On May 27, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that members of the management team will present during a fireside chat at the 2021 Jefferies Virtual Healthcare Conference, being held June 1 – 4, 2021 (Press release, Altimmune, MAY 27, 2021, View Source [SID1234580705]).

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Details on the Jefferies fireside chat presentation are as follows:

Title : 2021 Jefferies Virtual Healthcare Conference

Presenters: Vipin Garg, Ph.D., Chief Executive Officer
Scot Roberts, Ph.D., Chief Scientific Officer
Scott Harris, M.D., Chief Medical Officer

Date/Time: Wednesday, June 2, 2021 at 11:30 am ET
A webcast link to the fireside chat presentation will be accessible on the Events section of the Altimmune website.

On May 27, 2021 Centessa Pharmaceuticals plc ("Centessa"), a clinical-stage company employing its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, reported the pricing of its initial public offering of 16,500,000 American Depositary Shares ("ADSs"), each representing one ordinary share at a public offering price of $20.00 per ADS (Press release, Centessa Pharmaceuticals, MAY 27, 2021, View Source [SID1234583241]). All of the ADSs are being offered by Centessa. The gross proceeds to Centessa from the offering, before deducting underwriting discounts, commissions and other estimated offering expenses, are expected to be approximately $330.0 million. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 2,475,000 ADSs at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market under the ticker symbol "CNTA" on May 28, 2021. The offering is expected to close on June 2, 2021, subject to the satisfaction of customary closing conditions.

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Morgan Stanley, Goldman Sachs & Co. LLC, Jefferies, and Evercore ISI are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on May 27, 2021. The offering is being made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10012, by telephone at 877-821-7388 or by email at [email protected]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474 0200, or by email at [email protected].

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

On May 27, 2021 Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIRTM and ADAPTIR-FLEXTM platform technologies reported that the company has initiated the expansion phase of lead anti-leukemia drug candidate, APVO436, in adult patients with acute myeloid leukemia (AML) with a multi-center, multi-arm trial using the active recommended dose identified in the dose escalation phase (Part 1) of the study (Press release, Aptevo Therapeutics, MAY 27, 2021, View Source [SID1234583271]). During Part 1, APVO436 exhibited a manageable side effect profile, encouraging single agent activity and a promising benefit to risk profile in relapsed AML patients. The Company has plans to submit data from the dose escalation phase for publication later this year.

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The dose expansion phase (Part 2), has been rationally designed to further evaluate the tolerability and clinical impact potential of APVO436 for indications of unmet and urgent medical need. During Part 2, the dose expansion phase of the study, a total of 90 AML patients will be enrolled into 5 cohorts of 18 patients each, as explained in the detailed and publicly available study information provided at CinicalTrials.gov (NCT03647800) The study will be conducted under an FDA-approved IND and has been Central IRB-approved. Patient enrollment is anticipated to commence in June. The goal of the expansion phase is to evaluate the safety and tolerability of APVO436 at the recommended Phase 2 dose level, when it is used as an adjunct to the standard of care and to obtain a preliminary assessment of the anti-leukemia activity of APVO436 containing experimental monotherapy and combination therapy modalities.

Protocol-specific training has started for the participating academic cancer centers in the US. Aptevo is planning to conduct Part 2 of the study at up to 20 clinical trial sites.

"The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen" explained Dr. Fatih Uckun, leukemia expert and Chief Clinical Advisor. "By combining APVO436 with the standard of care, Aptevo hopes to develop an innovative approach that improves outcomes for patients with relapsed AML, who generally have a dismal prognosis," he stated.

Dr. Uckun explained further: "In addition, newly diagnosed AML patients with inherent drug resistance who have documented residual leukemia after standard frontline chemotherapy regimens, have a very poor prognosis and are in urgent need of therapeutic innovations. Part 2 of the Aptevo study will therefore seek proof of concept in the use of APVO436 as part of frontline multimodality regimens would enable the eradication of residual leukemia cells that have escaped standard chemotherapy. To this end we will carefully study the tolerability and clinical activity of APVO436 when used as rationally designed in each of the 5 cohorts of Part 2 of our Phase 1B study."

