or "the Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported its financial results and business highlights for the quarter ended June 30, 2021 (Press release, Aptevo Therapeutics, AUG 12, 2021, View Source [SID1234586473]).

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Business Highlights

Announced results from the Company’s Phase 1 dose escalation trial evaluating lead ADAPTIR candidate, APVO436, for the treatment of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS). Results showed that APVO436 was generally well tolerated and demonstrated a manageable side effect profile. Further, APVO436 showed preliminary single agent activity and an acceptable benefit to risk profile in patients with relapsed, advanced stage AML.
Activation of the Company’s Phase 1 dose expansion trial to evaluate APVO436 in adult patients with acute myeloid leukemia (AML) in a multi-center, multi-arm trial using the active recommended Phase 2 dose of 18mcg identified in the dose escalation part of the study. The expansion trial will include five discreet cohorts of 18 patients each (N=90) who will receive APVO436 in combination and monotherapy.
Announced inclusion in the Russell Microcap Index at the conclusion of the 2021 annual reconstitution. Aptevo’s inclusion in the index became effective after US market close on Friday, June 25, 2021.
"The second quarter was an exciting time for Aptevo as we announced results from our APVO436 Phase 1 dose escalation trial in AML/MDS patients, with both encouraging safety results and observed signs of clinical activity. These results drove the design and activation of the dose expansion part of the trial. This trial is currently recruiting and we anticipate dosing the first patient soon," said Marvin White, President and CEO of Aptevo. He added, "We were also very pleased to be added to the Russell Microcap, as this is a tangible indicator of our growth in the last year, achieved by a team of professionals who are singularly focused on bringing new therapeutic solutions to patients in need."

Second Quarter 2021 Financial Results Summary

Cash Position: Aptevo had cash and cash equivalents as of June 30, 2021 totaling $61.7 million, including restricted cash of $1.3 million. The restricted cash is expected to be released over the next twelve months. Aptevo’s current cash runway is extended through Q3 2022.

Royalty Revenue: Royalty revenue was $3.1 million for the three months ended June 30, 2021, related to the royalty from Pfizer on global net sales of RUXIENCE (rituximab-pvvr).On March 30, 2021, the Company entered into and closed a royalty purchase agreement (the Royalty Purchase Agreement) with an entity managed by HealthCare Royalty Management, LLC (HCR) pursuant to which the Company sold to HCR the right to receive royalty payments made by Pfizer Inc. (Pfizer) in respect of net sales of RUXIENCE. Due to our continuing involvement under our collaboration and license Agreement with Pfizer we continue to recognize royalty revenue on net sales of RUXIENCE and record the royalty payments to HCR as a reduction of the liability related to the sale of future royalties when paid. As such payments are made to HCR, the balance of the liability related to the sale of future royalties will be effectively repaid over the life of the Royalty Purchase Agreement. RUXIENCE is a registered trademark of Pfizer.

Research and Development Expenses: Research and development expenses increased by $0.3 million for the three months ended June 30, 2021, compared to the three months ended June 30, 2020. Research and development expenses increased as we continue to invest in the APVO436 clinical trial and our preclinical candidates, including ALG.APV-527, APVO603 and APVO442.

General and Administrative Expenses: General and administrative expenses increased by $1.3 million for the three months ended June 30, 2021, compared to the three months ended June 30, 2020. This increase was primarily due to higher costs for professional services.

Other Expense, Net: Other expense, net consists primarily of costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other expense, net was $2.3 million for the three months ended June 30, 2021 compared to approximately zero for the three months ended June 30, 2020. The increase in other expense, net is primarily related to interest expense and accrued exit fees for the MidCap Credit Agreement, as well as non-cash interest expense for the HCR Royalty Purchase Agreement.

Discontinued Operations: Income from discontinued operations was $0.1 million for the three months ended June 30, 2021 and there was no income for the three months ended June 30, 2020. For the three months ended June, 2021, we collected a deferred payment of $0.1 million from Medexus related to first quarter 2021 IXINITY sales.

Net Income (Loss): Aptevo’s net loss for the three-month period ended June 30, 2021 was $7.9 million or $1.75 per share, as compared to a net loss of $6.8 million or $2.10 per share for the corresponding period in 2020.

Liability Related to Sale of Future Royalties: We treat the HCR Royalty Purchase Agreement as a debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liabilities related to sale of future royalties and the debt amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. To the extent our estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. We are not obligated to repay the proceeds received under the Royalty Purchase Agreement with HCR.