Overview of Cohorts

In Cohort 1, AML patients in relapse will be treated with the standard chemotherapy drug cytarabine or the standard chemotherapy triple drug combination MEC (mitoxantrone, etoposide, cytarabine) plus APVO436. Also treated in this cohort will be patients with primary refractory AML whose leukemia failed to respond to frontline standard induction chemotherapy.

In Cohort 2, AML patients in first relapse will receive a combination of APVO436 + venetoclax + azacitidine. Also included in this cohort will be newly diagnosed AML patients with a poor prognosis who will receive this novel combination as their frontline induction regimen.

In Cohort 3, AML patients with poor prognosis who are newly diagnosed will receive their frontline chemotherapy to induce a remission and APVO436 will be added if there is evidence of residual leukemia remaining. Also included in this cohort will be AML patients who experienced an early first relapse within 1 year of receiving their frontline chemotherapy. Such patients are generally known to have a dismal outcome.

In Cohort 4, AML patients in 1st remission who have evidence of residual leukemia, also known as minimal residual disease (MRD), will receive the standard drug oral azacytidine in combination with APVO436.

In Cohort 5, AML patients in 2nd remission who are MRD+ will be treated with APVO436 monotherapy.

"New treatments are urgently needed for frontline adverse risk and relapsed AML populations and I look forward to working with Dr. Uckun and other investigators for a step-wise evaluation of the clinical potential of APVO436", says Dr. Justin Watts, Associate Professor of Medicine at the University of Miami Sylvester Comprehensive Cancer Center.

"This week has been exciting for Aptevo, as we announced both positive results from the dose escalation part of our Phase 1 trial and the initiation of the expansion phase. We are particularly excited about the fact that APVO436 did not cause severe neutropenia in any of the AML patients treated so far. This is a potentially paradigm-shifting discovery as it provides the unique opportunity to integrate APVO436 into standard treatment regimens that inherently cause severe neutropenia," said Mr. Marvin White, President and CEO of Aptevo. "The initiation of Part 2 in our APVO436 study emphasizes our commitment to advance our ADAPTIR and ADAPTIR-FLEX platforms as integral parts of a novel standard of care for the most difficult-to-treat forms of cancer. We look forward to sharing interim data from Part 2 of the trial, later this year."

On May 27, 2021 Oasmia reported that Interim report for the period January 1, 2021 – March 31, 2021 (Press release, Oasmia, MAY 27, 2021, View Source [SID1234580672])

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SIGNIFICANT EVENTS DURING THE FIRST QUARTER
In January, Oasmia appointed Dr. Heidi B. Ramstad as Chief Medical Officer.
In March Fredrik Järrsten took up the position as Chief Financial Officer. Robert Maiorana, who has been acting CFO since December 2020, will continue as Head of Accounting for the company.
In March, Oasmia signed an agreement with Kazia Therapeutics, an Australian oncology-focused biotechnology company, to acquire exclusive global development and commercialization rights for Cantrixil, a product candidate in development intended for the treatment of ovarian cancer.
In March Oasmia entered into a collaboration agreement with Karolinska Institutet in Stockholm. The collaboration will generate new information for the potential development of new therapeutic APIs in various cancer indications.
In March, an arbitral tribunal in Stockholm upheld Oasmia’s right to record assignment of its patents and patent applications in its own name, which enables a faster re-registration process.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In April, Oasmia appointed Dr Reinhard Koenig as Chief Scientific Officer.
In April, Oasmia presented Cantrixil final Phase I data at the 2021 AACR (Free AACR Whitepaper) Annual Meeting.
In April, a Phase 1b trial of Oasmia’s Docetaxel Micellar in advanced prostate cancer was granted ethical committee approval by Swissmedic.
In April, Andrea Buscaglia was proposed as a new Board member by the Nomination Committee.
FIRST QUARTER: JANUARY 1, 2021 – MARCH 31, 2020
Consolidated net sales amounted to TSEK 37 (201,220)
Operating profit/loss was TSEK –40,843 (128,607)
Net profit/loss after tax amounted to TSEK –41,209 (124,706)
Earnings per share was SEK –0.09 (0.36)
CEO REVIEW – WELL POSITIONED FOR FUTURE GROWTH
Oasmia achieved several key goals in the first quarter, making further important progress in implementing the strategic transformation initiated when I joined last year.

A critical goal for Oasmia is to significantly expand our pipeline of development-stage oncology assets through M&A and in-licensing opportunities that we believe will fit with our strategic goals. This ambitious ’string of pearls strategy’ will capitalize on our proven oncology development and regulatory skills and expertise. We have a solid cash position to execute on the current strategy as laid out, with the possibility to reevaluate the financing need when these opportunities occur and with the progress of our development projects.

The acquisition of global development and commercialization rights for Cantrixil from Kazia Therapeutics in March was an exciting development for Oasmia and represented the first stage in this pipeline expansion – the first "pearl" added to our portfolio. The acquisition brings to us a promising clinical program in late-stage ovarian cancer, an area we know exceedingly well. In April, we presented final Phase I results for Cantrixil at the prestigious American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting. These highly promising results underscore our optimism about this program. Cantrixil is believed to target a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse. In addition to its promise as stand-alone therapy, Cantrixil has the potential to complement Oasmia’s lead product for ovarian cancer, Apealea, through treatment protocols to be developed.

Since acquiring the rights to Cantrixil, we have been working to establish an advisory board of experts to provide input on the clinical development plan and have initiated discussions with regulators at the EMA and FDA. We have also made progress towards securing drug supply for forthcoming clinical trials.

Apealea (paclitaxel micellar), a non-Cremophor based formulation of paclitaxel, is Oasmia’s most advanced development program, approved in Europe and in development elsewhere for advanced ovarian cancer. Since it was out licensed to Elevar Therapeutics last year, we’ve been working closely with Elevar and its partners to support development and commercialization activities. Post period , in April, Elevar received notification from the FDA authorizing a pharmaco-kinetic study in the US. In parallel, preparations are being made for an additional clinical study. Both studies are intended to support an NDA application in the US.

We’re also pleased to report that Docetaxel micellar, a solvent-free formulation of docetaxel to avoid the need for solubility enhancers and mandatory high-dose steroid premedication, has been granted ethical committee approval in Switzerland, paving the way for the Swiss Group for Clinical Cancer Research (SAKK) to initiate a Phase Ib trial in advanced prostate cancer.

Our technology platforms remain an important part of our business and complement our development and regulatory expertise. During the period we signed a collaboration agreement with the world renowned Karolinska Institutet here in Stockholm. The goal is to generate additional data to help us gain a deeper understanding of the potential of our proprietary XR-17 platform technology, with a focus on niche cancer indications. Over the longer term this will help us generate new pipeline candidates.

A vital part of our transformation is building a leadership team with the experience to drive our future growth. I’m pleased to say that with Fredrik Järrsten joining as CFO, and Heidi B. Ramstad and Reinhard Koenig’s appointments as CMO and CSO, we have completed our leadership team. This greatly strengthens our ability to execute our strategy and thrive as a business in the future.

Business transformations take time to achieve, but in 12 months we have put in place the right leadership team supported by a stronger Board with new expertise to take us to the next level of success. We have clearly defined and started executing on our strategy to become a leading cancer biopharma company with an emerging oncology pipeline. Thank you for your continued support during this period as we transition to an exciting future

On May 27, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that Susan Molineaux, Ph.D., the company’s founder, president and chief executive officer, will present at the Jefferies 2021 Virtual Healthcare Conference on Friday, June 4, 2021 at 9:00 am ET (Press release, Calithera Biosciences, MAY 27, 2021, View Source [SID1234580690]).

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A live audio webcast of the presentation can be accessed through the Investors section of the Company’s website at www.calithera.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.